LEXINGTON, Mass. - Agenus Inc . (NASDAQ: NASDAQ:AGEN), an immuno-oncology company, has concluded its end-of-Phase 2 discussions with the U.S. Food and Drug Administration (FDA) regarding its BOT/BAL immunotherapy combination for treating a specific type of colorectal cancer. The FDA has agreed on the dosing regimen for the Phase 3 trial but has advised against seeking accelerated approval at this stage.
The agreed-upon dosing will involve 75mg of botensilimab (BOT) every six weeks for a maximum of four doses, combined with 240mg of balstilimab (BAL) every two weeks for up to two years. This decision follows interim Phase 2 data which showed an objective response rate (ORR) of 19.4% and a six-month survival rate of 90% for the combination at these dosages.
Despite these promising interim results, the FDA has recommended not to submit them for an Accelerated Approval, citing concerns that the observed response rates may not necessarily translate into a survival benefit. Additionally, the agency suggested Agenus may include a BOT monotherapy arm in the Phase 3 study at their discretion.
Dr. Steven O'Day, Chief Medical Officer of Agenus, expressed the company's commitment to exploring all possible avenues to make BOT/BAL available to patients, including partnerships for a successful Phase 3 trial in the U.S.
Agenus has also planned a strategic meeting with the European Regulatory Authority in Q3 2024 to discuss additional regulatory opportunities for BOT/BAL in Europe.
The company continues to investigate BOT/BAL's potential in other types of cancer, including lung, melanoma, and pancreatic cancers, with plans to present data from these studies at future medical conferences.
Botensilimab, designed to enhance immune responses against tumors, has been administered to approximately 1100 patients in clinical trials, showing responses across various late-stage cancers when used alone or with balstilimab.
Colorectal cancer is the second leading cause of cancer death in the U.S., with microsatellite stable (MSS) colorectal cancer, the form targeted by BOT/BAL, comprising about 95% of cases. The increasing incidence in younger individuals underscores the urgent need for effective treatments.
This update on Agenus' BOT/BAL program is based on a press release statement from the company.
InvestingPro Insights
Agenus Inc. (NASDAQ: AGEN) has been navigating the challenging waters of drug development with its BOT/BAL immunotherapy combination. While the recent discussions with the FDA reflect a cautious but progressive approach, investors and stakeholders may find the following data and tips from InvestingPro insightful in understanding the company's financial health and market performance.
InvestingPro Data shows that Agenus has a market cap of 165.2 million USD, indicating the size of the company in the biotechnological industry. Despite a significant revenue growth of 69.94% over the last twelve months as of Q1 2024, the company's gross profit margin stands at -37.72%, highlighting the cost challenges associated with its research and development efforts.
The company's performance in the stock market has been noteworthy with a strong return over the last three months, as indicated by a 256.74% three-month price total return. This metric may interest investors looking for companies with recent positive momentum in their share price.
InvestingPro Tips suggest that while two analysts have revised their earnings upwards for the upcoming period, showing some optimism about the company's prospects, Agenus is quickly burning through cash which may raise concerns about its long-term financial sustainability. Additionally, the company is not expected to be profitable this year, and it has been operating with a moderate level of debt.
Investors considering Agenus as part of their portfolio can find more detailed analysis and additional tips on https://www.investing.com/pro/AGEN. There are a total of 11 InvestingPro Tips available, which provide deeper insights into the company's financials, market performance, and potential risks. For those interested in gaining full access to these insights, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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