CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the “Don’t Eat Me” signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells. BI 765063 (OSE-172, anti-SIRPα mAb on SIRPα/CD47 pathway): developed in partnership with Boehringer Ingelheim myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors. Positive preclinical and human ex vivo results in August 2020. CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. In Phase 2 in ovary cancer (TEDOVA, sponsor ARCAGY-GINECO)ĭue to the COVID-19 crisis, accrual of new patients in TEDOPaM should restart in 2021. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) Tedopi® (innovative combination of neoepitopes): the company’s most advanced product positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile: The company’s immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. Presenting Author: Stéphane Champiat, MD, PhD, Institut de Cancérologie, Gustave Roussy, Villejuif Poster session: Developmental Therapeutics – Immunotherapy The abstract #2623 was posted on on at 5:00PM ET and 11:00PM CEST 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” *RECIST: Response Evaluation Criteria in Solid Tumours These promising data presented at ASCO 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.” The promising data presented at ASCO 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. 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.Īlexis Peyroles, CEO of OSE Immunotherapeutics commented: “ OSE Immunotherapeutics is moving forward to deliver highly innovative, first-in-class and best-in-class compounds. Furthermore, the on-treatment biopsy also showed an increase in PD-L1 expression on tumor cells. 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. Clinical benefit was observed in 45% of patients evaluable per RECIST* criteria. The data to be presented at ASCO 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. OSE Immunotherapeutics (ISIN: FR0012127173 Mnemo: OSE) and its development partner Boehringer Ingelheim announced today acceptance of an upcoming poster presentation at the 2021 American Society of Clinical Oncology (ASCO) 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). Data indicate BI 765063 was well tolerated and showed monotherapy activity in heavily pre-treated solid tumor patients.BI 765063, a first-in-class SIRPα inhibitor on the SIRPα/CD47 “Don’t eat me” pathway, is under collaborative development with Boehringer Ingelheim.
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