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.

Funding Opportunity: Gund-Harrington Scholar Award for Fighting Blindness

The Gund-Harrington Initiative for Fighting Blindness announces the call for proposals for the 2019 Gund-Harrington Scholar Award.

The Gund-Harrington Scholar Award supports innovative research efforts that could prevent, treat or cure blindness resulting from inherited retinal degenerative diseases. The Gund-Harrington Scholar Award is part of the Gund-Harrington Initiative for Fighting Blindness and sponsored by Foundation Fighting Blindness and Harrington Discovery Institute.

Who should apply?

  • U.S and Canadian scientists at accredited academic medical centers, research institutions and universities whose discoveries show promise for translation into novel treatments for inherited retinal degenerative diseases.
  • Multidisciplinary investigators outside the field of retinal disease developing a therapeutic strategy with a potential to benefit inherited retinal degenerative diseases are particularly encouraged to apply.

Multi-Level Support for Award Recipients includes:

  • Funding totaling up to $900,000 over three years based on progress made towards milestones
  • Drug development and project management support
  • Dedicated pharma team for each scholar
  • Clinical development strategy
  • Regulatory guidance

Letters of Intent are now being accepted through midnight on October 12, 2018.

Apply Here. 

Entrepreneurship Lab NYC (ELabNYC) – 2019 Program Application Open

LifeSci NYC has announced the launch of the seventh year of its life sciences entrepreneur training and networking program – Entrepreneurship Lab NYC (ELabNYC). Applications for the 2019 program are now being accepted.

ELabNYC is a six-month entrepreneurship training and networking program for scientists and engineers who are ready to launch their exciting ventures from New York City–based research institutions. Applications are due Monday, October 22, 2018.

Apply Here

Center for Biotechnology Tapped for New Healthcare Security Innovation Program

Stony Brook University Happenings recently profiled the Center for Biotechnology’s designation as on of eight national accelerators under the Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) Division of Research, Innovation and Ventures (DRIVe).  Excerpt below, read the full article here.

Sepsis occurs when chemicals released into the bloodstream to fight an infection trigger inflammatory responses throughout the body. It’s dangerous and often deadly. According to the U.S. Department of Health and Human Services, more than 250,000 people die from sepsis each year, and it is a leading cause of hospitalization in the U.S.

What if a simple test could identify the onset of sepsis as soon as it occurs? Better yet, what if wearable technology was available to alert doctors about sepsis in a patient before they ever show symptoms?

This may be possible in the future thanks to Stony Brook University’s participation in the federal government’s new BARDA-DRIVe initiative.

Stony Brook, NY; Stony Brook University: Center for Biotechnology’s (CFB) Director of Operations Diane Fabel talks with Alyssa Tuthill, Instructional Support Associate/Biomedical Engineering Labs Manager while Graduate Research Assistant Vaughn Greene works with samples.

The initiative, launched by the Division of Research, Innovation and Ventures (DRIVe), will be overseen by the Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA).

BARDA has selected Stony Brook’s Center for Biotechnology as one of eight national accelerators across the country to assist in scouting faculty innovators and businesses that are developing health security technology that meets the program’s goals. The initiative plans to focus first on sepsis and the early detection and diagnosis of infections that threaten national health. More goals will be identified over time. 

“National health security is essential for optimum public health, enabling our society to thrive,” said Stony Brook University President Samuel L. Stanley Jr. President Stanley is a biomedical researcher who specializes in emerging infectious diseases. He also chairs the Innovation Committee for the Long Island Regional Economic Development Council.

“With a proven record of research, discovery, innovation and product-development in the biomedical sciences, Stony Brook’s Center for Biotechnology is poised to become an important contributor to the BARDA-DRIVe initiative,” he said. “I am certain that the Center will advance and accelerate research discovery, and strategically collaborate with biotech companies to find solutions to better manage sepsis and emerging national health issues.”

CFB BioEntreprenuer-in-Residence Earns Spot in New JLABS @ NYC

Boris Shor, one of the Center for Biotechnology’s newest BioEntrepreneurs-in-Residence, has earned a place for his start-up, Manhattan Biosolutions, in Johnson and Johnson Innovations latest facility, JLABS @ NYC, as one of four winners of the company’s prestigious QuickFire Challenge. The winners of the QuickFire Challenge receive one year of residence in JLABS @ NYC, which provides to a bench, workstation and the global JLABS community

Manhattan BioSolutions’ lead platform is based on the safe, attenuated BCG bacteria targeting mutated cancer driver genes to induce innate and adaptive cancer-specific immune responses. Manhattan BioSolutions shares JLABS 30,000-square feet located at the New York Genome Center with 25 other companies.