What happened

Shares in Agenus (NASDAQ:AGEN) are rallying 23.65% at 2:10 pm EDT today ahead of a planned oral presentation of clinical trial data at the European Society of Medical Oncology (ESMO) Conference on Sept. 18, 2020.

So what

An immuno-oncology biotech company developing compounds to help the immune system fight cancer, Agenus' most advanced drugs in development are the anti-PD-1 targeting therapy, balstilimab, and the anti-CTLA-4 antibody, zalifrelimab.

A woman in a lab coat speaking through a megaphone.


Previously, the company announced promising results for these compounds in refractory or relapsing cervical cancer and on August 26, management said a late-breaker abstract involving these antibodies has been accepted for oral presentation at the high-profile ESMO conference.

Because oral presentations are typically reserved for particularly important discoveries, investors are optimistic that data to be announced at the conference will increase the likelihood of balstilimab and zalifrelimab securing Food and Drug Administration (FDA) approval someday. 

For perspective, early results reported so far include a 26% response rate to balstilimab and zalifrelimab combination therapy, exceeding the 10% to 15% response rate historically observed when using currently approved therapies in the second-line cervical cancer indication.

Now what

Agenus plans to initiate a rolling-FDA application for balstilimab's approval before the end of 2020; a filing for its use in combination with zalifrelimab could follow depending on discussions with regulators.

There's no guarantee data to be presented at ESMO will impress attendees or that the FDA will eventually sign off on these drugs, but there's significant potential if regulators cooperate. The market for anti-PD-1 therapy is worth over $20 billion per year, and combination therapies represent a significant opportunity to improve efficacy and garner greater market share. Because Agenus is developing its own PD-1 for use alongside its anti-CTLA-4 drug, it could eventually pull in meaningful revenue, especially if the combination can be used in other larger indications.

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