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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) presented new data on botensilimab (BOT) and balstilimab (BAL) combination therapy at ASCO GI, demonstrating significant potential in colorectal cancer (CRC) treatment. The data comes from multiple studies involving over 1,100 patients across 60+ centers worldwide.
Key findings include results from two neoadjuvant studies (UNICORN and NEST) with 80+ patients, showing promising pathological complete response rates: 93% in dMMR/MSI-H tumors and 29% in pMMR/MSS tumors. In first-line treatment, the combination with FOLFOX-Bevacizumab achieved 71% overall response rate in 14 patients.
A global Phase 2 study with 234 patients demonstrated 19% overall response rate and 55% disease control rate in refractory MSS mCRC, with 70% of responses ongoing at data cut-off. The therapy showed particular promise in treating microsatellite stable (MSS) CRC tumors, which represent 85-95% of CRC cases and typically don't respond to immunotherapy.
Agenus (NASDAQ: AGEN) announced five presentations featuring botensilimab (BOT) plus balstilimab (BAL) at the upcoming ASCO GI Symposium (January 23-25, 2025). The presentations will showcase BOT/BAL's activity across three distinct colorectal cancer settings: late-line metastatic, first-line, and neoadjuvant treatment.
The studies demonstrate BOT/BAL's consistent activity in microsatellite stable (MSS) colorectal cancer, which represents over 80% of CRC cases with treatment options, as well as microsatellite instability-high (MSI-H) CRC. An additional presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in refractory gastric cancer patients.
Agenus announced a strategic realignment focusing on its lead botensilimab/balstilimab (BOT/BAL) program, which has shown clinical activity in various cancers including microsatellite stable colorectal cancer. The company aims to reduce annual expenditures by 60% and achieve a cash burn of $100 million for FY 2025.
The restructuring follows a $22 million mortgage secured by real estate assets. Key measures include staff reductions, operational adjustments, and transitioning biologics CMC capabilities to a fee-for-service model. The company will provide transition support to affected employees while maintaining focus on advancing BOT/BAL for patients with treatment options.
Agenus (NASDAQ: AGEN) has secured a $22 million mortgage backed by its Berkeley and Vacaville properties, providing $20 million in net proceeds. The two-year mortgage includes interest payable 50% in cash and 50% in common stock, at rates of 12% for Year 1 and 13% for Year 2. The company announced a Strategic Operational Realignment Plan focusing on botensilimab/balstilimab (BOT/BAL) in MSS colorectal cancer, targeting a 60% reduction in annual external expenditures. The plan includes transforming CMC capabilities into a fee-for-service biologics manufacturing business, aiming to reduce FY 2025 cash burn to approximately $100 million.
Agenus (AGEN) reported Q3 2024 financial results and provided updates on BOT/BAL development. The company ended Q3 with $44.8 million in cash, down from $76.1 million in December 2023. Revenue was $25.1 million for Q3 2024, compared to $24.3 million in Q3 2023. Net loss was $67.2 million for Q3 2024. BOT/BAL showed promising clinical progress in MSS colorectal cancer and sarcomas. The company is pursuing strategic initiatives including asset monetization and operational efficiencies to strengthen its financial position. Cash used in operations decreased to $129.7 million for the first nine months of 2024, down from $183.8 million in the same period of 2023.
Agenus (NASDAQ: AGEN) will present new data on two promising immunotherapy candidates at the SITC 2024 Annual Meeting in Houston. The presentations will feature botensilimab, an Fc-enhanced anti-CTLA-4 antibody showing efficacy in treatment-resistant cancers, and AGEN1721, a first-in-class bifunctional antibody targeting FAP and TGFβ.
Botensilimab enhances both innate and adaptive immunity, demonstrating effectiveness in glioblastoma, melanoma, colorectal, pancreatic, and breast cancers. AGEN1721 works by remodeling the tumor microenvironment, depleting cancer-associated fibroblasts, and neutralizing TGFβ's immunosuppressive effects, transforming cold tumors into immune-responsive environments.
Agenus (NASDAQ: AGEN), a company focused on developing immunological cancer treatments, has scheduled its third quarter 2024 financial results release before market opening on Tuesday, November 12th, 2024. The company will host a conference call and webcast at 8:30 a.m. ET the same day, featuring executive discussions of the results and a corporate update.
GSK announced positive topline data from a phase 3 trial evaluating the co-administration of AREXVY (RSV vaccine) and SHINGRIX (shingles vaccine) in adults 50 years and older. The study met its primary endpoint, showing a non-inferior immune response when the vaccines were given together compared to separate administration. Co-administration was well-tolerated with acceptable safety profiles.
Key findings include:
- Comparable immune responses in co-administration and separate administration groups
- Most common adverse events: injection site pain, fatigue, and myalgia
- Similar duration of adverse events across groups
GSK plans to submit these results to support regulatory submissions to the FDA, EMA, and other regulators. The company aims to reduce barriers to adult immunization by potentially decreasing the number of healthcare visits required for vaccination.
Agenus Inc. (Nasdaq: AGEN) presented promising data at the ESMO Congress for their Phase 1 study of botensilimab (BOT) and balstilimab (BAL) combination in refractory sarcomas. Key findings include:
- 23% overall response rate (ORR) in the full sarcoma cohort
- 21.7 months median duration of response (DOR)
- 69% 12-month overall survival (OS)
- 39% ORR in angiosarcoma subtype
- Manageable and reversible adverse event profile
The study involved 64 patients with relapsed/refractory sarcomas, with a median of 3 prior lines of therapy. The results suggest BOT/BAL could be a significant treatment option for patients with alternatives, particularly in 'cold' sarcomas like visceral angiosarcoma, leiomyosarcoma, and dedifferentiated liposarcoma.
Agenus Inc. (Nasdaq: AGEN) announced that updated data from the clinical trial of botensilimab and balstilimab in refractory sarcomas will be presented at the ESMO Congress 2024 in Barcelona. The presentation will showcase updated efficacy and safety data from the ongoing Phase 1 trial, highlighting the potential of this combination therapy in treating patients with refractory sarcomas, including visceral angiosarcoma and leiomyosarcoma.
Botensilimab, a novel Fc-enhanced CTLA-4 inhibitor, and balstilimab, a PD-1 antibody, have shown promising clinical responses in multiple tumor types, including 'cold' tumors typically unresponsive to standard therapies. The presentation, titled 'Updated efficacy and safety of botensilimab plus balstilimab in patients with refractory metastatic sarcoma from an expanded phase 1 study,' will be given by Dr. Breelyn A. Wilky on September 13th, 2024.
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