Press Release

Preclinical studies of SHP2 inhibitors demonstrated promise across multiple forms of cancer; lead drug candidate expected to start clinical trials in second half of 2018

CAMBRIDGE, Mass. & REDWOOD CITY, Calif.--(BUSINESS WIRE)--Sanofi and REVOLUTION Medicines, Inc. today announced an exclusive worldwide partnership to develop and commercialize targeted therapies, based on the biology of the cellular enzyme SHP2, for patients with non-small lung cancer and other types of cancer carrying certain mutations. This collaboration builds on precision oncology discoveries by REVOLUTION Medicines and preclinical development of RMC-4630, the company’s lead small molecule inhibitor of SHP2, and will apply Sanofi’s expertise in oncology research and drug development.

In the collaboration, the companies will jointly develop SHP2 inhibitors, which are designed to reduce cell growth signaling that is overactive in cancer. Both parties will contribute to the research and development program, with REVOLUTION Medicines continuing to lead research and early clinical development, and Sanofi leading later development activities for the program. The companies expect to begin first-in-human clinical trials with RMC-4630 in the second half of 2018.

“REVOLUTION Medicines has made great progress in elucidating the role of SHP2 in cancer and advancing RMC-4630 into clinical development,” said Mark A. Goldsmith, M.D., Ph.D., president and chief executive officer of REVOLUTION Medicines. “The exciting collaboration benefits from the innovation culture and scientific capabilities of our team and the proven oncology research and development capabilities and global commercial resources of Sanofi to continue this momentum and maximize the potential impact for cancer patients.”

“This agreement demonstrates our continued commitment to develop new therapies for patients living with cancer,” said Joanne Lager, head of oncology development at Sanofi. “We look forward to working with REVOLUTION Medicines to advance investigational therapies that could provide a new way to treat patients with non-small cell lung cancer and other cancers that have specific types of genetic mutations.”

REVOLUTION Medicines will receive an upfront fee of $50 million, and Sanofi will cover R&D costs for the joint SHP2 program. Sanofi will receive an exclusive worldwide license for global commercialization of any approved products targeting SHP2, subject to a U.S. co-promote option for REVOLUTION Medicines. The companies will enter into a 50/50 profit and loss share arrangement in the U.S., and REVOLUTION Medicines will receive a tiered royalty reaching mid-double digits on sales in other markets. REVOLUTION Medicines could also receive more than $500 million in development and regulatory milestone payments.

The Role of SHP2 in Cancer

SHP2 (PTPN11), a cellular enzyme in the protein tyrosine phosphatase family, plays an important role in multiple forms of cancer and in regulating the immune system. Recently REVOLUTION Medicines reported discoveries about the regulation by SHP2 of a cell growth signaling pathway, known as the RAS-MAP kinase pathway, that frequently is hyperactive in human cancers. The research revealed that some mutated forms of proteins in the RAS-MAP kinase pathway depend on SHP2 for their oncogenic activity, and that small molecule inhibitors of SHP2 designed by the company can reduce their tumorigenic effects.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

About REVOLUTION Medicines

The mission of REVOLUTION Medicines is to discover and develop new drugs directed toward frontier oncology targets on behalf of cancer patients. Frontier targets include proteins that drive the growth and survival of cancer but carry atypical structural or regulatory features requiring unconventional drug discovery strategies. The company brings together deep talent in cancer biology and small molecule drug discovery supported by advanced chemical synthesis, computational and assay technologies to master these targets. Seasoned translational and development scientists help to fulfill the company’s commitment to precision oncology.

Headquartered in Redwood City, Calif. at the intersection of Silicon Valley and the birthplace of biotechnology, REVOLUTION Medicines is a private company financed by top-tier investors.

REVOLUTION Medicines: Translating frontier oncology targets to outsmart cancer