Celaid Therapeutics Inc. concluded the second close of its Series B financing round & also welcomed Shionogi & Co., Ltd. and Teikoku Ventures, Inc. as new investors. These investors have raised a total of JPY 400 million, i.e. nearly USD 2.6 million. Alongside this, Celaid pursued the second stage-gate review of AMED's "Strengthening Program for Pharmaceutical Startup Ecosystem" and was chosen for Stage 3 funding. In addition to this, the latest cumulative funding secured by Celaid mainly covers grants and currently totals roughly JPY 3.42 billion (nearly USD 22.1 million).
Major factors influencing the overall development expansion of CLD-001& its therapeutic potential are the involvement of these eminent investors via investment steps. This key engagement from pharma leaders shows substantial speed for Celaid as it bolsters the U.S. progression of CLD-001.
Let's have a look at CLD-001, which is a new ex vivo-expanded hematopoietic stem cell (HSC) therapy product & specifically indicated for severe pediatric non-malignant diseases. Moreover. Celaid is expanding the CLD-001 program toward the start of a first-in-human clinical trial in the United States, with preparations ongoing across the nonclinical, cell manufacturing and CMC (Chemistry, Manufacturing and Controls), clinical, and regulatory activities.
Furthermore, steps will be deployed mainly in manufacturing, safety assessment, clinical development, and regulatory efforts in support of CLD-001's IND application and the beginning of clinical trials in the U.S. Side by side, Celaid will also focus on reinforcing its proprietary hematopoietic stem cell expansion platform and push its application to innovative therapeutic modalities and business opportunities in the cell and gene therapy stream.
Nobuyuki Arakawa, President and CEO, Celaid Therapeutics, Inc. commented that:
"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."
New Investors are:
"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, Shionogi & Co., Ltd.
"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.
- Mitsuhiro Matsumura, Chief Executive Officer, Teikoku Ventures, Inc.
Hematopoietic stem cells (HSCs) are stem cells that differentiate into the diverse blood and immune cell types, such as red blood cells, white blood cells, and platelets. Besides this, HSCs also have self-renewal capabilities, which ensure long-term maintenance of the hematopoietic system. However, as HSCs are generally present only in small quantities within the body or within collected samples, securing a sufficient quantity for therapeutic use is a key challenge.
CLD-001 is being designed as an HSC product & has a specific use for severe pediatric non-malignant diseases. Across several severe issues, like primary immunodeficiency, inherited metabolic disorders, aplastic anemia, and sickle cell disease, allogeneic hematopoietic stem cell transplantation shows a significant treatment alternative with curative potential. On the other hand, allogeneic HSC transplantation is persistently facing unmatched needs, such as donor-related restraints, including a limited number of matched donors and HLA mismatches. Alongside this, major complications following transplantation include graft failure, transplant-related mortality, and graft-versus-host disease (GvHD).
Celaid Therapeutics Inc. is a biotechnology startup that was founded by the University of Tokyo and the University of Tsukuba, with proprietary technology for the selective ex vivo expansion of hematopoietic stem cells (HSCs), which elevates all blood cells. Celaid focuses on advancing next-generation cell and gene therapies by allowing the safe and efficient expansion of human HSCs, which further includes HSC-based therapies for hematologic and genetic diseases, ex vivo HSC gene therapies, & regenerative therapies for ischemic diseases.
