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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 (NASDAQ: AGEN) reported positive results from a Phase 2 clinical study of the combination therapy balstilimab and zalifrelimab for patients with recurrent/metastatic cervical cancer. The objective response rate (ORR) reached 32.8% in PD-L1-positive patients and 25.6% overall, significantly outperforming existing treatments. Notably, the median duration of response remains unachieved after 21 months of follow-up, indicating promising durability of response. The safety profile was well-tolerated, with no unexpected toxicities noted.
VBI Vaccines Inc. announced updated 12-month and 18-month overall survival data from its Phase 2a study of VBI-1901, a cancer vaccine targeting recurrent glioblastoma (GBM). The data showed a significant improvement in overall survival compared to historical controls, with some patients experiencing up to 93% tumor reduction. The company plans to expand the study to support an application for accelerated approval, with new trials anticipated in Q1 2022 for recurrent GBM and mid-2022 for primary GBM. These results suggest promising efficacy and a need for innovative therapies in GBM treatment.
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology firm, announced that Dr. Garo Armen and Dr. Steven O'Day will participate in a fireside chat hosted by Evercore on November 30, 2021, at 1:50 PM EST. This event aims to highlight Agenus' innovative pipeline of cancer therapies, including checkpoint antibodies and vaccines. Interested parties can register in advance for the webcast. A replay of the discussion will be available on Agenus' website afterward. The company focuses on advancing immunotherapy for broader patient populations, leveraging their extensive research capabilities.
Agenus (NASDAQ: AGEN) reported promising new clinical data for AGEN1181, an Fc-enhanced anti-CTLA-4, at the SITC 36th Annual Meeting. The study showed seventeen objective responses across nine cancer types, including colorectal, ovarian, and melanoma. Notably, four confirmed responses were seen in treatment-refractory tumors. The regimen was well-tolerated, with no high-grade safety issues observed. Phase 2/3 trials will commence in colorectal and gynecological cancers, potentially paving the way for regulatory approvals based on these strong efficacy signals.
Agenus Inc. (NASDAQ: AGEN) reported promising clinical results for AGEN1181, indicating durable responses across 9 cancer types, including those resistant to PD-1 therapy. The company plans to initiate Phase 2/3 trials for AGEN1181 in colorectal and gynecological cancers. Additionally, Agenus withdrew its BLA for balstilimab while launching an expanded access program. Financially, the third quarter showed significant revenue growth, with $275 million reported compared to $57 million in the prior year, alongside a net income of $177 million, up from a loss of $52 million.
Agenus (NASDAQ: AGEN) announced that Dr. Steven O’Day and Dr. Dhan Chand will participate in a fireside chat hosted by B. Riley on November 15, 2021, at 12:00 PM EST. The discussion will focus on the AGEN1181 program, an Fc-enhanced CTLA-4, following the presentation of clinical data at the Society for Immunotherapy of Cancer's 36th Annual Meeting on November 12, 2021. Registration for the webinar is available online, with a replay to be accessible on the company's Events & Presentations page post-call.
Agenus specializes in immuno-oncology with a focus on therapies to combat cancer.
Agenus (NASDAQ: AGEN) announced a webcast featuring Dr. Steven O’Day and Dr. Manuel Hidalgo, discussing updated Phase 1 clinical trial results for AGEN1181, an Fc-enhanced anti-CTLA-4 therapy, and its combination with balstilimab (anti-PD-1). This presentation is scheduled for November 12, 2021, during the SITC 36th Annual Meeting. The event will delve into the significance of the trial data and future development paths. Interested parties can register in advance for the webinar, with a replay available post-event on Agenus’ website.
Agenus (NASDAQ: AGEN) has announced its plan to release third quarter 2021 financial results on November 9, 2021, before the market opens. The company will also hold a conference call at 8:30 a.m. ET on the same day to discuss these results and provide a corporate update. Agenus, based in Lexington, MA, focuses on immuno-oncology therapies aimed at engaging the body’s immune system to combat cancer. Investors can access the live webcast and replay via the company’s website.
Agenus (NASDAQ: AGEN) has voluntarily withdrawn its Biologics License Application (BLA) for balstilimab, following the FDA's recommendation after the early approval of pembrolizumab. The BLA for balstilimab had received Fast Track and Priority Review status and was scheduled for action on Dec. 16, 2021. Balstilimab demonstrated a 20% response rate in PD-L1 positive patients during trials, outperforming pembrolizumab's 14%. Agenus plans to launch expanded access programs for balstilimab and will discontinue its BRAVA trial, potentially saving over $100M in R&D expenses.
Agenus (NASDAQ: AGEN) has announced the triggering of a $20 million milestone payment from Bristol Myers Squibb following the first patient dosing in the Phase 1 study of AGEN1777, a bispecific anti-TIGIT antibody. This agreement includes a total of $200 million upfront and up to $1.36 billion in additional milestones. AGEN1777 aims to enhance immune response against cancers, particularly targeting difficult tumors like non-small cell lung cancer. The trial's focus on safety and tolerability will help set the recommended Phase 2 dose.
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