Genentech acquires Regor’s CDK inhibitors for $850m

Genentech is enhancing its breast cancer drug development pipeline by acquiring Regor Pharmaceuticals’ CDK inhibitors in a transaction valued at $850 million. This acquisition was disclosed by Roche, Genentech’s parent company, during its pharmaceutical day in London, UK. Roche is concentrating on three primary therapeutic areas, including oncology.

Regor Pharmaceuticals will continue to manage its two ongoing Phase I clinical trials for the CDK4/2 inhibitor RGT-419B until the studies are completed. Post-completion, Genentech will assume responsibility for the global clinical development, manufacturing, and commercialization of the drug. Additionally, the deal comprises a preclinical candidate, RGT-587, which is poised for Phase I trials and aims to treat brain metastases.

The first of Regor’s Phase I trials (NCT05304962) involves 12 patients with HR+/HER2-negative advanced breast cancer who have previously received CDK4 treatment. Results indicated that RGT-419B, when used as a monotherapy, achieved a 28.6% partial response rate and a 44% clinical benefit rate without any observed dose-limiting toxicities. The second Phase I trial (NCT06299124) is being conducted in China with 40 participants, and it is expected to conclude by the end of the year.

Regor’s CEO Xiayang Qiu expressed confidence in Genentech’s ability to maximize the potential of these new treatments to help breast cancer patients globally.

During Roche’s recent presentation on September 30, CEO Teresa Graham described CDK inhibitors as highly compatible with Roche’s existing breast cancer treatments. She mentioned several successful products in Roche’s portfolio, like Phesgo, Kadcyla, and Perjeta, which collectively generated significant global sales in 2023. Graham also mentioned inavolisib, a promising first-line treatment for PIK3CA-mutated hormone receptor-positive breast cancer, which is awaiting FDA approval with a decision date set for November 27.

The acquisition of CDK inhibitors, which are designed to inhibit proteins that control cell division and thereby slow or stop the growth of cancer cells, has been a strategic move for several pharmaceutical companies. For instance, in July 2024, Exscientia acquired a CDK7 inhibitor that is being tested in patients with advanced or metastatic solid tumors. This deal followed Exscientia’s buyout of its development partner Apeiron Therapeutics’ shares in the program.

Roche’s Global Head of Oncology and Hematology Product Development, Charles Fuchs, pointed out the existing gap in addressing CDK4/6i resistance, as most patients eventually progress after CDK4/6i treatment. According to Regor, RGT-419B is the most advanced CDK4/2 inhibitor currently in clinical trials.

This is not Regor’s first major partnership with a large pharmaceutical company. In December 2021, Regor entered into a $1.5 billion agreement with Eli Lilly to discover, develop, and market new treatments for metabolic disorders. Under this agreement, Lilly obtained a license for certain intellectual property from Regor, with an option to extend the license.

Roche’s announcement at its annual pharma day underscores its commitment to expanding its oncology portfolio, particularly in the area of breast cancer, through strategic acquisitions and partnerships aimed at bringing innovative treatments to market.