JPM: Sanofi pays $125M to take lead in new checkpoint inhibitor space

Sanofi is paying Biond Biologics $125 million upfront for global rights to a novel immune checkpoint inhibitor. The agreement gives Sanofi a near-clinical anti-ILT2 monoclonal antibody designed to turn the innate and adaptive immune systems against tumors.

ILT2 is an inhibitory receptor expressed on innate and adaptive immune cells. When ILT2 binds to an immunosuppressive MHC molecule expressed by multiple tumor types, it hinders the proliferation of immune cells. Recognition of the role ILT2 plays in immunosuppression led Biond to design BND-22, an antibody that binds to the receptor to enhance the antitumor activity of immune cells. 

To date, cancer immunotherapies have primarily functioned by getting T lymphocytes in the adaptive immune system to attack tumor cells. The expression of ILT2 across the innate and adaptive immune systems, including on natural killer (NK) cells and macrophages, could enable BND-22 to orchestrate more potent anticancer attacks than existing therapies can.

Sanofi saw enough potential in the concept to bet $125 million on an asset that is yet to be tested in humans. The deal, which features more than $1 billion in potential milestones, gives Sanofi exclusive global rights to BND-22.

Biond is gearing up to start a first-in-human clinical trial of the checkpoint inhibitor by the middle of 2021. Having recently submitted an IND to the FDA, Biond will lead the phase 1a assessment of the drug, both as a monotherapy and in combination with other cancer therapies, before handing off to Sanofi for further development. 

BND-22 is moving into human testing on the strength of preclinical evidence of efficacy. Last year, Biond presented data to show BND-22 binds to ILT2, but not other ILT-family receptors, and stops it from interacting with the immunosuppressive MHC molecule HLA-G. 

The mechanism altered the activity of multiple immune cell types, increasing macrophage-mediated phagocytosis of tumor cell lines and patient-excised tumors and boosting the cytotoxicity of NK cells. Biond generated evidence BND-22 works synergistically with PD-1 checkpoint inhibitors, such as Sanofi’s Libtayo, to increase the production of pro-inflammatory cytokines. 

In mouse models of subcutaneous melanoma and colorectal carcinoma, BND-22 blocked tumor growth and prolonged survival. Another study found BND-22 inhibited the spread of metastases in a melanoma lung lesion model.

Having ceded a big head start to Bristol Myers Squibb and Merck in the PD-1/PD-L1 space, Sanofi has bet $125 million on the strength of preclinical data for the chance to lead the ILT2 field. The deal is part of a series of immuno-oncology and autoimmune deals struck by Sanofi, most recently the $1.1 billion takeover of Kymab.