LEXINGTON, Mass. - Agenus Inc . (NASDAQ:AGEN), an immuno-oncology company, announced today that it has scheduled a key regulatory meeting with the U.S. Food and Drug Administration (FDA) for July to discuss the development of its combination cancer therapy.
The meeting will address the results of botensilimab and balstilimab (BOT/BAL) studies for patients with certain types of metastatic colorectal cancer and will also cover the requirements for a future biologics license application (BLA).
The FDA has previously granted BOT/BAL fast track designation in April 2023, acknowledging the potential of this therapy for metastatic microsatellite stable colorectal cancer (MSS CRC) without active liver metastases—a subgroup that typically has limited treatment options and poor outcomes.
Steven O’Day, M.D., Chief Medical Officer of Agenus, stated that the upcoming meeting signifies a critical milestone in advancing BOT/BAL for this challenging cancer subtype. The company's Phase 1 and Phase 2 studies have provided insights into the therapy's potential efficacy.
Botensilimab is an antibody designed to enhance the body's immune response against tumors, including those that are typically resistant to existing immunotherapies. When used in combination with Agenus’s PD-1 antibody, balstilimab, the treatment has demonstrated clinical responses in various late-stage cancers.
Agenus has treated approximately 900 patients with botensilimab across different clinical trials. The company plans to present Phase 2 data at a major medical conference later this year and continues to investigate the combination therapy's potential in other cancer types.
Agenus is focused on developing a broad portfolio of therapies for cancer and infectious diseases, including antibodies, cell therapies, and adjuvants. Its mission is to broaden the range of patients who can benefit from immunotherapy.
This announcement is based on a press release statement from Agenus Inc.
InvestingPro Insights
Agenus Inc. (NASDAQ:AGEN) is navigating a pivotal period as it prepares for a key FDA regulatory meeting. The company's dedication to advancing cancer treatments is mirrored in its aggressive research and development efforts. Yet, the financial health of Agenus is an essential aspect to consider for investors tracking the company's progress. According to real-time data from InvestingPro, Agenus has a market capitalization of $226.37 million, reflecting its standing in the biotech industry. Despite a significant revenue growth of nearly 70% over the last twelve months as of Q1 2023, the company's gross profit margin stands at -37.72%, indicating challenges in translating sales into profitability.
InvestingPro Tips highlight that analysts have recently adjusted their earnings expectations upwards for the upcoming period, which could signal confidence in Agenus's future performance. However, it's worth noting that Agenus is quickly burning through cash, and its short-term obligations exceed its liquid assets. These financial pressures, combined with the fact that analysts do not anticipate the company will be profitable this year, underscore the importance of strategic financial management for Agenus moving forward. Furthermore, the company's stock has experienced volatility with a significant hit over the last week, yet it also showed a strong return over the last month.
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