Roche Collaborates with Startup to Discover Innovative Breast Cancer Treatments

Dive Brief:

• On Monday, Roche announced its decision to invest 0 million to acquire two experimental drugs aimed at treating breast cancer from the Chinese biotech startup Regor Therapeutics.
• Through this agreement, Roche gains access to two innovative medicines that Regor refers to as “next-generation” CDK inhibitors, commonly used in the treatment of specific breast cancer types. One of these candidates is already undergoing early-stage trials, and the other is poised to commence its initial human trials. Roche executives disclosed preliminary findings indicating that RGT-419B demonstrates “durable single-agent activity” in patients whose cancers have progressed following treatment with CDK drugs like Pfizer’s Ibrance and Eli Lilly’s Verzenio.
• Roche is expanding its pipeline of breast cancer therapies that target patients whose tumors respond to hormone treatment but do not react to HER2-targeted therapies such as the well-known Herceptin. An investigational therapy named inavolisib could potentially gain approval in the U.S. by November 27 for use in conjunction with Ibrance.

Dive Insight:

Nearly thirty years ago, Roche’s former subsidiary Genentech changed the landscape of breast cancer treatment. The launch of Herceptin in 1998 marked the introduction of the first targeted therapy for patients with HER2-positive breast cancer, a type associated with severe health challenges. The prognosis for those diagnosed with HER2 breast cancers has improved greatly due to the introduction of follow-up treatments such as Perjeta and Kadcyla, along with other innovative medicines.

Roche is now making strides in other areas of breast cancer therapy. In conjunction with inavolisib, the company is also advancing a late-stage treatment that aims to outperform conventional hormone therapies prevalent for decades. Furthermore, the new Regor acquisition equips Roche with two candidates that could succeed existing CDK 4/6 inhibitors like Ibrance, Verzenio, and Novartis’ Kisqali, which are utilized in various breast cancer treatment pathways.

Roche anticipates that these new drugs may potentially bypass some of the adverse effects related to immune, gastrointestinal, and cardiovascular systems commonly associated with CDK inhibitors. During its presentation on Monday, Roche highlighted how RGT-419B targets CDK2, a mechanism that tumors leverage to resist other therapeutic approaches. Roche suggests that the drug exhibits “best-in-class” potential.

In its ongoing Phase 1 trial, Regor has studied four different dose levels of RGT-419B in patients who have already shown progression on CDK therapy. As stated by Roche, the drug has effectively reduced tumor sizes in four out of twelve participants, with two experiencing benefits that extended for as long as 35 months. Plans are in place to launch a Phase 2 trial next year that will evaluate the drug in combination with hormone treatment.

Along with the initial 0 million payment, Regor could earn additional incentives based on achieving specified clinical, regulatory, and commercial objectives. Regor will maintain control over the current Phase 1 clinical trials, while Roche will assume responsibilities for further clinical development, manufacturing, and commercialization.