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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 Redesignation brings $10 million in funding to drive innovation, company formation, and economic growth.

The Center for Biotechnology (CFB) has announced its re-designated as a Center for Advanced Technology (CAT) by Empire State Development's Division of Science, Technology and Innovation (NYSTAR), a recognition that comes with $1 million in annual funding over the next ten years. The $10 million commitment underscores the CFB’s leadership in accelerating life science innovation, supporting early-stage technology development, and fueling economic growth through start-up formation and industry partnerships.

“The Center for Biotechnology has served as a critical bridge between academic research and commercial success,” said Dr. Clinton Rubin, Director of the Center for Biotechnology. “This re-designation ensures we can continue to expand our impact, helping innovators bring breakthrough technology to market and strengthening New York’s position as a leader in the bioscience industry.”

Empire State Development President, CEO and Commissioner Hope Knight said, “NYSTAR’s Centers for Advanced Technology are vital to our strategic efforts to grow New York’s economy and the state’s greater innovation ecosystem. By investing in the industries of tomorrow, New Yorkers benefit today through dynamic partnerships that help to create new jobs, generate more revenues, and encourage more companies to establish a footprint in communities all throughout the state.”

The Center for Biotechnology is located on the campus of Stony Brook University (SBU), the flagship research institution within the prestigious State University of New York (SUNY) system. Stony Brook University is recognized as a national and global leader in life sciences research, biomedical innovation, and clinical care. Situated on Long Island, New York, Stony Brook has built a formidable reputation as a hub for cutting-edge scientific discovery and translational medicine. The Center for Biotechnology builds upon these strengths by providing cutting-edge programming and competitive financial support to advance biomedical innovation and emerging company growth.

“We are excited to build upon the successful foundation of strong entrepreneurial networks, infrastructure, and programming that we have built over the last four decades” said Dr. Diane Fabel, Chief Operating Officer at the Center for Biotechnology. “The impacts we have had during our last designation period include over $1B in total economic impact with more than 1000 jobs created, and driving more than $315M in follow-on funding. We are excited to see those numbers continue to grow when we celebrate fifty years of hard work at the end of this redesignation period”.

As part of the New York State CAT program, the CFB will continue to work with emerging and established companies across the state to de-risk early-stage technologies, advance both technology and company value, foster public-private collaboration, and provide critical infrastructure for the region’s growing life science ecosystem. Additionally, the CFB team will continue its efforts to develop a life sciences workforce to support the region's bio-innovation economy with a specific emphasis on sectors deemed important to the NYS economy.

Dowload the full press release here.

[post_title] => Center for Biotechnology Announces Redesignation as New York State Center for Advanced Technology [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => redesignation2025 [to_ping] => [pinged] => [post_modified] => 2025-07-21 14:51:44 [post_modified_gmt] => 2025-07-21 18:51:44 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=4906 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 3128 [post_author] => 4 [post_date] => 2019-01-11 19:49:30 [post_date_gmt] => 2019-01-11 19:49:30 [post_content] => The Biomedical Advanced Research and Development Authority (BARDA) is leading an interagency group to develop a wearable device to detect, and possibly treat, an opioid overdose. This group, Technology Innovation to Combat Opioids (TICO) is holding a Deep Dive on Feb 12-13, 2019 to review possible technologies being developed in this area. Specifically, they are looking for wearables or software as a medical device that are no larger than the palm of your hand and measure a physiological response indicative of an opioid overdose. Examples of possible markers that could be incorporated into the device include, but are not limited to, respiratory rate, blood carbon dioxide or oxygen content, brain activity and opioid levels. The device should have the ability to alert potential caretakers nearby that the wearer is in distress and, potentially, have the capability to dispense a treatment for the overdose event. The technologies should be at a maturity level capable of undergoing pivotal clinical trials in 2020. TICO invites anyone with an innovative idea in this space to submit a 1-2 page summary of their device that addresses the following items:
  1. Provide a high-level device description including how the device detects possible opioid overdose.
  2. How does the device notify potential caretakers? Does it notify people nearby? If so, how?
  3. Description of the user population and use environment?
  4. What are the performance limitations for the device?
  5. How does the device treat an opioid overdose if that is a feature?
  6. Do you own the intellectual property for this technology?
TICO will review each submission and invite selected participants to present their technology at the Deep Dive on Feb 12-13, 2019. Travel funding is not available, however, this meeting will serve as market research for the solicitation that will be issued by BARDA to fund the clinical study. Accommodations can also be made for a virtual presentation. Submissions and questions can be sent to Kristen Herring Kristen.herring@hhs.gov and should be received no later than Jan. 22nd. [post_title] => BARDA: TICO Deep Dive 2 Announcement [post_excerpt] => The Biomedical Advanced Research and Development Authority (BARDA) is leading an interagency group to develop a wearable device to detect, and possibly treat, an opioid overdose. This group invites anyone with an innovative idea in this space to submit a 1-2 page summary of their device. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => barda-tico-deep-dive-2 [to_ping] => [pinged] => [post_modified] => 2019-04-09 14:41:18 [post_modified_gmt] => 2019-04-09 14:41:18 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=3128 [menu_order] => 105 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 3083 [post_author] => 3 [post_date] => 2018-11-16 14:26:57 [post_date_gmt] => 2018-11-16 14:26:57 [post_content] => Update courtesy of BBC Entrepreneurial Training and Consulting NIH is strongly encouraging small businesses to contact the appropriate Institute or Center early in their application planning to ensure their technology is a priority for the Institute/Center. An updated SBIR/STTR Application Guide with additional instructions for SBIR Direct Phase II application preparation and submission will be posted by November 26, 2018. The following sections of each FOA are changed: Part 2, Section I. Funding Opportunity Description The following has been added at the end of the section for each FOA: PA-18-573 The following Components will not accept an SBIR Direct-to-Phase II submission: - National Institute of Nursing Research (NINR) - National Center for Complementary and Integrative Health (NCCIH) PA-18-574 The following Components will not accept an SBIR Direct-to-Phase II submission: - National Institute of Environmental Health Sciences (NIEHS ) - National Institute of Nursing Research (NINR) - National Center for Complementary and Integrative Health (NCCIH) - Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP) - Centers for Disease Control and Prevention (CDC) (All Components of CDC) - U.S. Food and Drug Administration (FDA) (All Components of FDA) Part 2, Section II. Award Information for both PA-18-573 and PA-18-574. Application types now allowed are: - New (Phase I, Fast-Track) - New (Direct Phase II) - Renewal (Phase II) - Resubmission (all phases) - Phase IIB Competing Renewal (Phase IIB) - Revision The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types. [post_title] => Important SBIR/STTR Information Update from NIH [post_excerpt] => An updated SBIR/STTR Application Guide with additional instructions for SBIR Direct Phase II application preparation and submission will be posted by November 26, 2018. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => important-sbirsttr-information-update-from-nih [to_ping] => [pinged] => [post_modified] => 2018-11-16 14:26:57 [post_modified_gmt] => 2018-11-16 14:26:57 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=3083 [menu_order] => 110 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 3404 [post_author] => 3 [post_date] => 2020-01-02 16:35:15 [post_date_gmt] => 2020-01-02 16:35:15 [post_content] => ASPR/BARDA is issuing a Request for Information (RFI) to assist in understanding the developmental landscape of next generation blood products that could be used to treat mechanical trauma and bleeding associated with acute radiation syndrome and potentially supplement the blood supply in the wake of a mass casualty event such as a nuclear or radiological scenario. BARDA intends to use responses to this RFI for planning potential future acquisitions. BARDA seeks pertinent marketplace data to strengthen BARDA’s understanding of the current and future marketplace as well as enhance its ability to obtain quality services and products economically, and to efficiently and lawfully establish potential vendor source files and listings. BARDA will not award any potential contracts under this notice. This is strictly for market research. Link to the RFI: https://bit.ly/2LSjOEc . [post_title] => BARDA RFI: Next Generation Blood Products [post_excerpt] => ASPR/BARDA is issuing a Request for Information (RFI) to assist in understanding the developmental landscape of next generation blood products. 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The Redesignation brings $10 million in funding to drive innovation, company formation, and economic growth.

The Center for Biotechnology (CFB) has announced its re-designated as a Center for Advanced Technology (CAT) by Empire State Development's Division of Science, Technology and Innovation (NYSTAR), a recognition that comes with $1 million in annual funding over the next ten years. The $10 million commitment underscores the CFB’s leadership in accelerating life science innovation, supporting early-stage technology development, and fueling economic growth through start-up formation and industry partnerships.

“The Center for Biotechnology has served as a critical bridge between academic research and commercial success,” said Dr. Clinton Rubin, Director of the Center for Biotechnology. “This re-designation ensures we can continue to expand our impact, helping innovators bring breakthrough technology to market and strengthening New York’s position as a leader in the bioscience industry.”

Empire State Development President, CEO and Commissioner Hope Knight said, “NYSTAR’s Centers for Advanced Technology are vital to our strategic efforts to grow New York’s economy and the state’s greater innovation ecosystem. By investing in the industries of tomorrow, New Yorkers benefit today through dynamic partnerships that help to create new jobs, generate more revenues, and encourage more companies to establish a footprint in communities all throughout the state.”

The Center for Biotechnology is located on the campus of Stony Brook University (SBU), the flagship research institution within the prestigious State University of New York (SUNY) system. Stony Brook University is recognized as a national and global leader in life sciences research, biomedical innovation, and clinical care. Situated on Long Island, New York, Stony Brook has built a formidable reputation as a hub for cutting-edge scientific discovery and translational medicine. The Center for Biotechnology builds upon these strengths by providing cutting-edge programming and competitive financial support to advance biomedical innovation and emerging company growth.

“We are excited to build upon the successful foundation of strong entrepreneurial networks, infrastructure, and programming that we have built over the last four decades” said Dr. Diane Fabel, Chief Operating Officer at the Center for Biotechnology. “The impacts we have had during our last designation period include over $1B in total economic impact with more than 1000 jobs created, and driving more than $315M in follow-on funding. We are excited to see those numbers continue to grow when we celebrate fifty years of hard work at the end of this redesignation period”.

As part of the New York State CAT program, the CFB will continue to work with emerging and established companies across the state to de-risk early-stage technologies, advance both technology and company value, foster public-private collaboration, and provide critical infrastructure for the region’s growing life science ecosystem. Additionally, the CFB team will continue its efforts to develop a life sciences workforce to support the region's bio-innovation economy with a specific emphasis on sectors deemed important to the NYS economy.

Dowload the full press release here.

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Center for Biotechnology Announces Redesignation as New York State Center for Advanced Technology

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