NEW YORK – Incubator firm Invenshure this week said it has launched a new precision oncology company called MEKanistic Therapeutics, which is developing a new class of molecules that can block both EGFR and PI3K pathways. Preclinical studies have suggested that the company's lead agent, MTX-531, has a better efficacy and safety profile than currently marketed targeted drugs. The company, which has a specific focus on KRAS-mutant cancers, will launch its first round of funding soon to advance MTX-531 toward investigational new drug application-enabling studies. The Ann Arbor, Michigan-based company hopes to start Phase I trials next year, initially focusing on head and neck cancers and then expand into colon, esophageal, pancreatic, and certain breast cancers.
Hutchmed said this week that the Health Commission and Medical Products Administration of Hainan Province has approved Tazverik (tazemetostat) for certain sarcoma and lymphoma patients in the Hainan Boao Lecheng International Medical Tourism Pilot Zone. The approval makes the drug available in this specific region of China for patients with advanced epithelioid sarcoma; relapsed or refractory follicular lymphomas harboring EZH2 mutations; or relapsed or refractory follicular lymphoma without alternative treatment options. The Hainan Pilot Zone in China is a destination for international medical tourism. The drug is also approved in the US for the same patient population.
Iaso Bio and Innovent said this week that the China National Medical Products Administration (NMPA) has accepted a new drug application for the firms' jointly developed CAR T-cell therapy equecabtagene autoleucel as a treatment for relapsed or refractory multiple myeloma. The treatment is directed at the B-cell maturation antigen on the surface of multiple myeloma cells and is the first BCMA-targeting CAR T-cell therapy for which the NMPA has accepted a new drug application.
The US Food and Drug Administration this week granted fast track designation to PDS Biotech's HPV-specific immunotherapy PDS0101 in combination with Merck's Keytruda (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. The combination is currently being studied in a Phase II trial in this patient population. Initial data from that trial showed a 41 percent response rate among 17 evaluable patients who received PDS0101 and Keytruda.
The Global Coalition for Adaptive Research this week opened enrollment in Europe for its GBM AGILE platform trial exploring multiple drugs in glioblastoma patients, including those with MGMT methylated and unmethylated tumors. The first site enrolling patients in Europe is University Hospital Zurich in Switzerland. The trial is currently studying three drugs in newly diagnosed and recurrent glioblastoma: Bayer's Stivarga (regorafenib), Kazia Therapeutics' PI3K inhibitor paxalisib, and Kintara Therapeutics' VAL-083. In Q2, the trial will expand to include two more drugs, troriluzole from Biohaven Pharmaceuticals and VT1021 from Vigeo Therapeutics. There are more than 40 sites in the US and Canada participating in the trial, and GBM AGILE is expected to expand to China later this year.
Grail and Ochsner Health said this week that they have partnered to improve cancer detection rates in Louisiana. Under the three-year program, Ochsner, through a collaboration between its Ochsner Cancer Institute and Precision Medicine program, will offer Grail’s Galleri multi-cancer early detection (MCED) liquid biopsy test to eligible patients in Louisiana. Ochsner researchers will also begin enrolling people age 50 or older in the ongoing PATHFINDER 2 study, a prospective, multi-center interventional study of the Galleri test that aims to enroll 20,000 participants through healthcare systems in North America. In addition, the organizations will identify educational gaps and access barriers to cancer screening, develop patient education materials, and reach out to communities about early cancer detection. The partnership also includes the launch of the MCED Health Equity Demonstration Program, which aims to improve cancer detection rates in underserved populations in Louisiana and develop a deployment model for innovative technologies in community settings.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.