Flagship Pioneering, Inc.

Novo Nordisk is doubling down on its computational biotech partner Valo Health, expanding their collaboration from 11 potential drugs to 20. Wednesday morning’s extended pact with the Flagship-founded startup, which recently reverted to the preclinical stage following a diabetic retinopathy setback, now also includes obesity and type 2 diabetes. In 2023, they aligned around the broader cardiovascular landscape. Novo has in-licensed three programs thus far, newly-minted CEO Brian Alexander said in an interview. Boston-area Valo could get up to $190 million in new, near-term payments. The biobucks package has ballooned as well, going from $2.7 billion to $4.6 billion. The deal is part of Novo’s sprawling apparatus of obesity and cardiometabolic partnerships. As one of the leaders in the field with Wegovy and Ozempic, the Danish drug giant has been building up next-generation options, both internally and through deals. It’s looked to other Flagship-incubated startups in the space, including Omega Therapeutics and Metaphore Biotechnologies . “We have already begun to realize the potential of combining the capabilities of Valo and Novo Nordisk to advance multiple AI-powered, human-centric programmes,” Novo chief scientific officer Marcus Schindler said in a statement. The upfront money gives Valo some cushion: It is “not looking to do any fundraising right now,” Alexander said. The company had attempted a SPAC combination but amicably reneged on the blank-check with Khosla in November 2021. Going forward, Valo hopes to forge another biopharma alliance this year, Alexander said. The company’s computational platform can be applied to multiple different therapeutic areas, he said. For its own pipeline, Valo doesn’t plan to commercialize any of its in-house drugs. It plans to find partners along the way. “We’re really good and differentiated in identifying novel targets in real-world patient data, testing those in human-centric preclinical models and having AI-assisted human ingenuity small molecule design. Those are our core competencies,” the CEO said. “We’ll expand things into the clinic if we think we’re relatively better than anybody else at developing something in a pivotal-enabling study, but right now we’re looking at as many partnerships as we can.” Alexander said Valo’s computational platform wasn’t used for the target identification, small molecule development or biomarker selection in the Phase 2 trial that the company said last week had failed. Valo had in-licensed the drug candidate, a ROCK inhibitor known as OPL-0401, from Sanofi.

Novo Nordisk’s collaboration with artificial intelligence startup Valo Health has focused on developing new drugs for cardiovascular disease. The pharmaceutical giant likes what it’s seen so far, and it’s now committing $190 million to expand the alliance to more cardiometabolic disorders, including obesity and type 2 diabetes. The sum announced Wednesday encompasses an upfront payment, equity investment, and a potential near-term payment for a milestone that was not disclosed. The initial agreement inked in 2023 spanned up to 11 cardiovascular disease programs. Lexington, Massachusetts-based Valo received $60 million up front and was in line for as much as $2.7 billion in milestone payments. The alliance now spans 20 programs. Milestone payments in the expanded pact could reach up to $4.6 billion. While Novo Nordisk has established a strong position in metabolic disease with the GLP-1 agonist semaglutide, marketed as Ozempic for type 2 diabetes and Wegovy for obesity, the pharmaceutical giant has also invested in the R&D of next-generation medicines that could offer better tolerability and perhaps even greater weight loss. One of the company’s top prospects is CagriSema, a combination of semaglutide with cagrilintide. Last month the once-weekly injection posted statistically significant Phase 3 results. But shares of Novo Nordisk still took a hit as the magnitude of weight loss was below expectations. Health IT Reducing Clinical and Staff Burnout with AI Automation As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers. By Dr. Michael Blackman, Chief Medical Officer at Greenway Health Novo Nordisk has turned to business development to build its pipeline of metabolic medicines. These deals bring drug candidates in oral formulations that could expand the field to new targets. Specific targets covered by Novo Nordisk’s agreement with Valo remain undisclosed, but the companies say the collaboration has already led to identification of “several novel targets” with the potential to lead to differentiated cardiometabolic drugs. They add that work is underway on multiple small molecule programs in preclinical development. Valo launched in 2020, formed and initially financed by Flagship Pioneering, a firm that forms and invests in new startups based on platform technologies. The AI-driven simulations from its technology, called Opal Computational Platform, predict properties such as the safety and efficacy of a potential drug. Valo takes a human-centric approach to AI, CEO Brian Alexander said in an email. The company analyzes real-world human data to identify novel drug targets. Valo also utilizes human models to rapidly discover and develop small molecules that hit those targets. Opal is indication agnostic, but Valo has invested significantly in cardiometabolic disease as one of its focus areas, Alexander said. When Valo was preparing to go public in a SPAC merger, the company said it had 17 programs that spanned cancer and neurodegenerative diseases. Valo is not currently disclosing pipeline details. However, OPL-0401, a diabetic retinopathy drug candidate that was one of its most advanced programs, did not meet primary or secondary endpoints, Valo disclosed on New Year’s Eve. That in-licensed molecule was not produced by Opal. The company said it would suspend the program’s development and focus on leveraging Opal to develop new medicines. That includes medicines covered by the expanded Novo Nordisk pact. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech “Our experience with the Novo Nordisk partnership to date has demonstrated clear evidence of both the platform’s technological capabilities as well as the human-centric approach to data and ways of working internally and with partners to deliver on new medicines in CVM (cardiovascular medicine), but not limited to CVM,” Alexander said. “This expansion into obesity and type 2 diabetes is validating of that experience.”

Dec. 18, 2024 -- Tessera Therapeutics, a biotechnology company pioneering a new approach to genome engineering through the development of its Gene Writing™ and delivery platforms, announced today that it has entered into an agreement with the Bill & Melinda Gates Foundation to jointly fund the company’s in vivo program for sickle cell disease (SCD). The funding includes an initial investment, with potential total investment of up to $50 million, from the Gates Foundation intended to support the development of Tessera's SCD program into the clinic. The investment will support Tessera’s efforts towards advancing a SCD treatment and help further its objectives to develop transformative genetic medicines that are accessible globally. Tessera is developing Gene Writers™ for SCD designed to enable a true correction of the sickle mutation to wild-type with one-time intravenous administration in vivo, without the need for complex stem cell mobilization or toxic chemotherapy conditioning. Critical in enabling in vivo therapies, Tessera is leveraging its proprietary non-viral delivery platform to develop lipid nanoparticles targeting delivery of Gene Writers to long-term hematopoietic stem cells. “Sickle cell disease patients globally remain deeply underserved by existing treatment options. We are excited to develop what we believe will be a disruptive one-time curative treatment for SCD that is safer, easier, and more scalable than ex vivo genetic approaches,” said Michael Severino, M.D., CEO of Tessera Therapeutics. “We look forward to advancing a genetic medicine that can potentially reshape the treatment landscape for sickle cell disease worldwide.” Tessera Therapeutics is pioneering a new approach to genome engineering through the development of its Gene Writing™ and delivery platforms, with the aim to unlock broad new therapeutic frontiers. Our Gene Writing platform is designed to write therapeutic messages into the genome by efficiently changing single or multiple DNA base pairs, precisely correcting insertions or deletions, or adding exon-length sequences and whole genes. Our proprietary lipid nanoparticle delivery platform is designed to enable the in vivo delivery of RNA to targeted cell types. We believe our Gene Writing and delivery platforms will enable transformative genetic medicines to not only cure diseases that arise from errors in a single gene, but also modify inherited risk factors for common diseases and create engineered cells to treat cancer and potentially autoimmune and other diseases. Tessera Therapeutics was founded in 2018 by Flagship Pioneering, a life sciences innovation enterprise that conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. The content above comes from the network. if any infringement, please contact us to modify.