Agenus (AGEN) Stock News

GSK (NYSE:GSK) has received FDA approval for a new prefilled syringe presentation of SHINGRIX, its vaccine for preventing shingles. This new format eliminates the need to reconstitute separate vials before administration, streamlining the vaccination process for healthcare professionals.

The approval is based on data showing technical comparability between the new and existing presentations. SHINGRIX remains indicated for adults aged 50 years and older, and those 18 years and older with increased shingles risk due to immunodeficiency. The CDC continues to recommend two doses of the vaccine for these populations.

The prefilled syringe presentation is currently under review by the European Medicines Agency, with filing acceptance received in January 2025.

Agenus (NASDAQ:AGEN) reported significant clinical progress for its botensilimab and balstilimab (BOT/BAL) combination therapy in microsatellite-stable metastatic colorectal cancer (MSS mCRC). The expanded study of 123 patients demonstrated a 42% two-year survival rate and 20.9-month median overall survival, with a 20% objective response rate and 16.6-month median duration of response.

The FDA has agreed to a simplified two-arm Phase 3 BATTMAN trial design, waiving the need for a BOT monotherapy arm. The company plans to initiate the global registration trial in Q4 2025. The therapy showed particularly promising results in heavily pretreated patients, with those in fourth-line or later treatment showing 19% ORR and 43% two-year survival.

Agenus (AGEN) and Noetik announced a research collaboration to develop AI-powered predictive biomarkers for their immunotherapy combination BOT/BAL. The partnership leverages Noetik's OCTO virtual cell model, a 1.5B parameter foundation model trained on data from 200M tumor and immune cells. The collaboration aims to identify which patients are most likely to respond to BOT/BAL treatment, which has already been evaluated in over 1,200 patients across nine tumor types. Noetik's technology integrates spatial proteomics, transcriptomics, pathology, and clinical data to provide comprehensive tumor microenvironment insights. The BOT/BAL combination has shown promising results in both immunotherapy-resistant tumors and various cancer types. This AI-driven approach aligns with FDA priorities for advancing precision medicine in cancer care.

Agenus (NASDAQ: AGEN), a leading immuno-oncology company, has announced its Annual Shareholders Meeting will be held virtually on June 17, 2025, at 10:30 a.m. ET. Shareholders can participate by visiting www.virtualshareholdermeeting.com/AGEN2025 using their 16-digit control number from proxy materials. Registration opens at 10:15 a.m. ET. Guests can access the meeting in listen-only mode without a control number. The meeting will be available via webcast on the company's investor relations website. Shareholders of record as of April 24th, 2025, are eligible to vote, with voting assistance available through Alliance Advisors at 844-202-6561.

Zydus Lifesciences has announced its entry into the global biologics CDMO market through the acquisition of Agenus Inc.'s (NASDAQ: AGEN) U.S.-based biologics manufacturing facilities for $75 million upfront, plus $50 million in contingent payments. The deal includes two state-of-the-art facilities in Emeryville and Berkeley, California, establishing Zydus's presence in a major biotech hub. As part of the agreement, Zydus will become the exclusive manufacturer for Agenus's Phase-3 ready immunotherapy products Botensilimab and Balstilimab. The acquisition positions Zydus as a comprehensive biologics solution provider and aims to capitalize on the growing biologics CDMO market, which is projected to reach $84.9 billion by 2034, with a CAGR of 15.7% from 2025-2034.

Agenus (AGEN) has entered a strategic $141M collaboration with Zydus Lifesciences to advance their BOT/BAL immunotherapy program. The deal includes a $75M upfront payment for Agenus' biologics facilities in California, up to $50M in contingent payments, and a $16M equity investment at $7.50 per share. Zydus will launch a BioCDMO business using these facilities as U.S. flagship sites and become Agenus' first manufacturing customer. The agreement grants Zydus exclusive rights to develop and commercialize BOT/BAL in India and Sri Lanka, with Agenus receiving 5% royalties on net sales. This partnership aims to accelerate clinical development, scale manufacturing, and expand patient access to BOT/BAL cancer immunotherapy.

Agenus (AGEN) presented new translational data at ASCO 2025 demonstrating botensilimab's effectiveness in activating immune responses against microsatellite stable (MSS) colorectal cancer, which represents 85-95% of all colorectal cancers and is traditionally resistant to immunotherapy. The study shows that botensilimab-based therapy induces robust T cell immune responses within two weeks of treatment initiation. Key findings reveal that T-cells persist and expand across treatment cycles, correlating with improved clinical responses. The research, conducted in collaboration with Leuven University Hospitals, KU Leuven, and Omniscope, also found that blood-based immune markers can help identify patients most likely to respond to treatment, even before conventional imaging shows results.

Agenus (NASDAQ: AGEN) has announced it will present new data from its Phase 1 trial of botensilimab and balstilimab (BOT/BAL) combination therapy in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients at the ESMO Gastrointestinal Cancers Congress 2025. The expanded study now includes 123 patients, representing a 60% increase in patient enrollment, and will feature updated findings on clinical activity, durability of response, and both median and 2-year overall survival data.

The presentation, led by Dr. Benjamin Schlechter from Dana Farber Cancer Institute, will take place on July 4, 2025, at 3:30 PM CEST in Barcelona, Spain.

Agenus (NASDAQ: AGEN) reported Q1 2025 financial results and key updates on its botensilimab (BOT) and balstilimab (BAL) program. The company reported a net loss of $26.4 million ($1.03 per share) on revenue of $24.1 million. Cash position stood at $18.5 million, down from $40.4 million in December 2024. Key highlights include promising clinical data for BOT/BAL combination therapy in microsatellite stable (MSS) "cold tumors," with notable success in the NEOASIS study. The company achieved 100% pathological complete response in dMMR CRC patients at higher doses. Dr. Richard Goldberg joined as Chief Development Officer to advance the BOT/BAL program. Agenus plans to reduce its annual operating cash burn to below $50 million in H2 2025 and is finalizing a collaboration expected to provide substantial cash infusion. The company's cash used in operations decreased to $25.6 million from $38.2 million in the same period last year.