• Novel antagonist anti-SIRPα monoclonal antibody (mAb) targeting both V1 and V2 SIRPα alleles makes SIRPα antagonists an option for more cancer patients.
  • First clinical results of BI 770371 in monotherapy and in combination presented at ESMO 2023 conference.

NANTES, France I October 23, 2023 I OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced that first Phase 1 results for BI 770371, a novel anti-SIRPα monoclonal antibody evaluated in advanced solid tumors, have been presented, at the European Society for Medical Oncology conference, held in Madrid, Spain (October 20 – 24, 2023).

BI 770371 is an IgG1 mAb that recognizes both the V1 and V2 variants of SIRPα. In many cancer types, CD47 forms a potent ‘don’t eat me’ signaling complex with SIRPα that triggers a cascade of events that enables cancer cells to avoid detection by the innate immune system and inhibits the ability of macrophage cells to fight cancer. By blocking the interaction between SIRPα and cluster of differentiation 47 (CD47), SIRPα antagonism enhances innate immunity and restores the immune function of myeloid cells in the tumor microenvironment.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented:

“We congratulate our partner Boehringer Ingelheim for this important new achievement, performed in the frame of our global collaboration and license agreement, which demonstrates their commitment to selective SIRPα inhibitors targeting myeloid cells. We are very pleased to potentially make our selective SIRPα inhibitor technology available to more patients through this strategic collaboration. With the V1 and V2 alleles being similarly expressed across humans in western countries, and V2 being more prevalent in the Asian region, the additional BI 770371 program highlights a new step forward in our partnership with Boehringer Ingelheim aiming to provide this selective SIRPα innovation for the benefits of more patients.”

The BI 770371 development program will extend the therapeutic potential of selective SIRPα antagonists in various diseases or disorders, covering the most prevalent allelic variants* of SIRPα, V1 SIRPα and V2 SIRPα expressed on myeloid cells.

Boehringer Ingelheim is currently evaluating BI 770371 as monotherapy and in combination with ezabenlimab, a PD1 inhibitor (BI 754091), in an open-label, dose escalation/dose expansion Phase I clinical trial (NCT05327946) conducted in Canada, USA and Japan in patients with advanced solid tumours. The first clinical results of BI 770371 presented at ESMO 2023 conference (Madrid, Abstract #697P) showed that adverse events were manageable during the on-treatment period, Maximal Tolerated Dose (MTD) has not been reached. This clinical trial is ongoing. Boehringer Ingelheim is also evaluating BI 765063 (formerly OSE-172) in different combinations with patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC) in a Phase 1b trial conducted in the United States, Europe and Asia (NCT05249426).

ESMO, Abstract #697P title:
Open-label, Phase I dose escalation/expansion trial of the anti-SIRPa monoclonal antibody BI 770371 in patients with advanced solid tumours, alone or in combination with the anti-PD-1 monoclonal antibody ezabenlimab -NCT05327946

Martin E. Gutierrez1*, Rahima Jamal2, Noboru Yamamoto3, Toshihiko Doi4, Gunther Kretschmar5, Javier Ferrada5, Stephan Wojciekowski6, Manish R. Patel7
Hackensack University Medical Center at Hackensack Meridian Health, Hackensack, NJ, USA; 2 Centre Hospitalier de l’Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, QC, Canada; 3 National Cancer Center Hospital, Tokyo, Japan; 4 National Cancer Center Hospital East, Kashiwa, Japan; 5 Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA; 6 Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany; 7 Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA

* Qu et al. Biomarker Research (2022)

ABOUT OSE Immunotherapeutics

OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation.

The Company’s current well-balanced first-in-class clinical pipeline includes:

  • Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors.
  • OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. OSE-279 is the backbone therapy of the BiCKI® platform.
  • OSE-127lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics).
  • FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.).
  • BI 765063 and BI 770371 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC).

OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapeutics:

  • BiCKI® platform focused on immuno-oncology (IO) is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced BiCKI® candidate targeting anti-PD1xIL-7.
  • Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by the platform, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com
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SOURCE: OSE Immunotherapeutics