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 (AGEN) will participate in Chardan’s 10th Annual Healthcare Conference through a fireside chat and investor meetings on October 20, 2026.
Zack Armen, Head of Corporate Development and Investor Relations, will represent Agenus at the Lotte New York Palace in New York. The fireside chat begins at 11:00am ET. A recording will be available for 30 days after the event in the Events & Presentations section of the company’s investor relations website.
Agenus (AGEN) received Armenia’s first marketing authorizations for its BOT+BAL cancer treatment combination, effective October 2, 2026, the medicines’ first approvals worldwide.
Botvymo (botensilimab) and Evamplix (balstilimab) were separately approved for use together in adults with microsatellite stable metastatic colorectal cancer, a cancer subtype, without active liver metastases after available standard therapies. The approvals drew on Phase 1b and randomized Phase 2 clinical evidence published in peer-reviewed journals. Each authorization is conditional, valid for one year and renewable based on annual clinical updates to Armenia’s regulator. Agenus plans to evaluate potential marketing authorizations in other Eurasian Economic Union countries. The Armenian authorizations apply only within Armenia.
Agenus (AGEN) reported estimated three-year survival of 48% with botensilimab plus balstilimab (BOT+BAL) in its Phase 1b recurrent ovarian cancer cohort.
Among 35 patients evaluated for efficacy, estimated survival was unchanged from two years, and median overall survival was 14.8 months. Eight patients responded (23%), including one complete response; median response duration was 9.7 months. Eleven patients (31%) had a response or stable disease lasting at least 24 weeks. Patients had received a median of four prior treatment lines. Estimated three-year survival was 47% in platinum-resistant or refractory disease and 45% in platinum-sensitive disease.
At last follow-up, 11 of all 44 treated patients (25%) were alive and off all therapy. No new safety signals or treatment-related deaths were reported. The results were presented at IGCS 2026; the analysis used a December 13, 2025 data cutoff.
Agenus (AGEN) will present two BOT+BAL research posters at the SITC Annual Meeting in Phoenix on November 7, 2026. One covers long-term survivors with treatment-resistant microsatellite-stable metastatic colorectal cancer. The other examines BOT+BAL with MiNK Therapeutics’ agenT-797 cell therapy in a preclinical model of colorectal cancer that has spread to the liver.
Agenus (AGEN) will present new three-year overall survival data for botensilimab (BOT) plus balstilimab (BAL) in recurrent ovarian cancer at the IGCS Annual Global Meeting, held October 1–3, 2026, in Montreal, Canada.
The poster will report results from the recurrent ovarian cancer cohort of the Phase 1b C-800-01 study, including patients with platinum-refractory or platinum-resistant disease, with analyses by platinum sensitivity and long-term three-year overall survival. The poster, presented by Rebecca L. Porter, M.D. of Dana-Farber Cancer Institute, is abstract number 969 in the Poster Rounds with Professors, Ovarian Cancer 03 session, scheduled for Saturday, October 3, 2026, from 10:50am to 10:55am EDT.
Agenus (Nasdaq: AGEN)/b) announced that Chief Commercial Officer Robin Taylor and Head of Corporate Development and Investor Relations Zack Armen will join fireside chats and one-on-one investor meetings at the Cantor Global Healthcare Conference 2026 (September 9-11, New York) and the H.C. Wainwright 28th Annual Global Investment Conference (September 14-16, New York). Archived recordings of both fireside chats will be accessible for 90 days on the Agenus investor relations website.
Agenus (Nasdaq: AGEN) reported a peer-reviewed publication of mature Phase 1b data from the C-800-01 cohort evaluating botensilimab (BOT) plus balstilimab (BAL) in 123 heavily pretreated microsatellite-stable metastatic colorectal cancer patients without active liver metastases.
According to Agenus, BOT+BAL achieved a median overall survival of 21.2 months, with 24- and 36-month overall survival rates of 41% and 33%, respectively, a confirmed objective response rate of 21% (3 complete, 23 partial responses), and a disease control rate of 69% at six weeks. Median duration of response was not reached, with responses lasting at least 37.4 months, and 17% of patients were alive and off systemic anticancer therapy at last follow-up.
Exploratory biomarker analyses showed responses in tumors with low tumor mutational burden and no PD-L1 expression, consistent with BOT’s Fc-enhanced immune-priming design. Extended safety follow-up revealed no new safety signals or treatment-related deaths, and efficacy was similar across BOT 1 mg/kg and 2 mg/kg dosing, with fewer immune-mediated adverse events at the lower dose.
Agenus (Nasdaq: AGEN) reported updated peer-reviewed Phase 2 NEST data of neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable colorectal cancer, showing no colorectal cancer recurrences at the March 31, 2026 cutoff, with median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2.
Among 22 pMMR/MSS tumors, neoadjuvant BOT+BAL achieved a 59% pathologic response, including 41% major pathologic response and 32% pathologic complete response. 88% of evaluable patients with baseline ctDNA cleared ctDNA before surgery, which proceeded without treatment-related delays. No Grade 4 treatment-related adverse events, treatment-related deaths or study discontinuations were observed.
According to Agenus, these longer follow-up and immune microenvironment findings support its planned global Phase 3 ROBBIN trial in high-risk Stage II/III MSS colon cancer and the multicenter Phase 2 NEST3 study.
Agenus (Nasdaq: AGEN) reported second quarter 2026 revenue of $34.5 million, up from $25.7 million a year earlier, including $6.4 million in pre-commercial BOT+BAL revenue and $28.1 million in non-cash royalty revenue. Operating income was $11.3 million versus a $16.7 million loss, and net loss was $0.6 million. Cash was $18.7 million at quarter-end, excluding an oversubscribed July private placement that raised $85 million upfront with up to $255 million in potential warrant proceeds.
The financing is expected to fund ROBBIN, a planned global Phase 3 trial of neoadjuvant BOT+BAL in about 850 high-risk Stage II/III MSS colon cancer patients, targeting an annual U.S. market of roughly 38,000 patients. ROBBIN initiation and first dosing are anticipated in Q1 2027. Agenus highlighted NEST/UNICORN neoadjuvant data showing ~30% pCR and ~40% MPR among 38 patients, and metastatic data with median overall survival of 21.2 months in refractory MSS colorectal cancer. The company grew BOT+BAL access-program revenue and, to prioritize ROBBIN, stopped future funding for the CCTG-sponsored BATTMAN Phase 3 trial, which CCTG then terminated.
Agenus (Nasdaq: AGEN) announced it will release its second quarter 2026 financial results before the market opens on Thursday, August 6, 2026. The company also plans a webcast later in August to review corporate priorities.
According to Agenus, the webcast will address acceleration of the botensilimab and balstilimab (BOT+BAL) immunotherapy combination in neoadjuvant colon cancer through the Phase 3 ROBBIN trial, upcoming clinical and data milestones, and ongoing initiatives to support patient access to BOT+BAL. Detailed webcast agenda and access information will be provided closer to the event.