Sanofi and Regeneron Form Immuno-Oncology Pact

July 29, 2015
Pharmaceutical Technology Editors

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

Sanofi and Regeneron Pharmaceuticals have entered into a global collaboration to discover, develop, and commercialize new antibody cancer treatments in immuno-oncology.  The goal is to advance bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

Both companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor, which is undergoing Phase I evaluation. Clinical trials with new therapeutic candidates in preclinical development are expected to commence in 2016.

Under the terms of the agreement, Sanofi will make an upfront payment of $640 million to Regeneron. An investment of $1 billion will be dedicated to drug discovery through to proof of concept (POC) development (Phase 2a studies) of monotherapy and novel combinations of immuno-oncology antibody candidates. Regeneron will fund 25% of this sum, with the remaining 75% coming from Sanofi.

In addition, the companies will equally invest an additional $650 million (i.e., $325 million per company) for the development of REGN2810, a PD-1 inhibitor. Sanofi has agreed to pay Regeneron a one-time milestone of $375 million in the event that sales of a PD-1 product and any other collaboration antibody sold for use in combination with a PD-1 product exceed, in the aggregate, $2 billion in any consecutive 12-month period.

The two companies have also agreed to re-allocate $75 million (over three years) for immuno-oncology antibodies from Sanofi's $160 million annual contribution to their existing antibody collaboration, which otherwise continues as announced in November 2009. Beyond the committed funding, additional funding will be allocated as programs enter post-POC development.

The new agreement covers both monoclonal antibodies and new bi-specific antibodies, a variation of standard antibody therapeutics, in which two distinct targets within the body can be bound by the same molecule, usually the cancer cell and an immune cell.

Source: Sanofi and Regeneron