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 (Nasdaq: AGEN), a leading immunological cancer treatment developer, has scheduled its first quarter 2025 financial results announcement for Monday, May 12th, before market opening.
The company will host a conference call and webcast at 8:30 a.m. ET the same day, featuring company executives who will discuss quarterly results and provide a corporate update. Interested parties can access the event through:
- Conference call registration (Conference ID: 73242)
- Live webcast via the company's investor relations website
- Alternative webcast link through Q4's platform
A replay of the conference call will be made available through both the company website and Q4's platform for those unable to attend the live session.
Agenus presented promising results from their NEOASIS study at the AACR Annual Meeting, showcasing the effectiveness of their botensilimab and balstilimab (BOT/BAL) combination therapy in treating various solid tumors.
Key findings from the Phase 2 neoadjuvant study include:
- For dMMR/MSI-H tumors: 90% pathological response rate, 80% major pathological response, and 70% complete response
- For pMMR/MSS tumors: 80% pathological response rate, 70% major pathological response, and 20% complete response
- In triple-negative breast cancer patients, 63% achieved major pathological response
The study demonstrated that just two doses of BOT/BAL could induce significant responses across multiple cancer types, including triple-negative breast cancer. Importantly, no dose-limiting toxicities were observed, and all patients proceeded to surgery as scheduled. The treatment shows particular promise in early-stage cancers, including those typically resistant to immunotherapy.
Agenus (NASDAQ: AGEN) presented updated data from its Phase 1 study evaluating the combination of botensilimab (BOT) and balstilimab (BAL) in hepatocellular carcinoma (HCC) at the AACR Annual Meeting. The study focused on 19 heavily pretreated patients who had progressed after standard treatments, including immunotherapies.
Key results from the trial showed:
- Overall response rate: 17%
- Disease control rate: 72%
- Median progression-free survival: 4.4 months
- Median overall survival: 12.3 months
The BOT/BAL combination demonstrated durable responses in treatment-refractory HCC patients, including those who progressed on atezolizumab/bevacizumab. The safety profile remained consistent with previous cohorts and was manageable. The study results suggest potential clinical utility in treating advanced HCC patients who have options after progression on immune checkpoint inhibitors.
Agenus (Nasdaq: AGEN) announced three upcoming presentations at the 2025 ASCO Annual Meeting in Chicago (May 30 - June 3). The presentations include new translational data on botensilimab and balstilimab (BOT/BAL) in colorectal cancer and two trials-in-progress studies.
The first presentation focuses on T-cell dynamics monitoring in mismatch repair-proficient/microsatellite stable metastatic colorectal cancer. The other two presentations detail ongoing clinical studies of botensilimab-based combinations in advanced pancreatic cancer: one examining botensilimab with AGEN1423 (anti-CD73-TGFβ-trap bifunctional antibody), and another investigating a combination therapy including botensilimab, balstilimab, nab-paclitaxel, gemcitabine, cisplatin, chloroquine, and celecoxib.
Agenus (Nasdaq: AGEN) has announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago (April 25-30, 2025), highlighting their neoadjuvant immunotherapy program with botensilimab and balstilimab (BOT/BAL).
The presentations include:
- An oral presentation of initial results from the NEOASIS trial studying BOT/BAL in MMR proficient and deficient early-stage cancers, presented by Dr. Myriam Chalabi from Netherlands Cancer Institute on April 28, 2025
- A poster presentation featuring new data from the Phase 1 study of BOT/BAL in treatment-refractory hepatocellular carcinoma (HCC), presented by Dr. Anthony El-Khoueiry from USC Norris Comprehensive Cancer Center on April 29, 2025
These presentations build upon previous BOT/BAL data from two independent studies (UNICORN and NEST) in colorectal cancer presented earlier at ASCO-GI.
Agenus (NASDAQ: AGEN) has released findings from its national Colorectal Cancer in Focus survey, revealing critical gaps in current treatment options. The survey, conducted from October to December 2024, gathered insights from patients and healthcare providers (HCPs) about colorectal cancer (CRC) care.
Key findings show that over 50% of HCPs reported increased CRC diagnoses in adults under 50, with 82% of surveyed patients diagnosed before that age. An overwhelming 93% of HCPs believe current CRC treatments are insufficient. The survey highlighted that 61% of patients expressed interest in non-chemotherapy treatments, including immunotherapy, while 37% of HCPs identified immunotherapy as the most promising advancement in CRC treatment.
The study, conducted in partnership with the Colorectal Cancer Alliance and Fight Colorectal Cancer, emphasizes patients' prioritization of quality of life, with one-third citing minimal life impact as a top treatment priority. Most patients reported chemotherapy and radiation side effects as their most challenging aspect of treatment.
Agenus (NASDAQ: AGEN) has reported its Q4 and full-year 2024 financial results, highlighting significant operational improvements and cost reductions. The company achieved a Q4 2024 operational cash burn of $28.7 million and aims to reduce annual burn to approximately $50 million by mid-2025.
The company's botensilimab/balstilimab (BOT/BAL) program demonstrated promising clinical outcomes in resistant tumor types, particularly in colorectal cancer treatment. Data presented at ASCO-GI 2025 showed meaningful, durable responses across neoadjuvant and later lines of CRC treatment.
Financial highlights include:
- Year-end 2024 cash balance of $40.4 million (down from $76.1 million in 2023)
- 2024 revenue of $103.5 million
- Net loss of $232.3 million ($10.59 per share)
- Q4 revenue of $26.8 million with net loss of $46.8 million ($2.04 per share)
Agenus Inc. (NASDAQ: AGEN) has presented significant immuno-oncology data across multiple medical conferences and publications in 2024-2025, highlighting advances in cancer immunotherapy. The company's key antibody candidates, botensilimab (BOT) and balstilimab (BAL), have been evaluated in approximately 1,100 patients across 60+ centers worldwide.
The BOT/BAL combination has shown clinical responses across nine tumor types, including traditionally 'cold' tumors. Notable results include:
- High major pathological response rates in colorectal cancer (CRC) through the NEST and UNICORN trials
- 19% response rate in microsatellite stable (MSS) metastatic CRC patients with no liver metastases
- 71% objective response rate in combination with FOLFOX chemotherapy and bevacizumab in MSS metastatic CRC
- 19.2% overall response rate in sarcoma patients with 69% 12-month survival rate
Agenus (Nasdaq: AGEN), an immuno-oncology company, has announced its participation in the B. Riley Securities Precision Oncology & Radiopharma Investor Conference in New York. The company's Chief Commercial Officer, Robin Taylor, Ph.D., will join a panel discussion focused on 'What It Takes to Move the Needle in Improving Responses in Colorectal Cancer.' The event is scheduled for February 28th, 2025, from 1:00-2:00 p.m. ET. This in-person conference requires interested attendees to contact B. Riley for participation details.