OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will Present Early Clinical Evidence of Innate Immune Modulation and Anti-Tumor Activity via SIRPα Blockade in Two Ongoing Trials at ASCO 2025
OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will Present Early Clinical Evidence of Innate Immune Modulation and Anti-Tumor Activity via SIRPα Blockade in Two Ongoing Trials at ASCO 2025
BI 765063 in combination with programmed cell death-1 (PD1) inhibitor antibody ezabenlimab + cetuximab demonstrated a well-tolerated safety profile and potentially promising efficacy signals as second-line treatment in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Next generation SIRPα inhibitor BI 770371 was shown to be well tolerated alone and in combination with PD1 inhibitor ezabenlimab in a dose escalation trial in patients with advanced solid tumors. BI 770371 is currently being further investigated in a Phase 1b study in first-line patients with R/M HNSCC.
Nantes, France, 23 May 2025 – OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE), today proudly announced that its partner Boehringer Ingelheim will present new clinical data from two early-stage trials targeting the signal regulatory protein α (SIRPα) innate immune checkpoint at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 - June 3, 2025, in Chicago, IL, USA.
In a Phase 1b study conducted by Boehringer, its potential, first-in-class SIRPα monoclonal antibody, BI 765063, demonstrated a manageable safety profile as well as preliminary signs of immune activation and additive antitumor activity when combined with PD-1 inhibitor ezabenlimab and cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).1
Additionally, in an open-label, Phase I trial conducted by Boehringer, its next-generation SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab, was shown to be well tolerated in patients with advanced solid tumors. There were no dose-limiting toxicities in either treatment arm, and the maximum tolerated dose was not reached in either group.2
“The preliminary results from these early-stage programs are encouraging and further strengthen Boehringer’s robust immuno-oncology pipeline aimed at accelerating next-generation cancer therapies to address high unmet patient needs,” said Mike Akimov, Head of Medicine, Therapy Area Oncology at Boehringer Ingelheim. “Boehringer is developing various complementary approaches to activate the immune system against cancer cells and SIRPα blockade paired with a PD-1 inhibitor is a promising strategy. We look forward to seeing if this dual activation may lead to a broader and more sustained anti-tumor response as the programs progress.”
BI 765063 and BI 770371 are designed to block the “don’t eat me” signal that cancer cells use to hide from the immune system. By targeting SIRPα, these antibodies help immune cells like macrophages recognize and destroy tumor cells, bolstering the body’s natural defenses.3
Both antibodies have been developed in partnership with OSE Immunotherapeutics, with Boehringer solely responsible for future clinical development and commercialization. Boehringer will move forward with the improved next generation SIRPα inhibitor antibody BI 770371, which will now be tested in a Phase 1b study.
Presentation Details:
Title: An Open-Label, Phase Ib Trial of the SIRPα Inhibitor BI 765063 in Combination with the PD-1 Inhibitor Ezabenlimab and Cetuximab in Patients (pts) with Head and Neck Squamous Cell Carcinoma Abstract Number: 6019 Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – Immunotherapy Date/Time: 01 June 2025 – 11:30am – 1:30pm CDT
Title: An Open-label, Phase I Trial of the SIRPα Monoclonal Antibody, BI 770371, Alone and in Combination with the PD-1 Inhibitor Ezabenlimab in Patients with Advanced Solid Tumors Abstract Number: 2515 Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – Immunotherapy Date/Time: 01 June 2025 – 11:15am – 12:45pm CDT
Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer Ingelheim takes a long-term perspective, embedding sustainability along the entire value chain. More than 54,400 employees serve over 130 markets to build a healthier, more sustainable and equitable tomorrow. Learn more at https://www.boehringer-ingelheim.com (Global).
OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext.
Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Click and follow us on LinkedIn.
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