AGEN News & Events

Agenus announced three-year landmark Phase 1b data from the fully enrolled C-800-01 cohort evaluating botensilimab, an Fc-enhanced multifunctional anti-CTLA-4 antibody, plus balstilimab, an anti-PD-1 antibody, in patients with refractory microsatellite-stable metastatic colorectal cancer without active liver metastases. The data were presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2026 on July 2 in Munich, Germany. BOT+BAL demonstrated clinically meaningful long-term survival in a heavily pretreated patient population with historically limited benefit from conventional immune checkpoint inhibitors and few durable treatment options after progression on standard therapies. With extended follow-up, median overall survival was 21.2 months and the three-year overall survival rate was 33%, with the Kaplan-Meier curve showing a plateau beyond two years. Available later-line standards in refractory MSS mCRC without active liver metastases have historically reported median overall survival of approximately 10-14 months in relevant analyses, reflecting a treatment setting in which few patients have historically remained alive at later landmark timepoints and pivotal studies have generally focused on median survival rather than mature 36-month overall survival outcomes.i In this context, the survival profile, curve plateau beyond two years, and proportion of patients alive and off systemic anticancer therapy support the durability of benefit observed with BOT+BAL in this fully enrolled 123-patient Phase 1b cohort. The data build on the two-year overall survival results presented by Dr. Benjamin L. Schlechter of Dana-Farber Cancer Institute at ESMO GI 2025 and reflect an additional year of follow-up from the same cohort. With longer follow-up, the dataset now includes 26 confirmed responses; median duration of response was not reached; and 21 patients, or 17%, were alive and off all systemic anticancer therapy at last follow-up, including 13 responders. The Phase 1b cohort included 123 patients with MSS mCRC without active liver metastases. Patients had received a median of three prior lines of therapy; 67% had received at least three prior lines, 15% had received prior anti-PD-(L)1 with or without anti-CTLA-4 therapy, and 30% had received at least one later-line regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib. Key Efficacy Results: Median overall survival: 21.2 months, with 24-month and 36-month overall survival rates of 41% and 33%, respectively; Confirmed objective response rate: 21%, including three complete responses and 23 partial responses; Median duration of response: not reached; responses ranged from 1.9 months to at least 37.4 months; Disease control rate: 69% at six weeks; Clinical benefit rate: 28% at 24 weeks; Tumor regression: observed in more than 40% of patients; Treatment-free survival: 21 patients or 17%, were alive and off all systemic anticancer therapy, including 13 responders with a subset of patients remaining free from subsequent therapy or death for more than two years. In a post hoc late-line-exposed subgroup of 37 patients who had received at least one prior regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib, BOT+BAL showed a confirmed objective response rate of 22%, median overall survival of 16.2 months, and a three-year overall survival rate of 30%. In this subgroup, median duration of response was 16.6 months, disease control rate was 70%, and clinical benefit rate at 24 weeks was 27%. With extended follow-up, no new safety signals were observed and there were no treatment-related deaths. Immune-mediated diarrhea/colitis resolved in 98% of affected patients, with a median time to resolution of 14 days from onset. Treatment-related immune-mediated diarrhea/colitis was the most common immune-mediated adverse event. The selected Phase 3 regimen of BOT 1 mg/kg plus BAL demonstrated improved tolerability, with lower rates of immune-mediated diarrhea/colitis than the 2 mg/kg regimen.

Agenus announced the publication of Phase 1b data evaluating botensilimab, an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab, an anti-PD-1 antibody, in patients with treatment-refractory hepatocellular carcinoma who had progressed following prior immunotherapy. The manuscript, titled "A phase 1b study of botensilimab and balstilimab in treatment-refractory hepatocellular carcinoma," was published in Liver Cancer and is available at DOI: 10.1159/000551630. The publication reports results from an expansion cohort of the Phase 1b C-800-01 study in 19 patients with HCC who had progressed on or after prior immunotherapy. The cohort represents a difficult-to-treat population for which prospective data remain limited, including 47% of patients with albumin-bilirubin grade 2 liver function, a marker of poorer liver reserve and prognosis in HCC. In published HCC studies, ALBI grade 2 liver function has been linked to a 4- to 10-month decrement in median overall survival compared with ALBI grade 1, underscoring the poor prognosis and reduced responsiveness typically observed in this population.i Among 18 efficacy-evaluable patients, BOT+BAL demonstrated an objective response rate of 17%, including one complete response and two partial responses. The 18-week clinical benefit rate was 50%. Median duration of response was not reached, median progression-free survival was 4.4 months, and median overall survival was 12.3 months. All patients had received prior anti-PD-1 therapy, 68% had received prior tyrosine kinase inhibitors, and 58% had received prior atezolizumab/bevacizumab. One patient experienced stable disease for 66 weeks, supporting the conclusion that benefit with BOT+BAL was not confined to RECIST response alone. Treatment options after immune checkpoint inhibitor therapy in advanced HCC remain limited, and available systemic therapies have generally shown modest activity. Published studies evaluating lenvatinib, cabozantinib and regorafenib after ICI-based therapy have reported objective response rates of 6-14%, median progression-free survival of approximately 4-5 months and median overall survival of less than or equal to10.5 months.ii The BOT+BAL results therefore, provide early prospective evidence of activity in a post-ICI HCC population that included patients with adverse prognostic features often underrepresented in later-line studies.

The major averages were slightly higher near noon despite another deterioration in U.S.-Iran negotiations and continued disruption around the Strait of Hormuz. Markets are starting off in the green after six straight weeks of gains, with investors trying to reconcile resilient economic data, rising geopolitical risk and an AI trade that refuses to cool off.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:FoxreportedCircle Internetreportedand provided FY26 guidanceDream Finders HomesBeazer Homesfor $25.75 per shareMosaicreported, lowered its FY26 CapEx guidance, andd withdrew its FY26 phosphate production guidanceSeadrillprovided areport for Q12. WALL STREET CALLS:UBSDell Technologieson valuation after rallyUberto Outperform at Fox Advisors as investments start paying offWendy'sto Underweight at JPMorganStarz Entertainmentto Outperform at BairdWall Streeton two recent IPOs, Madison Airand Arxis3. AROUND THE WEB:Apollo Globalis in talks to sell MidCap Financial, WSJ reportsA Microsoftdata center site in East Africa has been delayed due to disagreements with the Kenyan government over guaranteed payments, Bloomberg reportsGeneral Motorswill pay $12.75M to resolve a California investigation into claims that it illegally sold the location and driving data of OnStar subscribers to brokers, Reuters saysAppleis working on a "slight redesign" for macOS 27 to address Liquid Glass issues, Bloomberg saysA Frontier Airlinesplane hit and killed a trespasser who breached airport security and ran out onto a runway at Denver International airport late on Friday, WSJ says4. MOVERS:Babcock & Wilcoxrises afterMonday.comhigher after reportingand providing guidance for Q2 and FY26Erascagains after entering into an AURORAS-1 clinical trial andCertarafalls afterTelephone & Data Systemslower after Raymond Jamesthe stock to Market Perform from Outperform5. EARNINGS/GUIDANCE:Townsquare MediareportedDolereported ain Q1 earningsKodiak Gas Servicesprovided areport for Q1LiquidiareportedAgenusreported ain Q1 revenueINDEXES:Near midday, the Dow was flat at 49,610.87, the Nasdaq was up 0.33%, or 87.72, to 26,334.80, and the S&P 500 was up 0.33%, or 24.13, to 7,423.06.