Agenus is putting its CTLA-4/PD-1 combo treatment center stage for the time being, while hauling all other unpartnered programs up to the attic for safekeeping. The strategic prioritization will also see 25% of the biotech’s employees headed out to the curb.
The immuno-oncology company had to pull one half of the combination, balstilimab, from FDA consideration in cervical cancer in 2021. Now the Massachusetts-based biotech is accelerating the PD-1 antibody in combination with the CTLA-4 antibody botensilimab, nicknamed BOT/BAL. Agenus hopes the layoffs and pipeline narrowing will together save $40 million that can be redirected to accelerate the lead program’s development as it gears up to resubmit to regulators next year.
It means that Agenus is temporarily postponing all preclinical and clinical programs that are not related to BOT/BAL, although partnered programs will continue as planned. The company said that the plan will concentrate quality, manufacturing, clinical, regulatory and R&D resources on the flagship program.
The company was keen to stress that there was a route back for these other programs, claiming that it “remains dedicated to its deep pipeline of immuno-oncology agents and plans to reactivate these programs in the future.”
The company’s phase 1 pipeline includes the anti-CD137 agonist AGEN2373 for melanoma, pancreatic cancer anti-CD73 therapy AGEN1423 and anti-ILT2 solid tumor candidate AGEN1571. Agenus is also working on an anti-TIGIT therapy with Bristol Myers Squibb, while other partners include Merck & Co., Incyte and UroGen Pharma.
But balstilimab has always been the star—albeit a troubled one. Agenus filed it for an accelerated approval in cervical cancer in October 2021 only to withdraw the application when the market closed upon the full approval of Merck’s blockbuster Keytruda.
Agenus then pointed to other indications where combining with with botensilimab might have more luck. BOT/BAL is currently being tested in phase 2 trials for colorectal cancer and melanoma, as well as a phase 1 trial for solid tumors, according to the company’s website.
Those hopes were given another boost in May, when Agenus unveiled data from a phase 1b study showing the combo treatment had resulted in a 33% overall response rate in 24 patients with platinum-resistant or refractory ovarian cancer.
"Now is the pivotal moment to concentrate our efforts on the BOT/BAL program,” CEO Garo Armen, Ph.D., said in today's release. “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."
Editor's Note: Annalee Armstrong contributed to this story. This story was updated at 12:11 p.m. ET on Aug. 23, 2023, to clarify that balstilimab alone was pulled from FDA consideration.