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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 has announced a significant milestone: an FDA Type B End-of-Phase 2 meeting set for July to discuss the botensilimab and balstilimab (BOT/BAL) combination therapy for relapsed/refractory metastatic colorectal cancer (r/r MSS mCRC).
This meeting aims to expedite the development of BOT/BAL and potentially support a future Biologics License Application (BLA) under the FDA’s accelerated approval pathway. The therapy previously received fast track designation in April 2023.
Phase 1 and 2 data from BOT/BAL studies provide insights into its potential efficacy for this challenging cancer type. These findings will be presented at a major medical conference later this year.
Beyond colorectal cancer, Agenus is exploring BOT/BAL for other cancer indications and plans to present further data at upcoming medical conferences.
Agenus Inc. reported first quarter 2024 results, including a $100M royalty financing agreement with Ligand, supporting BOT/BAL development. Reestablished market compliance with Nasdaq. Positive clinical results in colorectal cancer studies. Reduced cash burn rate with a reverse stock split. Financially, revenue was $28M, net loss $63.5M. BOT/BAL showed encouraging results in MSS CRC and neoadjuvant CRC. Agenus aims to engage with the FDA for BLA submission. Plan to release updated data in melanoma, lung cancer, sarcoma, and pancreatic cancer. Focus on commercial launch readiness activities.
Ligand Pharmaceuticals and Agenus have entered into a $100 million royalty financing agreement to support Agenus' key development initiatives in the BOT/BAL clinical development program. Ligand will pay $75 million initially and can invest an additional $25 million. They will receive royalties and milestone payments on six Agenus-partnered programs and future global net sales generated by BOT/BAL. Agenus can syndicate up to $125 million, with potential total capital infusion of $200 million. The partnership aims to advance transformative cancer treatments, including the BOT/BAL regimen.
Agenus Inc. has regained compliance with the minimum bid price requirement of $1.00 set by NASDAQ, ensuring continued listing on the NASDAQ Capital Market. The company focuses on immunology-based therapies for cancer, offering a robust pipeline of immunological agents. Agenus aims to enhance patient populations benefiting from cancer immunotherapy through combination approaches utilizing various antibody therapeutics, adoptive cell therapies, and adjuvants. Headquartered in Lexington, MA, Agenus is committed to advancing treatments for cancer and infectious diseases.
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