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Agenus Corporate Update and Fourth Quarter & Full Year 2020 Financial Report
Completion of balstilimab BLA filing on target for 1H 2021New clinical data for AGEN1181 to be presented at AACRTIGIT bispecific AGEN1777 IND to be filed in
About this update from Agenus Inc.
[{"type":"text","content":"Completion of balstilimab BLA filing on target for 1H 2021New clinical data for AGEN1181 to be presented at AACRTIGIT bispecific AGEN1777 IND to be filed in 2Q 2021iNKT cell therapy cancer trials to commence in 1H 2021 LEXINGTON, Mass., March 15, 2021 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today provided a corporate update and reported financial results for the fourth quarter and full year 2020. “2020 was a pivotal year for Agenus, marking the beginning of our transition to a commercial company with the initiation of our rolling BLA filing for balstilimab monotherapy. We also reported positive data on multiple programs,” said Garo Armen, PhD, Chief Executive Officer of Agenus. “We expect 2021 to be even more impactful, with the expected completion of our balstilimab monotherapy BLA filing in the first half. This filing, followed by an anticipated commercialization, will provide a solid foundation to support the development of our next-generation pipeline. Our best-in-class pipeline reveals true differentiation potential, notably our next-generation anti-CTLA-4 AGEN1181 and our anti-TIGIT bispecific AGEN1777.” Balstilimab (anti-PD-1): BLA completion expected in first half of 2021 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 productsBalstilimab 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 editorialBalstilimab + 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 maturesDiscussions with the FDA regarding accelerated BLA...