Agenus, an immuno-oncology firm, is reshaping its strategy to prioritize its CTLA-4/PD-1 combo treatment while temporarily redirecting its unpartnered programs. This reorientation involves placing a significant emphasis on the PD-1 antibody in conjunction with the CTLA-4 antibody, known as botensilimab or BOT/BAL, following setbacks experienced with the other component, balstilimab. Agenus withdrew balstilimab from FDA consideration for cervical cancer in 2021. Now, the Massachusetts-based biotech is intensifying the development of the combination therapy, with an aim to resubmit it for regulatory review next year.
As part of this strategic shift, Agenus is also implementing workforce reductions, affecting around 25% of its employees. The company anticipates that these measures, combined with the streamlined pipeline, will generate savings of approximately $40 million. These funds can then be channeled towards expediting the progression of the lead program, BOT/BAL.
“Now is the pivotal moment to concentrate our efforts on the BOT/BAL program. The observed clinical benefit in solid tumors underscores the program’s game-changing potential, and our rapid progress towards a first filing in 2024 highlights the necessity for prioritization in every aspect of our operations. By zeroing in on BOT/BAL, we expect to expedite regulatory approval and availability for healthcare providers and patients in need. Our decision to streamline operations reflects our commitment to the success of these programs while optimizing shareholder value. We deeply value the contributions of our employees and regret the necessity of these difficult decisions. We are thankful for their dedication and hard work, and we are committed to providing support to those affected during this transition.”
– Chairman and Chief Executive Officer, Garo Armen, Ph.D
Agenus is currently placing other preclinical and clinical initiatives on hold, with an exception for partnered programs. This approach intends to optimize the allocation of resources, concentrating on aspects such as quality, manufacturing, clinical trials, regulatory affairs, and research and development, to bolster the flagship program.
The company underscored its commitment to its broader immuno-oncology pipeline, assuring that these sidelined programs could be revitalized in the future. Among Agenus’s phase 1 pipeline candidates are AGEN2373, an anti-CD137 agonist for melanoma; AGEN1423, a therapy targeting pancreatic cancer through anti-CD73; and AGEN1571, an anti-ILT2 agent for solid tumors. Collaborative efforts are ongoing, including the development of an anti-TIGIT therapy in partnership with Bristol Myers Squibb, as well as collaborations with Merck & Co., Incyte, and UroGen Pharma.
Despite Agenus’s ambition to diversify, balstilimab has encountered challenges along the way. The company initially sought accelerated approval for cervical cancer in 2021 but withdrew the application following the full approval of Merck’s Keytruda. Agenus then shifted its focus to explore more promising indications for its combination therapy, BOT/BAL. This approach is reflected in ongoing phase 2 trials for colorectal cancer and melanoma, alongside a phase 1 trial for solid tumors. Encouragingly, in May, Agenus reported positive data from a phase 1b study, indicating a 33% overall response rate in platinum-resistant or refractory ovarian cancer patients receiving the combo treatment.
