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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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Governor Kathy Hochul has unveiled plans for New York BioGenesis Park, a groundbreaking $430 million Cell and Gene Therapy (CGT) Innovation Hub in Nassau County, Long Island. To be developed by The Albanese Organization, Inc., this state-of-the-art facility would catalyze CGT research, development, clinical manufacturing, and commercialization across New York State. With a historic $150 million state investment—the largest nationwide for a cell and gene therapy hub—NYBGP would accelerate the delivery of new therapies from lab to patient in New York's diverse communities. This transformative hub aims to establish New York as the leading global destination for CGT innovation, driving economic growth, attracting top talent, and revolutionizing patient care statewide and beyond.

The Center for Biotechnology is thrilled to be counted as a partner in this effort, and is looking forward to working with our colleagues in the initiative to help catalyze and accelerate life-changing therapies.

New York BioGenesis Park is envisioned as a cutting-edge, full-service campus dedicated to advancing cell and gene therapies and accelerating their commercialization. At full build-out, the 700,000-square-foot park would create an end-to-end Cell and Gene Therapy innovation and supply center, featuring interconnected areas for public engagement, research, manufacturing, and collaboration.

A cornerstone of New York BioGenesis Park is its incubator, supported by a $50 million investment from ESD's Long Island Investment Fund. This facility will empower early-stage therapeutic developers by offering state-of-the-art wet lab space, shared equipment, office space, and other essential resources. This nurturing environment will provide Cell and Gene Therapy companies with access to specialized equipment, mentoring, and stage-appropriate financial guidance. As a critical component of New York BioGenesis Park, the incubator is poised to catalyze the growth of promising Cell and Gene Therapy companies by providing them with resources and support, unlocking their potential for innovation and success.

New York BioGenesis Park would foster strong ties with academic and medical institutions throughout New York, creating a robust ecosystem for Cell and Gene Therapy innovation. Collaborating with the Empire State Cellular Therapy Consortium and world-class institutions like Cold Spring Harbor Laboratory, the Feinstein Institutes, Northwell Health, Roswell Park, Stony Brook University, Weill Cornell, Columbia University and others around the state, New York BioGenesis Park would enhance research synergies and accelerate medical breakthroughs. This ecosystem would bring together experts in advanced Cell and Gene Therapy therapies, offering specialized facilities, services, and resources to both tenants and collaborating institutions. By facilitating cutting-edge science, innovative technology development and novel approaches to clinical trials, New York BioGenesis Park would ensure New York's institutions remain globally competitive in groundbreaking Cell and Gene Therapy research and commercialization.

Read the press release of Governor Hochul's announcement here:
https://www.governor.ny.gov/news/governor-hochul-launches-next-phase-long-islands-nation-leading-cell-and-gene-therapy

[post_title] => Long Island to be location for Nation-Leading Cell and Gene Therapy Innovation Hub: New York BioGenesis Park. [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => long-island-to-be-location-for-nation-leading-cell-and-gene-therapy-innovation-hub-new-york-biogenesis-park [to_ping] => [pinged] => [post_modified] => 2025-02-26 16:35:20 [post_modified_gmt] => 2025-02-26 21:35:20 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=4488 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 3016 [post_author] => 3 [post_date] => 2018-08-06 13:25:37 [post_date_gmt] => 2018-08-06 13:25:37 [post_content] => 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 [post_title] => Entrepreneurship Lab NYC (ELabNYC) - 2019 Program Application Open [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => entrepreneurship-lab-nyc-elabnyc-2019-program-application-open [to_ping] => [pinged] => [post_modified] => 2018-08-06 13:25:37 [post_modified_gmt] => 2018-08-06 13:25:37 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=3016 [menu_order] => 117 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 2930 [post_author] => 3 [post_date] => 2018-01-30 19:19:22 [post_date_gmt] => 2018-01-30 19:19:22 [post_content] => The latest CFB Newsletter has been released - Catch up on client financings, newcos, expansions, and other happenings here. Be sure to follow us on Twitter, LinkedIn and Facebook for the latest Center news. [post_title] => Winter 2018 Newsletter [post_excerpt] => The latest CFB Newsletter has been released – Catch up on client financings, newcos, expansions, and other happenings. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => winter-2018-newsletter [to_ping] => [pinged] => [post_modified] => 2018-02-02 18:36:31 [post_modified_gmt] => 2018-02-02 18:36:31 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=2930 [menu_order] => 126 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 2696 [post_author] => 1 [post_date] => 2017-05-05 18:16:15 [post_date_gmt] => 2017-05-05 18:16:15 [post_content] => CFB Director of Operations, Diane Fabel, has been inducted into the Stony Brook University Chapter of the National Academy of Inventors (NAI-SBU) as an honorary member. At the chapter’s Annual Meeting on May 1, 2017, 16 new members and 2 honorary members were inducted into the Academy. Ms. Fabel and her fellow inductees join 30 stony brook faculty members, including CFB Director Clinton Rubin, who were inducted as inaugural members to the SBU-NAI in 2016.

Read more on the chapter and this year’s inductees here.

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Governor Kathy Hochul has unveiled plans for New York BioGenesis Park, a groundbreaking $430 million Cell and Gene Therapy (CGT) Innovation Hub in Nassau County, Long Island. To be developed by The Albanese Organization, Inc., this state-of-the-art facility would catalyze CGT research, development, clinical manufacturing, and commercialization across New York State. With a historic $150 million state investment—the largest nationwide for a cell and gene therapy hub—NYBGP would accelerate the delivery of new therapies from lab to patient in New York's diverse communities. This transformative hub aims to establish New York as the leading global destination for CGT innovation, driving economic growth, attracting top talent, and revolutionizing patient care statewide and beyond.

The Center for Biotechnology is thrilled to be counted as a partner in this effort, and is looking forward to working with our colleagues in the initiative to help catalyze and accelerate life-changing therapies.

New York BioGenesis Park is envisioned as a cutting-edge, full-service campus dedicated to advancing cell and gene therapies and accelerating their commercialization. At full build-out, the 700,000-square-foot park would create an end-to-end Cell and Gene Therapy innovation and supply center, featuring interconnected areas for public engagement, research, manufacturing, and collaboration.

A cornerstone of New York BioGenesis Park is its incubator, supported by a $50 million investment from ESD's Long Island Investment Fund. This facility will empower early-stage therapeutic developers by offering state-of-the-art wet lab space, shared equipment, office space, and other essential resources. This nurturing environment will provide Cell and Gene Therapy companies with access to specialized equipment, mentoring, and stage-appropriate financial guidance. As a critical component of New York BioGenesis Park, the incubator is poised to catalyze the growth of promising Cell and Gene Therapy companies by providing them with resources and support, unlocking their potential for innovation and success.

New York BioGenesis Park would foster strong ties with academic and medical institutions throughout New York, creating a robust ecosystem for Cell and Gene Therapy innovation. Collaborating with the Empire State Cellular Therapy Consortium and world-class institutions like Cold Spring Harbor Laboratory, the Feinstein Institutes, Northwell Health, Roswell Park, Stony Brook University, Weill Cornell, Columbia University and others around the state, New York BioGenesis Park would enhance research synergies and accelerate medical breakthroughs. This ecosystem would bring together experts in advanced Cell and Gene Therapy therapies, offering specialized facilities, services, and resources to both tenants and collaborating institutions. By facilitating cutting-edge science, innovative technology development and novel approaches to clinical trials, New York BioGenesis Park would ensure New York's institutions remain globally competitive in groundbreaking Cell and Gene Therapy research and commercialization.

Read the press release of Governor Hochul's announcement here:
https://www.governor.ny.gov/news/governor-hochul-launches-next-phase-long-islands-nation-leading-cell-and-gene-therapy

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Long Island to be location for Nation-Leading Cell and Gene Therapy Innovation Hub: New York BioGenesis Park.

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