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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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The Center for Biotechnology is pleased to announce a request for proposals for our Research Evaluation and Commercialization Hub (REACH) award program. Awards will be in two categories: Feasibility ($50k/12mo) and Proof of Concept ($100K/12 mo.) Details on the full funding program overview and proposal guidelines can be found here.

The development of promising innovations often stalls due to limited early-stage funding to address translational uncertainties. The Center for Biotechnology's Research Evaluation and Commercialization Hub (REACH) award program bridges the translation gap between biomedical discovery and their development toward commercial goals. Program funding is intended to determine feasibility, develop proof-of-concept, and ultimately lead to follow-on funding, a strategic partnership, or company formation.

The REACH program supports faculty and postdoctoral researchers in translating bio-based, bio-convergence, and bio-medical research discoveries by providing targeted funding and strategic guidance to bridge the translation gap between discovery and development for commercialization.

Learn more about the program, get information session details and access the full request for proposals here: https://centerforbiotechnology.org/what-we-do/technology-development/reach/

[post_title] => Funding Opportunity: Research Evaluation and Commercialization Hub (REACH)Awards [post_excerpt] => The Center for Biotechnology is pleased to announce a request for proposals for our REACH award program. Awards will be in two categories: Feasibility ($50k/12mo) and Proof of Concept ($100K/12 mo.) [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => news-reach25 [to_ping] => [pinged] => [post_modified] => 2025-03-24 12:11:36 [post_modified_gmt] => 2025-03-24 16:11:36 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=4804 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 4488 [post_author] => 4 [post_date] => 2024-10-24 10:45:00 [post_date_gmt] => 2024-10-24 14:45:00 [post_content] =>

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 ) [2] => WP_Post Object ( [ID] => 3319 [post_author] => 3 [post_date] => 2019-08-13 15:43:10 [post_date_gmt] => 2019-08-13 15:43:10 [post_content] => The newly re-authorized Commercialization Readiness Pilot (CRP) program is now accepting applications from previously or currently HHS-funded SBIR and STTR Phase II and Phase IIB awardees. NHLBI open and accepting applications from NHLBI grantees for the September 5th NIH SBIR/STTR receipt date; HHS/NIH general applications will be accepted from August 5, 2019 until April 6, 2022 via standard due dates. CPR can provide over $3 million in additional funding to facilitate the commercialization transition for projects, and support work that is not typically supported through SBIR/STTR Phase II or Phase IIB awards, including: - Preparation of documents for a Food and Drug Administration (FDA) submission - Development of an intellectual property strategy - Investigational New Drug (IND)-enabling studies - Clinical studies - Manufacturing costs - Regulatory assistance - Subcontracted work to other institutions, including contract research organizations (CRO) - A combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R&D throughout the award. Please note, this re-authorization includes (3) separate Funding Opportunity Announcements (FOAs) with varying participating NIH Institutes and Centers. Learn more here: https://sbir.nih.gov/funding#crp [post_title] => SBIR/STTR Commercialization Readiness Pilot (CRP) Program Deadlines [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => sbirsttr-commercialization-readiness-pilot-crp-program-deadlines [to_ping] => [pinged] => [post_modified] => 2019-08-13 15:43:10 [post_modified_gmt] => 2019-08-13 15:43:10 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=3319 [menu_order] => 89 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 2984 [post_author] => 4 [post_date] => 2018-06-22 14:46:11 [post_date_gmt] => 2018-06-22 14:46:11 [post_content] => The Center for Biotechnology at Stony Brook University has been selected as one of eight accelerators in the nation by the U.S. Department of Health and Human Services (HHS) to drive innovation in lifesaving medical technologies that solve challenging problems spanning modern health security threats and daily medical care. Accelerators will scout out innovative technologies and products that can be developed to solve healthcare challenges that extend beyond traditional vaccine and drug development. To assist startups and other businesses in developing their technologies and products, accelerators will connect them with essential product development and business support services. This support could position innovative technologies and products for follow-on investment from the public or private sectors. A new HHS unit called DRIVe – part of the Biomedical Advanced Research and Development Authority (BARDA) at the HHS Office of the Assistant Secretary for Preparedness and Response – will oversee the accelerator network and is recruiting a nonprofit partner that can work with private investors to fund innovative technologies and products to solve these and other systemic health security challenges. DRIVe also can invest in the projects using quick, streamlined funding methods. Read the full HHS press release here.  [caption id="attachment_2985" align="alignnone" width="584"] DRIVe Announcement at 2018 BIO International Convention. L to R, Rick Bright, Director, BARDA, Diane Fabel, Director Operations, Stony Brook Center for Biotechnology, Patricia Beckmann, President and Executive Director and Jessica Roberto, Associate Director, Life Science Washington Institute, and Robert Kadleck, Assistant Secretary for Preparedness & Response, HHS.[/caption] Additional Media Coverage: Forbes – June 8, 2018 “An Unlikely Biotech Investor: The Government” Newsday – June 5, 2018 “Stony Brook center tapped for federal anti-infection program” Innovate Long Island – June 5, 2018 “SBU Joins Elite HHS Business-Development Task Force” [post_title] => CFB Selected as DRIVe Accelerator [post_excerpt] => The Center for Biotechnology has been selected as one of eight accelerators in the nation by the U.S. Department of Health and Human Services (HHS). [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => cfb-selected-as-drive-accelerator [to_ping] => [pinged] => [post_modified] => 2018-08-20 14:56:27 [post_modified_gmt] => 2018-08-20 14:56:27 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=2984 [menu_order] => 121 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 1643 [post_author] => 4 [post_date] => 2015-09-15 18:44:52 [post_date_gmt] => 2015-09-15 18:44:52 [post_content] => Independently documented economic impact: $1.2 Billion Jobs created: 1,125 New corporate revenues: $812 Million Supported additional funding: $238 Million Center for Biotechnology documented economic impact over recent fifteen-year period Perhaps it is numbers like these which best illustrate the success CFB has had on the biotechnology industry and economy. And perhaps they contributed to the redesignation of the CFB as a Center for Advanced Technology for ten years by the New York State Foundation for Science, Technology and Innovation (NYSTAR) as a Center for Advanced Technology (CAT). The New York State redesignation recognizes the impact of the CFB over 30 years driving innovation toward commercial goals and resulting in accelerated product development cycles "from bench to boardroom to bedside." It recognizes the key role played by the CFB in facilitating a regional bioscience innovation ecosystem, collaborating with Stony Brook University, Cold Spring Harbor Laboratory, and Brookhaven National Laboratory. The redesignation by New York State validates all of the work we have done over the last 10-year period to create the foundation for exponential growth. We would not have secured the National Institutes of Health REACH award without it, says Clint Rubin, Director of the Center for Biotechnology."The REACH designation represents an $8.1M investment in technology development, commercialization, and new company formation. Visionary's like New York State Senator Kenneth La Valle deserve the credit. They recognized thirty years ago that universities represented a largely untapped pool of innovation and economic potential. Strikingly, it validates and provides the foundation for the new Long Island Bioscience Hub (LIBH), a CFB-led initiative to formally bring these institutions together to foster technology development, commercialization, and new company formation. The LIBH is a bold step made possible by a partnership with the National Institute of Health REACH initiative (Research Evaluation and Commercialization Hub). The NIH award places the CFB in the national spotlight along with other elite institutions. (Read more on the NIH REACH award here) "This redesignation occurs in an interesting and changing environment, where varying elements in the regional, state, and national biotech ecosystem are aligning. There is a confluence of events and issues that are creating a unique opportunity to build the biotech economy in the region and across the State." Commented Diane Fabel, Director of Operations, CFB. "We have learned a lot about the process of moving academic innovation into the commercial sector over time. And there have been such tremendous scientific advances recently that represent new commercial opportunities and life saving technologies. There is still much to learn and do, and it is an incredibly exciting time to be doing it.     [post_title] => Center for Biotechnology Redesignated by New York State: 'Unique Time of Change and Growth' [post_excerpt] => The New York State redesignation recognizes the impact of the CFB over 30 years driving innovation toward commercial goals and resulting in accelerated product development cycles from bench to boardroom to bedside. 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The Center for Biotechnology is pleased to announce a request for proposals for our Research Evaluation and Commercialization Hub (REACH) award program. Awards will be in two categories: Feasibility ($50k/12mo) and Proof of Concept ($100K/12 mo.) Details on the full funding program overview and proposal guidelines can be found here.

The development of promising innovations often stalls due to limited early-stage funding to address translational uncertainties. The Center for Biotechnology's Research Evaluation and Commercialization Hub (REACH) award program bridges the translation gap between biomedical discovery and their development toward commercial goals. Program funding is intended to determine feasibility, develop proof-of-concept, and ultimately lead to follow-on funding, a strategic partnership, or company formation.

The REACH program supports faculty and postdoctoral researchers in translating bio-based, bio-convergence, and bio-medical research discoveries by providing targeted funding and strategic guidance to bridge the translation gap between discovery and development for commercialization.

Learn more about the program, get information session details and access the full request for proposals here: https://centerforbiotechnology.org/what-we-do/technology-development/reach/

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Funding Opportunity: Research Evaluation and Commercialization Hub (REACH)Awards

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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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SBIR/STTR Commercialization Readiness Pilot (CRP) Program Deadlines

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CFB Selected as DRIVe Accelerator

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Center for Biotechnology Redesignated by New York State: ‘Unique Time of Change and Growth’

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