TED-A9 / S.Biomedics - LARVOL DELTA

Phase 1/2a clinical trial of hESC-derived dopaminergic progenitors in Parkinson's disease (MDS Congress 2025) - P1/2 | "Bilateral transplantation of A9-DPC into the putamen was safe and demonstrated clinical benefit over 12 months, providing preliminary evidence that this approach may offer a promising therapeutic strategy for improving parkinsonian motor symptoms in patients with PD (ClinicalTrials.gov number, NCT05887466). References: Nature. 2025 Apr 16; 641(8064):978–983, Nature."

Clinical • Late-breaking abstract • P1/2 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase 1/2a clinical trial of hESC-derived dopamine progenitors in Parkinson's disease. (PubMed, Cell) - P1/2 | "Dopamine transporter positron emission tomography (PET) imaging showed increased posterior putamen uptake with greater uptake in the high-dose group after transplantation, supporting graft survival. These findings indicate that bilateral transplantation of A9-DPC is safe and may improve parkinsonian motor symptoms in patients with PD."

Journal • P1/2 data • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

S.BIOMEDICS Cell Therapy for Parkinson's Disease Shows Positive Data from Its Phase 1/2a Clinical Trial (ACN Newswire) - P1/2a | N=12 | NCT05887466 | Sponsor: S.Biomedics Co., Ltd. | "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)....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."

P1/2 data • Parkinson's Disease

SbioMedics announced on the 16th that it has announced additional clinical trial analysis data for the Parkinson's disease cell therapy "TED-A9 (aka A9-DPC), which is undergoing phase 1/2a clinical trials at the "2025 ISSCR Annual Meeting," the world's largest international stem cell research conference held in Hong Kong. (Maeil) - P1/2a | N=12 | NCT05887466 | Sponsor: S.Biomedics Co., Ltd. | "18FP-CIT-PET is image data showing the density of dopamine transporters (DATs) involved in the process of reabsorbing dopamine after transplanted dopamine neurons secrete it, which can indirectly evaluate whether the dopamine nerve circuit is structurally restored....TED-A9 clearly shows a significant association between DAT expression restoration and behavioral improvement, indicating that important evidence data on the mechanism of action of therapeutic effects have been obtained. On the other hand, other international teams attempting Parkinson's disease clinical trials using embryonic stem cells or reverse differentiated stem cells (iPSCs), which are starchy stem cells, do not present a clear association between these behavioral improvements and brain dopamine imaging data for all transplant patients, or only some patients show a correlation."

P1/2 data • Parkinson's Disease

CLINICAL GRADE HESC-DERIVED DOPAMINERGIC NEURONS FOR TREATMENT OF PARKINSON'S DISEASE: A PHASE 1/2A CLINICAL TRIAL (ADPD 2025) - P1/2 | "Results The therapeutic potential and safety of hESC-derived mDA progenitors (TED-A9) were evaluated in rodent and primate models...It demonstrated significant motor function improvements in PD patients, consistent with preclinical Results . Furthermore, FP-CIT PET confirmed successful cell engraftment in the patient's brain after one year, supporting behavioral recovery."

Clinical • P1/2 data • CNS Disorders • Movement Disorders • Oncology • Parkinson's Disease • FOXA2

S.BIOMEDICS Investigational Cell Therapy for Parkinson’s Disease With TED-A9 Shows Positive Data at 12-months in Phase 1/2a Clinical Trial (Businesswire) - P1/2 | N=12 | NCT05887466 | Sponsor: S.Biomedics Co., Ltd. | "Utilizing the Hoehn and Yahr scale which is a key parameter for assessing the severity of motor symptoms in Parkinson’s disease, 3 low-dose recipients demonstrated an average improvement of 19.4% (from stage 3.7 to 3.0), while 3 high-dose patients experienced a more significant improvement of 44.4% (from stage 3.7 to 2.0), indicating a notable shift from severe to milder disease states. Another positive trend was observed through the MDS-Unified Parkinson’s Disease Rating Scale Part III...Low-dose patients showed a 22.7% improvement (12.7-point decrease), while high-dose patients experienced a 25.3% improvement (13-point decrease)...TED-A9 showed an overall increase in FP-CIT PET with higher increase in high-dose group compared to low-dose group, further confirming underlying mechanisms."

P1/2 data • CNS Disorders • Parkinson's Disease

SBiomedics plans clinical trials for Parkinson's disease treatment in the US next year… Seeking partnerships with global companies (Nate) - "Starting with the US clinical trial of its Parkinson's disease treatment (TED-A9) next year, SBiomedics is laying the foundation for technology commercialization and partnerships with large global companies. The company expects next year to be a turning point for the company...The company plans to derive the final safety results of the clinical phase 1/2a currently underway in Korea by February of next year, and based on this, to be exempted from the clinical phase 1 in the US and enter the phase 2 phase. It also plans to proceed with a global partnership along with these plans."

New P2 trial • P1/2 data • CNS Disorders • Parkinson's Disease

S.BIOMEDICS Dopamine Cell Therapy for Parkinson’s Disease with TED-A9 Shows Promising Results at 12 months in Phase I/IIa Clinical Trial (Businesswire) - P1/2 | N=12 | NCT05887466 | Sponsor : S.Biomedics Co., Ltd. | "S.BIOMEDICS...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...The data demonstrates that 3 participants showed safety and efficacy of TED-A9 in a one-year follow-up...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...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...Assessment data of further participants (first high dose cohort) will be announced in September or October of 2024 after a one-year follow-up."

P1/2 data • CNS Disorders • Parkinson's Disease

Long Term Follow-up of Patients With Parkinson's Disease Who Had Administered of A9-DPC in SB-PD-001 Study (clinicaltrials.gov) - P=N/A | N=12 | Active, not recruiting | Sponsor: S.Biomedics Co., Ltd.

New trial • CNS Disorders • Movement Disorders • Parkinson's Disease

S.BIOMEDICS completes brain transplant of hESC-derived dopaminergic progenitors (TED-A9) for Phase 1/2a study in patients with Parkinson’s disease (Businesswire) - P1/2a | N=12 | NCT05887466 | Sponsor: S.Biomedics Co., Ltd. | "S.BIOMEDICS Co., Ltd...announced that it has successfully completed the brain transplant of TED-A9 (hESC-derived dopaminergic progenitors) for Phase 1/2a study for treating Parkinson's disease. The clinical trial was conducted on 12 participants who have been diagnosed with Parkinson's disease for more than 5 years and exhibited motor complications such as drug 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 up to 3 months post-transplantation. There were no safety concerns within this timeframe."

P1/2 data • Trial status • CNS Disorders • Parkinson's Disease

Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: S.Biomedics Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: S.Biomedics Co., Ltd.

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

S-Biomedics “Registered domestic and international patents for Parkinson’s disease cell therapy core technology“ [Google translation] (Nate) - "S Biomedics obtained a patent for 'high-yield production and mass differentiation of dopaminergic neurons from stem cells', one of the key technologies for developing cell therapy products for Parkinson's disease....This technology is a technology for applying dopaminergic neural progenitor cells differentiated and produced from embryonic stem cells and artificial pluripotent stem (iPS) cells to the treatment of Parkinson's disease. In addition, registration screening is currently underway in the US, Europe, China, Hong Kong, India, Canada and Russia....S Biomedics announced that it has sequentially applied for a total of 42 derivative patents for the production of dopaminergic neurons and application to Parkinson's disease, and that it is solidifying its foothold for global commercialization of cell therapy for Parkinson's disease in the future."

Patent • CNS Disorders • Parkinson's Disease