Boehringer Ingelheim has committed a potential $1.4 billion-plus toward cancer immunotherapy by partnering with OSE Immunotherapeutics to develop its late-preclinical-stage candidate OSE-172 (Effi-DEM), a novel checkpoint inhibitor antibody designed to treat solid tumors.

Boehringer and OSE have entered into a global license and collaboration agreement to develop OSE-172, an anti-Signal Regulatory Protein Alpha (SIRP-alpha) monoclonal antibody (mAb) that targets myeloid lineage cells, including dendritic cells (DCs), tumor-associated macrophages (TAMs) and myeloid-derived suppressor cells (MDSCs). OSE-172 is designed to prevent the cluster of differentiation 47 (CD47) ligand from binding to SIRP-alpha, triggering its cellular inhibitory effects.

The companies reason that OSE-172 could enhance anti-tumor immunity by improving T-cell activity through the enhancement of DC antigen presentation functionality. That in turn is expected to enhance the phagocytic and inflammatory properties of macrophages in the tumor microenvironment, enabling differentiation of MDSCs to an effector state, according to Boehringer Ingelheim and OSE.

In addition, say the companies, OSE-172 could be developed in all cancers involving TAM and MDSC cells—and may also be combined with other immunotherapies, in particular with checkpoint inhibitors acting on T lymphocytes, checkpoint inhibitors targeting the PD-1/PD-L1 axis, or products triggering a stimulation of the immune system.

OSE-172 has obtained proof of concept in models of aggressive cancers such as primary liver cancer, melanoma, and breast cancer, OSE stated on its website.

Under the companies’ agreement, Boehringer Ingelheim has acquired global rights to develop, register, and commercialize OSE-172. Boehringer has agreed to pay OSE €15 million ($18.4 million) upfront, up to the same amount tied to the short-term milestone of launching a Phase I clinical study, and more than €1.1 billion ($1.35 billion) tied to achieving development, commercialization, and sales milestones, plus royalties on worldwide net sales. 

At approximately $1.4 billion, the deal would not be large enough to be among the Top 10 Immuno-Oncology Collaborations as ranked by GEN, most recently on March 26.

Immuno-Oncology “Core Pillar”

Boehringer Ingelheim said the deal “strengthens a core pillar of its cancer immunology and immune modulation strategy,” and reflects its commitment to oncology and immuno-oncology—one of the company’s core therapeutic areas along with cardiovascular and metabolic diseases, central nervous system disorders, and immunology and respiratory diseases.

“A key area of focus is the identification of drugs that target myeloid cell immune regulatory receptors, of which SIRP-alpha is a leading example,” Jonathon Sedgwick, Ph.D., Boehringer Ingelheim’s global head, cancer immunology & immune modulation research, said yesterday in a statement. “We are dedicated to developing ground-breaking, first-in-class therapies that can transform the lives of patients and help win the fight against cancer.”

Added OSE CEO Dominique Costantini, M.D.: “This partnership with Boehringer Ingelheim is a real recognition of the value of our innovative approach to treating cancer and will create an exciting new alliance to fuel the Phase I development of OSE-172.”

OSE is one of numerous companies developing immuno-oncology treatments that target CD47, according to Surface Oncology. In its Form S-1 registration statement, filed March 23, Surface cited OSE as well as Alexo Therapeutics, Arch Oncology, Aurigene, Blink Biomedical, Celgene, Forty Seven, Novimmune, Sorrento, Synthon Biopharmaceuticals, and Trillium Therapeutics.

Forty Seven, a developer of immune-oncology treatments spun out of Stanford University, in January announced a pair of collaborations with pharma giants Merck KGaA and Genentech, a member of the Roche Group, to develop its lead candidate Hu5F9-G4, a mAb targeting the CD47 receptor.

Last year, Synthon gained exclusive global rights to the Sanquin Blood Supply Foundation’s lead CD47-SIRP-alpha antibodies and intellectual property, through a collaboration whose value was not disclosed.

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