LEXINGTON, Mass. - Agenus Inc . (NASDAQ:AGEN), a biotechnology company specializing in immuno-oncology, revealed clinical trial results today at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain. The Phase 1 study data indicates that the combination of botensilimab (BOT) and balstilimab (BAL), both investigational drugs, showed promising activity in treating advanced sarcomas, a cancer with few existing treatment options.
The study involved 64 patients with relapsed or refractory sarcomas, who had undergone a median of three prior lines of therapy. They received doses of 1 or 2 mg/kg of BOT in combination with 3 mg/kg of BAL. Out of 52 patients who were evaluated for efficacy with at least one 6-week imaging scan post-baseline, an overall response rate (ORR) of 23% was observed, with a median duration of response (DOR) of 21.7 months. Notably, the 12-month overall survival (OS) rate was 69%, with the median OS not yet reached.
In particular, the angiosarcoma subtype showed a 39% ORR, with a median DOR also of 21.7 months. For this subtype, the 12-month OS rate was 64%. One patient with visceral angiosarcoma achieved a response lasting beyond three years, maintained even after discontinuing therapy.
According to Dr. Breelyn A Wilky from the University of Colorado Cancer Center, the results are significant and suggest that BOT/BAL could be an important treatment for sarcoma patients, especially considering the durable responses in "cold" sarcomas, which typically do not respond well to existing therapies.
The safety profile of the BOT/BAL combination was described as manageable and reversible, with no new safety concerns identified.
Botensilimab is designed to enhance both innate and adaptive anti-tumor immune responses, potentially extending immunotherapy benefits to tumors that are generally resistant to standard therapies. Approximately 1,100 patients have been treated with botensilimab across various clinical trials.
Dr. Steven O'Day, Chief Medical Officer at Agenus, expressed optimism about the transformative potential of the drug combination for patients with refractory sarcomas and possibly other types of cancer traditionally resistant to immunotherapy.
The information presented in this article is based on a press release statement from Agenus Inc. and does not constitute an endorsement of the company's claims. The clinical trial results are part of ongoing research and have not yet led to regulatory approval.
In other recent news, Agenus Inc. has made significant achievements in its cancer treatments, botansilamab (BOT) and bostilamab (BAL). The biotechnology company reported positive Phase II trial results for BOT/BAL in treating colorectal cancer, with an overall response rate of about 20%. Despite a setback with the FDA requiring an additional Phase III study, Agenus plans to initiate a Phase III trial and explore rapid approval pathways, particularly in Europe.
B.Riley adjusted its outlook on Agenus shares, reducing the price target to $18.00 from the previous $42.00 but maintaining a Buy rating. This adjustment came after the company's second-quarter financial results for 2024 and the subsequent conference call.
Financially, Agenus disclosed a consolidated cash balance of $93.7 million and recognized revenues of $23.5 million and $51.5 million for the three and six-month periods ending June 30, 2024, respectively. However, the company reported a net loss of $54.8 million and $118.3 million for the same periods.
In addition to these developments, Agenus regained full rights to AGEN1777 and AGEN2373 and is actively seeking new partnerships for these programs. The company is also in discussions with several large biopharmaceutical companies that have substantial gastrointestinal product portfolios, which could lead to significant synergies for the BOT/BAL program.
These are recent developments in Agenus Inc.'s ongoing efforts to advance its pipeline and secure its market presence in the biotechnology industry.
InvestingPro Insights
Agenus Inc. (NASDAQ:AGEN) has recently showcased promising clinical trial results for its investigational drugs, botensilimab and balstilimab, at the ESMO Congress. As investors consider the potential impact of these developments on the company's future, it's important to look at the financial health and market performance of Agenus to gauge its investment prospects.
An InvestingPro Tip that stands out is the analysts' anticipation of a sales decline in the current year, which could be a concern for investors looking for growth. Additionally, with three analysts revising their earnings downwards for the upcoming period, there appears to be a cautious outlook on the company's near-term financial performance.
On the data front, Agenus has a market capitalization of $133.31 million, which positions it as a small-cap stock in the biotech industry. The company's price-to-earnings (P/E) ratio stands at -0.54, reflecting that it is not currently profitable. This is further underscored by the fact that Agenus has not been profitable over the last twelve months. Moreover, the company's gross profit margin is negative at -25.07%, indicating challenges in maintaining profitability.
Despite these financial challenges, Agenus has experienced a significant return over the last week, with a 19.8% price total return. This suggests that recent news, such as the clinical trial results, may have positively influenced investor sentiment. However, it's worth noting that the stock has seen a substantial decline over the past year, with a -77.19% price total return, which may reflect longer-term concerns about the company's financial health and market position.
For those considering an investment in Agenus, it's recommended to review the full range of InvestingPro Tips available on the platform, which currently lists over 15 additional insights for a comprehensive analysis.
The information provided here is a snapshot of Agenus's financial metrics and analyst expectations, which can help investors make informed decisions. For further details and expert analysis, visit InvestingPro at https://www.investing.com/pro/AGEN.
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