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Agenus Reports Fourth Quarter and Full Year 2023 Results
FDA Grants Fast Track designation for BOT/BAL in metastatic, refractory colorectal cancer (CRC) patients who have failed 1st and 2nd line standard of care
About this update from Agenus Inc.
[{"type":"text","content":"\nFDA Grants Fast Track designation for BOT/BAL in metastatic, refractory colorectal cancer (CRC) patients who have failed 1st and 2nd line standard of care treatments\n\n\nData from Phase 1 of BOT/BAL in refractory CRC showed durable ORR of 24% in patients with non-active liver metastases (NLM); Completed enrollment of randomized Phase 2 trial (n=230)\n\n\nClinical data sets path for expansion opportunities in pancreas, lung, neoadjuvant CRC, and melanoma\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAgenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023.\n\n\n“In 2023, Agenus made significant advances across our BOT/BAL development program. Our first target indication is metastatic, refractory colorectal cancer that is not MSI-H/dMMR, for which we are focused on pursuing accelerated approval,” said Garo Armen, Ph.D., Chief Executive Officer. “We are also pursuing multiple strategies to capitalize the company through this important path in our efforts to bring BOT and BOT/BAL to the forefront of solid tumor cancer treatment. Our vision is to maximize BOT's utility to benefit patients in combination with other immune therapies as well as current standards of care for patients with both early and late-stage tumors.”\n\n\n2023 Highlights on Botensilimab\n\n\nColorectal Cancer:\n\n\n\nReceived Fast Track designation for patients with metastatic colorectal cancer that is not MSI-H/dMMR and who do not have liver metastases, and who were previously treated with standard combination chemotherapy, anti-VEGF and anti-EGFR if RAS wild type (“refractory MSS mCRC NLM”)\n\n\n\nCompleted enrollment of patients with refractory MSS mCRC NLM in a Phase 1 (n=150) and randomized Phase 2 (n=230) in October 2023.\n\n\n\nClinical data reported by Agenus in October 2023 revealed:\n\n\nAmong the 70 efficacy evaluable (\"EE\") patients in the refractory MSS mCRC NLM treatment setting, a 24% RECIST v1.1 response rate was observed in those treated with the BOT/BAL combination. Based on literature review, the response rate in a similar population treated with standard of care therapies ranges from 1% to 6.1%1, 2.\n\n\n\nThe 12-month overall survival (OS) rate is 74% with median O...