On May 20, 2021 OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) and its development partner Boehringer Ingelheim reported that acceptance of an upcoming poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 4 – 8, 2021, covering promising initial data from Phase 1 dose escalation of selective SIRPα inhibitor BI 765063 in patients with advanced solid tumors (Abstract #2623) (Press release, OSE Immunotherapeutics, MAY 20, 2021, View Source [SID1234580464]).

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The data to be presented at ASCO (Free ASCO Whitepaper) 2021 indicate that OSE Immunotherapeutics’ first-in-class signal regulatory protein α (SIRPα) inhibitor BI 765063 was well-tolerated, showed sustained receptor occupancy (RO) saturation and monotherapy activity. Clinical benefit was observed in 45% of patients evaluable per RECIST* criteria. A durable partial response was observed in an advanced hepatocellular carcinoma (HCC) patient, and the on-treatment biopsy of the responder showed an increase in CD8 T-cell infiltration and activation. Furthermore, the on-treatment biopsy also showed an increase in PD-L1 expression on tumor cells. A BI 765063 dose escalation study in combination with Ezabenlimab (PD-1 antagonist) is ongoing and will help determine the recommended dose for further Phase 2 clinical development in patients with advanced solid tumors.

Alexis Peyroles, CEO of OSE Immunotherapeutics commented: "OSE Immunotherapeutics is moving forward to deliver highly innovative, first-in-class and best-in-class compounds. The promising data presented at ASCO (Free ASCO Whitepaper) includes no serious dose limiting toxicities, as well as early evidence of efficacy, suggesting that selective myeloid cell targeting of SIRPα to modulate CD47-dependent inhibition of anti-tumor immunity including the ‘Don’t Eat Me’ axis is a sound therapeutic strategy in solid tumors. These promising data presented at ASCO (Free ASCO Whitepaper) 2021 on BI 765063 confirm the quality of our science and we look forward to continuing to accelerate our clinical development and pipeline diversification over the coming years."

*RECIST: Response Evaluation Criteria in Solid Tumours

PRESENTATION DETAILS

Title: "Safety, pharmacokinetics, efficacy, and preliminary biomarker data of first-in class
BI 765063, a selective SIRPα inhibitor: results of monotherapy dose escalation in phase 1 study in patients with advanced solid tumors"

The abstract #2623 was posted on ASCO (Free ASCO Whitepaper).org on May 19, 2021 at 5:00PM ET and 11:00PM CEST

From June 4th at 3:00PM CEST:
Virtual poster presentation on demand
Poster session: Developmental Therapeutics – Immunotherapy
Presenting Author: Stéphane Champiat, MD, PhD, Institut de Cancérologie, Gustave Roussy, Villejuif