STEM-PD continues its journey toward phase 2
Associate Professor Agnete Kirkeby from reNEW Copenhagen, together with Lund University Professor Malin Parmar and Cambridge University Professor Roger Barker, guided the preclinical development of STEM-PD, a novel stem cell therapy using human stem cell-derived dopamine producing nerve cells transplanted into patients with Parkinson’s disease. This project now has a new partner, Cellular Intelligence, who will take over future development.
STEM-PD targets Parkinson’s disease, a progressive neurodegenerative disorder characterised by the loss of dopamine-producing nerve cells in the brain. In February 2023, the first patient received the treatment, making STEM-PD the first European pluripotent stem cell therapy of this kind to reach clinical trial. The trial is sponsored by Skåne University Hospital and is still ongoing. Safety data is expected to be published in the coming months.
Earlier this month, it was announced that Boston-based biotech company Cellular Intelligence has entered an agreement with Novo Nordisk to acquire STEM-PD and to take over the clinical development of the product. To advance the program, Cellular Intelligence has established a lab at the BioInnovation Institute (BII) in Copenhagen, with currently 26 employees coming from the former Novo Nordisk Cell Therapy Unit.
‘‘For me this is really important, because we’ve spent so many years getting the product into clinical trial. We developed the protocol and initiated the phase I clinical trial, so it means a lot to me to see the product develop further, even though the project is no longer in my hands,’’ said Kirkeby.
This development is also good news for the wider stem cell ecosystem in Copenhagen. Since Novo Nordisk closed their Cell Therapy R&D unit, several new stem cell biotech companies have set up operations in the Copenhagen area, including Cellular Intelligence and Ibnova Therapeutics.
The phase 2 clinical trial is scheduled to start in late 2026 – early 2027. ‘‘Cellular Intelligence has taken on the task to develop the Parkinson’s product toward market, so it doesn’t stop with just a few people in a clinical trial. In the end, getting it out to a wider community of patients is what really matters,’’ Kirkeby concluded.
Watch the video where she explains more about the trial: https://www.youtube.com/watch?v=Z-16jgAVQqw