CDK4

Roche’s Genentech has agreed to pay Regor Pharmaceuticals $850m upfront to acquire the biotech’s portfolio of next-generation CDK inhibitors for breast cancer. Under the terms of the definitive purchase agreement, Genentech will be responsible for clinical development, manufacturing and commercialisation worldwide, while Regor will continue to manage two ongoing phase 1 trials to their completion. In addition to the upfront fee, Regor will be eligible to receive cash payments based on the achievement of certain predetermined development, regulatory and commercial milestones. Regor’s founder and chief executive officer, 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. We are proud of the strong data we have generated to date.” Breast cancer is the most common cancer in the UK, where approximately 56,800 new cases of the disease are diagnosed every year. Regor shared promising results from a phase 1a trial of its next generation CDK4 inhibitor in December last year. The candidate, RGT-419B, was shown to be safe and well-tolerated across 12 patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer who had progressed on CDK4/6 inhibitors and endocrine therapy, and demonstrated single agent efficacy. Qiu said at the time of the announcement: “With the favourable safety profile and promising monotherapy efficacy, RGT-419B has best-in-class potential as a single agent or in combination in HR-positive, HER2-negative breast cancer patients resistant to CDK4/6 inhibitors, and in earlier lines of treatments. “Clinical studies of single agent dose expansion and combination of RGT-419B with endocrine therapy are underway.” The deal comes less than two months after Genentech entered into a licence agreement worth over $1.9m with Sangamo Therapeutics to develop intravenously-administered genomic medicines for neurodegenerative diseases. The company also entered into a multi-year collaboration and licence agreement with GenEdit in January worth up to $644m to discover and develop novel nanoparticles to deliver its genetic medicines for autoimmune diseases.

The investment will help accelerate the company’s suite of targeted alpha radiopharmaceuticals intended to treat numerous solid tumour types. Credit: peterschreiber.media via Shutterstock. Aktis Oncology, a clinical-stage biotechnology company, has announced the successful closure of a $175m Series B financing round for advancing its radiopharmaceutical pipeline. This oversubscribed and upsized funding aims to advance the company’s pipeline of targeted alpha radiopharmaceuticals designed to treat a wide variety of solid tumours. The round was led by RA Capital Management, with RTW Investments and Janus Henderson Investors as co-leaders. The investment will support the development of Aktis Oncology’s new radiopharmaceuticals, including a first-in-class Nectin-4-targeted miniprotein radioconjugate. Aktis Oncology president and CEO Dr Matthew Roden said: “The overwhelming support from high-calibre investors underscores the progress we have made on our pipeline, platform, and supply chain capabilities, exemplified by the significant opportunity for AKY-1189, our first-in-class miniprotein alpha radioconjugate targeting Nectin-4 in development for several tumour types. See Also: Cyclin Dependent Kinase 4 drugs in development, 2024 Modalis wins FDA rare paediatric designation for CMD CRISPR therapy “With over $300m in cash, we are well-positioned to prosecute several opportunities to expand the benefit of this exciting modality into new patient populations.” The financing attracted a select group of new investors, such as funds and accounts advised by Avidity Partners, T. Rowe Price Associates, and an undisclosed life sciences-focused investment fund. All existing institutional investors participated, alongside strategic investors Eli Lilly and Company, Bristol Myers Squibb , and MRL Ventures Fund, the therapeutics-focused corporate venture fund of Merck . With the new funding, RA Capital Management partner and managing director Andrew Levin will join the Aktis Oncology board of directors. Additionally, Lauren Lee from RTW Investment and Vish Sridharan from Janus Henderson Investors will join as observers on the board. In May this year, Eli Lilly signed a multi-target discovery collaboration agreement with Aktis Oncology to develop targets for radiopharmaceuticals discovered by the latter.

The injection has been approved in the US to treat simple flu cases in patients as young as six months. Credit: pedro7merino via Shutterstock. BioCryst Pharmaceuticals has received a contract valued at up to $69m from the US Department of Health and Human Services (HHS) for the procurement of RAPIVAB to treat influenza. This contract is intended to bolster the US Strategic National Stockpile (SNS) with up to 95,625 doses over a five-year period. The HHS Office of the Administration for Strategic Preparedness and Response (ASPR) structured the contract with a one-year base ordering period and four optional one-year periods. ASPR has already committed $13.9m for the initial order, with BioCryst planning to deliver 19,125 doses by 29 September 2025. RAPIVAB, used in the H1N1 influenza pandemic under an emergency use authorisation in 2009, was previously part of a $34.7m contract for the SNS, completed by BioCryst in 2022. See Also: Cyclin Dependent Kinase 4 drugs in development, 2024 Modalis wins FDA rare paediatric designation for CMD CRISPR therapy It is approved in the US for acute uncomplicated influenza treatment in patients from six months of age and above who have been symptomatic for no more than two days. BioCryst chief research and development officer Dr Helen Thackray said: “Since the 2009 H1N1 pandemic, RAPIVAB has been an important component of the US government’s influenza preparedness efforts. “As we continue to see emerging changes to circulating influenza viruses, we are pleased to fulfil this order to ensure RAPIVAB remains readily available as a therapeutic option in the event of a potential serious influenza outbreak.” Administered intravenously, RAPIVAB’s efficacy is supported by clinical trials with the predominant infections being influenza A virus, and a smaller number of cases with influenza B virus. The recommended doses are 600mg for adults and adolescents, and 12mg per kilogram for six months to 12-year-old children. BioCryst gained marketing authorisation from Chile’s Public Health Institute in May 2023, for ORLADEYO, an oral treatment for hereditary angioedema attacks in patients aged 12 years and above.