Advancement of commercial-ready formulation supports scalability and late-stage development

SAN DIEGO, June 30, 2026 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical-stage regenerative medicine biotechnology company developing personalized, autologous cell therapies, today announced completion of dosing in Cohort 3 and Cohort 4 of its ongoing Phase 1/2a ASPIRO clinical trial evaluating sasineprocel (ANPD001) for the treatment of Parkinson’s disease (PD).

With the completion of these cohorts, a total of 15 patients have been dosed in the ASPIRO study to date, representing one of the largest clinical experiences reported for an autologous cell therapy in Parkinson’s disease.

Cohorts 3 and 4* utilize Aspen’s commercial-ready formulation of sasineprocel designed to support scalable, reproducible manufacturing and streamlined clinical delivery. This formulation incorporates a cryopreserved “thaw-and-inject” drug product, enabling cells to be administered upon arrival at the clinical site and increasing procedural efficiency.

“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.”

The ASPIRO study is an open-label Phase 1/2a clinical trial designed to evaluate the safety, tolerability, and potential efficacy of sasineprocel, an autologous induced pluripotent stem cell (iPSC)-derived dopaminergic neuron precursor cell (DANPC) therapy. Sasineprocel is designed to replace and restore damaged neural circuitry in patients with Parkinson’s disease without the need for immunosuppressive therapy.

Aspen continues to progress key activities supporting late-stage clinical development, including manufacturing scale-out and process optimization aligned with future pivotal trial requirements.

About Aspen Neuroscience

Aspen Neuroscience is a leading, clinical-stage regenerative medicine biotechnology company developing autologous induced pluripotent stem cell-derived (iPSC) therapies beginning with neurodegenerative diseases of high unmet need including PD.

Its lead product candidate is sasineprocel (ANPD001), the most advanced autologous investigational cell therapy in the United States for treating PD.

About Sasineprocel

Sasineprocel is a single-dose, autologous iPSC-based cell therapy being evaluated for the treatment of PD. We believe sasineprocel has the potential to be disease-modifying by replacing a patient’s lost dopaminergic (DA) neurons with DANPCs and aiming to reconstruct the underlying neural circuitry lost in the progression of disease.

Specifically, sasineprocel is created from a patient’s own cells via skin biopsy, reprogrammed to iPSCs (turning back the biological clock of the cells to a pre-disease state), and differentiated into DANPCs. Our proprietary cell composition is then delivered via image-guided administration to the putamen, the part of the brain where restoration of dopamine signaling is needed.

This approach is designed to establish a biologically active cellular microenvironment that supports engraftment, survival and functional integration of the transplanted cells to achieve durable clinical benefits for PD patients with the goal of slowing or halting disease progression.

Since it is autologous (using a patient’s own cells), immunosuppression, which is required for donor-derived (allogeneic) cell therapies, is not needed.

Sasineprocel has received Fast Track designation by the U.S. Food and Drug Administration (FDA).

For more information, visit www.aspenneuroscience.com.

* Cohorts 3 and 4 build on funding provided by the California Institute for Regenerative Medicine (CIRM), a state of California agency that supports regenerative medicine, stem cell, and gene therapy research, which enabled Cohorts 1 and 2.

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