Agenus Inc. Provides Corporate Update for Balstilimab (Anti-PD-1), Agen1181, Agen1777 (Anti-Tigit Bispecific) and iNKTs
March 15, 2021 at 07:45 am EDT
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Agenus Inc. provided a corporate update. Balstilimab (anti-PD-1): Balstilimab accelerated approval in second line cervical cancer expected to be a significant milestone in the transition to a commercial company and a key inflection point for Agenus’ combinations strategy both with its own pipeline agents and with partnered products; Balstilimab shows differentiation from commercial PD-1s and achieves response rates of 19% in PD-L1 positive tumors with 14% in all tumors (PD-L1 positive and negative) and a median duration of response of 15.4 months in a Phase 2 trial. Data presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and in an Oncogene editorial; Balstilimab + zalifrelimab Phase 2 trial in second line cervical cancer achieves response rates of 27% in PD-L1 positive tumors with 22% in all tumors (PD-L1 positive and negative) with a median duration of response not yet reached; data presented at ESMO 2020. Responses continue to improve as data matures; Discussions with the FDA regarding accelerated BLA filing for balstilimab plus zalifrelimab ongoing; additional guidance and updated response rate data to be provided upon FDA acceptance of balstilimab monotherapy BLA. AGEN1181: As of the company's February 9th report, six confirmed objective clinical responses were achieved in Phase 1/2 trial of AGEN1181 out of 46 evaluable patients: 1 confirmed response among 24 treated with monotherapy, and 5 confirmed responses among 22 treated with AGEN1181 in combination with balstilimab; New clinical data to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021; Optimized Fc-enhanced design differentiates AGEN1181 as a more active next-generation anti-CTLA-4; Responses seen in patients who do not generally respond to first-generation anti-CTLA-4 due to a genetic polymorphism, thus potentially expanding benefit to 3x more patients; Further, responses seen in cold tumor settings (microsatellite stable) and in indications that are generally not responsive to immunotherapy, including colorectal, endometrial, and ovarian; No complement-mediated toxicities typically seen with first-generation anti-CTLA-4 agents; First anti-CTLA-4 to demonstrate clinical depletion of Tregs, immunosuppressive T cells whose depletion can allow for an improved antitumor immune response; Phase 2 trial in colorectal cancer initiated; registrational trials targeted to commence in 2021 with focus on indications enabling a rapid path to BLA filing. AGEN1777 (Anti-TIGIT bispecific): Superior antibody candidate for bispecific targeting and Fc enhancement, designed for best-in-class performance; Optimized antibody designed to improve upon limited monotherapy activity of other anti-TIGITs; Potential to broaden clinical benefit to additional 40% of patients versus other TIGIT antibodies by expanding benefit to patients with a genetic polymorphism; Bispecific design enables dual blockade of tumor growth, cutting off a potential cancer escape mechanism to TIGIT blocking; IND planned for the second quarter of 2021; Phase 1 study to commence in the third quarter. iNKTs - Intelligent cell therapy: Trial underway in patients with COVID-19; cancer trials to commence in 1H 2021. Preliminary Phase 1 data suggest iNKTs can be dosed with no safety concerns and may demonstrate early signals of activity. Trial expansion is underway; Dose escalation expected to be completed in the first half of 2021 for initiation into a Phase 2 trial; Dosing in Phase 1 study to treat hematologic cancers and solid tumors expected to commence in the first half of 2021. Partnered program MK-4830: Phase 2 initiated; milestone received. MK-4830 (antibody targeting ILT4 licensed to Merck) advanced into Phase 2 in patients with PD-L1 positive advanced non-small cell lung cancer. $10M milestone payment received; Agenus is eligible for up to an additional $85M in potential milestone payments plus royalties. Agenus retains 90% of all milestones from Merck and 67% of future royalties under its Royalty Purchase Agreement with XOMA LLC. MK-4830 positive Phase 1 data presented at ESMO 2020.
Agenus Inc. is an immuno-oncology (I-O) company targeting cancer and infectious diseases with a pipeline of immunological agents. It is specialized in developing therapies to activate the body's immune system against cancer and infections. Its pipeline includes immune-modulatory antibodies, adoptive cell therapies (via MiNK Therapeutics, Inc.), and vaccine adjuvants (via SaponiQx, Inc.). Its primary focus is I-O, and its diverse pipeline is supported by its in-house capabilities, including current good manufacturing practice (cGMP) manufacturing and a clinical operations platform. Its most advanced antibody candidates are botensilimab (a multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody (AGEN1811)) and balstilimab (a programmed death receptor-1 (PD-1) blocking antibody). Its pipeline includes several classes of immunotherapies: checkpoint inhibitors, immune activators, and tumor microenvironment conditioning agents.