Welcome to our dedicated page for Agenus news (Ticker: AGEN), a resource for investors and traders seeking the latest updates and insights on Agenus stock.
Agenus Inc. (NASDAQ: AGEN) generates a steady stream of news centered on its immuno-oncology pipeline, with particular focus on the botensilimab (BOT) and balstilimab (BAL) combination. As a Lexington, Massachusetts-based biological products manufacturer focused on cancer immunotherapy, the company’s updates frequently highlight progress in clinical trials, early-access frameworks and strategic collaborations.
Many recent headlines relate to BOT+BAL’s performance in advanced solid tumors. Agenus reports data from the C-800-01 Phase 1b trial, which evaluates the combination across multiple refractory cancers, and from the global BATTMAN CO.33 Phase 3 trial in microsatellite-stable colorectal cancer conducted with the Canadian Cancer Trials Group and international academic partners. News coverage also includes peer-reviewed publications, such as results in treatment-refractory ovarian cancer, and presentations at major oncology congresses.
Another major theme in Agenus news is patient access. The company has announced that France’s medicines agency authorized a national Autorisation d’Accès Compassionnel (AAC) protocol for BOT+BAL, enabling fully reimbursed hospital-based access for eligible patients with microsatellite-stable metastatic colorectal cancer, certain ovarian cancers and soft-tissue sarcomas. Additional stories describe named-patient and early-access programs in other geographies where regulations allow.
Strategic and corporate developments also feature prominently. Agenus has disclosed a collaboration with Zydus Lifesciences involving the sale of biologics manufacturing facilities in California, an equity investment in Agenus, and an exclusive license for BOT and BAL in India and Sri Lanka, along with the creation of Zylidac Bio LLC to house the acquired U.S. manufacturing assets. Investors following AGEN news can expect updates on clinical milestones, regulatory interactions, early-access expansions, manufacturing partnerships and periodic financial and corporate communications.
Agenus (NASDAQ: AGEN) presented data at ASCO 2021, highlighting balstilimab's efficacy as an anti-PD-1 antibody and AGEN2373's favorable safety profile in a Phase 1 trial. Balstilimab demonstrated a 20% response rate in PD-L1 positive tumors and an overall 15% response rate in recurrent cervical cancer. AGEN2373 showed no liver toxicity in patients treated, reporting stable disease in 5 of 22 patients. The company submitted a Biologics License Application for balstilimab on April 19, 2021, aiming for broader therapeutic applications.
Agenus (NASDAQ: AGEN) will have its President and COO, Jennifer Buell, PhD, participating in a fireside chat at the Jefferies 2021 Virtual Healthcare Conference. This event is scheduled for June 4, 2021, from 10:30 a.m. to 10:55 a.m. ET. Interested attendees can register in advance for the webinar. A replay of the session will be made available on the Agenus Events & Presentations page following the call. Agenus is focused on immuno-oncology, developing therapies to enhance the immune response against cancer.
Agenus (NASDAQ: AGEN) announced promising data for its anti-PD-1 antibody, balstilimab, showcasing a 20% response rate in PD-L1 positive tumors and 15% overall response rate during a Phase 2 trial for recurrent/metastatic cervical cancer. The FDA accepted a Biologics License Application for balstilimab on April 19. Additionally, new Phase 1 data for AGEN2373, a CD137 agonist antibody, revealed no dose-limiting toxicities and stable disease in five patients out of 19 treated. Both findings will be presented at the ASCO Annual Meeting from June 4-8, 2021.
Agenus (NASDAQ: AGEN) announced a conference call on May 18, 2021, at 8:30 a.m. ET to discuss a global licensing agreement with Bristol Myers Squibb. This agreement marks a significant milestone for Agenus, which focuses on immuno-oncology, developing therapies to activate the immune response against cancer. Interested parties can join the call via dial-in numbers or through the live webcast accessible on the company's website. Agenus aims to enhance patient outcomes in cancer treatment through its diverse therapeutic pipeline.
Agenus has entered into a definitive licensing agreement with Bristol-Myers Squibb granting the latter a global exclusive license to AGEN1777, a bispecific antibody in late preclinical development targeting TIGIT and another undisclosed receptor. Agenus will receive a $200 million upfront payment and up to $1.36 billion in milestone payments, along with tiered royalties on sales. Bristol-Myers Squibb will lead the development and commercialization of AGEN1777, which aims to improve anti-tumor activity in non-small cell lung cancer and other high-priority tumors.
Bristol-Myers Squibb (BMY) has secured a global exclusive license for Agenus' bispecific antibody AGEN1777, targeting TIGIT. The deal entails a $200 million upfront payment and additional potential milestones totaling up to $1.36 billion, plus royalties on sales. AGEN1777, designed to enhance anti-tumor activities, is currently in late preclinical development, with an IND application expected in Q2 2021. Bristol-Myers Squibb aims to advance AGEN1777 for high-priority tumor indications like non-small cell lung cancer, highlighting its commitment to immuno-oncology.
Agenus Inc. (NASDAQ: AGEN) submitted a Biologics License Application (BLA) to the FDA for balstilimab aimed at treating recurrent/metastatic cervical cancer. The submission is based on promising clinical data showing response rates of 20% for PD-L1 positive tumors and 15% for all tumors. Additionally, data for balstilimab and AGEN2373 will be showcased at the upcoming ASCO meeting. The company also initiated a Phase 1 trial for iNKT cell therapy targeting cancer and ARDS related to COVID-19. Financially, Agenus reported a net loss of $54 million for Q1 2021.
Agenus (NASDAQ: AGEN) announced two presentations at the 2021 ASCO Annual Meeting, scheduled for June 4-8, 2021. The presentations include:
- Balstilimab: A PD-1 inhibitor with a differentiated activity profile (Abstract #5529, Gynecologic Cancer).
- AGEN2373: A first-in-human Phase I study of a CD137 agonist antibody in advanced solid tumors (Abstract #2634, Developmental Therapeutics - Immunotherapy).
Full abstracts will be released on May 19. Balstilimab is under FDA review for treating recurrent/metastatic cervical cancer.
Agenus (NASDAQ: AGEN) will release its first quarter 2021 financial results on May 6, 2021, before the market opens. A conference call and webcast will take place at 8:30 a.m. ET to discuss the results along with a corporate update. The company specializes in immuno-oncology with a focus on therapies that utilize the body's immune system to combat cancer. Agenus is headquartered in Lexington, MA, and emphasizes a diverse pipeline of treatments including checkpoint antibodies, cell therapies, and cancer vaccines.
Agenus Inc. has submitted a Biologics License Application (BLA) to the FDA for accelerated approval of balstilimab, an anti-PD-1 antibody for recurrent or metastatic cervical cancer. The submission is based on a Phase 2 trial showing a 20% response rate in PD-L1 positive tumors and a median response duration of 15.4 months. This approval could significantly enhance treatment options for women with limited therapies available. Fast Track designation was previously granted in April 2020 due to unmet medical needs.