LEXINGTON, Mass. - Agenus Inc . (NASDAQ: NASDAQ:AGEN), an immuno-oncology company, has released updated results from its Phase 1 clinical trial evaluating a novel combination therapy for patients with metastatic colorectal cancer (CRC) that is neither microsatellite instability-high (MSS) nor deficient mismatch repair (dMMR). The trial results showed a 71% overall survival rate at 12 months and a 62% rate at 18 months.
The study involved 77 patients with refractory MSS-CRC who did not have active liver metastases. During the trial, these patients demonstrated a 23% overall response rate (ORR) to the combination therapy of botensilimab and balstilimab (BOT/BAL). The median duration of response among the 18 responders has not been reached, with a median follow-up of 13.6 months as of March 1, 2024. The median overall survival (OS) was reported at 21.2 months.
Following the completion of enrollment for the Phase 2 trial of BOT/BAL, Agenus is planning to discuss the interim results with the U.S. Food and Drug Administration (FDA). The company anticipates submitting a Biologics License Application (BLA) for the therapy later this year.
Chief Medical Officer of Agenus, Dr. Steven O'Day, emphasized the potential of BOT/BAL in treating metastatic CRC, which is the second leading cause of cancer mortality in the United States. Agenus aims to present detailed Phase 2 efficacy results, including response durability and updated Phase 1 survival data, at a major medical conference in the latter half of 2024.
Agenus' pipeline includes a range of immunological agents designed to combat cancer and infectious diseases through combination approaches. The company is headquartered in Lexington, Massachusetts, and continues to focus on expanding the patient population benefiting from cancer immunotherapy.
The information provided is based on a press release statement.
InvestingPro Insights
As Agenus Inc. (NASDAQ: AGEN) makes strides in its clinical trials, the financial health of the company remains a crucial factor for investors. According to InvestingPro, Agenus is currently facing several financial challenges. The company's stock has experienced significant volatility, with a notable decline over the last week and month, reflecting a -7.58% and -30.44% price total return respectively. This is consistent with a broader trend, as the stock has seen a -54.36% price total return over the last six months.
InvestingPro Tips indicate that Agenus is quickly burning through cash and suffers from weak gross profit margins, with a -52.05% gross profit margin for the last twelve months as of Q4 2023. This financial metric is particularly relevant as the company is gearing up for further discussions with the FDA and potential BLA submission, which could entail significant additional costs. Moreover, analysts do not anticipate Agenus will be profitable this year, and the company does not pay a dividend to shareholders, which might be a concern for income-focused investors.
Despite these financial headwinds, Agenus' recent clinical trial results offer a glimmer of hope for the company's therapeutic pipeline. Investors interested in the biotech sector might consider these developments alongside the financial data when assessing Agenus' potential. For a deeper dive into Agenus' financial health and future prospects, readers can explore additional InvestingPro Tips, with a total of 11 tips available, which provide a comprehensive analysis of the company's financial position. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
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