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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 would 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] => 2024-12-05 11:35:07 [post_modified_gmt] => 2024-12-05 16:35:07 [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] => 2878 [post_author] => 1 [post_date] => 2017-11-21 14:36:09 [post_date_gmt] => 2017-11-21 14:36:09 [post_content] => The proposal submission deadline for the SUNY Technology Accelerator Fund Class of 2018 is February 16, 2018. Faculty, staff, and students from all disciplines and campuses are encouraged to submit proposals for the SUNY Technology Accelerator Fund Class of 2018 funding. The deadline for submitting proposals is February 16, 2018. See TAF Class of 2018 Application and Administrative Guidelines. The SUNY Technology Accelerator Fund (“TAF”) provides funding to support the advancement of SUNY innovations from the lab to the marketplace. Since its launch in 2011, the TAF has successfully advanced the commercial readiness of a number of SUNY-developed innovations. In most cases, SUNY innovations developed through sponsored research lack critical proof-of-concept data that is needed to attract investment by potential licensees or investors. TAF support targets the critical milestones needed to demonstrate that an innovation is worthy of external investment. TAF’s strategic objective is to facilitate the commercialization of SUNY-developed innovations for the public benefit in an expeditious and effective manner. The aim is to identify opportunities where small investments will provide significant impacts on making SUNY innovations available to the public. Different from fundamental research, TAF investments support proof-of-concept and technology development projects to validate the commercial feasibility of SUNY technology. The goal is to facilitate the translation of SUNY technology into marketable products and/or services by enhancing strategic academic-industry partnerships and building new entrepreneurial Please be advised that all proposals require the review and participation of your campus administration prior to submission. To be certain that you adhere to any local proposal submission deadlines, we urge you to immediately contact your technology transfer office and/or office of sponsored programs if you are interested in applying for TAF Class of 2018 funding. Questions? Please send any questions to TAF@rfsuny.org. All questions and answers will be posted to www.rfsuny.org/taf. [post_title] => Funding Opportunity: SUNY Technology Accelerator Fund Accepting Proposals [post_excerpt] => Proposal Deadline for the SUNY Technology Accelerator Fund Class of 2018 is February 16, 2018! SUNY Technology Accelerator Fund (“TAF”) provides funding to support the advancement of SUNY innovations from the lab to the marketplace. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => funding-opportunity-suny-technology-accelerator-fund-accepting-proposals-2 [to_ping] => [pinged] => [post_modified] => 2018-01-23 14:38:56 [post_modified_gmt] => 2018-01-23 14:38:56 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=2878 [menu_order] => 135 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 2237 [post_author] => 3 [post_date] => 2016-06-07 15:14:28 [post_date_gmt] => 2016-06-07 15:14:28 [post_content] => Traverse Biosciences has announced that it has secured $500,000 in convertible debt financing to support operations and advance product development efforts. The seed financing was led by Excell Partners, with matching funds from a number of individual accredited angel investors. The Research Foundation for the State of New York (RF/SUNY) also participated in the financing, as part of an exclusive license and option agreement executed last year that gave Traverse Biosciences access to the relevant intellectual property for use in animal and human health. Traverse Biosciences, which began when CEO Joseph Scaduto was serving as a BioEntrepreneur-in-Residence for the Center for Biotechnology, is working to commercialize its proprietary library of Stony Brook University invented chemically-modified curcumins for the treatment of chronic inflammatory conditions and cancers affecting humans and animals. Read more about Traverse and the recent financing:     [post_title] => Traverse Biosciences Secures $500k Seed Financing [post_excerpt] => Traverse Biosciences announced that it has secured $500,000 in convertible debt financing to support operations and advance product development efforts. The seed financing was led by Excell Partners, with matching funds from a number of individual accredited angel investors. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => traverse-biosciences-secures-500k-seed-financing [to_ping] => [pinged] => [post_modified] => 2016-06-07 15:14:28 [post_modified_gmt] => 2016-06-07 15:14:28 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=2237 [menu_order] => 177 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 1417 [post_author] => 3 [post_date] => 2015-02-19 19:17:30 [post_date_gmt] => 2015-02-19 19:17:30 [post_content] => Presented by Clean Energy Business Incubator Program Wednesday, March 11, 2015 Long Island High Tech Incubator 3:30 PM - 5:00 PM: Seminar 5:00 PM - 7:00 PM: Mixer In most cases for a startup, having patent, trade secret, trademark, and/or copyright protection is the key leverage needed to attract the life-blood investment necessary to sustain and grow the startup to exit. This discussion will address from a startup's perspective how to maintain the maximum potential value of Intellectual Property you may have AND future Intellectual Property that you don't even know about yet! You will learn about:
  • Patent, Trademark, Copyright and Trade Secret Basics
  • Common misconceptions about IP, e.g., Patentability and enforcement vs. Freedom-to-Operate
  • Preparing for your pitch and the resultant Due Diligence
  • What steps to take (or not to take) in order to avoid losing your precious IP leverage: Unintentionally forfeiting IP rights,Controlling ownership,And other IP portfolio building strategies
Speakers: Ray Farrell, founding partner of Carter, DeLuca, Farrell & Schmidt, LLP; Pina Campagna, Patent & Trademark Attorney at Carter, DeLuca, Farrell & Schmidt, LLP. RSVP to David C Hamilton Director, Business Development, Clean Energy Business Incubator Program (CEBIP): david.hamilton@stonybrook.edu [post_title] => Startup Mission Critical: How to build an IP portfolio investors will want to invest in early and often [post_excerpt] => In most cases for a startup, having patent, trade secret, trademark, and/or copyright protection is the key leverage needed to attract the life-blood investment necessary to sustain and grow the startup to exit. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => startup-mission-critical-how-to-build-an-ip-portfolio-investors-will-want-to-invest-in-early-and-often [to_ping] => [pinged] => [post_modified] => 2016-03-02 18:02:01 [post_modified_gmt] => 2016-03-02 18:02:01 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/new/?p=1417 [menu_order] => 214 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) ) [post_count] => 4 [current_post] => -1 [before_loop] => 1 [in_the_loop] => [post] => 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 would 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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