Agenus Announced Data from Phase 2 Trials of Balstilimab
Agenus (AGEN) immuno-oncology company announced that data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab will be orally presented in at the upcoming European Society of Medical Oncology (ESMO) Conference on September 18, 2020.
The data will be presented by Dr. David O’Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology at the James Cancer Hospital of The Ohio State University Comprehensive Cancer Center.
The Abstract Title
- Single-agent Anti-PD-1 Balstilimab or in Combination with Anti-CTLA-4 Zalifrelimab for Recurrent/Metastatic (R/M) Cervical Cancer (CC). Preliminary Results of Two Independent Ph2 Trials [LBA34].
- Session: Gynecological cancers.
- Date: September 18, 2020.
Agenus said it remains on track towards the initiation of rolling BLA submission for balstilimab monotherapy this quarter.
Agenus also plans to have a completed data packet supporting BLA submission of balstilimab in combination with zalifrelimab by the end of this year.
We remind that the Agenus pipeline today differs from the one that existed when we picked this firm in 2011. The pipeline now comprises checkpoint antibodies and cell therapy that made immunotherapy possible in 2011 when it had only adjuvants and vaccines. The products aim at boosting the immune response against cancers and infections.
Of the antibodies, Balstilimab (AGEN2034) is a fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2. The product has demonstrated clinical activity in patients with advanced or refractory cancer. This Agenus PD-1 blocker is in clinical trials as a monotherapy and in a combination with Agenus CTLA-4, AGEN1884, which is currently in Phase 1/2, open-label, a multi-arm trial that investigates the safety, tolerability, pharmacokinetics, biological and clinical activity of the product in patients with metastatic or locally advanced solid tumors including refractory cervical cancer.
Agenus announced that in April 2020 the anti-CTLA-4 antibody in combination with the anti-PD-1 antibody achieved 14 positive clinical responses in 55 patients with second-line cervical cancer (~26% ORR with ~12-month follow-up).
Agenus controls worldwide rights to Balstilimab (AGEN2034) except for certain South American rights which are controlled by Recepta Biopharma, and Greater China rights which are exclusively licensed to Betta Pharmaceuticals.
Prohost Biotech picked Agenus at $6.64 on March 18, 2011. In spite of the company’s walking in place, yearly losses and failures to thrive in all the years since 2011, we held onto it. We rather preferred to keep it in the Prohost Portfolio, especially when we observed it was making outstanding deals which handed the firm checkpoint monoclonal antibody blockers, the technological capability to create and design them and the immune checkpoints to be used as the newly discovered targets.
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