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Agenus Inc. (NASDAQ: AGEN) is a pioneering clinical-stage immuno-oncology company headquartered in Lexington, Massachusetts. Agenus is steadfast in its mission to develop innovative immunological therapies aimed at leveraging the body's immune system to combat cancer and other diseases. The company’s diverse product pipeline includes immune-modulatory antibodies, adoptive cell therapies through its subsidiary MiNK Therapeutics Inc., and vaccine adjuvants through its subsidiary SaponiQx Inc. These products are bolstered by in-house capabilities such as current good manufacturing practice (cGMP) manufacturing and a clinical operations platform.
Agenus has developed several key product candidates, including botensilimab (AGEN1811), a next-generation Fc-engineered CTLA-4 antibody, and balstilimab, a PD-1 antibody. They are currently under investigation for their potential to treat various cancers, particularly difficult-to-treat solid tumors.
The company has achieved significant milestones, including the initiation of various clinical trials for botensilimab and balstilimab. Notably, in April 2024, Agenus announced a one-for-twenty reverse stock split of its issued and outstanding common stock to increase its stock price and meet Nasdaq Capital Market listing requirements. This move is part of a strategic plan to enhance future financing and qualify for inclusion in the Russell Indices.
In its ongoing pursuit of innovative cancer treatments, Agenus recently announced Phase 1 trial results demonstrating encouraging survival rates in patients with metastatic colorectal cancer. The Phase 2 data is expected to be submitted to a major medical conference in the latter half of 2024.
Agenus also engages in strategic partnerships to accelerate its development programs. For instance, a recent agreement with Ligand Pharmaceuticals secures a $100 million capital infusion, specifically aimed at supporting the clinical development and launch readiness of the BOT/BAL combination therapy.
The team at Agenus comprises scientists, researchers, biotechnologists, physicians, and business professionals united by the shared goal of achieving breakthroughs in cancer treatment. This collaborative spirit ensures that Agenus remains at the forefront of transformative cancer therapies, aiming to enhance patient outcomes and extend lives.
For more information, visit www.agenusbio.com or follow @agenus_bio on social media.
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.
Agenus Inc. (NASDAQ: AGEN) announced the dosing of the first patient with agenT-797, an allogeneic iNKT cell therapy, in a Phase 1 clinical trial targeting hematologic cancers. This trial, led by the Dana-Farber Cancer Institute, aims to assess safety and preliminary efficacy, with initial data expected in Q4 2021. The iNKT cell therapy, which previously showed promise for COVID-19, is believed to offer a safer, more accessible treatment option for various cancers. Agenus leverages its extensive portfolio of checkpoint antibodies for optimal therapeutic combinations.
Agenus (NASDAQ: AGEN) presented new clinical data on AGEN1181, a next-generation anti-CTLA-4 antibody, at the American Association for Cancer Research Annual Meeting. Notable responses were observed across various tumor types, including melanoma and ovarian cancer, with emphasis on patients typically unresponsive to other immuno-oncology treatments. The promising safety profile revealed no significant immune-mediated side effects. Following these findings, Agenus is expanding AGEN1181 into Phase 2 trials for colorectal cancer, indicating potential growth and continued development in immunotherapy.
Agenus Inc. (NASDAQ: AGEN) reported fourth quarter and full year 2020 results, recognizing revenue of $88 million, down from $150 million in 2019. The company experienced a net loss of $183 million for 2020 versus $112 million the previous year. Key highlights include the ongoing BLA filing for balstilimab with expected completion in 1H 2021, positive clinical data for AGEN1181 and AGEN1777, and plans for upcoming trials in cancer and COVID-19. The company anticipates significant growth from its pipeline and strategic partnerships.
Agenus Inc. (NASDAQ: AGEN) announced promising data for its anti-CTLA-4 antibody AGEN1181, showcasing its efficacy in tumors previously unresponsive to therapies, notably colorectal, ovarian, and endometrial cancers. The Phase 1/2 clinical study revealed responses in patients with the low-affinity FcγRIIIA allele and confirmed no neuroendocrine toxicities. AGEN1181 is set to enter registrational trials in 2021. The data will be presented at the AACR Annual Meeting, highlighting its potential in combination therapies and superior effectiveness compared to first-generation agents.
Agenus (NASDAQ: AGEN) will release its Q4 and full year 2020 financial results on March 15, 2021, before market open. The company focuses on immuno-oncology, leveraging a strong pipeline of therapies to activate immune responses against cancers and infections. Following the results announcement, executives will host a conference call at 8:30 a.m. ET to discuss the outcomes and provide a corporate update. Interested parties can access the live webcast via the company’s website.
Agenus Inc. (NASDAQ: AGEN) announced the appointment of Andy Hurley as Chief Commercial Officer, aimed at advancing the company's transition to a commercial stage. Garo Armen, the Chairman and CEO, emphasized Hurley's expertise in commercializing biopharmaceuticals as essential for Agenus' portfolio and potential product launches. Hurley expressed enthusiasm for leading the launch of balstilimab and other candidates within the pipeline. With over 30 years of experience, he previously served in senior roles at various biopharmaceutical companies, strengthening Agenus' leadership team.
Agenus Inc. (NASDAQ: AGEN) announced its inaugural Agenus Insights webinar titled “Optimally Targeting TIGIT” on February 11, 2021, at 1:00 p.m. ET. The event will feature a 15-minute presentation followed by a Q&A session led by Dr. Steven O’Day and Dr. Dhan Chand. The focus will be on the clinical validation of TIGIT as a cancer target and Agenus' innovative design. Registration is available online, and a replay will be accessible post-event on the company’s website.
Agenus Inc. (NASDAQ: AGEN) reported promising results from its Phase 1/2 trial of AGEN1181, a next-generation anti-CTLA-4 antibody. The trial confirmed six objective clinical responses in patients with colon, ovarian, and endometrial cancers, showcasing AGEN1181's efficacy, particularly in difficult-to-treat tumors. No significant toxicities were observed, marking a notable improvement over existing therapies like ipilimumab. Phase 2 trials in additional cancer indications are set to begin soon, highlighting the company's commitment to advancing cancer immunotherapy.
Agenus Inc. (NASDAQ: AGEN) reported positive preliminary results from its Phase 1 trial of iNKT cell therapy aimed at patients with moderate to severe COVID-19 symptoms. Conducted by AgenTus Therapeutics, the trial showcased that 3 out of 4 intubated patients were discharged after treatment, and 2 patients were extubated within 24 hours of dosing. The company is currently in the dose escalation phase, with plans to initiate a Phase 2 trial by mid-2021, and data readouts expected by Q4 2021. Early results indicate good tolerance and potential benefits of the therapy for severely ill patients.
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