Roche Acquires Regor's CDK Inhibitors and AntlerA on Pharma Day

Genentech, a member of the Roche group, has secured a significant addition to its breast cancer treatment arsenal by acquiring Regor Pharmaceuticals' portfolio of CDK inhibitors. This acquisition, announced on Roche's Pharma Day, involves an upfront payment of $850 million, positioning Genentech to expand its influence in the realm of HR-positive breast cancer therapies. Notably, HR-positive breast cancer accounts for approximately 70% of all breast cancer cases.

The centerpiece of this acquisition is RGT-419B, a promising candidate designed to tackle breast cancer in patients who have shown resistance to existing therapies. Regor Pharmaceuticals, a Chinese-American biotech firm, presented encouraging phase 1a results for RGT-419B late last year. The drug is engineered to exhibit high potency against CDK4, with additional effects on CDK2 and selectivity against CDK6. These features are specifically aimed at overcoming resistance to CDK4/6 inhibitors and minimizing hematologic toxicity.

RGT-419B is being tested as a monotherapy in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients who no longer respond to prior CDK4/6 inhibitors. In the initial analysis, all 12 patients had previously been treated with Pfizer’s CDK4/6 inhibitor Ibrance, and some had also used Novartis’ Kisqali or Eli Lilly’s Verzenio. The phase 1a trial showed a 28.6% confirmed partial response rate among seven patients with measurable disease, and the absence of grade 3 or higher adverse events.

These promising results have led Regor to plan further dose expansions for RGT-419B both as a standalone treatment and in combination with endocrine therapy. Regor will continue to oversee the ongoing phase 1 trials until completion, after which Genentech will assume responsibility for the global clinical development, manufacturing, and commercialization of the drug. Milestone payments for development, regulatory approval, and commercialization could follow, although their amounts remain undisclosed.

This acquisition underscores Roche’s ongoing commitment to HR-positive breast cancer treatments. The company is developing giredestrant, a selective endocrine receptor degrader, and inavolisib, a PI3K inhibitor, both of which are aimed at HR-positive breast cancer. Roche envisions giredestrant as a potential alternative to current endocrine therapies, with a favorable safety profile when combined with CDK inhibitors. The ability to pair inavolisib with CDK inhibitors is a critical aspect of Roche’s strategy to distinguish it from other PI3K inhibitors.

Historically, Roche has combined its candidates with CDK inhibitors from Lilly, Novartis, and Pfizer. The acquisition of Regor’s portfolio will now provide Roche with its own set of CDK inhibitors, expected to close in the fourth quarter.

Beyond the CDK inhibitor portfolio, Regor will pivot its focus to its other assets in oncology, metabolic disease, and autoimmune disorders. Leading this pipeline is an oral GLP-1 receptor agonist currently in clinical development for diabetes and obesity. In 2021, Regor partnered with Eli Lilly to develop treatments for metabolic disorders.

In tandem with the Regor deal, Roche also announced the acquisition of AntlerA Therapeutics, a biotech firm specializing in Wnt signaling. This acquisition includes a collection of anti-FZD/LRP drug candidates, which Roche believes have strong potential for treating neovascular age-related macular degeneration and diabetic macular edema. Financial specifics of this deal were not disclosed, but Roche highlighted the alignment of AntlerA’s pipeline with its ophthalmology interests and the potential promise of the Wnt pathway for other diseases.

These oncology and ophthalmology deals are part of Roche’s broader strategy to fortify its pipeline in key therapeutic areas. During its Pharma Day, Roche reiterated its 10-year goal of delivering 20 transformative medicines targeting diseases with significant societal impact, emphasizing its ongoing commitment to innovative healthcare solutions.

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