Ratio Therapeutics, Inc.

Novartis’ Kisqali (ribociclib) has been approved by the European Commission (EC) to reduce the risk of disease recurrence in a broad population of early breast cancer patients. The drug has been authorised for use in combination with an aromatase inhibitor as an adjuvant treatment for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. The regulator’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage NATALEE trial, which included a broad patient population with HR-positive/HER2-negative stage 2 and 3 EBC, including those with node-negative disease. Adjuvant Kisqali plus endocrine therapy reduced the risk of disease recurrence by 25.1% compared to endocrine therapy alone, and demonstrated a consistent invasive disease-free survival benefit across all patient subgroups. Approximately 70% of breast cancer cases are diagnosed in the early stages of the disease and, despite current treatment options, those with HR-positive/HER2-negative stage 2 and 3 early breast cancer remain at risk of experiencing disease recurrence in the long term. Novartis’ Kisqali is designed to inhibit the CDK4/6 proteins which, when over-activated, can enable cancer cells to grow and divide too quickly, and is already approved in the EU for certain cases of advanced or metastatic breast cancer. Iris Zemzoum, president, Europe, Novartis, said: “Patients deserve access to treatment options that help minimise the risk of their cancer coming back and put their mind at ease. “We are proud of this approval, which will help to address a key unmet need and improve health outcomes for a broader population of patients in Europe.” The authorisation comes less than two weeks after Novartis entered into a worldwide licence and collaboration agreement worth $745m with Ratio Therapeutics to advance a somatostatin receptor 2-targeting radiotherapeutic candidate for cancer. The company also entered into a research collaboration and licence agreement worth over $2.4bn with Schrödinger earlier this month to identify and advance multiple drug candidates for it to develop and commercialise.

Novartis and Ratio Therapeutics’ have entered into a worldwide licence and collaboration agreement worth $745m to advance a somatostatin receptor 2 (SSTR2)-targeting radiotherapeutic candidate for cancer. The SSTR2 protein is expressed in many cancers, including neuroendocrine tumours, breast cancer, and head and neck carcinoma. The partners will work together on preclinical activities to research and select a development candidate, while Novartis will be responsible for all remaining development, manufacturing and commercialisation activities. The alliance will utilise Ratio’s technology platforms, which it says “enable the development of fit-for-purpose radiopharmaceuticals for therapy and imaging that possess pharmacokinetic modulation”. This approach improves drug availability, tumour delivery and tumour loading, according to Ration. In exchange, Ratio will receive combined upfront and potential milestone payments of up to $745m and will be eligible for tiered royalty payments. Fiona Marshall, president of biomedical research at Novartis, said: “Radioligand therapies hold transformative potential for certain forms of cancer… We are delighted to collaborate with Ratio to advance this… candidate and work together to bring forward additional therapeutic options for patients with difficult-to-treat cancer.” Also commenting on the agreement, Ratio’s chief executive officer, Jack Hoppin, said: “The team at Ratio is honoured and excited to partner with Novartis on the development of a next-generation SSTR2-targeting therapeutic. Together, we aim to develop a best-in-class therapy in the fight against SSTR2-expressing tumours.” The partnership comes shortly after Novartis and Schrödinger entered into a research collaboration and licence agreement worth over $2.4bn to advance multiple drug candidates for Novartis to develop and commercialise. The deal, announced earlier this month, will see the companies combine their existing research efforts to identify and advance drug candidates for undisclosed targets in Novartis’ core therapeutic areas. Novartis also expanded its peptide discovery collaboration with PeptiDream in May with a new agreement worth over $2.8bn, and entered into an exclusive licence agreement worth over $1bn in April for the development and commercialisation of Arvinas’ clinical-stage prostate cancer therapy.

Today, a brief rundown of news involving Astellas and Cytokinetics, as well as updates from Cybin, Neurogene and Novartis that you may have missed.The Food and Drug Administration rejected a request by Astellas Pharma to update the prescribing information for its geographic atrophy drug Izervay, the company said Tuesday. According to Astellas, the FDA turned back an application that would have enabled patients to receive injections of Izervay every other month, instead of monthly, because of a statistical matter related to labeling language and not the drug's “safety and benefit/risk.“ The decision, for now, maintains a dosing advantage for Apellis Pharmaceuticals rival medicine Syfovre, which can be administered once every 25 to 60 days. Apellis shares climbed about 10%. Ben FidlerFormer National Cancer Institute director Norman Sharpless and serial biotech entrepreneur Nathaniel David have teamed to launch a new startup creator, Jupiter Bioventures, with $70 million in funding. The firm will use small seed funds to acquire intellectual property, vet it through in-house experiments and then build companies around the concepts that show promise. Those companies, which will work on cancer or other unspecified diseases, can then go off and raise cash from Jupiter or other investors, the firm said in a Tuesday statement. The funding from the Mayo Clinic, Mission BioCapital and others will help Jupiter form eight to 10 startups. Ben FidlerBayer will pay Cytokinetics 50 million euros, or about $53 million, to license the biotechnology company's experimental heart drug aficamten in Japan. Under a deal the companies announced Tuesday, Bayer will conduct a Phase 3 trial of aficamten in Japanese people with obstructive hypertrophic cardiomyopathy, while Cytokinetics will expand into Japan an ongoing trial in people with non-obstructive disease. The studies are meant to support potential authorization in Japan, where Bayer will now hold exclusive commercialization rights. Cytokinetics could earn up to 90 million euros more if certain milestones are met through the market launch of aficamten. Ned PagliaruloNeurogene will continue a Phase 1/2 trial of its gene therapy for Rett syndrome, but only at the lowest planned dose, following a side effect that led to the hospitalization of one trial volunteer who received a high dose. The company said its executives had met with FDA officials and was cleared to continue testing the low dose. The changes in the trials design mean Neurogene will be unable to complete enrollment of the low-dose group by the end of 2024, the company said. The trial volunteer experienced systemic hyperinflammatory syndrome, which can be caused by exposure to high levels of the type of adeno-associated virus used to deliver Neurogenes therapy. Company shares fell by about 40% following the Monday announcement and have lost three-quarters of their value since the company first disclosed the adverse event. Jonathan GardnerShares of Cybin also dipped on Monday, after the company, which is developing psychedelic-based medicines, released results from a small, mid-stage clinical trial. The trial has been evaluating two doses of “CBY003,“ a version of a psychedelic compound found in certain mushroom species, to see if they can be helpful add-ons to psychotherapy for people with major depressive disorder. Cybin said that, one year into the study, patients' depression symptoms had substantially diminished. And all of those given the high dose were deemed “responders.“ Yet Cybin's stock price, which was up 15% at market's open but ended Monday down almost 9%, suggests investors still have questions about the program. Jacob BellNovartis has licensed a new radiopharmaceutical drug from startup Ratio Therapeutics, promising up to $745 million in total payments for rights to an experimental medicine targeting a protein called somatostatin receptor 2. Per the agreement, Ratio and Novartis will collaborate to research and select an SSTR2 candidate that Novartis will then take into clinical development. SSTR2 has been identified as a potential target in small cell lung cancer and some neuroendocrine tumors. Ratio was founded in 2022 with $20 million in funding and support from Bayer and Lantheus Holdings. It has since raised an additional $70 million in two funding rounds, receiving support from Bristol Myers Squibb. Jonathan Gardner '