Seven months after Novo Nordisk abandoned its push into cell therapy, the pharma’s Parkinson’s disease program looks like it’s secured a happy ending via a deal with Cellular Intelligence.
The AI biotech has licensed the clinical-stage Parkinson’s cell therapy, as well as locking in an equity investment from Novo. The May 11 press release made no mention of Cellular Intelligence handing over any money upfront, although Novo will be eligible for milestone payments as well as royalties if the therapy ever makes it to market.
Cellular Intelligence will now lead development of STEM-PD, a cell therapy where donor stem cells are transformed into new neurons and transplanted into patients’ brains. The candidate is currently in a first-in-human trial, and the biotech plans to launch a phase 2 study by the end of the year, Nuno Mendonça, M.D., Cellular Intelligence’s newly appointed chief medical officer, told Fierce.
The biotech has some competition in the Parkinson’s cell therapy space. Aspen Neuroscience, for example, is plotting a phase 3 trial of its own candidate, which is derived from the patients themselves rather than donors, after a promising phase 1/2 data readout.
Cellular Intelligence hopes to set STEM-PD apart from the crowd in its upcoming phase 2 trial, said Mendonça, thanks to the company's AI-powered platform.
“Based on the data that we've seen so far, I think we're all positioned,” Mendonça said.
The manufacturing advantage comes from the company’s ability to make “minor tweaks” to the stem cells, Cellular Intelligence co-founder and CEO Micha Breakstone, Ph.D., told Fierce, which can have “outsized effects” on factors like viability.
“Cell replacement therapies have been plagued by scalability, producibility, costs, etc.,” Breakstone explained. “Those are exactly the areas that we believe we can improve on.”
Novo decided to end its cell therapy work and fire nearly all of its 250 employees working in this space last October, as part of a broader restructuring. The Big Pharma has been seeking landing spots for select assets ever since. Aspect Biosystems took on the pharma’s diabetes cell therapies in January, with Novo also investing in the biotech.
Now, Boston-based Cellular Intelligence is the latest beneficiary of Novo’s strategic withdrawal, which was enacted by CEO Mike Doustdar at the beginning of his tenure.
“Finding the right steward for the program was critical, and we are convinced that Cellular Intelligence has the capabilities needed to advance it further,” Jacob Petersen, Novo’s senior vice president of global research, said in today's release. “The convergence of developmental biology and genomics, and the possibility of combining this with AI on a single platform, provide an exciting opportunity in medicine in general, and for the cell therapy field in particular.”
With STEM-PD rehomed and a collaboration with Heartseed scrapped, all of Novo’s former cell therapies that were in clinical or late-preclinical stages have met their ultimate fate, Novo communications lead Martin Havtorn Petersen told Fierce.
“Everything else we were doing in the unit was really early stuff,” Petersen said. “You should not expect any more deals for specific cell therapy programs.”
Cellular Intelligence was launched just two and a half years ago, with Breakstone providing the pre-seed funds himself. Originally called Somite Therapeutics, the company’s goal is to build foundation AI models for cell signaling pathways. But even with that tech focus, the goal has always been to develop a pipeline, Breakstone told Fierce. The biotech currently has six preclinical assets to go along with STEM-PD, he said.
"If you don't have your own assets, you'll basically be at the mercy of others,” the CEO said. “The idea was always to have something close to home that we could prove ourselves with.”
With STEM-PD in hand, Cellular Intelligence is now expanding into Copenhagen with a 26-person team that includes some staffers who worked on the Parkinson’s program while it belonged to Novo. There, they’ll join an effort to turn the Danish capital into the “Kendall Square of regenerative medicine,” as Breakstone recalls the CEO of the Novo Nordisk Foundation once saying was his goal.
“To be able to drive impact on patients,” Breakstone said, while also building a fully integrated, AI-native therapeutics company, is “a really rare opportunity, and one that we're extremely excited about.”
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