Agenus Inc. (NASDAQ: AGEN) is facing a class action lawsuit filed on behalf of investors who purchased the company's securities between January 23, 2023, and July 17, 2024. The lawsuit, led by The Portnoy Law Firm, alleges that Agenus made false and misleading statements regarding the efficacy and regulatory prospects of its immunotherapy combination, botensilimab and balstilimab.
The core of the lawsuit revolves around claims that Agenus overstated the potential of botensilimab, a CTLA-4 blocking antibody, and balstilimab, an anti-PD-1 treatment, particularly concerning their combined use. These therapies are currently under investigation in Phase 2 trials for various cancers, including pancreatic cancer, melanoma, and colorectal cancer.
The legal action highlights that Agenus allegedly failed to disclose critical information about the combination therapy's true effectiveness. Specifically, the lawsuit points to a July 18, 2024, announcement where Agenus revealed feedback from the U.S. Food and Drug Administration (FDA) regarding the use of botensilimab and balstilimab in a specific type of colorectal cancer. The FDA advised against pursuing accelerated approval based on the observed response rates, suggesting they might not translate into improved survival outcomes for patients. This announcement triggered a significant drop in Agenus' stock price, plummeting nearly 59%, according to the complaint.
The Portnoy Law Firm is encouraging affected investors to contact them to discuss their legal rights and options for recovering losses. Investors have until November 5, 2024, to file a lead plaintiff motion in the case.
Concerns Over Clinical Data
The lawsuit raises concerns about the validity of Agenus' clinical trial data and its communication to investors. The central claim is that Agenus presented an overly optimistic view of the clinical results and the potential for regulatory and commercial success of botensilimab and balstilimab. The FDA's caution against using current data for accelerated approval applications underscores these concerns.
Current Status of Botensilimab and Balstilimab
Botensilimab is Agenus' novel CTLA-4 blocking antibody, while balstilimab is an anti-PD-1 antibody. The combination is being explored in various Phase 2 trials. The outcome of the FDA's review and the subsequent lawsuit introduce uncertainty about the future development and commercialization of these therapies.
