Novo Nordisk has turned to Replicate Bioscience’s RNA drug platform in a lucrative research collaboration, marking the latest effort by the big pharma company to diversify its pipeline in the hope of regaining cardiometabolic disease market share.
Novo has agreed to pay up to $550m to use Replicate’s toolbox of self-replicating RNA (srRNA) technology in a multi-year research collaboration. The drugmaker will fund research into certain targets for cardiometabolic diseases, and in return receives an exclusive, worldwide licence to develop and commercialise the lead programmes borne from the partnership.
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The contract value ascribed to the deal includes an upfront cash payment and potential milestone payments. US-based Replicate is also eligible to receive tiered royalties on future product sales as part of the multi-year partnership.
Exact protein targets were not disclosed by the two companies, but treatments for obesity, type 2 diabetes (T2D) and other cardiometabolic diseases will be pursued.
Replicate’s platform aims to overcome shortcomings with linear mRNA. The biotech’s srRNA vectors aim to amplify protein expression via small amounts of synthetic material. Though efficacious, traditional mRNA approaches require a large dose to obtain enough protein production for therapeutic effect.
In addition, Replicate’s srRNA molecules copy themselves in a self-limiting fashion, with the genetic material then harnessed by the cell’s machinery to make a desired protein.
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By GlobalDataReplicate Bioscience’s chief business officer Rachael Lester said: “Replicate works with industry leaders to create fit-for-purpose srRNA that enables patients’ cells to naturally generate their own therapeutic proteins.
“This partnership combines the strength of Replicate’s proprietary srRNA vector library with Novo Nordisk’s therapeutic and clinical insights to create powerful new opportunities.”
The biotech claims it has demonstrated higher protein expression with greater durability and tunability in vivo, compared to other RNA modalities.
A clue to the platform’s potential can be garnered from Replicate’s pipeline, headed by its sole asset, rabies vaccine RBI-4000. Replicate says the candidate has demonstrated protective levels of immunity at doses lower than any other reported RNA-based vaccine in Phase I trials.
SrRNAs are a new modality, with only one approved product globally using this type of technology. This is Arcturus Therapeutics and CSL’s Kostaive, which is approved in Europe and Japan for the prevention of Covid-19 in adults.
For Novo Nordisk, enlisting Replicate’s services is the latest modality diversification strategy pursued by the Danish company to regain market share in the cardiometabolic disease space. A pioneer of glucagon-like peptide-1 receptor agonists (GLP-1RAs), Novo has lost momentum to Eli Lilly, on the back of better efficacy for the latter’s weight loss and T2D drugs.
In January, Novo expanded its partnership in a $4.6bn deal with Valo Health to leverage AI in finding new targets within cardiometabolic diseases. In May, the drugmaker outlaid $2.2bn to strike a collaboration and licensing deal with US biotech Septerna for oral small molecule drugs targeting obesity and T2D. A third partnership arrived in June, courtesy of an $812m deal with Deep Apple Therapeutics to find non-incretin G protein-coupled receptor targets within cardiometabolic diseases.
Still, Novo remains one of the largest pharma companies in Europe and could enjoy a market resurgence with its next-generation weight loss pill, set to be approved before Eli Lilly’s oral candidate.
Reacting to the Replicate partnership, Novo Nordisk’s nucleic acid research corporate vice president Karina Thorn said: “Novo Nordisk is continuously looking to build on its leading position in cardiometabolic diseases. We seek to combine our core capabilities with selected modality platforms to raise the innovation bar to the benefit of people living with serious chronic diseases.”
