Agenus Inc. develops immuno-oncology therapies for cancer, with recurring updates centered on botensilimab (BOT) and balstilimab (BAL), its CTLA-4/PD-1 immunotherapy combination. Company news regularly covers clinical data in solid tumors, including metastatic colorectal cancer, melanoma and gastroesophageal cancer, as well as translational biomarker work and combination approaches that use antibody therapeutics, adoptive cell therapy through MiNK Therapeutics and adjuvants.
Agenus updates also address regulatory-authorized access pathways for BOT+BAL, including France's AAC framework and paid named-patient programs where permitted, along with financial results, equity financing activity, commercial readiness, manufacturing collaborations and corporate governance developments.
Agenus Inc. (NASDAQ: AGEN) announced outcomes from its end-of-Phase 2 meeting with the FDA for its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), in treating relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC). Key points include:
1. Agreement on dosing regimen: 75mg BOT every 6 weeks (up to 4 doses) with 240mg BAL every 2 weeks (up to 2 years).
2. Interim Phase 2 data shows 19.4% ORR and 90% 6-month survival rate for BOT 75mg/BAL combination.
3. FDA advised against Accelerated Approval submission.
4. FDA recommended including a BOT monotherapy arm in Phase 3 study.
5. Agenus plans further FDA discussions as Phase 2 data matures.
6. European regulatory discussions scheduled for Q3 2024.
Agenus Inc. announced promising results from a trial of botensilimab and balstilimab (BOT/BAL) in colon cancer patients at the 2024 ESMO GI Congress. The trial included 20 patients with microsatellite stable (MSS) and microsatellite instability-high (MSI-H) tumors. After treatment, 78% of MSS patients in the NEST-2 cohort showed at least 50% tumor regression, and 56% achieved complete pathologic responses. The study highlighted manageable side effects and no delays in surgeries due to adverse events. The data suggests BOT/BAL therapy could significantly impact neoadjuvant colon cancer treatment, reducing disease recurrence and minimizing invasive procedures.
Agenus announced that the Cancer Therapy Evaluation Program (CTEP) is now accepting Letters of Intent (LOIs) for clinical studies involving botensilimab (BOT), a next-generation anti-CTLA-4 antibody. Researchers can apply to use botensilimab for both clinical and nonclinical studies. The initiative aims to identify new potential clinical applications and enhance the understanding of botensilimab's efficacy.
Botensilimab has demonstrated clinical responses across nine types of metastatic, late-line cancers in approximately 900 patients during phase 1 and phase 2 trials. This antibody boosts both innate and adaptive anti-tumor immune responses and shows potential even in
Agenus, a leader in developing novel immunological agents for cancer treatment, has appointed Dr. Jennifer Buell to its Board of Directors, effective June 11, 2024. Dr. Buell, who is also the President and CEO of MiNK Therapeutics, brings over 27 years of biopharmaceutical industry experience to the board. Her previous roles include pivotal positions at Bristol-Myers Squibb and the Harvard Clinical Research Institute. Dr. Buell aims to guide Agenus’ promising BOT/BAL program towards a Biologics License Application this year while exploring new therapeutic avenues. This appointment is seen as a strategic move to drive the company's next phase of growth.
Agenus published promising clinical trial results in Nature Medicine for a novel immunotherapy combination of botensilimab (BOT) and balstilimab (BAL) targeting microsatellite stable metastatic colorectal cancer (MSS mCRC). MSS mCRC is historically resistant to immunotherapy and affects 95% of colorectal cancer patients. The Phase 1 trial assessed 148 heavily pretreated MSS mCRC patients, showing an Objective Response Rate (ORR) of 22% in 77 patients without active liver metastases, with the majority of responses ongoing. No treatment-related deaths were reported. Updated results as of March 2024 showed an increased ORR of 23%, median Overall Survival (OS) of 21.2 months, and 12-month and 18-month OS rates of 71% and 62%, respectively. A Phase 2 study is completed, and a Phase 3 trial is planned for later this year.
Agenus, a leading immuno-oncology company, has announced its Annual Shareholders Meeting will be held virtually on June 11, 2024, at 10:30 a.m. ET. Registration starts at 10:15 a.m. ET. Shareholders can participate by visiting www.virtualshareholdermeeting.com/AGEN2024 and entering a 16-digit control number from their proxy materials. Guests can listen without a control number. Agenus focuses on cancer immunotherapy using a broad range of antibody therapeutics, adoptive cell therapies, and adjuvants. The company is headquartered in Lexington, MA, and more information can be found at www.agenusbio.com.
Agenus (Nasdaq: AGEN), a company specializing in immunological agents for cancer treatment, has announced inducement awards for Eric Olson, the newly appointed Head of Regulatory. The awards include options to purchase 7,500 shares of Agenus common stock with a 10-year term and an exercise price based on the closing price on June 3, 2024. These options will vest over four years in equal annual installments. Additionally, Olson will receive 5,500 restricted stock units, vesting over three years in equal annual installments, contingent on maintaining his service with Agenus. The awards were approved by the Compensation Committee under the 2015 Inducement Equity Plan and Nasdaq Listing Rule 5635(c)(4).
Agenus has announced new data from a Phase 1b trial involving botensilimab and balstilimab (BOT/BAL) in relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC). These findings, to be presented at the 2024 ASCO Annual Meeting, highlight the efficacy of BOT/BAL in metastatic sites beyond the lungs and lymph nodes, including the peritoneum, soft tissue, and brain. The trial involved 77 heavily pre-treated patients, showing overall response rates (ORR) between 18-33% and disease control rates (DCR) from 67-82%. The overall survival (OS) ranged from 20.7 months to not reached (NR). No new safety signals were reported.
Agenus, a leader in immuno-oncology, announced that CEO Dr. Garo Armen and Chief Commercial Officer Robin Taylor will participate in the Goldman Sachs 45th Annual Global Healthcare Conference. This event will be held from June 10-13 in Miami Beach, Florida. A fireside chat featuring both executives will occur at 8:00 a.m. ET on June 12. The chat will be available via live webcast and replay on the company's website. Agenus focuses on developing immunological agents to treat cancer and infectious diseases. Their approach includes a pipeline of antibody therapeutics and adoptive cell therapies. The company is based in Lexington, MA.
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.