Agenus Sets Sights on New California Site Near Genentech

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Agenus, an immuno-oncology company based out of Lexington, Mass., has purchased a 120-acre plot of land near Genentech’s manufacturing facility in Vacaville, Cali. The lot, which sold for $18 million by master-planned community builder A.G. Spanos, is expected to hold Agenus’ upcoming 400,000-sqaure foot facility.

Back in 1994, Genentech acquired its site near Agenus’ new parcel and completed construction on its manufacturing facility during the late 1990s. 

Agenus’ new lot is also near Kaiser Permanente's Vacaville Medical Center. Previously, Vacaville played home to a manufacturing facility for Novartis AG, but this site shuttered in 2015. A Johnson & Johnson plant also called Vacaville home before shutting down complete in 2019.

In addition to putting down millions of dollars for the new facility, Agenus recently announced it closed a $200 million upfront collaboration with Bristol Myers Squibb (BMS). The terms of the agreement saw Agenus receiving a $200 million upfront payment from BMS in exchange for the former company’s proprietary bispecific antibody program AGEN1777, as well as the FDA Investigational New Drug (IND) application clearance for the candidate. 

AGEN1777 is currently in late preclinical development and is being tested to target inhibitory receptors expressed on NK and T cells for the purposes of improving antitumor activity. According to a statement made on the collaboration, BMS has agreed to move ahead the research and development of the agent in immune-oncology for high priority tumor indications, such as non-small cell lung cancer. 

The two companies plan to begin Phase I dosing for AGEN1777 sometime in the third quarter of this year. The dose-escalation study will assess the safety, tolerability and preliminary clinical activity of the single agent as well as in combination with PD-1 inhibitor in advanced solid tumors.

“TIGIT is becoming an increasingly important immunotherapy target, and the Fc-enhanced and bispecific design of AGEN1777 could offer improved benefit, including the potential for both single-agent and combination activity,” according to a statement made by Agenus’ chief executive officer, Garo Armen, Ph.D. “Together with our partner Bristol Myers Squibb, we look forward to advancing this agent into clinical studies with the goal of providing a meaningful new option for cancer patients.”

Concurrent with its work on AGEN1777, Agenus has also made recent strides in its anti-PD-1 antibody balstilimab. The company announced in June the FDA had accepted the company’s Biologics License Application for the antibody designed to treat recurrent or metastatic cervical cancer that has progressed with or after chemotherapy.

At the American Society of Clinical Oncology (ASCO) Annual Meeting 2021 in June, Agenus presented differentiated activity of balstilimab as an anti-PD-1 antibody. A Phase II trial featuring patients with recurrent of metastatic cervical cancer showed a 20% response rate in PD-L1 positive tumors as well as an overall response of 15%. The median duration of response to therapy was 15.4 months.

The FDA granted Priority Review to the balstilimab submission, indicating its belief that it could offer “significant improvements” in the safety or efficacy of therapies for serious diseases, if approved. Agenus reported the FDA set a target action date on the approval for December 16, 2021.

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