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Noxxon continues enrolment in a glioblastoma therapy trial
Noxxon Pharma continues subject enrolment in the GLORIA clinical trial of NOX-A12 in brain cancer (glioblastoma) patients. The move comes after the Data Safety Monitoring Board (DSMB) evaluated safety results from the preliminary four-week treatment with NOX-A12 plus radiotherapy and bevacizumab in the first subject in the expansion arm of the trial.
The DSMB concluded that the treatment is safe and suitable to go further with recruitment to enroll five more subjects into this arm as per the trial protocol. Moreover, the company noticed that the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) approved the third expansion arm of the trial.
Subjects in this arm will be given NOX-A12 plus pembrolizumab, an inhibitor of programmed cell death protein 1 (PD-1) immune checkpoint, and radiotherapy.
In the GLORIA Phase I/II trial, the safety and efficacy of NOX-A12 plus radiotherapy will be evaluated in recently detected glioblastoma in subjects with unmethylated MGMT promoters. Three expansion arms of the trial will each enroll six subjects to evaluate NOX-A12 advantage in several treatment settings.
Exact Sciences buys PreventionGenetics in USD 190 Million deal
Exact Sciences, a cancer screening and diagnostic tests provider has bought PreventionGenetics in an agreement worth around USD 190 Million. The deal comprises 50% in Exact Sciences common stock and 50% in cash.
PreventionGenetics is a genetic testing laboratory proffering the clinical lab, expertise, and foundational technology to boost access to hereditary cancer testing (HCT) to benefit patients to assess their germline risk of cancer and other diseases. The CLIA-certified and CAP-accredited clinical DNA testing laboratory delivers over 5,000 predefined genetic tests for approximately all clinically relevant genes and additional custom panels.
PreventionGenetics delivers a thorough germline whole genome sequencing test called PGnome and a whole-exome sequencing test known as PGxome. Exact Sciences’ Cologuard and Oncotype DX tests are used by more than 300,000 health care providers in primary care, women’s health, oncology, and other specialties.
In collaboration with the PreventionGenetics team, Exact Sciences focuses on leveraging its commercial presence in diagnostics and expanding hereditary cancer and genetic testing across the US and globally. XMS Capital acted as financial advisor to Exact Sciences on the transaction, while K&L Gates served as its legal advisor. CrossTree Capital acted as financial advisor to PreventionGenetics, while Winston & Strawn served as legal advisor.
Nuvalent doses first subject in Phase I/II trial of NSCLC therapy
Nuvalent has dosed the first subject in the Phase I/II ARROS-1 clinical trial of NVL-520 in individuals with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other advanced solid tumors. NVL-520 is a brain-penetrant selective inhibitor of ROS1.
It can potentially address the clinical challenges of emergent therapy resistance, CNS adverse events, and brain metastases, limiting the usage of ROS1 kinase inhibitors currently available. The open-label, multicentre, dose-escalation, and expansion trial will evaluate NVL-520 as a single oral agent.
The study’s Phase I dose-escalation segment is presently enrolling advanced ROS1-positive solid tumor patients who have earlier got a minimum of one prior ROS1 tyrosine kinase inhibitor (TKI) treatment.
Moreover, this portion of the trial will analyze the overall tolerability and safety of NVL-520 and determine the recommended Phase II dose (RP2D), assess initial anti-tumor activity, and characterize the pharmacokinetics profile. On choosing a safe and tolerable RP2D, the trial will convert directly to the Phase II multiple cohort expansion segment.
Stryker acquires Vocera Communications for USD 2.9 Billion
Medical technology company Stryker has agreed to take over US-based digital care platform Vocera Communications for around USD 2.97 Billion. Under the deal, Stryker will acquire all outstanding shares of the common stock of Vocera by paying USD 79.25 per share in cash.
Vocera, established in 2000, proffers communication and workflow solutions to protect and connect team members and enhance the healthcare experience. Vocera solutions are currently utilized by over 2,300 facilities, including 1,900 hospitals and healthcare facilities, to help their workforce communicate and collaborate with co-workers and engage with patients and families.
The solutions integrate over 150 clinical and operational systems, comprising electronic health records, nurse call systems, ventilators, and physiological monitors. The acquisition of Vocera will let Stryker add a complementary and innovative portfolio to its medical division to support hospitals connect caregivers and disparate data-generating medical devices.
Vocera’s software and hardware solutions, which will facilitate secure remote communication between patients and their families, complement Stryker’s advanced digital healthcare offerings.