Molecular glue degrader (MGD) specialist Monte Rosa Therapeutics Inc. followed up last fall’s handsome deal with Roche Holding AG by inking a similarly sizeable pact with Novartis AG. Boston-based Monte Rosa turns over to Novartis exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with phase II studies. Monte Rosa remains responsible for finishing the current phase I trial. Novartis has agreed to pay Monte Rosa $150 million up front, and the latter could bank as much as $2.1 billion in development, regulatory, and sales milestone rewards, beginning upon the start of phase II work, as well as tiered royalties on ex-U.S. net sales. Monte Rosa will co-fund any phase III clinical development and share any profits and losses tied to the manufacturing and commercialization of MRT-6160 in the U.S. Shares of Monte Rosa (NASDAQ:GLUE) were trading at $10.67, up $5.78, or 118%.
Abbvie snags Alzheimer’s candidate in $1.4B Aliada buyout
Three years after it was co-founded by Johnson & Johnson, Aliada Therapeutics Inc. is being acquired by Abbvie Inc. in a deal valued at $1.4 billion. The buyout will give Abbvie rights to Aliada’s blood-brain barrier (BBB)-crossing Modular Delivery, or MODEL, platform technology designed to transport diverse therapeutic cargoes into the brain, as well as rights to early clinical-stage compound, ALIA-1758, an anti-pyroglutamate amyloid beta antibody, for Alzheimer’s disease. The move comes three months after Abbvie discontinued development of phase II-stage amyloid beta-targeting antibody ABBV-916 after determining the candidate would not be differentiated enough from other emerging treatments.
BioFuture 2024: Where AI leads, developers must follow
Artificial intelligence is enabling a foundational understanding of drug discovery that is changing the typical pathway used in modern drug development. That powerful new computer technology will lead developers from conducting hypothesis-driven research to more and deeper data-driven research, Manolis Kellis, professor at the Computer Science and Artificial Intelligence Laboratory at the Massachusetts Institute of Technology (MIT) and an associate member at the Broad Institute of MIT and Harvard University, told those attending the BioFuture 2024 conference in New York earlier today. The new way of doing things is the intersection of, as he put it, medieval institutions and godlike technologies.
Kidney Week 2024: Semaglutide tackles another organ
Semaglutide, the glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S that seemingly improves almost every disease, was a focus at Kidney Week 2024, where researchers presented data from multiple clinical studies in patients with kidney diseases. The drug improved kidney function in patients who were overweight or obese and had albuminuric chronic kidney disease without diabetes. There were also multiple presentations at the conference of different aspects of data from the phase III Flow clinical trial testing the effects of semaglutide on kidneys.
Sanofi bets on Resalis’ oligonucleotide RES-010 for obesity
After missing out on the glucagon-like peptide 1 (GLP-1) obesity market, Sanofi SA is making a strategic equity investment in Resalis Therapeutics Srl, providing the Italian biotech with funding to take its next-generation anti-obesity drug RES-010 through to phase II. RES-010 is a first-in-class antisense oligonucleotide targeting miR-22, a non-coding micro RNA that is a master regulator of lipid biosynthesis, mitochondrial function and the transformation of adipose tissue. Resalis said this mode of action could offer a more durable solution than GLP-1 receptor agonists, while at the same time the preclinical data indicate RES-010 could complement and enhance the efficacy of blockbuster GLP-1 drugs.
US CRS weighs in on improving gene therapy regulatory landscape
Although more and more gene therapies are getting the FDA stamp of approval, concerns persist about their potential long-term risks. To address some of the uncertainties, U.S. lawmakers have proposed several pieces of legislation over the past few years. Now the Congressional Research Service (CRS) is suggesting some requirements Congress may want to consider to improve the regulatory landscape for gene therapies, especially those intended to treat blood disorders. One of those suggestions is to look beyond the FDA to charge an entity such as the National Academy of Medicine with assessing the benefits and risks of the products for patients.
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