Botensilimab

Replimune's RP1 Melanoma Therapy Nears FDA Decision with July PDUFA Date as Commercial Infrastructure Readies for Launch

8 hours ago

• Replimune's BLA for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma is proceeding on schedule with a PDUFA date of July 22, 2025, following completed manufacturing inspections and late cycle review. • The company has fully established its commercial infrastructure ahead of potential launch, targeting approximately 13,000 annual U.S. patients who progress on PD-1 treatment, with an estimated 80% eligible for RP1 therapy. • Replimune maintains a strong financial position with $483.8 million in cash, cash equivalents and short-term investments as of March 31, 2025, providing runway into Q4 2026 to support commercialization efforts.

SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025

13 days ago

• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16. • Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options. • Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

Study Reveals Factors Influencing Immune Checkpoint Inhibitor Efficacy in Metastatic Colorectal Cancer

2 months ago

• Cleveland Clinic and Moffitt Cancer Center researchers analyzed data from nearly 19,000 metastatic colorectal cancer patients, confirming immune checkpoint inhibitors significantly improve survival in MSI-H tumors compared to chemotherapy alone. • The study identified specific factors that may enhance immune checkpoint inhibitor efficacy in traditionally unresponsive MSS tumors, including high albumin levels and recent antibiotic use, potentially expanding treatment options. • Approximately 12.3% of patients with MSS tumors achieved durable responses to immune checkpoint inhibitors, suggesting the need for further research to identify biomarkers that could predict treatment success in this population.

Novel Triple Immunotherapy Combination Shows Promise in PD-1 Resistant Gastroesophageal Cancer

3 months ago

• Phase II study evaluates innovative combination of AgenT-797 (iNKT cell therapy), botensilimab (CTLA-4 inhibitor), and balstilimab (PD-1 inhibitor) in PD-1 refractory gastroesophageal cancer patients. • Biomarker analysis reveals significant increases in tumor immune cell infiltration and activation of cytotoxic T cells, with enhanced antigen-presenting activity within the tumor microenvironment. • Treatment demonstrated sustained interferon-gamma response and increased proinflammatory biomarkers, suggesting robust immune system activation against cancer cells.

Agenus to Present New Data on BOT/BAL Combination Therapy at AACR IO Meeting

3 months ago

• Agenus will showcase interim data from a Phase 2 study combining BOT/BAL with iNKT cell therapy AgenT-797 in refractory gastric cancer patients at the AACR IO Annual Meeting. • A Trial-in-Progress poster will present findings from an ongoing Phase 1/2 study evaluating BOT/BAL as a first-line treatment for microsatellite stable colorectal cancer. • The presentations highlight Agenus's innovative approach using botensilimab, an Fc-enhanced CTLA-4 inhibitor, designed to extend immunotherapy benefits to traditionally unresponsive "cold" tumors.

Personalized Cancer Vaccine Shows Promising Results in Advanced Kidney Cancer Trial

4 months ago

• A groundbreaking Phase 1 trial at Yale Cancer Center demonstrated successful anti-cancer immune responses in all nine patients with advanced kidney cancer using personalized therapeutic vaccines. • The vaccine, designed to target specific tumor mutations, generated strong T-cell responses within three weeks of treatment and maintained effectiveness for approximately three years post-treatment. • Patients experienced minimal side effects, primarily mild flu-like symptoms, suggesting a favorable safety profile for this innovative approach to treating advanced clear cell renal cell carcinoma.

MiNK Therapeutics' Allo-iNKT Cell Therapy Shows Promise in Refractory Gastric Cancer

4 months ago

• MiNK Therapeutics' agenT-797, combined with botensilimab and balstilimab, demonstrates robust immune activation in refractory gastroesophageal cancer. • The Phase 2 study reveals increased interferon-gamma levels and enhanced T-cell infiltration, suggesting improved clinical outcomes. • Early administration of agenT-797 alongside checkpoint inhibitors before chemotherapy amplifies immune responses, optimizing T-cell priming. • The off-the-shelf allogeneic iNKT platform offers a scalable and accessible treatment option for patients with hard-to-treat cancers.

Novel Immunotherapy Combination Trial Launches for Advanced Gastroesophageal Cancer

4 months ago

A new Phase II study is investigating the combination of agenT-797, an innovative iNKT cell therapy, with botensilimab, an Fc-enhanced anti-CTLA-4 inhibitor, in gastroesophageal cancer. This trial addresses a critical need in a disease that causes 1.3 million deaths annually, targeting patients who have progressed after standard treatments.

Balstilimab Plus Botensilimab Shows Enhanced Response in MSS mCRC Without Liver Metastases

4 months ago

• Preliminary phase 2 data shows balstilimab combined with botensilimab yields a higher objective response rate in MSS mCRC patients without liver metastases. • The combination of botensilimab 75 mg Q6W plus balstilimab showed a confirmed ORR of 19% and a disease control rate of 55%. • The median duration of response has not been reached, with 70% of responses ongoing, indicating durable efficacy of the combination therapy. • A phase 3 trial is planned using botensilimab 75 mg with balstilimab 240 mg, based on the favorable safety and efficacy profile observed.

Gastrointestinal Cancer Symposium 2025: Key Advances in Treatment Strategies

4 months ago

• Nivolumab plus ipilimumab demonstrates superior progression-free survival compared to nivolumab alone in MSI-H/dMMR metastatic colorectal cancer. • Encorafenib combined with cetuximab and chemotherapy shows significant improvement in overall response rate for BRAF V600E-mutated metastatic colorectal cancer. • TACE plus camrelizumab and rivoceranib extends progression-free survival in patients with unresectable hepatocellular carcinoma, offering a manageable safety profile.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Nivolumab/Relatlimab Combination Demonstrates Sustained Overall Survival Benefit in Advanced Melanoma

5 months ago

• Extended analysis of the RELATIVITY-047 trial shows nivolumab/relatlimab significantly improves overall survival compared to nivolumab alone in advanced melanoma patients. • Median overall survival reached 51.0 months with the combination therapy versus 34.1 months with nivolumab monotherapy, indicating a substantial survival advantage. • The study also reported improved progression-free survival and melanoma-specific survival with the nivolumab/relatlimab combination. • No new safety signals were identified, reinforcing the combination's manageable safety profile in previously untreated advanced melanoma.

Combination Therapies Show Promise in Treating MSS Metastatic Colorectal Cancer

5 months ago

• Combination therapies are being explored to improve immunotherapy efficacy in pMMR/MSS metastatic colorectal cancer (mCRC) patients, who do not typically respond well to single-agent immune checkpoint inhibitors. • Multi-target tyrosine kinase inhibitors combined with ICIs have shown some success in converting 'cold tumors' to 'hot tumors,' enhancing immune response, but results vary across studies. • Dual ICI regimens and combinations with chemotherapy or radiotherapy are under investigation to overcome resistance and improve outcomes in MSS mCRC, with encouraging results in some trials. • Emerging biomarkers like TMB and POLE/POLD1 mutations may help identify MSS mCRC patients who are more likely to benefit from immunotherapy, guiding personalized treatment strategies.

FDA Grants Priority Review to Replimune's RP1 Plus Nivolumab for Advanced Melanoma

5 months ago

• The FDA has granted priority review to Replimune's BLA for RP1 in combination with nivolumab for advanced melanoma, setting a PDUFA action date of July 22, 2025. • The BLA is supported by data from the IGNYTE trial, which evaluated RP1 plus nivolumab in patients with anti-PD-1 failed melanoma. • RP1 is a novel oncolytic immunotherapy based on a modified herpes simplex virus, designed to maximize tumor killing and stimulate an anti-tumor immune response. • The ongoing Phase 3 IGNYTE-3 trial is assessing the combination in patients who have progressed on or are ineligible for anti-CTLA-4 therapies.

Botensilimab and Balstilimab Combination Shows Promise in Sarcoma Treatment

6 months ago

• A phase one trial of botensilimab and balstilimab shows promising results in treating sarcomas, particularly angiosarcoma, which typically responds poorly to immunotherapy. • The combination therapy yielded a 23% response rate across all sarcoma patients, with an impressive 44% response rate specifically in angiosarcoma cases. • Botensilimab blocks CTLA4, enhancing T cell education, while balstilimab inhibits the PD-1 receptor, preventing tumor cells from suppressing immune attacks. • Further trials are planned to assess the combination's efficacy in newly diagnosed sarcomas, both alone and in conjunction with chemotherapy, to address the unmet need for approved checkpoint inhibitors.

Replimune's RP1 Receives FDA Breakthrough Therapy Designation and BLA Submission for Advanced Melanoma

6 months ago

• Replimune has submitted a Biologics License Application (BLA) to the FDA for RP1 in combination with nivolumab to treat advanced melanoma patients after anti-PD-1 therapy. • The FDA granted Breakthrough Therapy designation to RP1 plus nivolumab, expediting its development for patients with limited options after anti-PD-1 regimen failure. • RP1 (vusolimogene oderparepvec) is an oncolytic immunotherapy designed to maximize tumor killing, enhance immunogenicity, and activate a systemic anti-tumor immune response. • A Phase 3 trial is underway to confirm RP1's efficacy with nivolumab in advanced melanoma patients who have progressed on or are ineligible for anti-CTLA-4 therapy.

Replimune's RP1 Receives Priority Review from FDA for Advanced Melanoma

6 months ago

• Replimune's BLA for RP1 in combination with Bristol Myers Squibb’s Opdivo to treat advanced melanoma has been accepted and granted priority review by the FDA. • The FDA's decision on the RP1/Opdivo combo is anticipated by July 22, 2025, with no advisory committee meeting planned currently. • The BLA submission is supported by positive data from the IGNYTE study, evaluating the combo in patients with anti-PD-1 failed melanoma. • A confirmatory phase III IGNYTE-3 study is underway, investigating RP1 plus Opdivo in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy.

Replimune's RP1 Receives FDA Breakthrough Therapy Designation for Advanced Melanoma

6 months ago

• Replimune's RP1, combined with nivolumab, has been granted Breakthrough Therapy designation by the FDA for advanced melanoma after anti-PD-1 treatment failure. • The BLA submission to the FDA for RP1 in combination with nivolumab was made under the Accelerated Approval pathway. • The designation is based on promising safety and clinical activity observed in the IGNYTE clinical trial's anti-PD-1 failed melanoma cohort. • A confirmatory Phase 3 trial, IGNYTE-3, is currently enrolling patients to further evaluate RP1 with nivolumab in advanced melanoma.

Replimune's RP1 Receives FDA Breakthrough Therapy Designation for Advanced Melanoma

6 months ago

• Replimune's RP1 (vusolimogene oderparepvec) has been granted Breakthrough Therapy designation by the FDA for advanced melanoma treatment. • The BLA for RP1 in combination with nivolumab has been submitted to the FDA under the Accelerated Approval pathway. • The designation is based on clinical activity observed in the IGNYTE clinical trial for patients who progressed on anti-PD1 regimens. • A confirmatory Phase 3 trial (IGNYTE-3) is currently enrolling patients with advanced melanoma who have progressed on prior therapies.

Drug Development Updates