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Client News: First In-Human Clinical Trial Targeting CD4 Protein for Aggressive T-cell Leukemia and Lymphoma to be Launched

Stony Brook University, iCell Gene Therapeutics and University of Louisville collaborate to offer a new CAR T immunotherapy to treat patients.

Stony Brook University, iCell Gene Therapeutics, and the University of Louisville, have received Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) for the treatment of relapsed and refractory T-cell leukemia and lymphoma. The approach is the first to use chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR). Together, Stony Brook University, the University of Louisville, and iCell Gene Therapeutics expect the first in-human Phase I clinical trial to begin accruing patients before the end of 2018.

“We are excited to partner with the University of Louisville and iCell Gene Therapeutics to offer this innovative first-in-human CAR T cell immunotherapy clinical trial for patients who are suffering from these extremely difficult to treat T cell lymphomas and leukemias,” said Huda Salman, MD, Principal Investigator for the IND and an oncologist at Stony Brook University Cancer Center. “CD4CAR T cells may prove to be a promising and novel therapy in this setting.”

“The development of this trial using CD4 as a target is the first of what we expect to be many CAR T-based clinical trials available to our patients over time,” said Yusuf Hannun, MD, Director of the Stony Brook University Cancer Center. “The pending trial is an example of the type of bench-to-bedside research that is building up at Stony Brook due to the growing expertise and collaborative research environment we are creating and new opportunities that will emerge upon the opening of our Medical and Research Translation (MART) Building.”

William Tse, MD, FACP, Chief of the Blood and Marrow Transplantation at the University of Louisville School of Medicine, is the Co-PI of the CD4CAR clinical trial at University of Louisville site.

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CFB Client, IAMBIC has been awarded approximately $1M in grant funding from the National Science Foundation Small Business Innovation Research program. IAMBIC is an innovative shoe company disrupting the centuries-old footwear industry with their sizeless, precision-fit footwear driven by proprietary AI algorithms. This substantial funding from NSF enables IAMBIC to scale its cutting-edge precision-fit shoe design and manufacturing.

The Center for Biotechnology and its accelerator programs have been instrumental in assisting IAMBIC with their SBIR pursuits and commercialization development.

Read more about IAMBIC and their recent funding here.

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The Long Island BioMentor Initiative (LIBMI), created and managed by the Center for Biotechnology, is excited to welcome two new mentors, Dr. Annie Rohan, PhD, RN, FAANP, FAAN and Mike Horan, MBA.

Dr. Annie Rohan is currently Dean of the Henry P. Becton School Nursing and Allied Health at Fairleigh Dickinson University. Dr. Rohan is a dual-certified Nurse Practitioner whose academic achievements rest on the foundation of a 25-year clinical career caring for critically and chronically ill infants and children, and highest-risk families. To support diversification of the healthcare workforce, she has procured over $10-million in federal funding to support the education of underrepresented and disadvantaged students into the allied health and nursing professions. Dr. Rohan is currently Associate Editor for MCN: The American Journal of Maternal-Child Nursing, and has been honored with Fellowship in both the American Academy of Nurse Practitioners (FAANP) and American Academy of Nursing (FAAN).

Mike Horan, MBA is a Product Development, Engineering, and Operations Executive. He is an accomplished engineering and technology business leader with over 30 years of experience in product development. At Zebra Technologies, he currently serves as the Sr. Director of Global Quality overseeing quality for their product and solutions portfolio, supply chain and QMS. Mike has experience in Strategic & Portfolio Planning, Engineering Leadership, Program Management, Supply Chain, Manufacturing and Operations —all in a global environment. He is a highly motivational leader with experience in building high-performing teams.

The LIBM brings highly qualified volunteer mentors together with motivated, early-stage bioentrepreneurs to provide actionable guidance and support as they advance their business strategy. The initiative was developed in an alliance with MIT’s successful Venture Mentor Service and employs a team mentoring approach which is guided by a statement of principles to ensure confidentiality and a conflict free environment.

To learn more about the program or get involved, visit the LIBMI website or contact Ashley Abid, LIBMI Operations Manger (ashley.abid@stonybrook.edu)

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CFB Client, IAMBIC has been awarded approximately $1M in grant funding from the National Science Foundation Small Business Innovation Research program. IAMBIC is an innovative shoe company disrupting the centuries-old footwear industry with their sizeless, precision-fit footwear driven by proprietary AI algorithms. This substantial funding from NSF enables IAMBIC to scale its cutting-edge precision-fit shoe design and manufacturing.

The Center for Biotechnology and its accelerator programs have been instrumental in assisting IAMBIC with their SBIR pursuits and commercialization development.

Read more about IAMBIC and their recent funding here.

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IAMBIC Receives $1 Million NSF SBIR Phase II Grant

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Long Island BioMentor Initiative Welcomes New Mentors

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QB Sonic Wins SBA InnovateHER Competition

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