S.BIOMEDICS Dopamine Cell Therapy for Parkinson’s Disease with TED-A9 Shows Promising Results at 12 months in Phase I/IIa Clinical Trial
09 Julio 2024 - 6:00AM
Business Wire
- TED-A9 is high-purity midbrain dopaminergic progenitor cells
derived from human embryonic stem cells (hESCs) under rigorous GMP
conditions
- Investigational cell therapy with TED-A9 completed
transplantation of 12 participants in a Phase I/IIa clinical trial
in February 2024
- No major safety issues in 3 low dose participants (first low
dose cohort) through one year
- 3 low dose participants (first low dose cohort) showed
clinical improvement with cell survival and engraftment after 12
months
S.BIOMEDICS (KOSDAQ: 304360) announced positive one-year
assessment data from the first 3 participants (first low dose
cohort) of Phase I/IIa clinical trial for Parkinson’s disease with
TED-A9, hESC (human embryonic stem cell)-derived midbrain
dopaminergic progenitors. The data demonstrates that 3 participants
showed safety and efficacy of TED-A9 in a one-year follow-up.
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Dong-Wook Kim, Professor at Yonsei
University College of Medicine and CTO of S.BIOMEDICS (Photo:
S.BIOMEDICS)
The clinical trial was conducted at Severance Hospital of Yonsei
University in South Korea led by Prof. Jin-Woo Chang, a
neurosurgeon and Prof. Phil Hyu Lee, a neurologist.
For the 3 participants who received initial low dose (3.15
million cells), MRI and CT scans after one year revealed no adverse
effects related to the cell transplantation or surgery.
Moreover, the MDS-UPDRS Part III (off) evaluation, which
objectively measures motor functions, showed a mean decrease of
12.7 points, from baseline 61.7 to 49.0 one-year post treatment.
The MDS-UPDRS Part III (off) evaluation indicated significant
improvement in their motor abilities. Improvement was also observed
in symptoms such as wearing off and freezing of gait.
DAT brain imaging (FP-CIT-PET), conducted one-year post
transplantation, revealed an increase in dopamine transporters
(DAT), suggesting the potential engraftment of dopamine neurons,
which correlated with improvements in the patients' Parkinson's
symptoms.
“Although this clinical evaluation only targets the first 3
low-dose patients, but not all 12 subjects, no adverse issues
related to transplant surgery or cell safety were observed in
one-year post transplantation. Importantly, the clinical results
demonstrated very promising efficacy,” said Prof. Dong-Wook Kim at
Yonsei University College of Medicine and CTO of S.BIOMEDICS. “The
results are believed to align closely with the findings from our
preclinical in vitro and in vivo studies. We are excited that
TED-A9 could be a fundamental treatment that directly replaces
dopaminergic neurons lost in patients with Parkinson's
disease.”
Assessment data of further participants (first high dose cohort)
will be announced in September or October of 2024 after a one-year
follow-up.
About TED-A9 and Phase I/IIa
clinical trial
TED-A9 is an investigational cell therapy designed to replace
ventral midbrain-specific dopaminergic cells lost in patients with
Parkinson's disease. These ventral midbrain-specific dopaminergic
cells are derived from hESCs by exclusively utilizing small
molecules only. TED-A9 represents a significant advancement in the
field, offering highly purified dopamine cells derived from hESCs.
Through surgical procedure, these hESC-derived dopaminergic
progenitor (precursor) cells (TED-A9) are transplanted to three
segments of the putamen; the anterior, middle, and posterior
sections, with three tracks per each putamen. Bilateral putamina
received cell transplantation in a single surgical procedure, with
cells injected at three points within each track. After
transplantation, the expectation is that the transplanted
dopaminergic progenitor cells will mature into dopaminergic neurons
which will supply the dopamine that Parkinson’s patients are
lacking, restoring the motor function of patients.
The Phase I/IIa clinical trial is conducted on 12 participants
who have been diagnosed with Parkinson's disease for more than 5
years and exhibited motor complications such as wearing-off,
freezing of gait or dyskinesia. The participant’s age was between
50 and 75 years old. TED-A9 were administered to 6 participants in
the low-dose group (3.15 million cells) and to another 6
participants in the high-dose group (6.30 million cells).
An initial cohort of three patients was enrolled at a low dose
to assess initial safety, including dose-limiting toxicity (DLT)
evaluation, over a period of up to 3 months post-transplantation.
There were no safety concerns within this timeframe. Thus, an
additional 3 patients were enrolled at a high dose for evaluation
over another 3-month period post-transplantation. As no safety
issues arose during this extended period, the clinical trial
continued by adding three further patients to each of the low-dose
and high-dose groups, totaling 12 patients. The final participant
was administered with TED-A9 on February 2024.
The primary objective of the Phase I/IIa trial is to assess the
safety and exploratory efficacy of TED-A9 transplantation over two
years post-transplant. Safety will be monitored for additional 3
years, making it a total 5 years.
About S.BIOMEDICS
Established in 2005, S.BIOMEDICS is at the forefront of stem
cell therapy, focusing on regenerative medicine powered by
data-driven biology. Based on two core platform technologies,
S.BIOMEDICS currently develops seven cell therapy programs,
targeting non-curable diseases. Its leading programs are under
clinical stage accelerating the journey of cell medicine as shown
below:
- 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 (Phase
1/2a)
For more information about S.BIOMEDICS, visit
www.sbiomedics.com. S.BIOMEDICS is listed on the Korea
Exchange (KOSDAQ: 304360) and is also the founder and controller of
S.THEPHARM (www.sthepharm.com), a corporation
specializing in anti-aging products such as HA-Filler. More
Information about the Phase 1/2a clinical trial for Parkinson’s
disease is available at ClinicalTrials.gov
(NCT05887466).
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S.BIOMEDICS Jong-Wan Kim jwkim@sbiomedics.com