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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 reported positive results from GSK's pivotal Phase III trial of its RSV vaccine for adults over 60, achieving an overall efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD). Notably, the vaccine demonstrated 94.1% efficacy against severe disease and high efficacy rates in those aged 70-79 and with comorbidities. Regulatory filings are expected in the second half of 2022, potentially leading to the approval of one of three vaccines utilizing Agenus' proprietary QS-21 STIMULON adjuvant.
VBI Vaccines and Agenus have announced a collaboration to evaluate VBI-1901, a cancer vaccine, alongside Agenus' balstilimab in a clinical study for frontline Glioblastoma (GBM) patients. The INSIGhT adaptive trial is set to begin around the end of 2022. VBI-1901 has shown promising results in recurrent GBM patients, with one individual experiencing a 93% tumor reduction over two and a half years. GBM is a highly aggressive brain cancer with a low survival rate, underscoring the need for effective treatments.
VBI Vaccines and Agenus announced a collaboration to study VBI-1901, a cancer vaccine, in combination with Agenus's balstilimab for primary glioblastoma (GBM) patients. The INSIGhT adaptive platform trial is set to begin around year-end 2022, focusing on GBM patients post-tumor resection and radiotherapy. Promising results from an ongoing Phase 2a study show one patient sustained a 93% tumor reduction over two and a half years. The collaboration aims to enhance anti-tumor immunity in an area with limited treatment options.
Agenus (NASDAQ: AGEN) has announced an in-person and virtual Research & Development event titled "The Road Taken" on November 12, 2022, from 2:00 p.m. to 5:00 p.m. ET at Prudential Tower, Boston, MA. The event will feature key opinion leaders discussing Agenus’ clinical-stage immunotherapy pipeline, focusing on botensilimab and strategies to overcome immuno-oncology resistance. The scientific program runs from 2:00 p.m. to 4:00 p.m. ET, followed by a reception. Interested parties can register via Agenus Investor Relations.
Agenus (NASDAQ: AGEN) announced the presentation of clinical data on its immuno-oncology programs at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, scheduled for November 8-12, 2022. Key presentations will focus on botensilimab, an anti-CTLA-4 antibody, and its efficacy in cold tumors. Dhan Chand, PhD, will present on enhanced CTLA-4 blockade. The data includes nine cancer indications from a trial involving 264 patients and aims to address heavily pretreated populations. Full abstracts will be released on November 7, 2022.
Agenus (NASDAQ: AGEN) announced the appointments of Patricia Carlos as Chief Regulatory, Quality, and Safety Officer and Todd Yancey, MD as Senior Global Clinical Development, Medical Affairs, and Commercial Advisor. These leaders bring extensive experience to advance Agenus' pipeline, particularly the Phase 2 botensilimab programs targeting MSS colorectal cancer and metastatic melanoma. Carlos has over 20 years in regulatory affairs, while Yancey has 40 years in clinical development.
Agenus has initiated a global Phase 2 program for botensilimab, an Fc-enhanced anti-CTLA-4 therapy, targeting metastatic patients resistant to available treatments. The trials include ACTIVATE-Colorectal and ACTIVATE-Melanoma, focusing on microsatellite stable colorectal cancer and advanced melanoma, respectively. Botensilimab has shown robust clinical activity in nine tumor types, with particularly significant results in MSS colorectal cancer, achieving a 24% response rate. These studies aim to offer transformative treatment options for patients with limited existing therapies.
Agenus Inc. (NASDAQ: AGEN) reports promising results for botensilimab/balstilimab in treating microsatellite stable colorectal cancer (MSS CRC), showcasing a 24% overall response rate and a 73% disease control rate from a recent study. The company also initiated a Phase 1 study of AGEN1571 for advanced solid tumors. Financially, Agenus ended Q2 with $238 million in cash and achieved $21 million in revenue, a $10 million increase year-over-year. However, net losses narrowed to $49 million from $84 million in Q2 2021, signaling improved financial management.
Agenus (NASDAQ: AGEN), an immuno-oncology company, will participate virtually in the BTIG Biotechnology Conference and hold one-on-one meetings with investors on August 9, 2022, following its second quarter corporate update. The company focuses on developing therapies that activate the immune system to combat cancer and infections, utilizing a combination of antibody therapeutics, adoptive cell therapies, and adjuvants. Agenus is headquartered in Lexington, MA, and aims to expand access to cancer immunotherapy.
Agenus Inc. (Nasdaq: AGEN) has initiated a Phase 1 study of AGEN1571, a novel anti-ILT2 antibody, in patients with advanced solid tumors. The trial aims to evaluate the safety, tolerability, and pharmacokinetic profiles of AGEN1571, both as a standalone treatment and in combination with botensilimab and balstilimab. Preclinical data suggest AGEN1571's potential to enhance immune responses by modulating tumor-associated macrophages and activating various immune cells. The company believes this therapy may overcome resistance to current PD-1 therapies.
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