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As we step into the crisp corridors of 2024, the healthcare landscape unfolds a compelling saga of mergers, strategic funding, and transformative acquisitions. In this month-by-month analysis, we delve into the intricate tapestry of industry dynamics, exploring the impactful maneuvers that are shaping the healthcare narrative.

Major Collaboration, Funding, and Merger & Acquisitions From March 2024

Pi Health, a BeiGene Spin-Off, Secures $30 Million to Boost Cancer Trial Participation

Pi Health has entered the clinical trial software-as-a-service (SaaS) sector following the successful $30 million Series A funding round. This US-based company, established as a subsidiary of BeiGene three years back, has engineered a platform aimed at boosting patient participation in cancer trials. With leadership from American venture capital entities AlleyCorp and Obvious Venture, this funding empowers Pi Health to now function autonomously as a standalone enterprise.

Pi Health highlights the limited involvement of cancer patients in clinical trials and the ineffective structures of such trials. Pi Health introduces its Front-End Interoperable Capture Software (FOCS), which aims to link sponsors with trial locations. This software automates manual tasks, facilitating faster data gathering and less administrative workload. According to the company, this technology accelerates and streamlines drug development processes, making them more cost-effective.

Apogee Therapeutics, Inc. Reveals Pricing for Increased $420 Million Underwritten Public Offering

Apogee Therapeutics, Inc. revealed on March 07, 2024, that it has set the price for its expanded previously declared underwritten public offering of 6,774,193 shares of common stock at a per-share price of $62.00. Apogee anticipates receiving approximately $420.0 million in total gross proceeds from the offering, before subtracting underwriting discounts, commissions, and other associated offering expenses. This amount excludes any potential exercise of the underwriters’ option to purchase additional shares. The closing of the offering is scheduled for March 12, 2024, pending the fulfillment of standard closing conditions. Furthermore, Apogee has provided the underwriters with a 30-day option to buy up to 1,016,128 more shares of common stock at the public offering price, with deductions for underwriting discounts and commissions. All shares in this offering are being put forth by Apogee.

Gilead Receives $210M Investment for Trodelvy’s NSCLC Clinical Progress

Gilead Sciences has secured up to $210 million in funding from the life sciences investment firm Abingworth to aid the advancement of its antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) for non-small cell lung cancer. ADC is a recent revolutionary class of antitumor drugs showing promising results with more than 35+ ADCs making their way into the oncology pipeline. Clinical trial analysis of oncology shows more than 30 companies are developing ADC in which many companies are working in the NSCLC domain. In January 2024, Trodelvy failed to meet expectations in the Phase III Evoke-01 trial, showing no significant enhancement in overall survival (OS) among patients previously treated for metastatic NSCLC. When compared to the chemotherapy docetaxel, Trodelvy only demonstrated a slight enhancement in OS, described as a ‘numerical improvement.’

This funding will not only boost the ADC therapeutic segment but also the NSCLC market too. As per DelveInsight, the metastatic non-small cell lung cancer market is anticipated to grow at a significant CAGR of 9.4% by 2032 and aggressive commercial and clinical developments are paving the way for tremendous market growth. This financial support will facilitate Gilead in conducting specific clinical trials for Trodelvy, as stated in the announcement. Alongside this financing arrangement, Gilead has also initiated a clinical collaboration with Launch Therapeutics, a biotech company backed by Abingworth and its parent firm Carlyle. A joint steering committee will be responsible for overseeing the development of Trodelvy under this funding agreement.

Abingworth will get a set payment from Gilead, amounting to $210 million if the antibody-drug conjugate makes a successful entry into non-small cell lung cancer and obtains regulatory approval for expanded labeling. Additionally, Abingworth will receive royalties from the sales of Trodelvy within NSCLC. Nevertheless, Gilead will maintain complete ownership rights over Trodelvy.

Trodelvy, designed for intravenous infusion, is aimed at the Trop2 transmembrane glycoprotein, found in high levels across various cancer types. Initially developed by Immunomedics in New Jersey, Trodelvy gained FDA approval in April 2020 for metastatic triple-negative breast cancer that had been previously treated and its launch has boosted the mTNBC market. According to DelveInsight’s analysis, the market size for TNBC reached USD 1.3 billion in 2022 across the 7MM and is expected to grow with a significant CAGR by 2032. Subsequently, this ADC has expanded its approved uses to include locally advanced or metastatic urothelial cancer, as well as HR-positive, HER2-negative breast cancer.

Artiria Secures Investment for Advancing Stroke Research in Europe and USA

Artiria Medical has reported the completion of a prosperous Series A2 funding round amounting to $6 million, alongside acquiring a $600,000 Fit Tech Growth loan. Spearheaded by 4FOX Ventures, the Series A2 funding saw participation from the Wyss Center for Bio and Neuroengineering in Geneva, Switzerland, as well as previous investors such as Verve Ventures, Zürcher Kantonalbank, NEST pension fund, and business angels.

Artiria manufactures advanced neuro-interventional technologies aimed at treating strokes and brain aneurysms. Its primary innovation is a cutting-edge deflectable guidewire, uniquely crafted to help surgeons reach affected neurovascular areas swiftly. This groundbreaking product has already undergone human trials, with initial patients receiving treatment in the third quarter of 2023.

Innovative Shape Memory Medical Secures $38 Million to Advance Endovascular Embolization

Shape Memory Medical has recently concluded a Series C financing round totaling $38 million, led by Earlybird Venture Capital, with contributions from both existing and new investors. Shape Memory Medical develops an exclusive shape memory polymer, designed as a porous embolic material with low density, crimped for catheter delivery. As per the release, upon blood contact, this polymer self-expands swiftly into an organized thrombus. The company aims for this innovative technology to present distinctive qualities such as vascular space-filling, radiolucency, minimal radial force, and the activation of the immune response and healing mechanisms.

Shape Memory also recently reported that it has received approval from the FDA for an investigational device exemption (IDE). This approval enables the company to commence a forward-looking, multi-center, randomized, open-label study to assess the safety and efficacy of the Impede-FX RapidFill device in enhancing the behavior of abdominal aortic aneurysm (AAA) sacs during elective endovascular aneurysm repair (EVAR).

With this increased funding, the abdominal aortic aneurysm is likely to be propelled in the coming years. In 2021, the abdominal aortic aneurysm market size in the 7MM was reported to be USD 1.5 billion, which is further expected to increase by 2032, as per DelveInsight.

Pyxis Oncology Secures $50 Million in Private Investment

Pyxis Oncology, Inc. has announced an agreement to sell 8,849,371 shares of its common stock at $4.78 per share, along with pre-funded warrants for the purchase of 1,611,215 shares of its common stock at $4.779 per pre-funded warrant. This sale is to a specific group of institutional and accredited healthcare specialist investors in a private offering. The exercise price for the pre-funded warrants is set at $0.001 per share. The closing of this private placement is expected to occur around February 29, 2024, pending standard closing conditions. Pyxis Oncology estimates the total gross proceeds from this private placement to be approximately $50 million, before accounting for estimated fees and expenses.

Pyxis Oncology plans to utilize the funds raised from this proposed financing to support the ongoing advancement of PYX-201, the company’s primary antibody-drug conjugate therapy under evaluation in a phase I study for solid tumors. Additionally, the funds will also be allocated for general corporate purposes and working capital needs. As a result of this funding, the antibody-drug conjugate market will witness an upsurge in growth in the coming years, as per DelveInsight.

NINDS Awards $4.1 Million Grant to Fortress Biotech and Cyprium Therapeutics for Advancing AAV-ATP7A Gene Therapy in Menkes Disease

Cyprium Therapeutics, Inc. reported that the National Institute of Neurological Disorders and Stroke of the National Institutes of Health has granted approximately $4.1 million over three years to the Research Institute at Nationwide Children’s Hospital. This funding will support the finalization of preclinical research, manufacturing, and preparation of an Investigational New Drug Application. The aim is to progress adeno-associated virus-ATP7A gene therapy, referred to as AAV-ATP7A, for the treatment of Menkes disease into its first human clinical trial. Menkes disease, a rare genetic disorder, faces significant challenges with unmet needs and treatment gaps. Due to its low prevalence and complex diagnostic criteria, early detection remains a hurdle, delaying crucial interventions like copper-histidine therapy. This underscores the urgent necessity for improved awareness, diagnostic tools, and accessible treatments to enhance the prognosis and quality of life for affected individuals.

Preclinical research has shown a collaborative impact between AAV-ATP7A and CUTX-101 in a dependable mouse model of Menkes disease. Initial investigations revealed that AAV gene therapy targeted at the cerebrospinal fluid saved 22-53% of mice with a mutation in the equivalent of the human Menkes disease gene (known as mottled-brindled), especially when used with CSF or subcutaneous copper. Furthermore, mice with mutations treated with CSF-directed AAV9 carrying a smaller version of ATP7A, along with CUTX-101, exhibited elevated levels of copper in the brain, normalized neurochemical levels in the brain, improvements in brain mitochondrial irregularities, and outcomes in growth and neurobehavior that were nearly normal.

Becton, Dickinson, and Company Partners with Camtech Health to Advance Cervical Cancer Screening Efforts

Becton, Dickinson, and Company, along with Camtech Health, have just revealed their new strategic alliance aimed at improving cervical cancer screening for women in Singapore. They are introducing a groundbreaking option for women to self-collect samples in the comfort and privacy of their homes. This collaboration seeks to increase the rate of cervical cancer screening in Singapore, which currently stands at less than half of eligible women.

Cervical cancer ranks as the 10th most prevalent cancer in Singapore, while among women aged 30 to 39, it stands as the fourth most common form of cancer. The total incident cases of cervical cancer in the 7MM comprised 40K in 2023, with the US accounting for nearly 34% of the total cases. The primary challenges to screening among Singaporean women include limited time, feelings of embarrassment and anxiety, as well as inconvenience. Until recently, the nation exclusively offered HPV testing within hospital or clinic environments, necessitating a speculum examination and collection by a physician.

AstraZeneca Finalizes Purchase of Gracell Biotechnologies in $1.2bn Deal

AstraZeneca has finalized its purchase of Gracell Biotechnologies, a clinical-stage biopharmaceutical firm based in China, for $1.2 billion. The acquisition, originally outlined in December 2023, establishes Gracell as a fully-owned subsidiary of AstraZeneca, with its activities ongoing in the United States and China. Through a merger at a rate of $2 per ordinary share in cash, AstraZeneca will take possession of all of Gracell’s fully diluted share capital, including those represented by American depositary shares.

This is alongside an additional non-tradable contingent value right of $0.3 for each ordinary share, which will be paid upon reaching a specific regulatory milestone. The initial cash component of the deal amounts to a transaction value of $1.0 billion. AstraZeneca’s integration of Gracell into its operations is a strategic maneuver aimed at enhancing its pipeline with cell therapies targeting cancer and autoimmune diseases. Through this acquisition, AstraZeneca will obtain access to GC012F, a pivotal asset from Gracell. GC012F is currently in the clinical development phase and is a FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy.

Major Collaboration, Funding, and Merger & Acquisitions From February 2024

Freenome Secures $254 Million in Latest Funding Round to Advance Early Cancer Detection Platform

Freenome, a biotechnology firm specializing in developing blood tests for early cancer detection, has revealed an injection of $254 million in funding from new and existing investors. This financial boost empowers Freenome to progress its pipeline of early detection tests for single cancers and customized multi-cancer approaches, all based on its comprehensive multiomics platform. Roche led the investment round, with participation from a16z Life Sciences Growth Fund, BrightEdge Ventures of the American Cancer Society, ARK Investments, ArrowMark Partners, Artis Ventures, Bain Capital Life Sciences, Cormorant Capital, DCVC, Eventide Asset Management LLC, Intermountain Ventures, Perceptive Advisors, Polaris Partners, Pura Vida Investments, Quest Diagnostics, RA Capital Management, Sands Capital, Section 32, Squarepoint Capital, along with funds and accounts managed by T. Rowe Price Associates, Inc., among others.

Numerous individuals succumb to cancer due to its frequent late detection. Freenome is employing its multiomics platform, utilizing computational biology, machine learning, and related technologies, to create screening instruments for identifying cancer during its initial and most manageable phases. Furthermore, the platform is under assessment in collaboration with Freenome’s biopharma and diagnostic partners to detect minimal residual disease (MRD) non-invasively, enriched with biological understandings from the multiomics platform.

COUR Pharmaceuticals Raises $105 Million in Series A Funding with Lumira Ventures and Alpha Wave Ventures as Key Investors

On January 30, 2024, COUR Pharmaceuticals disclosed the completion of its Series A funding round. This round secured around $105 million in financial backing. Lumira Ventures and Alpha Wave Ventures jointly led the investment, joined by contributors such as Roche Venture Fund, Pfizer, Bristol Myers Squibb, Angelini Ventures, and the JDRF T1D Fund. As part of this funding initiative, Dr. Benjamin Rovinski, Managing Director of Lumira Ventures, and Simon Greenwood, Senior Investment Director of Roche Venture Fund, will be appointed to the COUR Board of Directors.

The funds raised will allow COUR to progress various proprietary product candidates utilizing its immune tolerance platform, including Phase IIa proof-of-concept clinical trials in Myasthenia Gravis and Type 1 Diabetes, along with other prospects in its pipeline. With increased funding, the Myasthenia Gravis and Type 1 Diabetes market is on track for substantial expansion in the forthcoming years, as per DelveInsight analysis. 

ProfoundBio Raises $112 Million to Propel Cancer-Fighting ADC Portfolio

ProfundBio has raised $112 million in a Series B funding round. This capital will drive the development of its clinical-stage antibody-drug conjugate (ADC) lineup aimed at treating cancer. Ally Bridge Group spearheaded the funding, with participation from healthcare-focused and mutual fund institutional backers. Among the new investors are Nextech Invest, funds and accounts managed by T. Rowe Price Associates, Janus Henderson Investors, RA Capital Management, and Medicxi, among others. Existing investors like Lilly Asia Ventures and LYFE Capital also contributed to this round.

The recent funding will enhance ProfoundBio’s clinical and preclinical ADC initiatives, focused mainly on addressing solid tumor cancers. This involves progressing a significant program, rinatabart sesutecan (Rina-S), an ADC designed for the folate receptor-alpha (FRα). Rina-S is currently undergoing Phase II trials for ovarian and endometrial cancers, with crucial studies in ovarian cancer set to start later in the current year. In addition, according to DelveInsight’s analysis, the Antibody Drug Conjugates market is poised for significant growth in the coming years with the implementation of this funding. The FDA has already granted fast-track designation for FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. 

TILT Biotherapeutics Secures $2M Grant from US Department of Defense to Fuel Ovarian Cancer Immunotherapy Research

TILT Biotherapeutics (TILT), a biotechnology company in the clinical stage of developing cancer immunotherapies, announces its selection by the U.S. Department of Defense (DOD), the nation’s largest government agency, to receive a $2 million grant over three years. The project focuses on treating ovarian cancer using TILT-123, the company’s asset. The DOD-funded project aims to evaluate the safety and potential effectiveness of TILT-123 in conjunction with pembrolizumab for patients with platinum-resistant/refractory ovarian cancer. Additionally, the project will assess immune responses, virus persistence, and the biological impact on tumors. Ovarian cancer, a deadly disease, is in critical need of improved treatments, as there are currently no approved oncolytic viruses or checkpoint inhibitors for this condition. According to DelveInsight analysis, the ovarian cancer market is poised for significant growth in the coming years, thanks to the increased funding.

BioSenic Secures €500,000 Through Private Placement with Esteemed New Investors

On February 2, 2024, BioSenic announced that it successfully secured €500,000 in total funds through a private offering of 12,195,120 new shares at a price of €0.041 per share, aimed at institutional investors including Gestys Santé Biotech and Friedland Gestion. The company plans to utilize the proceeds from this placement, alongside other funding sources, to ready itself for an Investigational New Drug (IND) application submission to the FDA. This application is intended for the Phase III clinical investigation involving oral arsenic trioxide (OATO) as a primary treatment for chronic graft-versus-host disease (cGvHD). Additionally, these funds will be allocated toward general operational costs, particularly those associated with clinical regulatory obligations and overall corporate activities at BioSenic.

Anbogen, with Focus on Cancer Treatments, Raises $12.5M in Series A Funding

Anbogen Therapeutics has announced the successful conclusion of its Series A financing round. The primary investor in this round is China Development Industrial Bank (CDIB), joined by significant contributions from Taian Venture Capital, Maxpro, and the National Development Fund through its Business Angel Investment Program and Implementation Project for Strengthening Investment in SMEs, totaling approximately $12.5 million. This funding will be allocated towards the ongoing advancement of Anbogen’s key drug candidates, ABT-101 and ABT-301. Notably, both of these drug candidates received support from the National Research Program for Biopharmaceuticals (NRPB) before Anbogen’s involvement. Anbogen’s continued efforts are propelling these drug candidates through clinical trials, aiming to assess their effectiveness.

ABT-101, a tyrosine kinase inhibitor (TKI) that targets HER2, showed significant effectiveness and safety in both its pre-clinical testing and phase 1b clinical trial. In pre-clinical research, ABT-101 displayed exceptional specificity in inhibiting the HER2 exon20 insertion mutation.

RenovoRx Secures $6.1M for Phase III Cancer Trial Funding

RenovoRx Inc. (NASDAQ: RNXT) announced on January 29, 2024, a significant milestone in its journey towards advancing treatment options for locally advanced pancreatic cancer (LAPC). The company has successfully secured $6.1 million in private placement funding, a development poised to substantially bolster its financial capabilities and provide vital support for the ongoing Phase III TIGeR-PaC clinical trial. This pivotal trial holds immense promise in transforming the landscape of Locally Advanced Pancreatic Cancer treatment by evaluating innovative therapeutic approaches. With the infusion of funding, RenovoRx is strategically positioned to extend its financial runway, ensuring continued momentum in the progression of the trial. Anticipated to reach a second interim analysis by the end of 2024, the TIGeR-PaC trial represents a crucial endeavor in the quest to enhance outcomes and quality of life for LAPC patients. This collaboration between RenovoRx and its investors signifies a shared commitment to addressing unmet medical needs and advancing the frontier of cancer therapeutics.

RenovoRx’s TIGeR-PaC study represents a groundbreaking endeavor, structured as a randomized multi-center trial, aimed at assessing the efficacy of RenovoRx’s flagship product candidate, RenovoGem™. This innovative therapy harnesses the power of RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMP™) technology. RenovoGem™ stands out for its unique combination of TAMP with the FDA-approved cancer drug, gemcitabine. This novel approach holds immense potential, offering a promising alternative to the conventional standard of care represented by systemic intravenous chemotherapy. By leveraging the precision of TAMP technology alongside the therapeutic efficacy of gemcitabine, RenovoGem™ seeks to redefine treatment paradigms for locally advanced pancreatic cancer (LAPC) patients. 

Major Boost For Dementia Research: £49.9 Million Funding Injection Announced

The UK government has allocated a substantial funding boost of £49.9 million to advance dementia research, aiming to bolster efforts in accelerating the development of new treatments. This funding infusion is poised to establish a comprehensive network, overseen by University College London Hospitals (UCLH), with the objective of broadening access to dementia research opportunities across the country. By assembling partners from various regions, the network will focus on enhancing capacity and expertise in early-phase dementia trial sites. This strategic initiative aims to ensure that individuals with dementia, regardless of where they live and widen access, have equitable access to participate in early-phase clinical trials. Consequently, this will facilitate the inclusion of a larger and more diverse population in dementia research, thereby fostering a more comprehensive understanding of the condition and expediting the discovery of effective treatments.

As per the update from the University College London, the National Institute for Health Research (NIHR) will spearhead efforts to strengthen capacity and expertise in early-phase dementia trials throughout the UK. This will be accomplished through the expansion of the Dementia Translational Research Collaboration (D-TRC) and the establishment of the new Trials Network (D-TRC-TN). Once operational, the network will adopt an open and transparent approach in selecting sites, facilitated by the coordinating center. Invitations for membership to the D-TRC-TN will be extended, with a focus on building capacity and expertise at each member site to optimize functionality.

Alzheimer’s Disease Study Receives Additional $1.5M in Funding

The investigation into the progression of neuroinflammation and Tau aggregates in Alzheimer’s Disease (AD) undertaken by a McGill University team has received a significant boost of $1.5 million in Follow-on Funding (FOF) from the Weston Family Foundation. Spearheaded by two esteemed researchers at The Neuro (Montreal Neurological Institute-Hospital), Dr. Pedro Rosa Neto, a distinguished Professor of Neurology, Neurosurgery, and Psychiatry, and Yasser Iturria-Medina, Ph.D., an accomplished Assistant Professor of Neurology and Neurosurgery, the study aims to deepen the understanding of Alzheimer’s Disease pathology.

Building upon insights gleaned from a prior Weston Family Foundation grant, Dr. Rosa Neto and his team uncovered compelling evidence suggesting that inflammatory responses may exacerbate brain damage in Alzheimer’s Disease, thereby contributing significantly to the propagation of Tau pathology across various brain regions—a process intricately linked to cognitive decline in affected individuals.

Dr. Rosa Neto’s Follow-on Funding endeavor seeks to enhance the understanding of the natural progression of neuroinflammatory responses by embarking on a three-year follow-up study involving participants from his prior research grant. This comprehensive investigation will involve the collection and analysis of clinical, imaging, and fluid biomarker data, leveraging advanced artificial intelligence methodologies in collaboration with co-PI Iturria-Medina. The findings from this study are anticipated to yield crucial insights into the design of effective therapeutic interventions aimed at attenuating the advancement of Alzheimer’s Disease (AD).

This latest funding injection will enable the research team to delve further into elucidating the mechanisms underlying neuroinflammation and Tau aggregation in Alzheimer’s Disease. By unraveling these intricate pathways, the study seeks to identify novel therapeutic targets and intervention strategies aimed at halting or mitigating disease progression. Ultimately, this comprehensive investigation holds immense promise in not only advancing scientific knowledge but also in paving the way toward more effective treatments for Alzheimer’s Disease, thus alleviating the burden borne by individuals and families affected by this debilitating condition.

Vivet Therapeutics Secures €4.9M for Advancing Gene Therapy Development

On February 1, 2024, Vivet Therapeutics reported a significant milestone with the announcement of securing EUR 4.9 million in financing from the French government. This funding infusion is earmarked to propel the advancement of a gene therapy tailored for the treatment of Cerebrotendinous Xanthomatosis (CTX), a rare neurodegenerative disorder. The financial support stems from the “Innovations in biotherapies” framework under the France Health Innovation Plan 2030, particularly under the acceleration strategy known as Biotherapies – Bioproduction in innovative therapies. Coordinated by the French Health Innovation agency, this funding initiative will span a three-year period and will be administered by Bpifrance, a leading French investment bank.

Vivet intends to allocate the funds towards advancing the development of its gene therapy product, VTX-806, with the overarching goal of providing a viable treatment option capable of halting or even reversing disease progression, or potentially offering a cure for Cerebrotendinous Xanthomatosis (CTX) patients over the long term. By utilizing adeno-associated viruses (AAV) vectors to restore the activity of the impaired CYP27A1 gene—central to Cerebrotendinous Xanthomatosis pathology—Vivet aims to showcase a safe and feasible therapeutic approach for managing this debilitating condition.

Cerebrotendinous Xanthomatosis, an uncommon autosomal recessive genetic disorder, disrupts the body’s capacity to metabolize cholesterol fats. Currently, there exists no cure for Cerebrotendinous Xanthomatosis, with treatment options limited to slowing down disease advancement. However, the funding provided to Vivet will play a crucial role in easing the burden of Cerebrotendinous Xanthomatosis by accelerating the development of VTX-806. This innovative approach aims not only to potentially reverse or halt disease progression over the long term but also offers hope for ultimately curing Cerebrotendinous Xanthomatosis. Thus, the funding serves as a significant step toward alleviating the challenges faced by individuals affected by this debilitating condition.

Corbus Unveils Preliminary Clinical Data for Next-Generation Nectin-4 ADC Candidate

On January 26, 2024, Corbus Pharmaceuticals made a significant announcement regarding the progress of CRB-701 (SYS6002) through its collaboration with CSPC Pharmaceutical Group. Following the announcement, Corbus Pharmaceuticals experienced a significant surge in its stock value. The groundbreaking data from the initial human clinical study of CRB-701 is being showcased as a poster presentation at the prestigious American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) (2024). This Phase 1 study, conducted in China, focuses on enrolling patients diagnosed with metastatic urothelial cancer (mUC) and other solid tumors with confirmed nectin-4 positive status

Since its initiation in January 2023, the study has meticulously collected data up to December 2023, involving the participation of eighteen individuals across the initial six dose cohorts ranging from 0.2 to 3.6 mg/kg. The poster, titled “Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate,” authored by DingWei Ye et al., is being presented during the poster session on January 26. 

The study’s dose escalation and expansion phases are actively ongoing, indicating a commitment to furthering understanding and potentially expanding the therapeutic applications of CRB-701. Furthermore, stakeholders can anticipate additional data presentations later in the year, underlining the ongoing dedication to advancing the fight against genitourinary cancers and beyond.

Corbus Pharmaceuticals, along with several other key players, is actively engaged in the ADC market with the aim of solidifying their presence and potentially dominating this rapidly evolving landscape. The intensifying competition within this sector reflects a concerted effort among pharmaceutical companies to capitalize on the promising therapeutic potential of ADCs in oncology and beyond. As research and development efforts continue to expand and refine, Corbus Pharmaceuticals, among other key players in the segment, is set to advance innovative ADC therapies, positioning them strategically in the quest to address unmet medical needs and revolutionize cancer treatment paradigms.

CG Oncology Sets Record as First Biotech IPO of 2024, Raises $380M

On January 24, 2024, CG Oncology made public the pricing details of its expanded initial public offering, comprising 20,000,000 shares of its common stock, each priced at $19.00. All shares are offered by CG Oncology, with an anticipated gross proceeds of $380.0 million before accounting for underwriting discounts, commissions, and other associated expenses. Trading of CG Oncology’s common stock on the Nasdaq Global Select Market commenced on January 25, 2024, denoted by the ticker symbol “CGON.” The offering concludes on January 29, 2024. Furthermore, CG Oncology has afforded the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of common stock at the IPO price, reduced by underwriting discounts and commissions.

CG Oncology’s expanded IPO will provide crucial backing for the pivotal testing phase of cretostimogene, an oncolytic virus designed specifically for non-muscle invasive bladder cancer treatment. This robust clinical program encompasses trials evaluating the engineered virus both as a standalone therapy and in combination with other treatment modalities. Additionally, the company aims to explore the potential synergistic effects of cretostimogene in conjunction with existing therapies, underscoring its commitment to maximizing therapeutic efficacy and patient outcomes in the fight against bladder cancer.

Nanobiotix Achieves $20M Milestone in Global Phase 3 Head and Neck Cancer Study

On January 29, 2024, NANOBIOTIX made a significant announcement regarding the NANORAY-312 study, a pivotal Phase 3 trial investigating the potential of NBTXR3, a novel radioenhancer, as a first-in-class treatment for elderly patients with head and neck cancer. 

The achievement of operational requirements within this trial has triggered a $20 million milestone payment from NANOBIOTIX’s strategic partner, Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson. This milestone payment signifies the first development milestone reached under the comprehensive global licensing agreement between Nanobiotix and Janssen, as initially disclosed in a press release dated December 4, 2023. This achievement not only underscores the progress of NANOBIOTIX’s innovative therapeutic approach but also highlights the strength of its collaboration with a leading pharmaceutical entity like Janssen.

NBTXR3 is an innovative oncology product comprising functionalized hafnium oxide nanoparticles, administered via a single intratumoral injection and activated by radiotherapy. Originally proven effective in soft tissue sarcomas, it received European CE marking in 2019. The product’s unique mechanism of action induces significant tumor cell death upon radiotherapy activation, leading to an adaptive immune response and long-lasting anti-cancer memory. Due to this mechanism, Nanobiotix anticipates the scalability of NBTXR3 across various solid tumors treatable with radiotherapy, particularly in combination with immune checkpoint inhibitors.

Agilent and Incyte Join Forces for Cutting-Edge Companion Diagnostics in Hematology and Oncology

Agilent Technologies Inc. has entered into a partnership with Incyte Corporation, leveraging Agilent’s established expertise in creating companion diagnostics (CDx) to bolster the development and launch of Incyte’s range of hematology and oncology products. The anticipated growth of the companion diagnostics market to approximately $12 billion by 2030 is fueled by the impactful role these tests play in guiding treatment choices across an expanding spectrum of cancers and chronic illnesses, as per DelveInsight. Specifically designed for use alongside targeted therapies, companion diagnostics assess biomarker expression to pinpoint patients who stand to gain from treatment with these precise therapeutic offerings.

The partnership between Agilent and Incyte permits joint efforts in CDx development initiatives. This collaboration empowers Agilent to broaden its range of companion diagnostics by incorporating innovative biomarkers, while also granting Incyte access to Agilent’s proficiency in IVD assay development, global regulatory endorsements, and commercialization strategies. These combined strengths will bolster support for clinical trials, and potentially facilitate the registration and commercial launch of CDx products in the United States and Europe.

Immunome Secures Cancer Drug Candidates in Acquisition Deal with Ayala

Immunome, Inc. has revealed the purchase of AL102 and its associated medication AL101 from Ayala Pharmaceuticals, Inc. This deal involves an upfront cash payment of $20 million and $30 million worth of Immunome common stock, along with a potential additional $37.5 million dependent on reaching development and commercial goals.

AL102 is a daily pill designed to treat desmoid tumors, which are rare cancers of the soft tissue known to cause considerable pain and impairment. Through clinical trials, this medication has displayed encouraging outcomes, possibly surpassing OGSIVEO, the initial FDA-endorsed treatment for desmoid tumors. Findings from the Phase II RINGSIDE study have revealed notable rates of positive responses and a median reduction in tumor size of 88%.

Nascent Biotech Collaborates with Manhattan BioSolutions to Explore Pritumumab ADC

On February 6, 2024, Nascent Biotech disclosed its latest venture—a research collaboration pact with Manhattan BioSolutions. This partnership aims to delve into antibody-drug conjugates (ADCs) leveraging Nascent’s flagship clinical candidate, pritumumab (PTB), as the pivotal tumor-targeting antibody component. This strategic collaboration is poised to significantly bolster the outlook of the antibody-drug conjugates (ADCs) market and propel company growth within this dynamic segment.

Pritumumab (PTB) represents a naturally occurring human antibody with notable therapeutic potential. This monoclonal antibody is specifically designed to target the extracellular form of vimentin, a protein intricately associated with cancer progression and metastasis. Notably, vimentin is known to be overexpressed in challenging tumor types, including brain and pancreatic cancers. PTB serves as a targeted immunotherapeutic agent, effectively binding to vimentin within tumors and orchestrating the recruitment of the immune system to combat cancerous cells. Encouragingly, PTB has exhibited a promising safety profile and early signs of efficacy, as evidenced by the successful completion of Phase I trials in glioblastoma patients. With recent FDA clearance, Nascent is poised to embark on Phase II clinical trials targeting brain cancer, further underscoring the potential impact of PTB in advancing cancer treatment paradigms.

BD (BDX) and Camtech Health Collaborate to Support Cervical Cancer Screening

On February 21, 2024, BD (Becton, Dickinson and Company) unveiled a strategic collaboration with Camtech Health, a digital health enterprise specializing in at-home health testing. The partnership aims to revolutionize cervical cancer screening in Singapore by introducing the first-ever option for women to self-collect samples in the comfort and privacy of their homes. This innovative program integrates the Camtech Health HPV (human papillomavirus) test for self-collection with the BD Onclarity™ HPV Assay, a clinically validated test capable of detecting 14 high-risk HPV strains simultaneously. This assay can analyze specimens collected for cervical cancer screening purposes using both BD SurePath™ Preservative Fluid and Hologic PreservCyt® Solution, as well as in the Cervical Brush Diluent tube.

In late 2020, the World Health Organization (WHO) initiated its Global Strategy to Accelerate the Elimination of Cervical Cancer, with the ambitious goal of virtually eradicating cervical cancer as a public health concern. This strategy set forth explicit targets to be accomplished by 2030, including achieving HPV vaccination coverage of over 90%, screening coverage exceeding 70%, and ensuring access to treatment for more than 90% of affected individuals. At-home collection methods offer a promising solution to the pressing public health issue of reaching women who do not regularly attend traditional cervical cancer screening appointments.

The overarching goal of this strategic initiative is to address the low rate of cervical cancer screening in Singapore, where less than half of eligible women currently undergo testing. Through this collaboration, BD and Camtech Health aspire to significantly enhance access to cervical cancer screening, thereby potentially reducing the incidence and mortality rates associated with this disease.

AstraZeneca Finalizes Gracell Biotechnologies Acquisition at $1.2 Billion

On February 22, 2024, AstraZeneca revealed the successful finalization of its acquisition of Gracell Biotechnologies, a renowned global clinical-stage biopharmaceutical entity specializing in pioneering cell therapies targeting cancer and autoimmune disorders. This strategic acquisition serves to bolster AstraZeneca’s commitment to advancing cell therapy as a cornerstone of its therapeutic endeavors, aligning with its overarching ambition in the field.

Under the definitive agreement, AstraZeneca has completed the acquisition of all fully diluted share capital of Gracell, including shares represented by ADSs, through a merger. The price stands at $2.00 per ordinary share in cash at the closing, equivalent to $10.00 per ADS of Gracell. Additionally, there’s a non-tradable contingent value right of $0.30 per ordinary share (equivalent to $1.50 per ADS of Gracell) in cash, payable upon the accomplishment of a specified regulatory milestone.

The initial cash portion of the consideration totals approximately $1.0 billion. When combined with the potential contingent value payments, if achieved, the total transaction value amounts to approximately $1.2 billion.

Under the arrangement, Gracell will function as a wholly-owned subsidiary of AstraZeneca, maintaining operational bases in both China and the United States. This strategic alignment positions AstraZeneca to leverage Gracell’s expertise and infrastructure to further advance its commitment to pioneering cell-based therapies for patients worldwide.

The acquisition will enhance AstraZeneca’s expanding pipeline of cell therapies by integrating GC012F, an innovative, clinical-stage FasTCAR-enabled BCMA, and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy. GC012F presents a promising avenue for the treatment of multiple myeloma, along with other hematologic malignancies and autoimmune disorders such as systemic lupus erythematosus (SLE).

Major Collaboration, Funding, and Merger & Acquisitions From January 2024

Taro and Sun Pharma Enter Merger Agreement

On 17 January 2024, Sun Pharmaceutical Industries Limited and Taro Pharmaceutical Industries Ltd. declared their commitment to a formal merger agreement. According to this agreement, Sun Pharma, the majority shareholder of Taro, has consented to purchase all outstanding common shares of Taro, excluding those already owned by Sun Pharma or its affiliates, at US$43.00 per share in cash, with no added interest. 

The acquisition cost of US$43.00 per share signifies a 48% markup compared to the closing price of US$28.97 per share on May 25, 2023—the final trading day before Sun Pharma initially presented its non-binding proposal to Taro. Additionally, it reflects a 58% premium over the volume-weighted average price of the shares in the 60 days leading up to and including May 25, 2023. Furthermore, this purchase price marks a 13% escalation from the initially suggested purchase price of US$38.00 per share on May 26, 2023.

Basilea Pharmaceutica Completes $2.34M Acquisition of Spexis’ Preclinical Antibiotics Program

Basilea Pharmaceutica and Spexis have agreed to the acquisition of a preclinical antibiotics program that specifically targets gram-negative bacteria, including newly identified multidrug-resistant strains. Under the terms of the agreement, Basilea will gain ownership of all program compounds, knowledge, and intellectual property from Spexis in exchange for a total payment of $2.34 million (CHF 2 million). This sum encompasses an initial upfront payment, a payment related to the transfer, and a potential final milestone payment, contingent on securing external funding for the program’s development in the near term. In addition to the program assets, Basilea will also assume Spexis’ associated rights and responsibilities, including the possibility of low single-digit percentage royalties on sales through licensing agreements.

BostonGene and Prisma Health Join Forces to Anticipate Immunotherapy Effectiveness in Rare Cancers

BostonGene has announced a partnership with Prisma Health to advance the comprehension of rare tumors. This collaboration focuses on characterizing the tumor microenvironment (TME), mutational landscape, and host immune profiles of patients undergoing treatment with immune checkpoint inhibitors. Working alongside Prisma Health’s Rare Tumor Center, BostonGene will examine tissue and peripheral blood samples from individuals with rare solid-tumor cancers. The objective is to gain insights into the molecular foundations of immune-activating drugs commonly employed to bolster the body’s inherent mechanisms against cancer. In the ongoing patient enrollment phase of the trial, BostonGene will conduct thorough analyses of primary tumors and immune profiling of corresponding peripheral blood samples.

Merger Agreement Inked Between Bowen Acquisition Corp and Shenzhen Qianzhi BioTech

Bowen Acquisition Corp has revealed the completion of a merger agreement with Shenzhen Qianzhi BioTechnology Co., Ltd, a Chinese biotechnology firm specializing in the development, manufacturing, and sales of ozonated health and wellness products. Following the Merger Agreement, BOWN’s fully owned subsidiary, Bowen Merger Sub, which is a Cayman Islands-exempt company, is set to undergo a merger with Qianzhi Group Holding Limited. Qianzhi Group Holding Limited is the parent company of Qianzhi BioTech, and it is also an exempted company incorporated with limited liability in the Cayman Islands. Following the merger, NewCo will emerge as the surviving entity and become a wholly-owned subsidiary of BOWN. As part of the merger process, the NewCo Shareholders will be entitled to receive a total of 7,246,377 ordinary shares of BOWN. Additionally, they retain the right to receive a potential extra 1,400,000 ordinary shares of BOWN contingent upon meeting specific earnout targets outlined in the Merger Agreement.

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Lassen Therapeutics Secures $85 Million in Series B Funding Round

Lassen Therapeutics is commencing the upcoming year with a financial injection to support its monoclonal antibody therapies designed for fibro-inflammatory diseases. The San Diego-based biotech firm revealed on December 19th that it successfully concluded an oversubscribed Series B funding round, securing $85 million. This round was co-led by Longitude Capital, a new investor, and Frazier Life Sciences, an existing investor that spearheaded Lassen’s $31 million Series A funding in 2020.

The funds obtained through the financing will be utilized to back Lassen’s LASN01 clinical initiative. This program focuses on the interleukin-11 receptor (IL-11R), which, based on preclinical data, indicates a potential advantage in orbital fibroblasts—the pertinent cell type associated with thyroid eye disease (TED).

As per the analysis by DelveInsight, the thyroid eye disease market, spanning across the 7MM, achieved a valuation of USD 1.9 billion in 2022 and is anticipated to experience noteworthy growth with a considerable CAGR by 2032. 

Moreover, with Lassen’s ongoing exploration of LASN01 as a potential therapy for idiopathic pulmonary fibrosis (IPF), the IPF therapeutics sector is set to undergo a surge in growth attributable to this financial support. DelveInsight predicted the IPF market’s size in the seven major markets amounted to USD 3.1 billion in 2021 and is poised for significant expansion by 2032.

Rune Labs Secures $12 Million in Strategic Funding to Drive Innovation in Parkinson’s Solutions

On 11 January 2024, Rune Labs, a company specializing in precise neurology software and data, disclosed a strategic funding round of $12 million. This brings the total funds raised by the company to surpass $42 million. The leading participant in this round is the recently established brain disorder fund, Nexus NeuroTech Ventures, accompanied by continued support from existing investors such as Eclipse, DigiTx Partners, Moment Ventures, and TruVenturo GmbH. Jordi Parramon, Ph.D., CEO, General Partner, and Co-Founder of Nexus NeuroTech Ventures, as well as the former President of Medical Devices at Verily, will assume a position on Rune Labs’ board of directors.

In the year 2022, the FDA granted 510(k) clearance to Rune Labs’ StrivePD software ecosystem designed for Parkinson’s disease. This clearance allows the software to gather patient symptom data, such as tremors and dyskinesia, utilizing measurements from the Apple Watch. Throughout the preceding year, Rune Labs disclosed multiple partnerships with prominent players in neuroscience, including collaborative efforts with cell therapy developers BlueRock Therapeutics and Aspen Neuroscience. These partnerships aim to assess symptom activity in the respective Parkinson’s clinical trials of each company, utilizing Rune Lab’s clinical development platform called StriveStudy.

Harbor Health Secures $95.5 Million Investment to Bolster Healthcare Services Across Central Texas

Harbor Health, a clinic group focused on prioritizing consumers in their healthcare, revealed on January 11, 2024, that it successfully obtained an extra $95.5 million in funding. The leading contributor in this funding round is General Catalyst, with significant involvement from Alta Partners, and ongoing backing from 8VC. The cumulative investment amassed thus far exceeds $128 million.

The extra funding will support ongoing expansion in delivering primary care services, diversifying the range of specialty care options, and creating plan designs that facilitate collaborative care journeys between consumers and their clinicians. Texas employers can leverage these plan designs to reduce costs while implementing an enhanced, well-coordinated care system, ultimately leading to healthier and more content employees.

Stalicla Raises $17.4 Million in Series B Funding to Advance Precision Medicine for Neuropsychiatric and Neurological Disorders

Stalicla, a clinical-stage biopharmaceutical company dedicated to advancing precision medicine solutions for neuropsychiatric and neurological disorders, has marked a significant accomplishment by successfully concluding the first phase of its Series B financing round. The substantial funding received signals strong support for the company’s innovative pipelines, poised to transform the treatment landscape for complex brain-related conditions.

The funds will be utilized for Stalicla’s precision Autism Spectrum Disorder (ASD) Phase II trial, advancing its platform development, initiating a Phase III study in Substance Use Disorders set for 2025 with full backing from the NIH/National Institute on Drug Abuse, and accelerating the ongoing patient identification trial, currently enrolling participants in the USA, Spain, and Australia. With increased funding, the autism spectrum disorder market is on track for substantial expansion in the forthcoming years, as per DelveInsight analysis.

Vico Secures $60 Million Investment to Advance Innovative Treatment for Neurodegenerative Disorders

Vico, a genetic medicine company in the clinical stage, has disclosed securing $60 million in Series B funding. This funding is earmarked to facilitate a phase I/II clinical trial and progress of the primary candidate aimed at addressing spinocerebellar ataxia types 1 and 3, along with Huntington’s disease. As per Vico Therapeutics’ announcement, the upcoming trial will assess the safety and tolerance of escalating doses of intrathecal VO659 in individuals with mild to moderate SCA3, SCA1, and early manifest HD. The initial patient is anticipated to receive the first dose in April.

Opthea Gains Further Financial Support for Development Initiatives

Opthea has obtained the remaining $35 million in committed funds from the Development Funding Agreement (DFA) with Carlyle and Abingworth. The company has finalized binding documentation with a new co-investor as part of an Amended DFA, securing an extra $50 million in funding. Carlyle and Abingworth had initially committed $120 million under the DFA, with $85 million received so far. Opthea stated that the outstanding $35 million and the additional $50 million will increase the total committed funding to $170 million under the amended DFA.

The funding of $85 million announced by the company will be allocated to progress Phase III clinical trials and pre-commercialization efforts for sozinibercept in the treatment of wet age-related macular degeneration (wet-AMD). According to DelveInsight analysis, the wet AMD market is poised for significant growth in the coming years, thanks to the increased funding. DelveInsight anticipated that the market size for wet AMD in the seven major markets reached USD 8 billion in 2021 and is expected to undergo substantial growth by 2032.

ENYO Pharma Raises €39m Series C Funding to Advance Vonafexor

In a significant financial development within the Healthcare Market, ENYO Pharma has revealed the successful acquisition of €39 million in Series C funding. This funding will be utilized to progress Vonafexor, a synthetic non-steroidal, non-bile acid nuclear receptor subfamily 1 group H member 4 agonists, specifically designed for treating Alport syndrome. Notably, existing investors such as AndEra Partners, Bpifrance InnoBio, and Bpifrance Large Ventures were actively involved in this funding round.

OrbiMed and Morningside Ventures are jointly spearheading the funding round, aiming to bolster the Phase II Alpestria-1 clinical trial and extend support for research and development endeavors related to Vonafexor until the initial half of 2026. Additionally, ENYO Pharma has obtained approval from the US Food and Drug Administration for its investigational new drug application, marking a pivotal step towards initiating the Phase II clinical investigation of Vonafexor for Alport syndrome. The ALPESTRIA-1 trial is scheduled to kick off in the first half of 2024.

Tr1X, Inc. Secures $75 Million In Series A Funding

Tr1X, Inc. unveiled its debut from stealth mode on January 17, 2024, revealing a successful $75 million Series A funding round. The company aims to introduce universal allogeneic regulatory T (Treg) and CAR-Treg cell therapies into clinical practice, targeting the treatment and potential cure of autoimmune and inflammatory diseases. The funding initiative was spearheaded by The Column Group, a Bay Area-based entity, and saw contributions from NEVA SGR and Alexandria Ventures.

Tr1X is guided by seasoned industry professionals possessing extensive expertise in cell therapy. They boast a proven track record in the discovery, development, and commercialization of over a dozen innovative medicines, many of which were pioneering firsts or best-in-class treatments.

At present, Tr1X is actively advancing its initial investigational Tr1 cell therapy, TRX103. The company intends to subject TRX103 to a Phase 1 trial, targeting the prevention of Graft versus Host Disease (GvHD) in patients undergoing mismatched hematopoietic stem cell transplant. Simultaneously, Tr1X is in the process of developing additional pipeline programs geared towards addressing conditions such as inflammatory bowel disease, Type 1 diabetes, and multiple B-cell-mediated autoimmune diseases. Furthermore, the company anticipates initiating Phase 1 clinical trials for multiple indications in 2024.

BridgeBio Bags $1.25bn to Support its Genetic Therapy Development Programme

In a significant business milestone, BridgeBio Pharma revealed securing strategic funding totaling $1.25 billion from Blue Owl Capital and the Canada Pension Plan Investment Board (CPP Investments) for genetic therapies. This financial agreement encompasses a royalty arrangement with Blue Owl and CPP Investments, along with Blue Owl refinancing BridgeBio’s existing senior credit facility.

The infusion of capital will expedite the advancement and potential launch of genetic therapies, specifically acoramidis, which is poised to play a pivotal role in treating transthyretin amyloid cardiomyopathy (ATTR-CM). According to the latest information, BridgeBio is set to receive a $500 million cash injection upon the FDA’s approval of acoramidis. This financial support is expected to facilitate the drug’s commercial entry into the market. Notably, the payment is divided, with $300 million coming from Blue Owl and $200 million from CPP Investments, in exchange for future royalty payments amounting to 5% of global net sales of acoramidis.

Myrobalan Therapeutics Receives $24M to Develop Neurorestorative Therapies

Myrobalan Therapeutics revealed on January 10, 2024, that it had successfully concluded a Series A funding round, securing a total of $24 million. Co-win Ventures spearheaded the funding, and notable contributions came from both new and existing investors such as Guan Zi Equity Investment (Li Shui) Partnership (Limited Partnership), 3E Bioventures Capital, and AB Magnitude Ventures Group.

Headquartered in Medford, Massachusetts, Myrobalan Therapeutics specializes in the development of oral neurorestorative therapies designed to reverse critical pathologies associated with brain dysfunctions and central nervous system (CNS) conditions. The company is actively advancing a diverse pipeline of innovative remyelination and anti-neuroinflammation programs, leveraging strategic support from esteemed institutional co-founders and a prominent chemistry partner.

At present, Myrobalan Therapeutics is actively engaged in the development of orally administered small molecule neurorestorative therapies. This includes the creation of an antagonist targeting G-protein coupled receptor 17 (GPR17), a key focal point for promoting remyelination. Additionally, the company is working on an inhibitor for colony-stimulating factor-1 receptor (CSF1R), a factor implicated in both demyelination and neuroinflammation, as well as an allosteric tyrosine kinase 2 (TYK2) inhibitor aimed at reducing neuroinflammation. Myrobalan’s strategic approach involves addressing a broad spectrum of neurological conditions through these innovative programs.

ZWI Therapeutics Announces a Series A Financing

ZWI Therapeutics revealed on January 24, 2024, that it has secured $10 million in Series A financing from Co-win Ventures and Sherpa Healthcare Partners. Established in 2020 by Drs. Bob Langer and Shaoyi Jiang, ZWI is a biotech firm dedicated to advancing protein therapeutics through the utilization of innovative proprietary polymers. The primary focus of ZWI is on its leading initiative, ZWI-001 (uricase-poly carboxybetaine conjugate), which has exhibited preclinical proof of concept. Currently, the program is in the developmental stage aimed at addressing hyperuricemia in severe cases of gout.

Furthermore, ZWI Therapeutics announced the addition of esteemed pharmaceutical industry experts Drs. Larry Miller and Ron Cohen as Independent Directors to the company’s Board of Directors. Additionally, Dr. Ed Mascioli has been appointed as the Chief Executive Officer and also joins the Board of Directors.

Newly Launched Calluna Raises $81M 

Calluna Pharma secures €75 million ($81 million) in Series A funding, with leading investors Forbion, Sarsia, p53, and Investinor participating. The funds will be directed toward advancing a pipeline of monoclonal antibodies focused on treating immunological diseases.

Calluna, formed through the merger of Oxitope Pharma and Arxx Therapeutics, is a clinical-stage company dedicated to developing therapies for inflammatory and fibrotic diseases. According to recent information, Calluna has four monoclonal antibody candidates (CAL101, CAL102, CAL103, and CAL104) in its development pipeline specifically designed for the treatment of inflammatory and fibrotic conditions.

Calluna’s primary candidate, CAL101, is a monoclonal antibody (mAb) specifically created to counteract S100A4, a damage-associated molecular pattern (DAMP) protein. CAL102, another monoclonal antibody, targets oxidized phospholipids, disrupting pathways related to conditions marked by inflammation and fibrosis. Additionally, Calluna has two candidates, CAL103 and CAL104, currently in the discovery phase, further expanding their potential therapeutic offerings.

CardioSignal Secures $10M Series A

CardioSignal has recently concluded its Series A funding round, securing $10 million in investment. DigiTx Partners took the lead in this funding round, with contributions from Sandwater and existing investor DigiTx’s managing director, David J. Kim, M.D., is set to join the board as a result. This latest funding brings CardioSignal’s total raised capital to $23 million. The funds from the Series A investment will be allocated towards further clinical validation of CardioSignal’s innovative technology and the expansion of its commercial initiatives.

CardioSignal’s technology utilizes the motion data captured by the gyroscope and accelerometer in smartphones to assess precise rotational movements of the heart, enabling the accurate detection of abnormal heart function. This analysis is conducted by placing the smartphone on the patient’s chest for a brief one-minute measurement. The motion data is then processed by a clinically validated algorithm in a secure cloud service, delivering immediate and reliable results.

With cardiovascular diseases causing over 20 million annual fatalities, the funding secured by CardioSignal will enable the expansion of its advanced detection and remote monitoring solution. This solution is specifically designed for primary care physicians and their patients. Currently, primary care faces a shortage of comprehensive tools for the timely identification of heart diseases, especially in patients already showing symptoms like those with heart failure. Our initiative seeks to revolutionize cardiovascular care by prioritizing early detection and prevention, moving away from the current emphasis on treating complications. This shift aims to greatly improve the proactive management of cardiovascular health.

Sano Genetics Raised $11.4M In a New Funding Round

Sano Genetics revealed on January 22, 2024, that it secured $11.4 million in fresh funding. Plural led the funding round, with contributions from existing investors such as MMC Ventures, Episode 1, and Seedcamp. The company is experiencing initial successes by implementing AI to simplify the trial process and enhance customer satisfaction. With the additional funding, totaling $22 million, Sano Genetics aims to address the increasing demand for its products, intensify the utilization of AI, and extend its presence to additional countries, solidifying its position as the premier precision trial platform.

Co-founded by Patrick Short (CEO), Charlotte Guzzo (COO), and William Jones (CTO), Sano Genetics is in the process of developing software that facilitates the precision medicine revolution. The overarching mission of Sano Genetics is to hasten the global transition to precision medicine. The company integrates genetic testing, recruitment, and long-term engagement into a single platform, expediting enrollment processes and streamlining operations for precision medicine teams dedicated to making breakthroughs for patients. In the year 2023 alone, Sano Genetics achieved a remarkable 5x Annual Recurring Revenue (ARR) growth year-on-year, doubled its workforce to 62 employees, and entered the expansive pharmaceutical market by collaborating with four of the top 20 pharmaceutical companies.

Healthcare Competitive Intelligence Services

Lipocine and Verity Pharma Forge Licensing Deal for TLANDO Franchise Across North America

On 18 January 2024, Lipocine Inc., a biopharmaceutical company specializing in the treatment of Central Nervous System (CNS) disorders, partnered with Gordon Silver Limited and Verity Pharmaceuticals, Inc. to establish an exclusive licensing agreement. According to the agreement, Verity Pharma will be responsible for marketing TLANDO® in the United States and, pending approval, in Canada. TLANDO is notable as the first oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that eliminates the need for dose titration. Additionally, the agreement grants Verity Pharma the rights in the U.S. and Canada to develop and commercialize LPCN 1111 (TLANDO XR), an advanced once-daily oral product candidate designed for TRT.

According to the terms outlined in the agreement, Lipocine is set to receive an $11 million license fee from Verity Pharma. This sum includes an initial payment of $2.5 million upon the signing of the License Agreement. Subsequently, Verity Pharma is obligated to make payments of $5 million by February 1, 2024, $2.5 million no later than January 1, 2025, and $1 million no later than January 1, 2026. Additionally, Lipocine stands to gain a potential total of $259 million through milestone payments tied to development and sales achievements, along with tiered royalty payments ranging from 12% to 18% on net sales of TLANDO franchise products.

Under the terms of the agreement, Verity Pharma assumes responsibility for regulatory and marketing duties in the U.S. and Canada, as well as all further development activities. Meanwhile, Lipocine retains exclusive rights to the TLANDO franchise for regions outside the U.S. and Canada, along with full rights to non-Testosterone Replacement Therapy (TRT) indications on a global scale.

Glenmark Secures Licensing Rights for KN035 through Agreement with Alphamab Oncology and 3DMedicines

Alphamab Oncology and 3DMedicines have recently forged a licensing agreement with Glenmark Specialty S.A. for the subcutaneous injection PD-L1 antibody drug. Under this agreement, Glenmark has been exclusively granted licensing rights for the clinical development and commercialization of oncology indications in various regions, including India, Asia Pacific (excluding Singapore, Thailand, Malaysia), the Middle East, Africa, Russia, CIS, and Latin America. Glenmark will independently handle the development and commercialization of KN035 in the specified regions, bearing all associated costs and expenses.

According to the License Agreement, GSSA will provide Licensors with (a) a non-refundable upfront payment and milestone payments totaling up to US$700.8 million, contingent upon achieving specific development, regulatory, and commercialization milestones, and (b) a royalty fee ranging from single to double digits based on the net sales of KN035. The Licensors’ entitlement to these payments (including upfront payment, milestone payment, and royalty fees) is dependent on agreements between Jiangsu Alphamab and 3D Medicines. Jiangsu Alphamab retains the exclusive right to manufacture KN035 for any purpose within or outside the Territory, while 3D Medicines retains the right to develop and commercialize KN035 for any purpose related to tumors outside the Territory.

MediciNova Secures New Patent Approval for MN-166 in China, Targeting Macular Injury Treatment

MediciNova, Inc. has disclosed that it received a Notification of Grant from the Chinese Patent Office for a fresh patent related to MN-166 (ibudilast) in treating macular injury linked to progressive multiple sclerosis. The anticipated expiration date for this patent is no earlier than April 2040. The approved claims pertain to the application of MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis, as well as for reducing macular volume loss associated with progressive multiple sclerosis.

Vesper Bio Awarded Grant by Michael J. Fox Foundation

The Michael J. Fox Foundation (MJFF) has granted Vesper Bio $873,000 to investigate a sortilin inhibitor in Parkinson’s disease. The project, led by principal investigators Louise Klem, senior research scientist, and Anders Nykjær, chief scientific officer of Vesper Bio, is set to begin in January 2024.

Vesper Bio’s orally administered sortilin inhibitors, composed of small molecules, aim to increase central progranulin levels and show potential in treating specific central nervous system (CNS) diseases, such as Parkinson’s disease. The program is designed to finance therapeutic advancements with a specific emphasis on preventing, halting, or slowing down disease progression, as well as alleviating the daily symptoms. Additionally, Vesper is actively accelerating the development of VES001 for frontotemporal dementia through ongoing phase 1 studies.

Cellergy Pharma Receives $300K Grant for Cell Therapies

On January 5, 2024, Cellergy Pharma revealed that it had secured a $300,000 grant from the National Institute of Allergy and Infectious Diseases to advance the development of therapies targeting severe allergic diseases, particularly CAR-T cell therapies. Situated at the Delaware Innovation Space on the DuPont Experimental Station campus, Cellergy Pharma, a two-year-old company, also took part in the Delaware BioScience Association’s 2023 pitch competition.

Empowered by this funding, Cellergy Pharma is poised to propel the progress of its primary CAR T cell product, CP-010. This autologous CAR T cell product is designed to target membrane IgE. The focus of Cellergy’s CAR T cells is to identify and eliminate cells responsible for producing immunoglobulin E (IgE), a pivotal mediator in all atopic diseases. Conditions associated with IgE-mediated responses encompass allergic asthma, chronic urticaria, atopic dermatitis, and food allergies.

Lotte Biologics Enters Business Agreement with US Company NJ Bio

Lotte Biologics has recently revealed the formalization of a significant business partnership with NJ Bio, a Contract Research Organization (CRO) located in the United States. NJ Bio specializes in both non-clinical and clinical contract research. The collaboration aims to offer comprehensive services for Antibody-Drug Conjugates (ADC). NJ Bio, established in 2018 and situated in New Jersey, boasts pharmaceutical production facilities dedicated to Phase I and II clinical trials. Notably, NJ Bio has received the prestigious Best CRO award three consecutive times at the ADC World Summit, the prominent conference in the ADC domain.

Through this agreement, both companies aim to attract a diverse range of new clients interested in ADCs by capitalizing on their individual expertise in critical components of the ADC pipeline. This includes proficiency in payload, linker, antibody, and conjugation processes. NJ Bio will contribute its technological capabilities in ADC process development, analytical method development, and linker-payload development and synthesis to Lotte Biologics. Lotte Biologics, in turn, will utilize these technologies in preclinical research and the production of antibodies and ADCs for clinical and commercial purposes. Additionally, the two companies, Lotte Biologics and NJ Bio, will collaborate on the development of a bio-conjugation process. This process will be applied to the expansion of the ADC production facility at the Syracuse site in the U.S., with the shared goal of manufacturing optimized ADC pharmaceuticals. According to DelveInsight’s analysis, the Antibody Drug Conjugates (ADC) market is poised for significant growth in the coming years with the implementation of this business agreement.

Haystack Oncology Partners with TriSalus Life Sciences to Advance the Clinical Exploration of TriSalus’ TLR9 Agonist

Haystack Oncology and TriSalus Life Sciences have partnered in a research collaboration aimed at assessing therapeutic responses and gaining molecular insights related to the clinical advancement of TriSalus’ SD-101. SD-101, an investigational toll-like receptor-9 (TLR9) agonist of class C, is administered through hepatic arterial infusion or pancreatic retrograde venous infusion in their phase 1 and 1b clinical trials. These trials utilize TriSalus’ proprietary Pressure-Enabled Drug Delivery™ (PEDD™) to address intratumoral pressure challenges, particularly for patients diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma.

Kyverna Sets Plans for IPO in 2024

According to preliminary information, Kyverna might initiate the process of filing for an IPO in February 2024. The company could disclose its IPO intentions as soon as next week and potentially launch the offering in the early part of the following month. However, it’s important to note that these plans are subject to potential changes.

Kyverna Therapeutics, situated in California, specializes in the development of a groundbreaking class of therapies for autoimmune and inflammatory diseases. The company’s pipeline features advanced chimeric antigen receptor T-cell (CAR T) therapies, available in both autologous and allogeneic formats, designed specifically for addressing B cell-driven autoimmune diseases. Kyverna is actively progressing with two key programs: the autologous KYV-101 and the allogeneic KYV-201, both tailored for B-cell-driven autoimmune conditions. KYV-101 is currently undergoing clinical trials for lupus nephritis and has recently received FDA clearance for evaluation in myasthenia gravis and multiple sclerosis.

HDT Bio Receives $749,000 EZBAA Contract and Partners with BARDA

HDT Bio Corp., a clinical-stage biopharmaceutical development company headquartered in Seattle, revealed on January 23, 2024, that it has joined forces with the Biomedical Advanced Research and Development Authority (BARDA) as part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. This collaboration falls under the Enabler’s program of Project NextGen. Specializing in nucleic acid formulation, HDT Bio focuses on creating products that aim to leverage host-directed immune responses.

According to the information provided by HDT Bio, as part of this collaboration, the company has secured a $749,000 contract. This funding will facilitate proof-of-concept studies focused on on-demand manufacturing and release processes, utilizing HDT Bio’s LION™ formulation for RNA vaccine production. The objective of the Project NextGen Enabler’s program is to propel advancements in next-generation vaccine and therapeutic technologies. This includes pioneering cGMP manufacturing of vaccines to reduce costs, expedite production, enhance efficacy, and broaden access. The financial support will also contribute to the development of innovative microfluidic mixing chips designed to enable automated, swift-release, assay-free preparation of vaccines.

CerraCap Ventures Invests in Acorai

On January 19, 2024, CerraCap Ventures made a strategic investment in Acorai, an innovative company specializing in cardiovascular health technology. This investment will significantly accelerate the advancement and implementation of Acorai’s groundbreaking Acorai Heart Monitor (AHM), designed to address critical challenges in heart failure management.

The AHM stands out as a revolutionary solution in heart failure monitoring, offering unparalleled accuracy and reliability in non-invasive intracardiac pressure measurements. It is capable of providing precise data on key parameters such as pulmonary artery pressure (PAP), right atrial pressure (RAP), and pulmonary capillary wedge pressure (PCWP). These parameters are essential for the effective management of heart failure patients.

Acorai is committed to delivering clinically relevant information and empowering healthcare providers to make well-informed decisions in the management of heart failure. Leveraging the support of CerraCap Ventures’ strategic investment, Acorai is poised to make a significant impact in the healthcare sector. The current funding round will be dedicated to conducting global clinical studies for FDA approval, paving the way for the market launch of the Acorai Heart Monitor (AHM). This milestone will introduce the groundbreaking technology to healthcare providers and patients worldwide.

Psyence Group Inc Subsidiary Psyence Biomedical Ltd. Announces Signing of Definitive Agreement

On January 16, 2024, Psyence Group disclosed that its subsidiary, Psyence Biomedical Ltd (“Pubco”), has formally entered into a definitive securities purchase agreement with a US-based investment firm. This agreement outlines the provision of up to US$10 million in funding through the issuance of up to four senior secured convertible notes (referred to as the “Notes” and “Note Financing”). 

The anticipated funding at the closing of this agreement is approximately USD $ 2.5 million, expected to occur immediately before or concurrently with the completion of the previously announced business combination involving Newcourt Acquisition Corp (Nasdaq: NCAC) (“Newcourt”) and Pubco (the “Business Combination”). This strategic move marks a significant step forward for Psyence Biomedical’s financial trajectory.

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