Roche is spending $850 million upfront to buy Regor Pharmaceuticals’ suite of next-generation CDK inhibitors as it doubles down on its strategy to prioritize three therapeutic categories, including oncology.
Cambridge, MA-based Regor announced the deal on Monday morning. The company is also eligible for undisclosed milestones, in addition to the upfront payment.
Regor is developing two CDK-targeting drugs: Phase 1 asset RGT-419B for breast cancer and preclinical candidate RGT-587 for brain metastases. The former is the only CDK4 inhibitor with “single agent efficacy” in refractory ER+/HER2- breast cancer, according to Regor.
Charles FuchsThe biotech is expected to advance the two candidates through Phase 1 development. After that, Roche’s Genentech is set to take the reins on global clinical development, manufacturing and commercialization activities. The transaction is set to close by the end of the year.
During the company’s pharma day in London on Monday morning, head of oncology and hematology Charles Fuchs said Roche “really wrote the book on targeted therapies for breast cancer,” and the Regor acquisition could bring in a potentially best-in-class CDK4 inhibitor for the hormone receptor-positive form of the disease.
RGT-419B has “increased activity on CDK2,” which may help address a resistance pathway that limits marketed drugs with the same mechanism, according to a Roche presentation. In Regor’s Phase 1a trial of the drug in 12 subjects with HR+/HER2- advanced breast cancer who had previously undergone CDK4 treatment, RGT-419B given alone achieved a 28.6% partial response rate and a 44% clinical benefit rate. There were no dose-limiting toxicities.
“We will be initiating studies combining the agent with aromatase inhibitors” as well as Roche’s other breast cancer candidates, giredestrant and inavolisib, Fuchs said.
Barclays analysts described the deal as a “sensible bolt-on.” They spotlighted the RGT-419B plus giredestrant combo in particular, because preclinical studies of Regor’s drug showed “further augmentation of tumor cell suppression” when combined with a selective estrogen receptor degrader.
Roche Pharmaceuticals CEO Teresa Graham described the deal as a “perfect fit” with Roche’s existing breast cancer franchise. The Swiss pharma has three key breast cancer drugs on the market — Perjeta, Kadcyla and Phesgo, which generated CHF 3.7 billion ($4.38 billion) in sales in the first half of the year.
Thomas SchineckerA fourth treatment may be on its way. The FDA is set to decide whether to approve inavolisib for first-line PIK3CA-mutated HR+ breast cancer by Nov. 27, and an approval in Europe may follow in 2025. Graham said the company expects inavolisib to bring in between CHF 2 billion ($2.37 billion) and CHF 3 billion ($3.55 billion) in peak sales.
Roche’s oncology pipeline is one of three “shared priority areas” alongside neurology and cardiovascular reno-metabolism, which are expected to account for 80% of Roche’s future growth, Graham said. Roche decided to focus on them in part because they could account for around half of the global disease burden by 2035, CEO Thomas Schinecker said at the event.
Schinecker said the company plans to launch 20 “transformative” medicines from 2020 through 2029 for diseases with the “highest societal burden.” The company has achieved seven of these launches so far, he added.
The next three priorities for the company will be infectious disease, immunology and ophthalmology. While ophthalmology has a smaller market potential compared with the others, it will likely become a more significant opportunity as populations age, Graham said.
Vabysmo is currently the “center stone” of that franchise, with approvals in wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion, generating CHF 1.79 billion ($2.12 billion) in half-year sales. The company is also hopeful for a preclinical candidate targeting the Wnt pathway partnered with AntlerA.
Editor’s note: This article was updated to add more information from the Roche event and to clarify the development stages of the Regor drugs.