Agenus Pivots to CDMO Services Amid Regulatory Setbacks

Massachusetts biotech Agenus is undergoing its second reorganization in 16 months, pivoting to include CDMO services at its 25,000-square-foot Berkeley clinical facility and 83,000-square-foot Emeryville commercial plant for third-party biologics manufacturing.

The restructuring aims to reduce 2025 spending to USD 100 mn and cut annual external costs by 60% and focus exclusively on developing its botensilimab/balstilimab combination therapy for microsatellite stable colorectal cancer, following an FDA setback in July.

The following article originally appeared in Fierce Pharma.

For the second time in 16 months, Massachusetts biotech Agenus is reorganizing after failing to gain traction with the FDA on its PD-1 candidate balstilimab.

Last week, the immuno-oncology specialist revealed that part of the new setup will include CDMO services, as it will produce biologics for clients at its existing manufacturing sites in California.

Agenus has a 25,000-square-foot facility in Berkeley that performs clinical manufacturing. Its 83,000-square-foot plant in Emeryville conducts commercial manufacturing.

To support the reorganization, Agenus has secured a $22 million mortgage, facilitated by L&L Capital, which will fortify the company’s cash reserves.

Agenus' plan is to reduce its spending in 2025 to $100 million and to eventually cut its annual external expenditures by 60%. As part of the reorganization, the company is planning "staff reductions," it said in a Dec. 5 press release.

The biotech has several pipeline projects, but with the reorganization, it will focus solely on developing its combination therapy of botensilimab/balstilimab (BOT/BAL) in microsatellite stable (MSS) colorectal cancer (CRC). Botensilimab is Agenus’ CTLA-4 blocking antibody.

In July, when Agenus revealed that the FDA had derailed its attempt to gain an accelerated approval of BOT/BAL in the indication, its share price slid by 38%. Agenus said the FDA had discouraged the company from filing for an accelerated approval because the available data in an ongoing phase 2 trial weren't sufficient to make a case for approval.

The feedback from the regulator increased the likelihood that Agenus would have to run a phase 3 trial to pursue approval for BOT/BAL.

“BOT/BAL has exhibited exceptional clinical activity in MSS CRC and multiple other cancers resistant to existing therapies,” Agenus said in its Nov. 27 release. “Agenus is prepared to execute its late-stage development and regulatory strategy for MSS CRC, targeting both regional and global registration pathways.”

In 2021, when Agenus appeared headed for an approval of balstilimab to treat cervical cancer, its bid was trumped by Merck’s Keytruda, which scored an early expansion in the indication. According to Agenus, the Keytruda approval negated Agenus’ ability to win its potential accelerated nod, so the company withdrew its application.

In 2023, Agenus laid off 25% of its workforce and announced it was sidelining all of its pipeline projects other than its BOT/BAL combo.

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