- BI 765063, a first-in-class SIRPα inhibitor in the SIRPα/CD47 “Don’t eat me” pathway, is being developed under collaborative agreement between
OSE Immunotherapeutics andBoehringer Ingelheim .
NANTES,
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 SIRPα 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
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
The Phase 1 clinical study of BI 765063 is being conducted by
On-demand ePoster presentation – From
(1) | 983P - Phase I dose escalation study in patients (pts) with advanced solid tumors receiving first-in-class BI 765063, a selective signal-regulatory protein α (SIRPα) inhibitor, in combination with ezabenlimab (BI 754091), a programmed cell death protein 1 (PD-1) inhibitor Presentation Number: 983P Speaker : |
(2) | Manz S., Losa M., Fritzch R. et A. Efficacy and side effects of immune checkpoint inhibitors in the treatment of colorectal cancer. Ther Adv Gastroenterol 2021, Vol. 14: 1–12. Green A.K., Feinberg J., Makker V. A Review of Immune Checkpoint Blockade Therapy in Endometrial Cancer. 2020 ASCO educational book. Cao W., Ma X., Fischer JV. et al. Immunotherapy in endometrial cancer: rationale, practice and perspectives. Cao et al. |
ABOUT BI 765063 (formerly OSE-172)
BI 765063 is a monoclonal antibody antagonist of the key myeloid cell checkpoint inhibitor SIRPα. BI 765063 prevents the SIRPα ligand CD47, from binding to SIRPα thereby preventing cellular signalling that can reduce the anti-tumorigenic properties of myeloid cells such as macrophages and dendritic cells. In
ABOUT
Vaccine platform
- 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 CellLung Cancer post checkpoint inhibitor failure.
In Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
In Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
In Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT. - CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results. Voluntary and temporary Phase 1 enrollment suspension on-going (July 2021).
- BI 765063 (OSE-172, anti-SIRPα mAb on SIRPα/CD47 pathway): developed in partnership with
Boehringer Ingelheim in advanced solid tumors; positive Phase 1 results in monotherapy and BI 765063 dose escalation study ongoing in combination with Ezabenlimab (PD-1 antagonist). - 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.
- BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.
Auto-immunity and inflammation platform
- FR104 (anti-CD28 monoclonal antibody): Licensing partnership agreement with Veloxis in the organ transplant market; ongoing Phase 1/2 in renal transplant (sponsored by the
Nantes University Hospital ); Phase 2-ready asset in an autoimmune disease indication. - OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with
Servier ; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2a is being conducted in Sjögren’s syndrome (Servier sponsor). - OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
For more information: https://ose-immuno.com/en/
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Contacts
Sylvie Détry sylvie.detry@ose-immuno.com +33 153 198 757 Investor Relations thomas.guillot@ose-immuno.com +33 607 380 431 | Media darren@lifescicomms.com +1 646 627 8387 French Media: FP2COM fportejoie@fp2com.fr +33 607 768 283 | gvanrenterghem@lifesciadvisors.com +41 76 735 01 31 |
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