Relay Therapeutics Passes Baton to Genentech for Development of Tumor Treatment

 

Relay Therapeutics announced today that it has entered a global license and collaboration agreement with Genentech for the commercialization and development of RLY-1971, a potent inhibitor of SHP2. Genentech will take on the responsibility of developing RLY-1971 under the agreement, with the potential to expand into several combination studies. Relay will receive an upfront payment of $75 million, and is eligible to receive an additional $25 million in near-term payments.

“RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients,” said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. “Roche and Genentech’s global footprint and deep expertise in oncology makes them the perfect partner for us to execute the broad development and commercialization of RLY-1971.”

In addition, Relay has the right to opt in to a 50/50 U.S. profit/cost share on RLY-1971. If the company chooses to opt in, it will be eligible to receive 50% of all profits from U.S. sales, and up to $410 million in additional ex-U.S. commercialization and sales-based milestone payments.

If both RLY-1971 and Genentech’s GDC-6036 are approved by regulatory bodies, Relay will become eligible to receive additional royalties. Relay will retain the rights to combine RLY-1971 with its selective FGFR2 and mutant-selective PI3Kα programs.

“Genentech has a longstanding commitment to understanding the underlying biology of KRAS, the most commonly mutated oncogene and an important driver of cancer growth,” said James Sabry, M.D., Ph.D., global head of pharma partnering, Roche. “We are excited to partner with Relay Therapeutics, and we believe that the combination of KRAS G12C and SHP2 inhibitors together represents a promising approach that we hope could become a new treatment option for patients with KRAS G12C mutant tumors.”

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). SHP2 is a signaling node and regulator that promotes cancer cell survival and growth. However, it is just one product in Relay’s pipeline that is currently in development.

Relay has also been working on developing RLY-4008, another selective and oral small molecule inhibitor. This product inhibits FGFR2, a receptor tyrosine kinase that is often altered in certain cancers. Back in September, the company announced that it had dosed its first subject in its clinical trial of RLY-4008, enriched for patients with intrahepatic cholangiocarcinoma (ICC) and other advanced solid tumors that harbor a FGFR2 alteration.

“We are excited to bring RLY-4008, our second targeted therapeutic, into clinical development,” said Don Bergstrom, M.D., Ph.D., executive vice president of R&D of Relay Therapeutics, at the time of the announcement. “FGFR2 altered tumors are known to respond clinically to pan-FGFR inhibitors but with limited benefit to patients. RLY-4008 is an exquisitely selective and purpose-built medicine, discovered with our Dynamo platform, designed to dramatically alter the course of disease for patients with FGFR2 altered cancers.”

This trial is designed to evaluate the safety and tolerability of RLY-4008 in patients with advanced or metastatic solid tumors. Specifically, patients are being enrolled who are naïve to pan-FGFR inhibitors. The objectives of the study are to evaluate safety, tolerability, pharmacokinetics and anti-tumor efficacy. Up to 125 subjects may be enrolled in this trial.

Relay, a clinical-stage precision medicines company, was built on insights into protein motion and how this behavior relates to protein function. The company focuses on enhancing small molecule therapeutic discovery in targeted oncology.