FDA approves IND application of Accutar for a prostate cancer treatment trial

The US Food and Drug Administration (FDA) has granted Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC).

An investigational orally bioavailable, chimeric degrader molecule, AC0176, is designed to aim and degrade androgen receptor (AR) for prostate cancer treatment. AR is a hormone-regulated transcription factor, which plays a prominent role in the initiation and progression of prostate cancer.

Accutar stated that AC0176 showed selective and robust degradation of AR protein with broad coverage of AR mutants and favorable pharmacological properties in the preclinical studies. In the Phase 1 study, AC0176’s pharmacokinetics, preliminary anti-tumor activity, safety, and tolerability will be assessed to treat mCRPC patients.

Accutar Biotechnology CEO Jie Fan said that the IND clearance for AC0176 is another vital validation. After their AC0682 entered the clinic, their AI platform can bolster and progress the discovery of potentially differentiated clinical candidates quickly, incredibly complex compounds such as chimeric degraders.

The IND clearance for AC0176 is also critical towards delivering a potential new treatment for prostate cancer based on a differentiated mechanism of action from second-generation nonsteroidal AR antagonists, which are the current standard of care for this patient population.

Bio-Thera Solutions begins dosing in Phase I trial of cancer drug

China-based commercial-stage pharmaceutical firm Bio-Thera Solutions has initiated dosing in Phase I clinical trial of BAT6005, a monoclonal antibody to target TIGIT in cancer patients.

The trial will assess the pharmacokinetics and safety of BAT6005, which was discovered using the firm’s fully synthetic human antibody discovery platform, called IDEAL that stands for Intelligent Design and Engineered Antibody Libraries. BAT6005 has normal IgG1 ADCC function. 

Bio-Thera Solutions SVP Dr. Jin-Chen Yu said that TIGIT is an immune-oncology drug target of tremendous interest. Preclinical data generated in support of the BAT6005 IND is very promising. BAT6005 is one of various IO assets entering Phase 1 studies and transitioning Bio-Thera’s innovative IO pipeline from a preclinical pipeline to a clinical pipeline. They plan to look for combinations of BAT6005 with BAT1308, their novel PD-1 antibody, for treating several ranges of cancers.

The multicentre, open-label, dose-escalation Phase I trial to assess the safety and tolerability aspects of BAT6005 as a single agent. This trial anticipates the enrollment of patients suffering from advanced solid tumors. The trial’s primary aim comprises ascertaining maximum tolerated dose, preliminary anti-tumor activity, and pharmacokinetics.

Nykode doses first participant in Phase I/II Covid-19 vaccine trial

Nykode Therapeutics has dosed the first participant in Phase I/II VB-D-01 clinical trial of its T cell-specific Covid-19 vaccine candidate in unvaccinated individuals.

The shot can potentially prime T cells, thereby eliciting a wide-ranging immune response against present and future viral variants. The open-label, two-arm dose-escalation, and dose-expansion trial is designed to evaluate the safety, reactogenicity, and immunogenicity of both the T cell-specific/VB10.2210 and the RBD/VB10.2129 vaccine candidates in healthy subjects.

The Research Council of Norway supports the trial being carried out in Norway at the Oslo University Hospital and the Haukeland University Hospital, Bergen. In the dose-escalation portion, three dose levels of both the vaccines will be searched, while the dose-expansion segment will evaluate a selected dose. Furthermore, single and two doses of both vaccines will be assessed in the dose-escalation phase.

The VB10.2210 vaccine encodes a mixture of conserved and immuno-dominant T cell epitope hotspots covering various antigens of the SARS-CoV-2 virus. It encodes 96 immunogenic T cell epitopes of eight viral proteins, including Spike. According to preliminary analysis, no epitopes outside the Spike were impacted by the Omicron variant of the SARS-CoV-2 virus.

Heat Biologics to acquire Elusys Therapeutics

Heat Biologics, Inc., a clinical-stage biopharmaceutical company zeroed in on developing first-in-class therapies for modulation of the immune system, has executed a definitive merger agreement to buy Elusys Therapeutics, a commercial-stage biodefense company, and the manufacturer of ANTHIM® (obiltoxaximab) Injection, according to which Elusys will merge into a wholly-owned subsidiary of Heat. The acquisition is anticipated to close during the first quarter of 2022 and is subject to customary closing conditions. ANTHIM is approved for use in the U.S. and Canada and Europe, and the United Kingdom under the brand name Obiltoxaximab SFL.

The strategic acquisition of Elusys is planned to improve Heat’s immunotherapy portfolio and further position Heat to take a vital role in the biodefense space. The addition of ANTHIM, together with Heat’s previously announced RapidVax® platform designed for targeting emerging biological threats, would tremendously expand the company’s infectious disease product portfolio. To date, Elusys has been awarded over USD 350 million in research and development contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR), the National Institute of Allergy and Infectious Disease (NIAID), and the Department of Defense (DOD).

Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM to the U.S. Strategic National Stockpile (SNS)—the government’s repository of critical medical supplies for biowarfare preparedness. Following the closing of this acquisition, Elusys will continue to operate as a wholly-owned subsidiary of Heat. Under the terms of the merger agreement with Elusys, Heat will buy all outstanding shares of Elusys. No stock or warrants will be issued to the acquisition, and Elusys has no outstanding debt.