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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/

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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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CFB Client JelikaLite has been awarded a 2-year, $959,000 National Science Foundation (NSF) grant to develop a non-invasive therapeutic brain stimulation medical device to improve the communication, responsiveness, and social integration of autistic children.

JelikaLite is a clinical stage medical technology company developing a transformational neuromodulation platform for unmet needs in developmental pediatric disorders whose lead product is focused on Autism Spectrum Disorder (ASD).

The NSF project’s objectives are to finalize the current clinical prototype into a manufacturing-ready product and implement a platform for personalizing transcranial photobiomodulation (tPBM) treatment based on individual sensor -derived patient characteristics.

Details of the award can be found here.

[post_title] => CFB Client JelikaLite Awarded NSF Grant to Further Clinical Prototype [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => jelikalite-nsf24 [to_ping] => [pinged] => [post_modified] => 2025-02-24 12:44:30 [post_modified_gmt] => 2025-02-24 17:44:30 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=4482 [menu_order] => 0 [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] => 1493 [post_author] => 3 [post_date] => 2015-04-08 19:48:55 [post_date_gmt] => 2015-04-08 19:48:55 [post_content] => Gaurav Lalwani, PhD, Biomedical Engineering department at Stony brook University and Center for Biotechnology Fundamentals Program alumnus, has Co-founded Millennial Materials and Devices, a company which was recently awarded second place in the Stony Brook Entrepreneurs Challenge 2015, with a cash reward of $10,000 and $3000 prize in 'DARE to RISK' Business Plan Competition at Farmingdale State University, Long Island Regional Affiliate of the New York State Business Plan. Millennial Materials will now be presenting at the Finals of New York Business Plan Competition (NYBPC) in Albany on April 24, 2015 in the Nanotechnology/Advanced Technology category. The NYBPC is the only leading collegiate business competition that is a regionally coordinated, collaborative statewide program representing over 75 colleges and universities, which sets it apart from all other competitions in the nation. Millennial Materials and Devices is working towards the commercialization of a novel proprietary formulation and method to fabricate large-area transparent conductive films for applications ranging from the fabrication of flexible unbreakable displays to electromagnetic shielding and biomedical coatings. [post_title] => Millennial Materials and Devices Presenting at NY Business Plan Competition Finals [post_excerpt] => Millennial Materials and Devices, co-founded by BME and FOBIP Alumnus, will be presenting in the finals of New York Business Plan Competition (NYBPC) after placing in the Stony Brook Entrepreneurs Challenge 2015. 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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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CFB Client JelikaLite Awarded NSF Grant to Further Clinical Prototype

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CFB Selected as DRIVe Accelerator

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Millennial Materials and Devices Presenting at NY Business Plan Competition Finals

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