We are pleased to announce that Celaid Therapeutics has successfully passed the interim (stage-gate) evaluation under “Strengthening Program for Pharmaceutical Startup Ecosystem” by the Japanese Agency for Medical Research and Development (AMED) for our lead asset, CLD-001, an ex vivo expanded hematopoietic stem cell (HSC) therapy product.
Our successful progress through the evaluation was based on several key achievements, including:
• Approval of our Pre-IND meeting request with the U.S. FDA, in line with our original development plan.
• Positive preclinical efficacy and safety data obtained in animal models.
• Advancements in cell manufacturing and CMC activities.
We will continue to advance CLD-001 toward obtaining clinical proof-of-concept (PoC) in the United States.
For more details, please refer to the official AMED announcement at the following link:
▶ Results of the FY2025 Interim Evaluation for the AMED Strengthening Program for Pharmaceutical Startup Ecosystem Program (Japanese only)
The original announcement of our selection for this grant 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, an allogeneic Hematopoietic Stem Cell (HSC) Therapy
CLD-001 is being developed as a hematopoietic stem cell therapy product for severe pediatric non-malignant disease. Rare blood diseases such as aplastic anemia, primary immunodeficiency, inherited metabolic disorder, and sickle cell disease, which start in childhood and are associated with various physical and neurological complications, have a very poor prognosis. Currently, the only curative therapy is allogeneic hematopoietic stem cell transplantation (HSCT). On the other hand, there are still significant unmet needs for allogeneic HSCT due to donor problems such as bone marrow donor shortage and HLA type mismatch, as well as side effects such as transplant-related mortality and graft-versus-host disease (GvHD).
CLD-001 is a hematopoietic stem cell product that solves the donor problem, side effects, and disadvantages described above.
In addition to solving the donor problem by using frozen cord blood stored in a cord blood bank as the cell source, CLD-001 also solves the bottleneck of low HSC counts in cord blood with our proprietary HSC expansion technology, enabling us to provide HSCs with the best HLA type for the patient. CLD-001, the HLA best-match and bone marrow-constructible HSCs, is expected to significantly improve overall survival after HSC therapy.