Sanofi and Regeneron Ink $2.2 Billion Immuno-Oncology, PD-1 Inhibitor Deal

Sanofi and Regeneron Ink $2.2 Billion Immuno-Oncology, PD-1 Inhibitor Deal
July 28, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Tarrytown, N.Y.-based Regeneron Pharmaceuticals announced today it had inked a global collaboration agreement with Paris-based Sanofi to develop and market cancer treatments utilizing programmed cell death protein 1 (PD-1) inhibitors.

Sanofi is making an upfront payment of $640 million to Regeneron. The two companies will pony up $1 billion for discovery through proof of concept (POC) development of monotherapy and novel combinations of candidates. Regeneron will put forward $250 million of the $1 billion and Sanofi will kick in $750 million.

In addition, both companies have agreed to equally fund an additional $625 million, $325 million each, to develop REGN2810, a PD-1 inhibitor. On top of that, Sanofi will pay a one-time milestone of $375 million to Regeneron if sales of a PD-1 product and any other collaboration antibody sold for use in combination with a PD-1 product exceeds $2 billion in any consecutive 12-month period.

One more component of the agreement involves reallocating $75 million over three years for immuno-oncology antibodies. This is from Sanofi’s $160 million annual contribution to their already existing collaboration, which otherwise continues unchanged.

Anti-PD-L1 is one of the most promising new areas in cancer drug research. On June 2, 2015, Amgen announced a collaboration with Roche on a Phase Ib clinical trial to evaluate talimogene laherparepvec combined with atezolizumab (MPDL3280A) for the treatment of triple-negative breast cancer and colorectal cancer with liver metastases. MPDL3280A is an investigational anti-PDL1 therapy.

On July 13, 2015, Genentech announced positive trial results for MPDL3280A in urothelial bladder cancer (UBC).

On May 29, 2015, Amgen inked a deal with Merck & Co. that expands their collaboration on talimogene with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase I, open-label trial in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

On Nov. 17, 2014, Pfizer and Merck KGaA, announced they were working on an anti-PD-L1 antibody. Pfizer paid Merck an upfront fee of $850 million, as well as up to $2 billion in regulatory and commercial milestone payments. The drugs are being studied in non-small cell lung cancer, ovarian cancer and Merkel cell carcinoma, a rare type of skin cancer.

“The field of immuno-oncology has shown the potential to dramatically improve outcomes for patients with certain types of cancer,” said George Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories in a statement about today’s collaboration with Sanofi. “However, the field is still in its very early days. We believe the approaches most likely to deliver the best results to patients will combine multiple innovative therapies acting on different pathways and targets both in the tumor and the body’s immune response—and will precisely target these medicines to the right patient. The efficiency and power of our suite of technologies, such as Velocimmune and VelociGene, combined with our human genetics capabilities, uniquely positions the Sano-Regeneron Alliance to accelerate the development of potential new immuno-oncology treatment options for cancer patients.”

The companies have been collaborating for more than eight years. This new agreement will cover both monoclonal antibodies and bi-specific antibodies. Bi-specific antibodies are a new variation of antibody therapeutics where two specific targets within the body can be bound by the same molecule, typically the cancer cell and an immune cell.

“Despite many advances over the last decades, cancer remains a leading cause of death and suffering around the world,” said Israel Lowy, vice president of Clinical Sciences and head of Translational Science and Oncology at Regeneron in an statement. “Although initial advances with immuno-oncology have helped certain patients, there is tremendous opportunity to further unlock the potential of this new approach to help even greater numbers of people living with cancer.”

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