Aspen Neuroscience Initiates Cohort 3 in ASPIRO Phase 1/2a Trial, Highlighting Commercial Formulation of ANPD001 and Its Transformative Potential for Parkinson’s Disease

SAN DIEGO, September 25, 2025 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical-stage biotechnology company pioneering autologous regenerative therapies, today announced the initiation of Cohort 3* in its ASPIRO Phase 1/2a clinical trial of ANPD001, the company’s personalized dopaminergic neuronal precursor cell (DANPC) therapy for moderate to advanced Parkinson’s disease (PD).

This milestone marks the first administration of Aspen’s commercial formulation of ANPD001, designed to support scalable, reproducible manufacturing for future clinical and commercial use. The Cohort 3 formulation has been deemed preclinically comparable to the formulation used in the first two Cohorts, ensuring continuity as we advance to this next phase. In earlier cohorts, positive six-month data reported at IAPRD demonstrated strong safety and tolerability, along with clinician- and patient-reported improvements, achieved without the need for immunosuppression.

“Cohort 3 represents an important step toward commercial readiness,” said Damien McDevitt, Ph.D., President and CEO of Aspen Neuroscience. “We’ve optimized our formulation and delivery system to meet the rigorous demands of late-stage development and future market access, while preserving the personalized nature of our autologous approach.”

This new formulation allows for the cryopreserved cells to be available for dosing immediately upon arrival to the institution, streamlining the surgical workflow and minimizing the impact on hospital cell processing labs.

Aspen’s Three Pillars of Innovation in Autologous Regenerative Cell Therapy
Aspen’s commercial formulation of ANPD001 sets a new benchmark for neurodegenerative disease treatment through a proprietary, integrated approach:

Manufacturing Platform. The proprietary and high-tech manufacturing process converts patient-derived skin cells into DANPCs leveraging machine learning–algorithms that help produce the highest quality personalized cells for the patient.
Therapeutic Platform. ANPD001 is an autologous induced pluripotent stem cell (iPSC)-derived DANPC therapy. It is a personalized regenerative cell therapy that uses a patient’s own cells, avoiding immune rejection and offering tailored treatment.
Proprietary Device for Cell Transplantation Procedure. Aspen’s precision delivery system combines its metered dosing syringe and MRI guidance to ensure sub-millimeter accuracy, minimally invasive surgery, and a streamlined clinical workflow.

“Together, these three pillars form a unified platform that is personalized, precise, and scalable—setting a new standard in autologous iPSC-derived cell therapy,” said Lisa Johnson-Pratt, M.D., Executive Vice President, Therapeutic Program Lead. “This commercial formulation is designed not just for clinical success, but for real-world impact. Enabling precision dosing without immunosuppression, ensuring scalable and consistent cell quality, and simplifying surgical workflows reduces the time and burden on hospital cell processing labs which is critical for commercial viability. Our vision is to deliver a commercial-ready solution positioned to redefine how neurodegenerative diseases are treated.”

A Competitive Edge in Parkinson’s Therapeutics
Aspen’s autologous approach (using a patient’s own cells) positions ANPD001 uniquely in the PD treatment landscape. Unlike allogeneic therapies, which use foreign cells from donors, ANPD001 avoids immune rejection and the need for prolonged immunosuppression. Its personalized nature allows for tailored treatment, while the commercial formulation ensures consistency and scalability.

With more than one million people living with Parkinson’s disease in the U.S. alone, and no disease-modifying therapies currently available, ANPD001 offers a potential first-in-class opportunity to restore lost dopaminergic function with curative intent.

About ANPD001
ANPD001 is the most advanced autologous investigational cell therapy in the United States for treating Parkinson’s disease. More information about the Phase 1/2a trial is available at clinicaltrials.gov (NCT06344026).

Aspen’s personalized approach means that patients do not require immunosuppressive (IS) drugs to dampen the body’s immune response against foreign cells. This approach will eliminate IS-associated adverse events, IS drug-monitoring requirements, and enable dosing for those with contraindications to IS therapies.

Aspen’s manufacturing process starts from a small biopsy of the patient’s own skin cells, followed by reprogramming to induced pluripotent stem cells (iPSCs) and then differentiation of the iPSCs into DANPCs. These DANPCs are transplanted into the posterior putamen, replacing cells that were lost or damaged due to disease. The quality of each person’s cells is assessed at every manufacturing stage using Aspen’s proprietary machine learning-based genomics tests.

ANPD001 has received Fast Track designation by the U.S. Food & Drug Administration (FDA).

About the ASPIRO Trial
ASPIRO is the first multi-patient, multi-center clinical trial of an autologous cell therapy for Parkinson’s disease. It is evaluating safety, tolerability, and preliminary efficacy of ANPD001 in levodopa-responsive patients aged 50–70. Primary endpoints will be reported at 12 months, with long-term follow-up extending to 15 years.

For more information, visit www.aspenneuroscience.com.

* We are entering testing for the third Cohort, building 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.

SOURCE Aspen Neuroscience, Inc.

Aspen Neuroscience to Present at the International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting

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.

Aspen Neuroscience to Present at American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

Presentation Covers Aspen’s Autologous iPSC-derived Approach for Neuron Replacement Therapy in Trial for Parkinson’s Disease

SAN DIEGO, May 14, 2025 /PRNewswire/ — Aspen Neuroscience Chief Scientific Officer Xiaokui Zhang, Ph.D., will present at the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting, held this week May 13-17, at the Ernest N. Morial Convention Center in New Orleans, Louisiana. The annual meeting, the largest gathering of cell and gene therapy professionals, hosts a global audience of attendees from academia, the biotechnology and pharmaceutical industries, government, and non-profit patient foundations.

“We are excited to be part of this meeting, which covers the latest advancements in cell and gene therapies,” commented Dr. Zhang. “The members of the ASGCT community share our vision to translate the potential of these therapies into safe and effective medicines to improve patients’ lives.”

Dr. Zhang will present during the Scientific Symposium “Next Generation Strategies for Evading Immunity in Stem Cell Therapies” (Organized by the Stem Cell Committee), scheduled for Friday May 16 from 1:30 – 3:15 PM. She will discuss recent developments in personalized, autologous cell therapy research and development, including for ANPD001, Aspen’s iPSC-derived neuron replacement therapy currently under investigation for Parkinson’s disease in a Phase 1/2a clinical trial.

Dalen Meeter Joins Aspen Neuroscience as Chief Financial Officer

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.

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.

The Aspen Neuroscience Team is Proud to Sponsor and Participate in the Annual Step-by-Step 5k Hosted by The Parkinson’s Association of San Diego (PASD) on Saturday, April 5th

April 1st marks the beginning of Parkinson’s Awareness Month. This Saturday, April 5th, the Aspen Neuroscience team is proud to sponsor and participate in the annual Step-by-Step 5k hosted by The Parkinson’s Association of San Diego (PASD).

This is Aspen Neuroscience’s fifth year supporting this incredible event.

Please help us make an impact by donating to sponsor individual team members and the Aspen team as a whole here: https://raceroster.com/events/2025/97165/fighting-parkinsons-step-by-step-5k/pledge/team?id=27.

All donations we raise will go directly to the Parkinson’s Association of San Diego. These funds will facilitate PASD in fulfilling their mission to enable San Diego County residents affected by Parkinson’s Disease to live their best lives through support, resources and education.

If you are curious about PASD’s resources, you can check out their website here: https://parkinsonsassociation.org/.

Aspen Neuroscience Announces Completion of First and Second Cohorts in ASPIRO Phase 1/2a Trial for Parkinson’s Disease

SAN DIEGO, Jan. 13, 2025 /PRNewswire/ — Aspen Neuroscience, Inc. has successfully completed dose escalation and the first two cohorts of patients in the ASPIRO study, an ANPD001 Phase 1/2a clinical trial in Parkinson’s Disease (PD).

The Autologous-derived Study of a Parkinson’s Investigational Regenerative therapy in an Open-label trial (ASPIRO) was launched in 2024 to assess ANPD001 in patients with moderate to severe PD.

The study is examining escalating doses, with the primary endpoint being safety and tolerability of ANPD001. Secondary endpoints include improvement in “on” time, when patients experience periods of symptom control, and improvements in motor symptoms and quality of life based on standard PD rating scales.

“This is a major milestone for the first multi-patient, multi-center clinical trial of an autologous therapy for Parkinson’s disease,” said Edward Wirth III, MD, PhD, Chief Medical Officer of Aspen Neuroscience. “We are happy to announce that to date, ANPD001 and its delivery have been well tolerated, and no serious adverse events have been observed in the first two cohorts of patients in the ASPIRO study. All patients were discharged within 48 hours, per protocol. We are now advancing the program to investigate our new commercial formulation.”

ANPD001 is the most advanced autologous investigational new cell therapy in the United States for treating Parkinson’s disease. More information about the Phase 1/2a trial is available at clintrials.gov (NCT06344026).

The study trial includes patients 50–70 years of age, and excludes patients with cognitive impairment and other comorbidities that could preclude treatment. All enrolled patients are under the care of a movement disorder specialist.

About ANPD001
ANPD001 is an investigational autologous dopaminergic neuronal precursor cell (DANPC) therapy being studied as a regenerative treatment for PD. Aspen’s personalized approach means that patients do not require immunosuppressive drugs to counteract the body’s immune response against foreign cells.

Aspen’s manufacturing process starts from a small sample of the patient’s own skin cells, followed by reprogramming to induced pluripotent stem cells (iPSCs) and then differentiation of the iPSCs into DANPCs. These DANPCs are transplanted into the putamen, replacing cells that were lost or damaged due to disease. The quality of each person’s cells is assessed at every manufacturing stage using Aspen’s proprietary machine learning-based genomics tests.

ANPD001 has received Fast Track designation by the U.S. Food & Drug Administration (FDA).

SOURCE Aspen Neuroscience, Inc.

Aspen Neuroscience Advances the Automated Production of Personalized Autologous Cell Therapy for Parkinson’s Disease

Company is scaling out production of ANPD001 investigational cell therapy

SAN DIEGO, Jan. 8, 2025 /PRNewswire/ — Aspen Neuroscience, Inc. has advanced its plans for automating production of ANPD001, including a capacity expansion for autologous manufacturing at its San Diego-based GMP facility. ANPD001, an investigational cell therapy program for treating people with Parkinson’s disease (PD), is currently being studied in the company’s ASPIRO Phase 1/2a clinical trial.

Designed and built for the manufacture and testing of ANPD001, this 22,000 square foot facility contains an additional 8,000 square feet to accommodate future automation.

As part of this expansion, Aspen has entered into a collaboration agreement with Mytos, a leader in automated cell manufacturing, to focus on advancing plans to automate production of dopaminergic neuronal precursor cells (DANPCs) for ANPD001.

Designed to replace lost dopamine-producing neurons in the brain, Aspen differentiates these DANPCs from patient-specific induced pluripotent stem cells (iPSCs), derived from the patient’s own skin cells. This autologous approach has the potential of restoring lost function without the need for immunosuppressive drugs.

“This collaboration with Mytos addresses an important step for automating the manufacturing process for differentiation of DANPCs from induced pluripotent stem cells,” explained Kim Raineri, Chief Technology Officer, Aspen Neuroscience. “The Mytos platform, combined with our bioinformatics and other enabling technologies, will allow us to further automate production of ANPD001 and treat greater numbers of patients with their own cells.”

ANPD001 is evaluated at every stage of manufacturing, utilizing Aspen’s proprietary genomic platforms, a battery of in vitro and in vivo assays, and machine learning-based genetic tests to ensure the highest product quality.

As part of its mission to deliver personalized cell therapies for patients with unmet medical needs, Aspen is driving innovative efforts to study, develop and manufacture iPSC-derived therapies, including the development of its autologous platform. The company recently announced plans for manufacturing scale-out, including its facility expansion, and a collaboration and license agreement with Cell X Technologies to advance the company’s plans to automate the iPSC stage of the autologous cell manufacturing process.

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.aspencorpstg.wpenginepowered.com.

About Mytos

Mytos is a leader in automated cell manufacture. The company’s platform enables life sciences companies to grow human cells with unparalleled precision and efficiency. Mytos has assembled a world-class team of engineers and scientists to develop an automated platform to accelerate the development of life-saving therapies. The company is based in London, UK. For more information, visit www.mytos.bio.

SOURCE Aspen Neuroscience, Inc.

CEO, Damien McDevitt, Named in San Diego Business Journal’s 500 Most Influential People in San Diego

Our CEO, Damien McDevitt, was named in the San Diego Business Journal’s 500 Most Influential People in San Diego. With over two decades of experience in life sciences, Damien is leading our mission to bring personalized, induced pluripotent stem cell treatments to patients with Parkinson’s Disease.

Aspen Neuroscience Announces Collaboration and License Agreement with Cell X Technologies

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.

Endpoints News Honors Aspen Neuroscience Co-Founder Dr. Jeanne Loring in “20 Women Breaking New Ground”

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.

Jeanne Loring, PhD, was recently honored by EndPoints News as one of "20 Women Breaking New Ground in BioPharma" — Jeanne Loring, PhD, was recently honored by EndPoints News as one of “20 Women Breaking New Ground in BioPharma”

“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.