As part of a pact with Flagship Pioneering, Novo Nordisk has inked separate cardiometabolic disease research deals with two Flagship-founded biotechs that are worth up to $532 million each.
The freshly formed agreements are with Omega Therapeutics and Cellarity, two Massachusetts biotechs that fall under Flagship’s umbrella. The partnerships are part of a broader ecosystem collaboration Flagship and Novo Nordisk’s Bio Innovation Hub struck up in mid-2022 that aims to quickly build a portfolio of breakthrough medicines for cardiometabolic and rare diseases.
Using Novo’s disease expertise and technology from Flagship’s bioplatform companies, the goal is to generate three to five research programs within the first three years of the partnership, Novo Nordisk’s head of the Bio Innovation Hub Uli Stilz, Ph.D., told Fierce Biotech in an interview.
For these first two deals, each company, Novo Nordisk and Flagship’s Pioneering Medicines—an initiative that develops treatments by using and expanding Flagship innovations—will work together to advance their respective programs through preclinical development. Novo will then have the chance to take the programs into the clinic.
The Big Pharma will reimburse R&D costs and give each company and Pioneering Medicines the chance to make up to $532 million dollars in upfront and milestone payments, plus tiered royalties.
With Omega, Novo will look to expand upon its blockbuster obesity franchise (does the drug Ozempic ring a bell?) with the biotech’s platform, which is made to design programmable epigenomic mRNA medicines that precisely target and modulate gene expression at the pre-transcriptional level.
“We have been pioneers over a 20-year journey in obesity and we want to continue to be a pioneer,” Stilz said, adding that being a pioneer means entering uncharted scientific territory, which is where Omega comes in.
The biotech will use its platform technology to develop an epigenomic controller as part of a new obesity management approach. While many existing therapeutics for weight management focus on appetite regulation, Omega wants to target thermogenesis, a natural metabolic function that regulates overall energy balance.
“What is so exciting for us is that it’s a very different approach than what we have been doing so far,” Stilz said. “I haven’t seen something similar anywhere else. So, we’re really pushing the boundary of science and innovation through this co-creation and collaboration.”
Omega already has some proof-of-concept to support its mission to design programmable mRNA medicines by replicating how nature’s control system works, Omega President and CEO Mahesh Karande told Fierce Biotech. The company’s platform is applicable across almost every disease process, Karande said, and Omega is currently evaluating one of its assets in a phase 1/2 trial for patients with hepatocellular carcinoma.
Now, the company will put its platform to work to control metabolic activity and potentially develop a more durable approach to obesity management.
“Epigenomic control and epigenomic controllers have not existed before. We have literally created this field,” Karande said. “And now we have signed our first major agreement with a company that is an expert in obesity, metabolics and cardiovascular. So, for us, this is hugely validating.”
Meanwhile, Cellarity will plug away at creating a small molecule therapy to treat metabolic dysfunction-associated steatohepatitis (MASH)—the new term for nonalcoholic steatohepatitis (NASH)—a chronic and progressive liver disease for which there is no currently approved treatment. The indication has a high unmet patient need, with only four investigational treatments ever making it into phase 3 development for MASH, led by Madrigal Pharmaceutical’s resmetirom, which is awaiting an FDA decision this spring.
Cellarity and Novo hope to develop a small molecule therapy for the indication by using the biotech’s platform that is designed to provide new insight into cellular dysfunction and allow for drug creation that has been historically inaccessible using traditional drug discovery methods.
Cellarity combines biology, chemistry and AI machine learning to understand cell behavior, Novo’s Stilz explained. Novo Nordisk has previously connected with Cellarity, asking the biotech in September 2022 to identify novel cell behaviors involved in MASH disease progression, work that will now be expanded upon under the new research collaboration.