Agenus Strategic Decision to Withdraw the BLA for Balsitilimab

Agenus to Withdraw BLA for Balstilimab

Agenus (AGEN) announced a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor. The firm stated that its decision will not change the development plans for balstilimab with regard to its combination with AGEN1181, which will be launched in multiple tumor types.

Following the full approval of pembrolizumab, which was announced four months earlier than the FDA goal date, the U.S. FDA no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw. The BLA submission for balstilimab received Fast Track and Priority Review designation from the FDA with a target action date of December 16, 2021.

Concurrent with the withdrawal, Agenus will discontinue its ongoing confirmatory trial (BRAVA) in this population, which is expected to reduce R&D expenses by over $100M.

Given the clinical benefit demonstrated by balstilimab, Agenus plans to launch expanded access programs to give patients and doctors access to balstilimab in several countries, including the US, pending regulatory processes.

From Agenus

Garo Armen, CEO and Chairman of Agenus, said, “While the commercial market for balstilimab monotherapy in second line cervical cancer was always anticipated to be small, Agenus’ priority remains developing balstilimab as a necessary component of highly effective and affordable combination therapies, both with its own portfolio and with partners, including in combination with Agenus’ next-generation CTLA-4, AGEN1181.

Steven O’Day, MD, Chief Medical Officer of Agenus, said, “Balstilimab has demonstrated meaningful clinical activity and an excellent safety profile in second-line cervical cancer, including in PD-L1 negative patients, who are ineligible to receive standard of care anti-PD-1 therapy, which makes the decision to withdraw so difficult for us. Balstilimab remains a critical component of our combination regimens, including with our next-generation CTLA-4 agent, AGEN1181. Concomitant with presentation of new data at SITC next month, we continue to accelerate development of AGEN1181 in combination with balstilimab in trials designed to rapidly support full or accelerated approval in multiple tumor types.”

Prohost Observations

Upon learning about Agenus’ decision to withdraw its BLA for balstilimab, investors tried and succeeded in causing a selloff of the stock in pre-trading and trading hours. The stock lost around 23% as a result. It seems investors might have forgotten about the firm’s announcement on October 12th in which it was stated that Agenus will receive $20 million cash payment with the dosing of the first patient with AGEN1777, an Fc-enhanced bispecific anti-TIGIT antibody.

In the same October 12th press release, Steven O’Day, MD, Chief Medical Officer of Agenus, stated that, “AGEN1777 represents Agenus’ latest innovation to activate the immune system against cancer and combat therapeutic resistance, as well as the firm’s fifth pharmaceutical collaboration to reach clinical development.”

The Phase 1 dose escalation study of AGEN1777 is designed to evaluate the safety, tolerability, and preliminary clinical activity of the product as a single agent and in combination with a PD-1 inhibitor in patients with advanced solid tumors. The first patient was treated at Providence Cancer Institute by Dr. Rachel Sanborn. The trial will follow a standard dose-escalation design and will be used to establish the recommended Phase 2 dose. 

We also learned that Bristol Myers Squibb (BMY) intends to advance the research and development of AGEN1777 for high priority tumor indications including non-small cell lung cancer and that the global license agreement with Bristol Myers Squibb included a $200 million upfront payment paid in July 2021, and up to $1.36 billion in development, regulatory and commercial milestones in addition to tiered double-digit royalties on net product sales.

And, furthermore, that although Bristol Myers Squibb is solely responsible for the development and commercialization of AGEN1777 and its related products worldwide, Agenus retains options to conduct under the development plan a combination studies with certain other Agenus pipeline assets, to co-fund global development for increased US royalties, and to co-promote AGEN1777 in the US upon commercialization.

AGEN1777 is a potentially first-in-class bispecific anti-TIGIT antibody engineered with an enhanced Fc region for high binding affinity and improved T and NK cell activation.

AGEN is trading now at $4.02.

Does this decline in price offer an opportunity for a bargain?

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