Boehringer Ingelheim and OSE Immunotherapeutics to Present Phase 1 Results with First-in-Class SIRPa Inhibitor BI 765063 in Advanced Solid Tumors at ESMO 2021
NANTES, France, Sept. 13, 2021 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced that promising data from dose escalation Phase 1 of selective SIRPa inhibitor BI 765063 in patients with advanced solid tumors (ePoster 983P) will be presented(1) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference to be held on September 16 – 21, 2021.
This Phase 1 clinical trial aims to evaluate the safety and efficacy of BI 765063 as monotherapy and in combination with ezabenlimab (BI 754091; anti-PD-1 mAb) in patients with advanced solid tumors.
The dose escalation part (Step 1) of the Phase 1 trial has enrolled SIRPa V1/V1 homozygous or V1/V2 heterozygous patients with advanced solid tumors who failed or were not eligible for standard therapies. Two dose levels of BI 765063 (18 and 24 mg/kg IV every 3 weeks) were evaluated in combination with BI 754091 (240 mg IV every 3 weeks).
As of April 2021, a total of 12 patients had received at least one or more doses of each therapy. The combination BI 765063 + BI 754091 has shown a good safety profile and demonstrated clinical activity in two patients, including a tumor shrinkage in a patient with colonic adenocarcinoma and a confirmed partial response in a patient with endometrial carcinoma. Both patients were Micro Satellite Stable (MSS) and PD-1 treatment naïve.
Micro Satellite Instable (MSI) biomarkers are recognized as effective for immunotherapy by checkpoint inhibitor alone. The majority of colorectal and endometrial cancers are MSS and achieve limited benefit from immune checkpoint inhibitor monotherapy(2). Updated data of June 2021 on this dose escalation part of Phase 1 will be featured in an ePoster presentation at the upcoming 2021 ESMO meeting.
The Phase 1 clinical study of BI 765063 is being conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to the product.
On-demand ePoster presentation – From September 16, 2021?
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