SEOUL, S.KOREA, July 21, 2025 - (ACN Newswire) - S.BIOMEDICS announced encouraging one-year post-transplant results from Phase 1/2a clinical trial evaluating A9-DPC cell therapy for Parkinson's disease. The data demonstrate a favorable safety and efficacy profile of A9-DPC in 12 participants at 12 months compared to baseline. Participants were divided equally into a low-dose group (3.15 million cells) and a high-dose group (6.30 million cells).

• A9-DPC (TED-A9) consists of high-purity ventral midbrain dopaminergic progenitor cells derived from human embryonic stem cells (hESCs) under rigorous GMP conditions.
• A total of 12 participants received bilateral putamen transplantation with either a low-dose (3.15 million cells; n = 6) or a high-dose (6.30 million cells; n = 6) of A9-DPC, with the last participant receiving treatment in February 2024.
• At 12 months, the safety profile was favorable, with no tumorigenesis, overgrowth of transplanted cells, ectopic cell migration, or immune-mediated inflammation observed.
• Clinical improvements were observed, along with evidence of cell survival and engraftment at the 12-month follow-up.
• Increased dopamine transporter (DAT) signals in putamen, measured by [18F]FP-CIT PET, correlated with the observed improvements of motor function.

The MDS-UPDRS Part III (off) score, a standard scale for assessing motor symptom severity in Parkinson's disease, showed a mean decrease (improvement) of 12.7 points in the low-dose group and 15.5 points in the high-dose group at 12 months compared to baseline. There were also improvements in MDS-UPDRS Part I, II and IV scores. The MDS-UPDRS Total (off) score showed mean improvements of 29.0 points and 34.7 points in the low- and high-dose groups, respectively.

Clinical improvements were further supported by changes in the Hoehn and Yahr stage, an ordinal scale categorizing disease severity based on motor function. On average, low-dose recipients improved (decreased) from stage 3.7 to 2.7, while high-dose recipients demonstrated a greater improvement from stage 3.8 to 2.2.

A9-DPC also demonstrated favorable outcomes in other assessments, including the Non-Motor Symptoms Scale (NMSS), the Parkinson's Disease Questionnaire-39 (PDQ-39) and the Schwab and England Activities of Daily Living Scale (SEADL). NMSS score improved by 31.7 points in the low-dose group and by 35.8 points in the high-dose group.

[18F]FP-CIT PET imaging showed an overall increase in putamen DAT signals, with greater increases observed in the high-dose group, providing additional evidence for the underlying mechanism of action. Notably, there was a statistically significant correlation between improvements in MDS-UPDRS Part III (off) scores and increased DAT signal in the posterior dorsal putamen, supporting the hypothesis of synaptic restoration through engrafted cells.

In terms of safety, the safety profile remained favorable. No treatment-emergent adverse events (TEAEs) related to the transplanted cells were reported. Tumorigenesis, cell overgrowth, or ectopic cell migration was not observed. Most of TEAEs were mild to moderate. One participant experienced an asymptomatic mild hemorrhage, but no neurological abnormalities or other serious side effects were observed.

"Our data show a consistent positive trend throughout the study period, demonstrating the favorable safety and efficacy profiles. Importantly, increased DAT signals on PET imaging correlated with the observed behavioral recovery, which is very promising in terms of the mechanism of A9-DPC through neuroimaging." said Prof. Dong-Wook Kim of Yonsei University College of Medicine and CTO of S.BIOMEDICS. "We will continue to present additional data through our ongoing study."

About A9-DPC and Phase 1/2a clinical trial

A9-DPC (also called TED-A9) is an investigational cell therapy designed to replace ventral midbrain-specific dopaminergic neurons lost in patients with Parkinson's disease. These ventral midbrain-specific dopaminergic cells are derived from hESCs (human embryonic stem cells) by exclusively utilizing small molecules under strict GMP conditions. A9-DPC represents a significant advancement in the field, offering highly purified dopaminergic cells derived from hESCs. Through a stereotactic surgical procedure, these hESC-derived dopaminergic progenitor (precursor) cells are transplanted into three segments of the putamen: the anterior, middle, and posterior sections, with three tracks per each putamen. Bilateral putamina were treated in a single surgical procedure, with cells injected at three points within each track. After transplantation, the progenitor cells are expected to mature into dopaminergic neurons, enhancing neural connectivity and restoring motor function in patients.

The Phase 1/2a clinical trial enrolled 12 participants diagnosed with Parkinson's disease for more than 5 years who exhibited motor complications such as wearing off, freezing of gait, or dyskinesia. Participants ranged from 50 to 75 years old. An initial low-dose cohort (3.15 million cells) of three patients was first enrolled to assess initial safety including dose-limiting toxicity (DLT) over three months. After confirming safety, an additional three patients received the high dose (6.30 million cells) for similar evaluation. With continued safety confirmation, three more patients were enrolled in each dose group, totaling 12 participants. The final participant received A9-DPC in February 2024.

The primary objective of the Phase 1/2a trial is to evaluate the safety and exploratory efficacy for up to two years post-transplantation, with safety follow-up continuing for an additional three years.

About S.BIOMEDICS

Established in 2005, S.BIOMEDICS Co., Ltd. is a leading innovator in stem cell therapy, specializing in regenerative medicine powered by data-driven biology. Leveraging two core platform technologies, S.BIOMEDICS is currently advancing seven cell therapy programs targeting intractable diseases. Several of its lead candidates are now in clinical development, demonstrating the company's leadership in advancing cell-based medicine:

• A9-DPC (TED-A9): Ventral midbrain-specific dopaminergic progenitor cells derived from hESCs for Parkinson's disease (Phase 1/2a)
• TED-N: PSA-NCAM-positive neural progenitor cells derived from hESCs for spinal cord injury (Phase 1/2a)
• FECS-Ad: 3D MSC spheroids for critical limb ischemia (completed Phase 1/2a)

As the foremost authority and trailblazer in Parkinson's disease treatment in South Korea, S.BIOMEDICS is setting the national standard for cell therapy innovation.

More Information about the Phase 1/2a clinical trial for Parkinson's disease is available at ClinicalTrials.gov (NCT05887466).

For more information about S.BIOMEDICS, visit https://www.sbiomedics.com/. S.BIOMEDICS is listed on the Korea Exchange and is also the founder and controller of S.THEPHARM (www.sthepharm.com), a corporation specializing in anti-aging products such as HA-Filler.

Media contact
Brand: S.BIOMEDICS
Contact: Sarang Kim
Website: https://www.sbiomedics.com

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