Celaid Therapeutics has raised JPY 400 million, or approximately $2.6 million, in the second close of its Series B financing to support preparations for U.S. clinical development of its CLD-001 hematopoietic stem cell therapy.
Shionogi & Co. and Teikoku Ventures joined the financing as new investors.
Alongside the financing, Celaid passed the second stage-gate review of the Japan Agency for Medical Research and Development’s Strengthening Program for Pharmaceutical Startup Ecosystem and was selected to receive Stage 3 funding.
Including grants, Celaid has now secured approximately JPY 3.42 billion, or approximately $22.1 million, in cumulative funding.
The company plans to direct the latest proceeds primarily toward manufacturing, safety assessment, clinical development and regulatory activities supporting an Investigational New Drug application and the initiation of U.S. clinical trials for CLD-001.
CLD-001 is a novel ex vivo-expanded hematopoietic stem cell therapy being developed for severe pediatric non-malignant diseases.
Celaid is preparing for a first-in-human U.S. trial and has advanced nonclinical, manufacturing, chemistry, manufacturing and controls, clinical and regulatory work around the program.
The company has generated positive nonclinical data supporting the potential efficacy and safety profile of CLD-001 in animal models.
Celaid has also established a manufacturing process for CLD-001 and completed technology transfer to a U.S. contract development and manufacturing organization.
The company has completed a Pre-IND meeting with the U.S. Food and Drug Administration and is advancing preparations for an IND submission and clinical trial initiation.
Beyond CLD-001, Celaid plans to continue developing its proprietary hematopoietic stem cell expansion platform for additional cell and gene therapy applications.
The company sees potential opportunities across severe hematologic diseases, genetic diseases and ex vivo hematopoietic stem cell gene therapies.
KEY QUOTES:
“We are greatly encouraged by the participation of Shionogi & Co. and Teikoku Ventures as new investors in this round. We are also deeply grateful for AMED’s approval of our advancement to Stage 3 under the “Strengthening Program for Pharmaceutical Startup Ecosystem” and for its continued support. Through this financing and AMED’s support, we will steadily advance our preparations toward initiating clinical trials for CLD-001 in the United States. Our goal is to become a global leader in the hematopoietic stem cell field and, from Japan, deliver innovative treatment options to patients worldwide by advancing both our HSC-based pipeline and our platform business.”
Nobuyuki Arakawa, President and CEO of Celaid Therapeutics
“Hematopoietic stem cell transplantation can offer the only curative treatment option for certain serious hematologic and inherited diseases, particularly in pediatric patients. However, significant challenges remain, including donor shortages and post-transplant complications.
We believe Celaid’s hematopoietic stem cell expansion technology represents an innovative approach with the potential to overcome these challenges and provide treatment opportunities to more patients. We highly value Celaid’s technology and vision, which strongly align with SHIONOGI’s commitment to protecting people’s health and addressing societal challenges through the creation of new value. For these reasons, we have decided to invest in Celaid Therapeutics Inc.
We look forward to Celaid’s continued progress in global development and hope that CLD-001, an innovative cell therapy, will ultimately reach as many patients as possible.”
Keisuke Kusumoto, Director, Head of CVC, Corporate Planning Department, Corporate Strategy Division at Shionogi & Co.
“We are highly encouraged by Celaid Therapeutics’ novel ex vivo hematopoietic stem cell expansion technology, which has the potential to serve as a foundational platform for cell and gene therapies targeting hematologic malignancies, other severe hematologic disorders, and genetic diseases, as well as for ex vivo hematopoietic stem cell gene therapies.
We also view this investment as an important opportunity to support a Japan-originated startup with innovative scientific capabilities. Furthermore, we believe it represents a significant milestone in our efforts to advance open innovation and contribute to the creation of new treatment options for patients.”
Mitsuhiro Matsumura, Chief Executive Officer of Teikoku Ventures
