Clinical development of the anti-FAS ligand monoclonal antibody M3T01 for treatment of advanced cancers

The National Cancer Institute awarded Gamma Biotherapeutics, Inc. (doing business as Straterx Inc.) $979,068 on August 11, 2026, under the Cancer Treatment Research program (CFDA 93.395) to conduct the first-in-human Phase I clinical trial of M3T01, a fully-human monoclonal antibody that blocks Fas ligand to prevent tumor-specific T cell destruction in patients with advanced solid tumors.

The award funds evaluation of M3T01 safety, tolerability, and dose-limiting toxicity when administered as monotherapy and in combination with systemic therapies in adults with advanced solid tumors. The study will include clinical and laboratory testing to assess treatment side effects and will evaluate the drug's pharmacokinetics and pharmacodynamics. M3T01 has completed GLP toxicology testing showing no drug-related toxicity, GMP manufacturing, and received FDA approval of its investigational new drug (IND) application prior to award.

Performance occurs in Portland, Oregon 97229. The period of performance runs through July 31, 2028. This is a Project Grant, an assistance type under the Small Business Innovation Research (SBIR) program component of Cancer Treatment Research, which supports development and clinical testing of improved cancer treatment methods including molecularly targeted therapies and biological therapy in both fundamental and applied research settings.

Abstract

The development of modern immunotherapies has revolutionized the treatment of patients with advanced cancer. Unfortunately, these therapies fail to help the majority of patients battling cancer. The lack of efficacy of these therapies is due, in part, to cell death of tumor-specific t cells. Tumor-specific t cells are triggered to undergo cell death (apoptosis) through interaction with FAS ligand (fasl) encountered within the tumor microenvironment. The long-term objective of this project is to advance the clinical development of our novel potent therapeutic monoclonal antibody (M3T01) that blocks fasl to prevent the destruction of tumor-specific t cells. This therapy is intended to promote t cell survival and facilitate effective antitumor immunotherapy. Currently, there are no fasl inhibitors approved for clinical use. To address this unmet clinical need, we have developed a fully-human IGG4/kappa monoclonal antibody (M3T01) that has picomolar binding affinity and potent inhibition of fasl. GLP toxicology testing of M3T01 showed no drug related toxicity and GMP manufacturing of M3T01 has been completed. Our IND application has been approved by the FDA and we are ready to begin clinical testing of M3T01. The purpose of this grant application is to support the first-in-human phase i clinical trial of M3T01 in patients with advanced cancer. This will be accomplished through completing the following specific aims: 1) evaluate the safety, tolerability, and dose-limiting toxicity (DLT) of M3T01 administered as monotherapy and in combination with systemic therapies in adults with advanced solid tumors. Patients treated in our phase i clinical trial will undergo clinical and laboratory testing to evaluate for side effects caused by M3T01. 2) evaluate the pharmacokinetics (PK) and pharmacodynamics of M3T01 in adults with advanced solid tumors. Blood and tumor biopsy specimens will be collected from patients treated on the clinical trial to measure blood levels of M3T01 and evaluate for physiologic changes caused by M3T01. 3) evaluate the antitumor activity of M3T01 administered as monotherapy and in combination with systemic therapies in adults with advanced solid tumors. Patients treated on the clinical trial will undergo CT and MRI scans to evaluate for efficacy of therapy with M3T01 administered as monotherapy and in combination with other systemic therapies. Through the successful completion of these aims, we will generate a comprehensive data set that includes characterization of the safety, tolerability, pharmacokinetic profile, immunogenicity, and preliminary clinical efficacy of the fasl inhibitor M3T01. These data will serve as a critical catalyst to attract venture capital investment, facilitate series a funding, and form a partnership with a pharmaceutical company to further CO- develop and commercialize M3T01 for the treatment of patients with advanced cancers.