Presentation of Data from Clinical Trial of Aspen’s Autologous iPSC-derived Approach for Neuronal Replacement Therapy in Parkinson’s Disease

SAN DIEGO, June 9, 2025 /PRNewswire/ — Aspen Neuroscience, Inc. announced its participation in “Illuminating the Future,” the International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, to be held in Hong Kong June 11-14.

Aspen Co-founder and Senior Vice President, Research and Development, Andrés Bratt-Leal, PhD will deliver a presentation, Safety, tolerability, and efficacy of transplanted autologous iPSC-derived dopaminergic precursors in moderate to advanced Parkinson’s Disease.

Dr. Bratt-Leal’s presentation will cover data for the first four patients of the ASPIRO Study*, a Phase 1/2a trial of the company’s iPSC-derived autologous cell therapy (ANPD001). The open label trial was designed to evaluate the safety, tolerability and efficacy of intracranial implantation of autologous induced pluripotent stem cell (iPSC)-derived dopaminergic neuronal precursor cells (DANPCs) in patients with moderate to advanced Parkinson’s disease.

The primary objective of the ongoing study is to assess safety and tolerability of the procedure. A secondary objective is to evaluate clinical efficacy as measured by change from baseline in multiple patient-reported and clinician-reported Parkinson’s disease outcome measures. Continued follow up and evaluation of a higher-dose cohort in the study are ongoing.

“Early data from the first four patients show that precision intracranial delivery of DANPCs is safe and well-tolerated,” reported Dr. Bratt-Leal. “Both patient-reported and clinician-reported outcomes show early signs of changes from baseline in multiple clinically meaningful outcome measures. Autologous iPSC-derived therapy as a regenerative medicine approach has the unique advantage of not requiring immunosuppressive medications.”

About Aspen Neuroscience 
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company’s patient-derived iPSC platform is used to create personalized therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for PD. 

Aspen combines cell biology with the latest machine learning and genomic approaches to investigate patient-specific, restorative cell treatments. The company has developed a best-in-class platform to create and optimize pluripotent-derived cell therapies, which includes in-house bioinformatics, manufacturing and quality control. For more information and important updates, please visit https://www.aspenneuroscience.com or email media@prodcopy1.wpenginepowered.com.  

* The study was made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, and gene therapy research (Grant Number CLIN2-15547).

SOURCE Aspen Neuroscience, Inc.

CFO Further Positions Company for Growth and Continued Advancement of Clinical Programs

SAN DIEGO, April 30, 2025 /PRNewswire/ — Aspen Neuroscience, Inc., a private biotechnology company developing personalized, autologous cell therapies, has appointed Dalen Meeter, CPA, MBA, as Chief Financial Officer (CFO).

“We are excited to welcome Dalen to our executive team during this significant period of growth and development at Aspen,” said Damien McDevitt, PhD, president and CEO of Aspen Neuroscience. “His financial leadership experience within the biotech sector will be important during our corporate evolution, as we advance our clinical programs and prepare for the future.”

“It is an honor to join this groundbreaking company at such a pivotal time,” said Mr. Meeter. “I look forward to contributing to the company’s mission of developing transformative therapies for patients with Parkinson’s disease.”

With more than two decades of finance and accounting expertise, Dalen brings extensive experience in scaling private and public companies to his new role. Prior to Aspen, most recently he served as CFO of Singular Genomics Systems, Inc. After guiding Singular’s finance transformation from a private, development-stage startup to a publicly traded, commercial-stage company, he then led as CFO of the public entity.   

Before joining Singular, Dalen spent many years in Finance leadership at Illumina, as well as in auditing during his time at KPMG. Mr. Meeter holds an undergraduate degree from the University of California, Santa Barbara, and an MBA from the University of Southern California’s Marshall School of Business.

About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company’s patient-derived iPSC platform is used to create personalized therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson’s Disease. 

Aspen combines cell biology with the latest machine learning and genomic approaches to investigate patient-specific, restorative cell treatments. The company has developed a best-in-class platform to create and optimize pluripotent-derived cell therapies, which includes in-house bioinformatics, manufacturing, and quality control. For more information and important updates, please visit https://www.aspenneuroscience.com.

SAN DIEGO, Oct. 8, 2024 /PRNewswire/ — Aspen Neuroscience has entered into a collaboration and license agreement with Cell X Technologies to advance Aspen’s plans for automating the iPSC stage of its autologous manufacturing platform.

Aspen will leverage its established bioinformatics-based platform, and will lead all discovery, preclinical, development and commercialization activities associated with the advancement of automated manufacturing for its personalized cell therapy programs. Aspen paid an undisclosed amount to support the collaboration with Cell X on hardware and software to enable Aspen’s automated GMP manufacturing process.

Cell X will lead efforts relating to the development of its automated intelligent cell processing platform, including Cx Suite™ and Colonyze™. The collaboration includes creating tools, methods and additions to the Celligent™ platform to support Aspen’s autonomous manufacturing goals.

“This is a major step in our mission to develop and deliver personalized cell replacement therapies for people with unmet medical needs, starting with Parkinson’s disease,” said Kim Raineri, Chief Technology Officer of Aspen Neuroscience. “In order to treat greater numbers of patients with their own cells, Aspen is developing a robust, scalable, and automated biomanufacturing system. We have worked with the Celligent platform and believe that, combined with our bioinformatics and other enabling technologies, it has the potential to successfully automate iPSC production.”  

Aspen’s autologous manufacturing platform starts with a small sample of the patient’s own skin cells, which are then reprogrammed to iPSCs unique to each patient, before differentiation into their final cell type for therapeutic delivery. For ANPD001, currently under investigation in a Phase 1/2a human clinical trial, the patient’s iPSCs are converted into personalized dopaminergic neuronal precursor cells (DANPCs) for the treatment of Parkinson’s Disease (PD).

Before being implanted, these cells are evaluated at every stage of the manufacturing process by Aspen’s proprietary genomics platform, which includes several machine learning based genetic tests to evaluate cell quality.

“Our visionary team, the best in the world at creating and characterizing iPSCs, has enhanced throughput and performance of our manufacturing platform with automation, machine learning, and innovative technology operation solutions,” said Damien McDevitt, PhD, president and CEO of Aspen Neuroscience. “Aspen is leading the way in addressing the autologous industry’s historical challenges.”

In the autologous manufacturing field, iPSC generation has historically been labor intensive. Aspen and Cell X have worked together to ensure that iPS cells manufactured utilizing the Celligent platform are highly comparable to control cell lines (from the same patient) made using Aspen’s current process.

“The Celligent platform provides gentle and precise positive and negative cell selection that uses machine learning (ML) and deep learning (DL) computer vision algorithms trained by experienced subject matter experts to first automate cell processing workflows and to achieve adaptive process control,” said Cell X President and CEO Lynne Frick. “We are excited to be working with the leading autologous cell platform company to advance the field in scaling iPSC production.”

About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company’s patient-derived platform is used to create personalized cell therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for PD. For more information and important updates, please visit https://www.aspenneuroscience.com.

About Cell X Technologies

Cell X Technologies, headquartered in Cleveland with applications labs in greater Boston, is revolutionizing cell processing. At the core of this revolution lies the transformative Celligent™ platform – a novel combination of robotics, imaging, and artificial intelligence that enables innovators to develop consistent, reproducible, and scalable GMP-compliant processes. Through this unique fusion of cutting-edge technologies, Cell X has unlocked the ability to commercialize autologous and allogeneic cell therapies, as well as explore tissue engineering and artificial organ applications.  www.cellxtechnologies.com

SOURCE Aspen Neuroscience, Inc.

SAN DIEGO, Oct. 8, 2024 /PRNewswire/ — EndPoints News has named Jeanne Loring, PhD, Aspen Neuroscience co-founder and senior advisor, a recipient of the 20 Women Breaking New Ground in BioPharma.

The publication’s annual 2024 Women in BioPharma R&D Special Report recognizes the field’s most inspiring and driven women leaders.

“Dr. Jeanne Loring is one of the earliest pioneers in human stem cell research, and she’s been called the ‘stem cell godmother’ because of her impact on this field,” said Damien McDevitt, president and CEO of Aspen Neuroscience. “Research launched by Dr. Loring and continued by Aspen is making significant strides in the field of human pluripotent stem cells. It is not only groundbreaking but also holds immense promise for the future of regenerative medicine.”

A world-renowned stem cell scientist, in the earlier days of research Dr. Loring organized the first NIH-funded stem cell training course. She founded the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, Calif., and after pivoting to discovery and development in the field of induced Pluripotent Stem Cells (iPSCs) she co-founded the autologous cell therapy company Aspen Neuroscience with Andres Bratt-Leal, PhD, SVP of Research.

In addition to advising Aspen, Dr. Loring’s work with iPSCs has led to a collaboration with The Frozen Zoo (San Diego Zoo Institute for Conservation Research), which has collected and frozen samples from animals in danger of extinction, and the “stem cells in space” project to study the effects of microgravity on neurons on the International Space Station (ISS), which is supported by the National Stem Cell Foundation and in collaboration with the New York Stem Cell Foundation.

In addition to serving as a senior adviser, Loring currently serves as Professor Emeritus, Scripps Research, Board of Directors, Summit for Stem Cell Foundation and Senior Scientific Advisor, National Stem Cell Foundation. 

Previously, Dr. Loring has held research and management positions at multiple biotechnology companies, and was a professor and principal investigator at the Burnham Institute and Scripps Research for 16 years. She is author of more than 250 highly cited scientific publications, including the first reports of single cell RNA sequencing, iPSCs from an endangered species, gene expression, microRNA profiling, and SNP genotyping of pluripotent stem cells, and DNA methylome sequencing of both undifferentiated and differentiated human pluripotent stem cells.  

The EndPoints annual report has now celebrated more than 120 women breaking boundaries in biopharma R&D. The vision has transformed into a newsroom-wide effort involving more than 17 reporters and editors. For additional information on Dr. Loring and the other honorees, go to Endpoint News’ 2024 Women in Biopharma R&D.

About Aspen Neuroscience

Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company’s patient-derived platform is used to create personalized cell therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson’s Disease. For more information and important updates, please visit https://www.aspenneuroscience.com.

SOURCE Aspen Neuroscience, Inc.

Company Outlines Plans for Industrialization of Personalized Cell Therapy Manufacturing

SAN DIEGO, Oct. 1, 2024 /PRNewswire/ — Aspen Neuroscience, Inc., a private biotechnology company developing personalized (autologous) cell therapies, announced the expansion of its San Diego footprint near its headquarters in Torrey Pines, with a new 22,000 square foot facility for GMP manufacturing of induced pluripotent stem cell (iPSC)-derived cell therapies.

This facility was designed and built for GMP manufacture and testing of Aspen’s ANPD001 drug product, which is an iPSC-derived cell therapy for Parkinson’s Disease (PD). Aspen will use the cells in its ASPIRO study.

In addition to gaining investigational new drug (IND) clearance from FDA and starting its first-in-human clinical trial, the company has developed a robust multi-organizational strategy for further industrialization of autologous cell therapy manufacturing; and to automate, close processes and increase throughput.

The new facility is certified by the Food and Drug Branch (FDB) of the California Department of Public Health. The Aspen team is currently producing its patient-specific clinical drug product using in-house manufacturing and Quality Control (QC).

The project comprises a 14,000 sq ft facility with 3,000 sq ft of controlled manufacturing space, including three ISO qualified manufacturing suites, QC labs, warehouse, and offices; as well as an additional 8,000 sq ft expansion space available for future manufacturing suites, additional process automation and QC labs. This adds to the existing and certified 500 sq ft of controlled manufacturing space used for processing of patient skin biopsies, and laboratory space for research and process development at company headquarters.

“We are proud to have expanded in San Diego, given that ANPD001 was originally developed here. This new site will help accelerate the manufacture of patient-specific cell lines for our ASPIRO trial patients in California and across the U.S.,” said Damien McDevitt, PhD, president and CEO of Aspen Neuroscience. “We continue to advance the entire cell therapy field with this new treatment modality.”

Aspen’s autologous manufacturing platform starts with a small sample of the patient’s own skin cells, which are then reprogrammed to iPSCs unique to each patient, before differentiation into their final cell type for therapeutic delivery. For ANPD001, the patient’s iPSCs are converted into personalized dopaminergic neuronal precursor cells (DANPCs) for the treatment of PD.

Before implantation, the cells are evaluated at several stages of the manufacturing process by Aspen’s proprietary genomic tests and Machine Learning-based bioinformatics tools to evaluate cell quality.

“Aspen is leading the field when it comes to pluripotent stem cell-derived cell therapies,” said Kim Raineri, Chief Technology Officer. “Our goal is ‘scaling out, not up.’ We are innovating to produce small quantities of cells specific to the patient, for many patients in parallel.”

The autologous cell therapy approach was pioneered by Aspen’s co-founders, Jeanne Loring, PhD, Professor Emeritus and Director of The Center for Regenerative Medicine, Department of Molecular Medicine at the Scripps Research Institute, and Andres Bratt-Leal, PhD, Aspen Senior Vice President, Research and Development. With help and support from the Parkinson’s patient community and the Summit for Stem Cell Foundation, the Loring lab team formed Aspen Neuroscience in 2018. The company received an early California Institute for Regenerative Medicine (CIRM) grant, to support the company’s research on using machine learning to identify cell lots that have successfully differentiated from iPSCs into DANPCs. Earlier this year the company was awarded a CLIN2 grant from CIRM to help advance the clinical development of ANPD001.

About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company is developing personalized cell therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson’s disease. For more information and important updates, please visit https://www.aspenneuroscience.com.

SOURCE Aspen Neuroscience, Inc.