Resalis Therapeutics SRL

Today, a brief rundown of news from Biogen and Novartis, as well as updates from Resalis Therapeutics and Moderna that you may have missed.Biogen's top ranks underwent major changes this week, as the big biotechnology company appointed a new chief medical officer and a new finance head. Daniel Quirk took over the former role on Monday, after serving as senior vice president of worldwide medical affairs for Bristol Myers Squibb's immunology and neuroscience units. Meanwhile, Biogen said its chief financial officer for the past four years, Michael McDonnell, plans to retire from the company at the end of February. He will be replaced by Biogen's top accountant, Robin Kramer. In a statement, McDonnell was praised for his “pivotal role in recent strategic acquisitions of late-stage assets and in creating a culture of financial discipline.“ Jacob BellNovartis has slashed the value it ascribes to the MorphoSys business it acquired earlier this year, revealing in a third quarter earnings statement that it took an $800 million write down to the acquired assets goodwill value. The acquisition was primarily focused on MorphoSys drug pelabresib, which treats myelofibrosis. While Novartis initially expected to file it this year for approval, results since have forced the company to push back those plans. Ned PagliaruloSanofi has taken an equity stake in Resalis Therapeutics, the privately held biotechnology company said Monday. Based in Torino, Italy, Resalis is working on an RNA medicine it believes could help treat metabolic diseases such as obesity. The company is preparing to start a Phase 1 trial of the medicine, an antisense oligonucleotide aimed at a non-coding strip of RNA that regulates the production of lipids and function of mitochondria. Resalis thinks it could enhance the efficacy of GLP-1 agonists. Ned PagliaruloPartners Moderna and Merck & Co. are starting a third Phase 3 trial of their personalized cancer vaccine, announcing Monday the initiation of a study testing it with Keytruda as adjuvant treatment of earlier-stage non-small cell lung cancer. A little less than one year ago, the companies released promising data on their vaccine, dubbed V940 or mRNA-4157, in people with melanoma. The two ongoing Phase 3 studies, respectively in melanoma and lung cancer, are set to complete in 2029 and 2030, according to a federal database. Ned Pagliarulo '

Plus, news about Novartis, CombiGene, ProQR and Aardvark Therapeutics: Biogen presents full Phase 2 data for felzartamab: The drug, which was acquired in Biogen’s $1.15 billion buyout of HI-Bio earlier this year, showed patients with IgA nephropathy maintaining a 50% average reduction in a measurement of kidney stabilization after two years. Biogen expects to take the drug into a Phase 3 study but exact details have not yet been disclosed. — Max Gelman Sanofi snags equity in Resalis Therapeutics for undisclosed amount: The new tranche of cash will help the biotech pay for a Phase 2 proof-of-concept study of its lead obesity medicine, called RES-010. Resalis raised €10 million ($10.8 million) in early 2024 to afford the drug’s first obesity trial. — Max Bayer Novartis shares one-year data for Fabhalta in ultra-rare kidney disease: For patients with C3 glomerulopathy, Fabhalta at 12 months sustained reductions in proteinuria that had been seen at six months, when the study reported a 35.1% reduction in protein buildup in the urine compared to placebo. At six months, patients who received placebo in the Phase 3 study were switched over to iptacopan, which Novartis markets as Fabhalta for a rare blood disorder and an autoimmune kidney disease. Novartis submitted the drug for approval in C3G in the EU, China and Japan, and it expects to be in the US by the end of this year. — Lei Lei Wu CombiGene trims pipeline, headcount: The Swedish drugmaker is ending work on its gene therapy candidate for epilepsy, called CG01, and instead prioritizing its chronic pain program, dubbed COZY. CombiGene is also reducing the number of its employees and external consultants by 45% in a bid to extend its cash runway through the second quarter of 2026. It had 11 employees, as of December 2023. — Ayisha Sharma Eli Lilly invests in ProQR as it nabs $75.3M: The company is selling shares for $3.50 apiece, getting $63 million. In addition, the funding includes a private placement from Eli Lilly that totals $12.3 million. — Max Gelman Aardvark Therapeutics buys MEI Pharma’s solid tumor drug: The San Diego-based biotech paid $500,000 upfront for the rights to MEI’s ME-344, an inhibitor of mitochondrial oxidative phosphorylation. MEI is eligible for up to $62 million in milestones. — Ayisha Sharma

TORINO, Italy--(BUSINESS WIRE)-- Resalis Therapeutics today announced the appointment of Almut Nitsche, PhD, as its Chief Medical & Development Officer (CMDO). Dr. Nitsche brings with her over 25 years of experience in the pharmaceutical industry, particularly in drug development and project management, at companies including Sanofi and Aventis. In her role at Resalis, she will spearhead the clinical development of RES-010, a non-coding RNA drug candidate designed to address obesity. “Almut’s extensive track record in new product development and healthcare solutions, coupled with her deep expertise in metabolic disease and diabetes, positions her as an important addition to our team to guide our clinical development strategy. She joins us at the right moment as we near completion of our preclinical development for RES-010 and move toward our first-in-human trial,” said Alessandro Toniolo, CEO of Resalis Therapeutics. “Resalis' RES-010 candidate, developed based on cutting-edge metabolic disease insights, offers a unique opportunity to develop an orthogonal approach to currently marketed obesity treatments. I look forward to joining the Resalis team as we advance into the Phase 1 trial and seek to establish initial clinical proof of concept for RES-010,” added Almut Nitsche, CMDO of Resalis Therapeutics. Dr. Almut Nitsche is a seasoned expert in pharmaceutical research and development. Prior to joining Resalis, she served as a consultant to Proxidrugs and worked for over 17 years at Sanofi, holding key positions such as Project Director for Early Development and Project Director for R&D in the Diabetes Division. Before this, she held positions at Aventis (acquired by Sanofi) and Hoechst Marion Roussel Genomic Center. As part of her commitment to therapeutic innovation in the metabolic disease space, Dr. Nitsche has also served as a Management Board Member at INNODIA, an international non-profit organization accelerating the development of new cures for type 1 diabetes. She holds a PhD in Biochemistry and Molecular Biology from the University of Stuttgart, Germany. About Resalis Therapeutics Resalis Therapeutics’ transformative metabolic disease approach targets a master regulator of multiple pathways underlying obesity and fatty liver disease. The company is applying its profound understanding of the non-coding RNA drug modality and lipid metabolism to develop its lead program, RES-010, into a safe and convenient treatment providing disease-modifying therapeutic impact including durable weight loss and reduction of hepatic steatosis. Building on robust preclinical evidence, Resalis will rapidly bring RES-010 into clinical trials for a range of metabolic disorders. For more information visit our website . View source version on businesswire.com: Contacts Contact Resalis Alessandro Toniolo, CEO +393386092544 alessandro.toniolo@resalistherapeutics.com Media Relations Trophic Communications Gretchen Schweitzer or Dr. Charlotte Spitz Trophic Communications +49 171 351 2733 resalis@trophic.eu Source: Resalis Therapeutics View this news release online at: