Seema Khaneja MD
Updated on: October 11, 2024 4:32 am GMT
At this year’s European Society for Medical Oncology (ESMO) Congress held in Barcelona, Agenus Inc. unveiled promising findings from a Phase 1 clinical trial investigating the efficacy of two investigational drugs, botensilimab (AGEN1181) and balstilimab (AGEN2034), for patients with refractory metastatic sarcoma. This is particularly noteworthy given the limited treatment options available for this aggressive cancer.
Clinical Study Highlights
The Phase 1 study, identified by the clinical trial number NCT03860272, focused on a cohort of 64 patients diagnosed with relapsed or refractory sarcomas. These individuals had previously undergone a median of three lines of therapy before participating in this trial. Participants were administered doses of either 1 or 2 mg/kg of botensilimab in combination with 3 mg/kg of balstilimab.
Efficacy Results
Among the 52 patients evaluated for treatment efficacy, the study revealed an overall response rate (ORR) of 23%, with the median duration of response (DOR) extending to an impressive 21.7 months. The 12-month overall survival (OS) rate was documented at 69%, although the median OS has not yet been reached for the studied population.
Specific subtypes of sarcoma received particular attention. For instance, the angiosarcoma subtype exhibited a notable ORR of 39%, also maintaining a DOR of 21.7 months. Among angiosarcoma patients, the 12-month OS rate was recorded at 64%. One participant with visceral angiosarcoma achieved a response lasting over three years, which persisted even after the cessation of therapy.
Expert Commentary
Dr. Breelyn A. Wilky, director of Sarcoma Medical Oncology at the University of Colorado Cancer Center, emphasized the significance of these results. “These findings suggest that the combination of botensilimab and balstilimab could be an important new treatment avenue for sarcoma patients, especially considering their promising durability in cases typically resistant to therapy,” she stated.
The safety profile of the combined therapy was reported as manageable with no new safety concerns emerging from the study. Botensilimab is designed to enhance both innate and adaptive immune responses, which could potentially extend the benefits of immunotherapy to tumors that typically resist conventional treatments.
Company Overview and Future Outlook
Agenus, a clinical-stage biotechnology company, specializes in developing immunotherapies for cancer treatment. As of the latest updates provided during the ESMO Congress, approximately 1,100 patients have been treated with botensilimab in various clinical studies. Dr. Steven O’Day, Chief Medical Officer at Agenus, expressed optimism about the combined therapy’s potential, suggesting it could transform treatment for patients with refractory sarcomas and potentially extend to other cancers historically resistant to immunotherapy.
While the results from the trial are promising, it is crucial to note that they are part of ongoing research and will not immediately lead to regulatory approval.
Financial Context and Market Position
In tandem with the latest clinical results, Agenus reported a consolidated cash balance of $93.7 million. The company recognized revenues of $23.5 million and $51.5 million for the three-month and six-month periods ending June 30, 2024, respectively. However, it also posted a significant net loss of $54.8 million for the same three-month period, and $118.3 million for the first half of the year, highlighting the ongoing financial challenges that the company faces.
The financial landscape for Agenus is further complicated by updated analyst projections. B. Riley recently adjusted its price target for Agenus shares from $42.00 to $18.00, retaining a Buy rating despite the reduction. Analysts anticipate a decline in sales this year and have noted that three analysts revised their earnings expectations downward, which signals a cautious outlook on the company’s near-term financial performance.
Recent Developments
In addition to the Phase 1 study results, Agenus has made considerable progress regarding its other investigational therapies. The company reported positive Phase 2 trial results for the combination of botensilimab and balstilimab for colorectal cancer, achieving an ORR of approximately 20%. Following FDA recommendations for an additional Phase 3 study, Agenus plans to initiate this trial while also seeking potential rapid approval pathways, particularly in European markets.
Furthermore, Agenus has regained full rights to two of its drugs, AGEN1777 and AGEN2373, and is actively pursuing partnerships with larger biopharmaceutical firms, particularly those with established gastrointestinal product portfolios. Such collaborations could create significant synergies for the BOT/BAL program.
Although Agenus faces financial hurdles, the unveiling of promising trial results may lead to an increase in investor confidence, as evidenced by a recent 19.8% price total return despite a substantial 77.19% decline in share value over the past year.
Investor Considerations
For investors evaluating the potential impact of Agenus’s recent progress, it is essential to consider the company’s comprehensive financial metrics, including a current market capitalization of $133.31 million. The company’s price-to-earnings (P/E) ratio of -0.54 reflects ongoing challenges in profitability, as Agenus has not reported a profit over the last twelve months.
In light of recent developments, prospective investors are advised to conduct thorough research. Resources such as InvestingPro may provide valuable insights and a broader perspective on Agenus’s market position and financial health.
Agenus is making exciting progress in cancer treatment, especially with their BOT/BAL combination. This could be a big step forward for treating hard-to-treat cancers, but we will need more studies and reviews to confirm how well it works.
