Celaid Therapeutics, Inc. (“Celaid”) is pleased to announce that the development program for its lead asset, CLD-001, a hematopoietic stem cell (HSC) therapy, has passed the second stage-gate review under AMED’s “Strengthening Program for Pharmaceutical Startup Ecosystem” and will advance to Stage 3.
CLD-001 is being developed for severe pediatric non-malignant diseases, with the goal of establishing clinical proof of concept (PoC) in the United States.
In its interim evaluation, AMED recognized the steady progress of the program, including the establishment of the CLD-001 manufacturing process, technology transfer to a U.S. CDMO, and preparations for manufacturing cells to support nonclinical safety studies. AMED also noted that Celaid had secured the funding required for the next stage.
In Stage 3, Celaid will further advance manufacturing and CMC, nonclinical, clinical, and regulatory activities toward the submission of an Investigational New Drug (IND) application and initiation of clinical trials for CLD-001 in the United States.
For further details, please refer to AMED’s official announcement:
▶ Results of the FY2026 Interim Evaluation for the AMED Strengthening Program for Pharmaceutical Startup Ecosystem (Japanese only)
Celaid’s original announcement regarding its selection for the AMED program in FY2024 is available here:
▶ Celaid Therapeutics Inc. Secures up to $19M Grant from the Japanese Agency for Medical Research and Development
About CLD-001
CLD-001 is being developed as an HSC product for severe pediatric non-malignant diseases. For serious diseases such as primary immunodeficiency, inherited metabolic disorders, aplastic anemia, and sickle cell disease, allogeneic hematopoietic stem cell transplantation represents an important treatment option with curative potential. However, allogeneic HSC transplantation continues to face significant unmet needs, including donor-related challenges such as a shortage of matched donors and HLA mismatches, as well as serious complications following transplantation, including graft failure, transplant-related mortality, and graft-versus-host disease (GvHD).
Using frozen umbilical cord blood stored in cord blood banks as its cell source, CLD-001 applies Celaid’s proprietary hematopoietic stem cell expansion technology to overcome the limited number of hematopoietic stem cells contained in cord blood, while enabling greater flexibility in selecting cord blood units with more favorable HLA matching. Through this approach, Celaid aims to contribute to improved overall survival following allogeneic hematopoietic stem cell transplantation.