Celaid Therapeutics Inc., a Tokyo-based biotechnology startup, said it has completed the second close of its Series B financing round, raising JPY 400 million, or roughly USD 2.6 million, with Shionogi & Co., Ltd. and Teikoku Ventures, Inc. joining as new investors. The company also passed the second stage-gate review of AMED's Strengthening Program for Pharmaceutical Startup Ecosystem and was selected for Stage 3 funding, the company said. Cumulative funding to date, including grants, now totals about JPY 3.42 billion, or roughly USD 22.1 million, Celaid said.
CLD-001, the company's lead product, is a novel ex vivo-expanded hematopoietic stem cell therapy in development for severe pediatric non-malignant diseases. Celaid said it is advancing the programme toward the start of a first-in-human clinical trial in the United States, with preparations under way in nonclinical, cell manufacturing and CMC (chemistry, manufacturing and controls), clinical and regulatory activities.
Celaid said the programme has produced positive nonclinical data supporting the efficacy and safety of CLD-001 in animal models, has established a manufacturing process and completed technology transfer to a U.S. contract development and manufacturing organisation, and has completed a Pre-IND meeting with the U.S. Food and Drug Administration, with work continuing toward an IND submission and trial initiation. The participating investors cited CLD-001's development progress and its therapeutic potential as key factors in their investment decisions, according to the company.
Proceeds from the financing will be allocated mainly to manufacturing, safety assessment, clinical development and regulatory activities in support of the IND application and the start of U.S. trials. Celaid said it will also continue to strengthen its proprietary hematopoietic stem cell expansion platform and pursue its application to new therapeutic modalities and business opportunities in the cell and gene therapy field. President and CEO Nobuyuki Arakawa said the company's goal is to become a global leader in the hematopoietic stem cell field and, from Japan, to deliver innovative treatment options to patients worldwide.
