Aspen Neuroscience Completes Cohort 3 and 4 Dosing in iPSC-Derived Phase 1/2a for Parkinson’s
The ASPIRO trial of sasineprocel is progressing; fifteen patients have been dosed with the commercial-ready formulation of the autologous cell therapy.
Key Points
- Aspen Neuroscience has completed dosing in Cohorts 3 and 4 of its Phase 1/2a ASPIRO trial of sasineprocel for Parkinson’s disease.
- Fifteen patients have now been dosed; the latest cohorts received a commercial-ready cryopreserved “thaw-and-inject” formulation.
- Sasineprocel is an autologous (sourced from the patient) induced pluripotent stem cell (iPSC)-derived dopaminergic neuron precursor cell therapy being developed without the need for immunosuppression.
Aspen Neuroscience has completed dosing in Cohorts 3 and 4 of the ongoing Phase 1/2a ASPIRO clinical trial evaluating sasineprocel (ANPD001) for Parkinson’s. With these cohorts completed, 15 patients have been dosed in the study so far.
The company said Cohorts 3 and 4 used a commercial-ready formulation intended to support scalable manufacturing and later-stage development. That formulation uses a cryopreserved “thaw-and-inject” product, allowing the cells to be administered upon arrival at the clinical site.
“We are proud to reach this important milestone, which reflects meaningful progress in the sasineprocel program and underscores the growing clinical experience with our personalized, autologous approach,” said Damien McDevitt, Ph.D., President and Chief Executive Officer of Aspen Neuroscience. “Importantly, the use of our commercial formulation in these cohorts represents a critical step toward scalable manufacturing and commercial readiness as we prepare for Phase 3 initiation.”
About the Therapy
ASPIRO is an open-label trial designed to assess the safety, tolerability, and potential efficacy of sasineprocel. The therapy is an autologous (sourced from the patient) induced pluripotent stem cell (iPSC)-derived dopaminergic neuron precursor cell (DANPC) product intended to replace cells affected in Parkinson’s disease and restore damaged neural circuitry.
It’s made from a patient’s own cells collected through a skin biopsy. Those cells are reprogrammed into iPSCs and then differentiated into DANPCs before being delivered to the putamen using image-guided administration. Because the therapy is autologous (sourced from the patient), Aspen says it is designed to avoid the need for immunosuppressive therapy that is typically used with allogeneic (donor derived) approaches.
Sasineprocel has received Fast Track designation from the FDA.
Aspen said it is continuing work tied to late-stage development, including manufacturing scale-out and process optimization for a future pivotal trial.
Cohorts 3 and 4 build on earlier support from the California Institute for Regenerative Medicine, which funded Cohorts 1 and 2.
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