ADO-Trastuzumab Emtansine

Roche announced the agreement at its annual pharma day in London, UK. Image shows Roche’s head office in California, USA. Credit: Michael Vi via Shutterstock. Genentech is strengthening its oncology pipeline by acquiring Regor Pharmaceuticals’ portfolio of breast cancer cyclin-dependent kinase (CDK) inhibitors in an $850m deal. The deal, anticipated to close in Q4 2024, was unveiled by Genentech’s parent company Roche at its pharma day in London. The pharmaceutical giant also shared that it is focusing on three major therapeutic areas – one being oncology. Regor will continue to oversee its two ongoing Phase I trials of the CDK4/2 inhibitor RGT-419B until their completion. At that point, Genentech will take over the global clinical development, manufacturing, and commercialisation of the candidate. The deal also includes preclinical candidate RGT-587, which is a “Phase I ready” CDK4 inhibitor, intended to treat brain metastases. One of Regor’s Phase Ia trials (NCT05304962) is investigating RGT-419B in 12 patients with HR+/HER2-negative advanced breast cancer who had previously undergone CDK4 treatment. Data showed that RGT-419B, administered as a monotherapy, achieved a 28.6% partial response rate and a 44% clinical benefit rate with no dose-limiting toxicities observed. The other Phase I trial (NCT06299124) is enrolling 40 subjects in China and is set to conclude at the end of this year. In the announcement accompanying the deal, Regor’s CEO Xiayang Qiu said: “Genentech is well-positioned to bring these novel therapeutics to their full potential to benefit patients with breast cancer around the world.” See Also: Fresenius Kabi wins FDA approval for Stelara biosimilar Otulfi BMS and Prime ink potential $3.5bn deal to develop T cell therapies During Roche’s 30 September presentation, CEO Teresa Graham said CDK inhibitors are “a perfect fit” with the company’s breast cancer franchise. Graham also touted some of the breast cancer assets that Roche already has on the market, including Phesgo (hyaluronidase, pertuzumab and trastuzumab), Kadcyla (trastuzumab emtansine), and Perjeta (pertuzumab). These three assets pulled in global sales of $1.25bn, $2.2bn, and $4.2bn respectively in 2023, as per Roche’s financials. Graham also highlighted inavolisib, a first-line PIK3CA-mutated hormone receptor for positive breast cancer. The candidate has a 27 November PDUFA date. Several companies have struck deals to acquire CDK inhibitors, targeted therapies that block proteins that regulate cell division to slow or stop the growth of cancer cells. In July 2024, Exscientia acquired a CDK7 inhibitor being trialled in patients with advanced or metastatic solid tumours. This is after buying out its development partner Apeiron Therapeutics’ shares of the programme. However, Roche’s global head of oncology and haematology product development Charles Fuchs highlighted that there is an unmet need for agents targeting CDK4/6i resistance, with most patients progressing after CDK4/6i treatment. According to Regor, RGT-419B is the most advanced CDK4/2 inhibitor in the clinic. It’s not the first time Regor has struck a deal with a big pharma company. In December 2021, the biotech entered into a $1.5bn agreement with Eli Lilly to discover, develop and market new treatments for metabolic disorders. Under the terms of the deal, Lilly secured a licence to select the intellectual property of Regor with an option for a licence extension.