Natick, MA – The U.S. Food and Drug Administration (FDA) has completed review of IND #32893, allowing the Phase 1/1b clinical study evaluating ProtoNK™ (HC101) in adolescent and young adult patients with recurrent or refractory Ewing sarcoma to proceed in the United States.
The milestone advances HC101 into clinical evaluation and represents an important step in the development of HebeCell's stem cell-derived NK cell platform.
The study is sponsored by University Hospitals Cleveland Medical Center and will be led by Dr. Verania Huerta Urrutia, Pediatric Hematology/Oncology, Angie Fowler Adolescent & Young Adult Cancer Institute at UH Rainbow Babies & Children’s Hospital and Assistant Professor of Pediatrics at Case Western Reserve University School of Medicine. The Phase 1/1b study will evaluate the safety, tolerability, and exploratory efficacy of HC101 in adolescent and young adult patients with recurrent or refractory Ewing sarcoma.
HC101 is an allogeneic natural killer (NK) cell therapy derived from human pluripotent stem cells using HebeCell's proprietary manufacturing platform. The program is designed to provide a scalable and renewable source of NK cells for clinical use and represents the company's lead oncology product candidate.
“I am very happy for the recent FDA clearance of the IND application for HebeCell’s unique ProtoNK™ (HC101) cell therapy for relapsed/refractory Ewing sarcoma in the adolescent and young adult (AYA) population,” said Dr. Verania Huerta Urrutia. “This milestone speaks to the great partnership and collaboration we have with HebeCell. We are working on opening this Phase 1 clinical trial in the upcoming months, and we are hopeful and excited to keep bringing new alternative therapies for our patients.”
HebeCell leadership also highlighted the importance of the milestone and the company's commitment to advancing ProtoNK™ into the clinic.
"Advancing HC101 into clinical evaluation is an important milestone for HebeCell and reflects years of work developing our stem cell-derived NK cell platform. We are excited to support the study and look forward to learning from this next phase of development," said Dr. Shi-Jiang Lu, Co-Founder and Chief Executive Officer of HebeCell.
About HebeCell
HebeCell Corp. is a biotechnology company focused on developing scalable, off-the-shelf natural killer (NK) cell therapies derived from pluripotent stem cells. Through its proprietary ProtoNK™ platform, the company is advancing next-generation immunotherapies designed to improve access to cell-based treatments for cancer and other serious diseases. Founded in 2016 and headquartered in Natick, Massachusetts, HebeCell is advancing a pipeline of stem cell-derived NK cell therapies for the treatment of cancer and other serious diseases.
About University Hospitals / Cleveland, Ohio
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including 'America’s Best Hospitals' from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org.
The milestone advances HC101 into clinical evaluation and represents an important step in the development of HebeCell's stem cell-derived NK cell platform.
The study is sponsored by University Hospitals Cleveland Medical Center and will be led by Dr. Verania Huerta Urrutia, Pediatric Hematology/Oncology, Angie Fowler Adolescent & Young Adult Cancer Institute at UH Rainbow Babies & Children’s Hospital and Assistant Professor of Pediatrics at Case Western Reserve University School of Medicine. The Phase 1/1b study will evaluate the safety, tolerability, and exploratory efficacy of HC101 in adolescent and young adult patients with recurrent or refractory Ewing sarcoma.
HC101 is an allogeneic natural killer (NK) cell therapy derived from human pluripotent stem cells using HebeCell's proprietary manufacturing platform. The program is designed to provide a scalable and renewable source of NK cells for clinical use and represents the company's lead oncology product candidate.
“I am very happy for the recent FDA clearance of the IND application for HebeCell’s unique ProtoNK™ (HC101) cell therapy for relapsed/refractory Ewing sarcoma in the adolescent and young adult (AYA) population,” said Dr. Verania Huerta Urrutia. “This milestone speaks to the great partnership and collaboration we have with HebeCell. We are working on opening this Phase 1 clinical trial in the upcoming months, and we are hopeful and excited to keep bringing new alternative therapies for our patients.”
HebeCell leadership also highlighted the importance of the milestone and the company's commitment to advancing ProtoNK™ into the clinic.
"Advancing HC101 into clinical evaluation is an important milestone for HebeCell and reflects years of work developing our stem cell-derived NK cell platform. We are excited to support the study and look forward to learning from this next phase of development," said Dr. Shi-Jiang Lu, Co-Founder and Chief Executive Officer of HebeCell.
About HebeCell
HebeCell Corp. is a biotechnology company focused on developing scalable, off-the-shelf natural killer (NK) cell therapies derived from pluripotent stem cells. Through its proprietary ProtoNK™ platform, the company is advancing next-generation immunotherapies designed to improve access to cell-based treatments for cancer and other serious diseases. Founded in 2016 and headquartered in Natick, Massachusetts, HebeCell is advancing a pipeline of stem cell-derived NK cell therapies for the treatment of cancer and other serious diseases.
About University Hospitals / Cleveland, Ohio
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including 'America’s Best Hospitals' from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org.