Cell BioEngines, Inc. is strengthening its Intellectual Property portfolio with a patent licensed from the Icahn School of Medicine at Mount Sinai, in New York, NY, for the use of allogenic hematopoietic stem cell expansion and transplantation technology in blood and bone marrow cancer. This technology has the potential to revolutionize the availability of universal donor cells derived from umbilical cord-blood and expand access to allogenic hematopoietic cell transplantation for patients, regardless of their geographical location or ethnic background.

Cell BioEngines, Inc. is a biotechnology company with the mission of revolutionizing cell therapies through the development of novel technologies and treatments. Their latest innovation is a patent-licensed technology for allogeneic hematopoietic cell transplantation in blood and bone marrow cancer, which leverages small molecule-mediated expansion of engraftable cord-blood-derived HSCs to address donor availability for allo-HCT.

"Only about 45% of patients have human leukocyte antigens (HLA)-matched sibling donors available. The alternative for the remaining approximate 55% of patients is HLA-matched unrelated donors. Umbilical cord-blood as a source for Hematopoietic Stem Cell Transplantation (HSCT) has emerged as an alternative donor platform due to its immediate availability, less strict HLA matching requirements (critical for patients from ethnic minorities) and reduced incidence of graft-versus-host-disease," said Dr. Ajay Vishwakarma, MBA, Founder and CEO of Cell BioEngines.

"It is really difficult to create stem cells outside of our body. Ex vivo culture conditions are associated with loss of HSC function due to silencing of the gene expression program which encodes the functions that defines HSCs," said Ronald Hoffman, MD, the Albert A. and Vera G. List Professor of Medicine and Director of the Myeloproliferative Disorders Research Program at Icahn Mount Sinai, Scientific Inventor and Advisor to Cell BioEngines. "Our ex vivo expansion strategy using chromatin-modifying agent provides a potential avenue by which to expand the number of HSC with a single CB unit for use as an alternative source of HSC grafts for adult recipients. Ex vivo culture in the presence of such modifiers has the potential to maintain “stemness” while expanding HSCs," he adds.

"While Umbilical cord-blood stem cells offer great advantage for all-HCT therapy, unmanipulated CB grafts contain lower numbers of CD34+ HSCs than those available for peripheral blood and bone marrow HSCT. Ex vivo expansion of HSCs to accelerate engraftment and improve clinical outcomes is an unmet need we want to address," said Alexey Bersenev, MD PhD, Co-founder and CTO of Cell BioEngines. 

"Cell BioEngines will pick up the baton from Icahn Mount Sinai for an FDA-approved Phase 1 clinical trial to optimize the proprietary small molecule-expansion strategy in our laboratory and manufacture expanded cord-blood stem cells as allogeneic grafts for adults with refractory hematological malignancies in a large cohort Phase I/II study," said Dr. Vishwakarma. "Five patients are transplanted to date and no safety concerns have been raised. All patients engrafted and remain disease free."

The large-scale generation of expanded cord-blood stem cells as an allogeneic donor source for adults with hematological malignancies is based on technology developed by Mount Sinai faculty and licensed to Cell BioEngines. Mount Sinai and Mount Sinai faculty, including Dr. Hoffman and Patrima Chaurasia, PhD, Assistant Clinical Professor of Medicine (Hematology and Medical Oncology) at Icahn Mount Sinai, have a financial interest in Cell BioEngines pursuant to the Mount Sinai Intellectual Property Policy.