Gensaic, Inc

Novo Nordisk has said will be gaining exclusive worldwide rights to United Laboratories International’s investigational triple receptor agonist in a deal worth up to $2bn. The candidate, UBT251, is a long-acting synthetic peptide triple agonist targeting the receptors for (GLP-1), gastric inhibitory polypeptide (GIP) and glucagon, and is currently in early-stage clinical development for type 2 diabetes, obesity and other diseases. The licence agreement gives Novo the rights to develop, manufacture and commercialise UBT251 everywhere except Chinese mainland, Hong Kong, Macau and Taiwan, where United Laboratories’ subsidiary, United Biotechnology, will retain these rights. In exchange, United Biotechnology is eligible to receive an upfront payment of $200m and potential milestone of up to $1.8bn, as well as tiered royalties. Martin Holst Lange, executive vice president for development at Novo, said: “The addition of a candidate targeting glucagon, as well as GLP-1 and GIP, will add important optionality to our clinical pipeline, as we look to develop a broad portfolio of differentiated treatment options that cater to the diverse needs of people living with these highly prevalent diseases. “We look forward to building on United Biotechnology’s scientific work and further exploring the potential best-in-class properties of UBT251 across cardiometabolic disease indications.” United Biotechnology recently completed a phase 1b trial of multiple subcutaneous injections of UBT251 in China in individuals who are obese or overweight, and has initiated a phase 2 trial for the drug in this indication. In the highest dose group of the phase 1b study, the average weight of UBT251-treated patients decreased by 15.1% from baseline, compared to an increase of 1.3% in the placebo group, and the safety profile of the candidate was shown to be consistent with incretin-based therapies. Tsoi Hoi Shan, chairman of United Laboratories, said Novo “holds a strong position in the treatment of chronic diseases”, adding that its “expertise will play a key role in accelerating the global development of UBT251”. The deal comes just three weeks after Novo Nordisk and Gensaic entered into a partnership worth up to $354m to develop new therapies for cardiometabolic diseases. The licence and discovery collaboration will utilise Novo’s drug development experience and Gensaic’s protein design technology, and will focus on discovering tissue targeting ligands and developing new therapeutic candidates to treat cardiometabolic diseases via undisclosed targets.

Novo Nordisk and Gensaic have entered into a partnership worth up to $354m to develop new therapies for cardiometabolic diseases. The license and discovery collaboration will utilise Novo’s drug development experience and Gensaic’s protein design technology, and will focus on discovering tissue targeting ligands and developing new therapeutic candidates to treat cardiometabolic diseases via undisclosed targets. Tissue targeting allows drugs to be delivered to a specific site or group of cells in the body. The approach is considered key to unlocking the next generation of precision medicines, however, there is a need to discover new biological mechanisms for therapeutic delivery to selected organs or cell types beyond the liver. Gensaic’s FORGE technology engine combines “unbiased protein evolution with machine guided design to map and leverage the complex network of protein interactions that determine where molecules travel to in the body,” the biotech said. The agreement will see Gensaic discover novel protein ligands, with Novo retaining rights to leverage these for further development. In exchange, Gensaic will be eligible to receive up to $354m in upfront payments, development and commercial milestones per target, as well as tiered royalties. Novo Nordisk will also reimburse research and development costs and participate in a future financing round. Uli Stilz, head of Novo’s Bio Innovation Hub, said: “Tissue targeting has so much potential – both in terms of the modalities that can be leveraged, but also for the diseases that can be addressed… By coupling Gensaic’s technology with our team’s deep understanding of disease and drug development, we have the potential to reach challenging targets, while increasing efficacy and reducing potential side effects.” Gensaic’s chief executive officer and president, Lavi Erisson, added: “Combining Gensaic’s… FORGE engine with Novo Nordisk’s therapeutic and market insights creates powerful new opportunities.” The announcement comes less than two months after Novo and Valo Health expanded their agreement to discover and develop new treatments for type 2 diabetes, obesity and cardiovascular disease, with the deal now worth $4.6bn Novo also recently partnered with Ascendis Pharma to develop therapies for metabolic and cardiovascular diseases, including a once-monthly GLP-1 receptor agonist that will initially target type 2 diabetes and obesity.

Novo Nordisk has formed a $354 million research collaboration with Gensaic, the protein design company said on Monday , as the Danish pharma giant works to incubate new approaches in the metabolic disease space. Many of the details remain under wraps. The partners are not disclosing which cardiometabolic conditions they are aiming to treat or which mechanisms they are investigating, much less when clinical trials might start. They also won’t reveal how much of the $354 million is being paid upfront. Gensaic uses AI-guided protein design along with a wet lab process of protein evolution, with the aim of discovering new ligands and mechanisms. Its tech could also enable tissue-selective intracellular delivery of molecules including siRNA. It is challenging to deliver siRNAs to tissues other than the liver, and extrahepatic tissue targeting was a major focus of Alnylam’s recent R&D day . “One of the most persistent challenges we have with delivery is that there are very few known mechanisms of action, and we keep hitting them again and again,” Gensaic CEO Lavi Erisson told Endpoints News . He said that Gensaic’s approach can design protein scaffolds that are superior to those that are available in nature, which “gives us the ability to find novel mechanisms of action, whether these are novel receptor surface elements or epitopes that can mediate more efficient delivery of therapeutic molecules.” Seeking unproven pharmacological approaches is clearly more perilous than simply developing me-too drugs which, in the cardiometabolic arena, largely means GLP-1s. “It is really risky,” Erisson said. “It is why the way we develop looks at, every step of the way, whether or not we’re actually delivering the right function … of delivery we’re interested in. It is not a guaranteed process.” Novo’s interest in Gensaic’s tech was sparked in 2022, according to Uli Stilz, head of the Danish company’s Bio Innovation Hub — the unit that seeks out, funds and helps develop promising early research. At that point, Novo provided lab space, mentoring and other input, despite the fact that Gensaic’s focus was not aligned with Novo’s. “We felt there was a great team of founders and scientists and a cool idea, but there wasn’t, at the time, a real concrete idea for collaboration,” Stilz said. Gensaic’s focus shifted in 2023, leading to the research agreement disclosed Monday. Novo takes this kind of pre-collaboration interest in between five and 10 very young companies each year, Stilz said. Not all lead to partnerships, let alone commercially successful products. Novo has the cash to do much bigger deals, but its security as one of the leading metabolic drug developers also enables it to take these high-risk bets. It will be some time before a clinical lead emerges from the Gensaic deal, but Novo is in it for the long haul. As well as promising Gensaic milestone payments for each target plus tiered royalties, Novo will reimburse its R&D costs and participate in a future financing round, while a Novo exec will join Gensaic’s board as a non-voting observing member.