Novo Nordisk and Vivtex have announced a partnership focused on developing a new crop of oral biologics for obesity, diabetes, and associated comorbidities. The partnership pairs Novo Nordisk’s expertise in peptide and protein therapeutics with Vivtex’s proprietary gastrointestinal screening and formulation platform.
Under the terms of the agreement, Vivtex will license select oral drug-delivery technologies to Novo Nordisk. In return, Vivtex is eligible to receive upfront consideration, research funding and milestone payments totalling up to $2 billion and tiered royalties on future product sales as part of the deal. Following research and formulation, Novo Nordisk will assume responsibility for global development, regulatory activities, manufacturing, and commercialization of any resulting products.
Vivtex was founded by scientists from Massachusetts Institute of Technology (MIT) to address perceived challenges with orally delivering potential biologics that are traditionally limited to delivery as injectables due to poor absorption in the gastrointestinal (GI) tract. The company’s proprietary platform combines gastrointestinal screening assays with simulation and artificial intelligence. Some of the technology underlying Vivtex’s platform was published in a Nature Biomedical Engineering paper in 2020.
In a conversation with GEN this week, Thomas von Erlach, PhD, CEO and co-founder of Vivtex explained his company’s rationale for working on oral biologics. He noted that previous attempts to develop oral biologics have had limited success because they tended to oversimplify the architecture and mechanisms of the GI tract’s natural barriers. The GI system has evolved “exquisite” and “complex” mechanisms that allow the absorption of certain chemicals and not others. That is why despite years of effort, few oral biologics have successfully crossed that barrier, he said.
Von Erlach, who has a background in tissue engineering, began working on Vivtex’s underlying platform during his postdoctoral program at MIT in the laboratory of Robert Langer, ScD, an institute professor at MIT. Langer is listed as a co-founder of Vivtex along with Giovanni Traverso, PhD, an associate professor in MIT’s School of Engineering. Their platform utilizes intact human or animal-derived GI tissue in high-throughput screening experiments to generate large quantities of physiologically-relevant data that could be analyzed using predictive models and computational simulations to identify new kinds of drug delivery opportunities. Basically, the company’s platform captures “the entire complexity we have in the GI tract” so that “we can empirically understand and design [strategies to] trick drugs to get through the GI tract that would otherwise not be absorbed,” he explained.
Vivtex spun out of MIT in 2018. As a young company, von Erlach said Vivtex made the decision to partner early with pharmaceutical companies to get clear guidance on “the key things we need to capture” to create usable oral drug delivery systems. “We knew how to build the platform, that’s really our expertise, but we wanted to partner with pharma to make sure that ultimately what we are building … has a clear line of sight [from a] commercial and clinical point of view,” he said. That approach seems to have worked out in the Vivtex’s favor. Since its launch, the company has forged at least 10 partnerships with pharma companies, and has a program in Phase I clinical trials.
“We don’t consider ourselves to be a drug delivery company” rather “we [are a] technology-based screening company,” von Erlach said when asked how his company sets itself apart from others focused on the oral biologics space. “We would like to go even beyond that application, but for the time being, [we are] focusing on that challenge [and] really are setting ourselves apart from other approaches out there.”
Neither Novo Nordisk nor Vivtex is disclosing the details of the exact drug delivery systems that will be licensed as part of the agreement. “Novo [Nordisk] will have access to our existing drug delivery systems” as well as “use of our screening platform for creating new drug delivery systems for [their] assets,” von Erlach said. Novo Nordisk is known globally for its slate of glucagon-like peptide 1 (GLP-1) receptor agonists for obesity/weight management and diabetes. The company markets semaglutide for adult type 2 diabetes as Ozempic® and for obesity as Wegovy®.
Commenting on the partnership with Vivtex, Brian Vandahl, senior vice president, therapeutics discovery, at Novo Nordisk, noted that the company launched the “first-ever oral biologic more than five years ago” and “recently launched the world’s first oral biologic for obesity.” The company announced late last year that the U.S. Food and Drug Administration had approved a once-daily oral semaglutide pill for weight reduction/management and to reduce the risk of major adverse cardiovascular events. The pill became broadly available in the U.S. in January this year.
And other companies have their own plans for oral biologics in the metabolic space. Earlier this year, Eli Lilly and Nimbus Therapeutics announced a deal to develop an oral treatment for obesity and other metabolic diseases, through a multi-year research collaboration and exclusive, worldwide license agreement that could generate more than $1.3 billion for the Boston AI-based drug developer. “With Wegovy or Semaglutide … there is a high demand in the patient population for [multiple treatment] options,” von Erlach noted. Serving those patients with the best possible therapeutics in an oral form is important so “hopefully with this collaboration that we have with Novo, we can work towards that.”
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