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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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Attention Stony Brook University Faculy and Staff: Applications for the second cycle of the President’s Fast Impact Fund (FIF) opened August 3, 2026. Open to all Stony Brook faculty and staff, this special initiative supports immediate-impact projects that can be launched quickly and deliver results within six to ten months.

The FIF provides awards of up to $300,000 focused on low‑investment, high‑reward initiatives that create visible, positive change. Examples of projects that would be considered include specialized equipment or technology acquisitions, pilot programs or proof‑of‑concept initiatives, targeted renovations or seed funding, among other opportunities.

All proposals must include a customized, high-level budget and be endorsed by the relevant vice president or dean with authority to implement the project. Applications for the August cycle will be available beginning August 3 with submissions due Friday, August 21 by 5 pm, ET. Please visit the Fast Impact Fund website for additional information and to submit an application.

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Apply for the first cohort of FY2023 by Nov. 16!

The I-Corps™ at NIH Program helps current Phase I SBIR/STTR awardees from the NIH and CDC transition from researcher to entrepreneur.

This 8.5-week training program provides practical guidance from experienced industry professionals that will move you forward on your path toward commercialization. Past participants have written strong SBIR/STTR Phase II applications, won partnerships and investments, and built vast networks in the field.

Apply for the first cohort of FY2023 through the NIH ASSIST platform by 5:00 p.m. your local time on Wednesday, November 16.

Questions? Review the FAQs or contact us if you need help at icorps@mail.nih.gov.

Learn More and Apply: https://sbir.cancer.gov/commercialization/business/icorps

[post_title] => NIH iCorps: Apply by Nov. 16 [post_excerpt] => Apply by 11/16 to joing the I-Corps™ at NIH Program helping current Phase I SBIR/STTR awardees from the NIH and CDC transition from researcher to entrepreneur. [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => nih-icorps-apply-by-nov-16 [to_ping] => [pinged] => [post_modified] => 2022-12-13 17:01:52 [post_modified_gmt] => 2022-12-13 17:01:52 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=3954 [menu_order] => 13 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 3099 [post_author] => 3 [post_date] => 2018-12-17 20:28:10 [post_date_gmt] => 2018-12-17 20:28:10 [post_content] => The course is presented in a series of five sequential videos. The video modules and course details can be found here: https://www.nibib.nih.gov/entrepreneurial-finance-course The National Institutes of Health (NIH) supports the development and commercialization of biomedical technologies through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. With the goal of bringing life-saving innovations to market, NIH SBIR/STTR funding provides early-stage seed capital to US-owned small businesses. While the commercialization of biomedical technologies can require a significant amount of both time and money, rigorous financial planning can help navigate and mitigate risks for small businesses and can enhance chances of success along the pathway to market. For biomedical innovators considering funding through the NIH SBIR/STTR programs (https://sbir.nih.gov), it is imperative to evaluate the use of federal grant funding within the context of a broader financial plan. Course Objectives The purpose of this course is to present biomedical entrepreneurs with a detailed framework for building a step-wise, validated financial plan. Moving beyond the short-term perspective of immediate financing needs to a comprehensive, long-term financial plan will increase the probability of success for your venture. The primary learning objectives for this course are as follows: - Understand the importance of financial planning for your small business - Gain perspective on SBIR/STTR funding within the broader context of your financial plan - Learn practical approaches to developing a long-term financial plan - Evaluate the various sources of funding - Examine the use of comparables in validating your financial plan   [post_title] => Free Course from NIH: Entrepreneurial Finance for Biomedical Innovators [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => free-course-from-nih-entrepreneurial-finance-for-biomedical-innovators [to_ping] => [pinged] => [post_modified] => 2018-12-17 20:28:10 [post_modified_gmt] => 2018-12-17 20:28:10 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=3099 [menu_order] => 109 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 3778 [post_author] => 4 [post_date] => 2021-05-12 19:17:37 [post_date_gmt] => 2021-05-12 19:17:37 [post_content] =>

Wednesday, May 26, 2021 | 2:00 PM-4:00 PM

BARDA DRIVe has launched a Mask Innovation Challenge to support the development of innovative solutions that can protect Americans from respiratory pathogens such as SARS-CoV-2.

The Center for Biotechnology, a BARDA DRIVe Accelerator Network site, is hosting this Mask Challenge event in partnership with the The Science Center, during which applicants who have made it past the first round will be pitching their mask design and plan for commercialization.

Register Here: https://venturecafeglobal-org.zoom.us/meeting/register/tJIvcOCvrzMiEtPblEbmB3cwezwMIleFe3xr

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Attention Stony Brook University Faculy and Staff: Applications for the second cycle of the President’s Fast Impact Fund (FIF) opened August 3, 2026. Open to all Stony Brook faculty and staff, this special initiative supports immediate-impact projects that can be launched quickly and deliver results within six to ten months.

The FIF provides awards of up to $300,000 focused on low‑investment, high‑reward initiatives that create visible, positive change. Examples of projects that would be considered include specialized equipment or technology acquisitions, pilot programs or proof‑of‑concept initiatives, targeted renovations or seed funding, among other opportunities.

All proposals must include a customized, high-level budget and be endorsed by the relevant vice president or dean with authority to implement the project. Applications for the August cycle will be available beginning August 3 with submissions due Friday, August 21 by 5 pm, ET. Please visit the Fast Impact Fund website for additional information and to submit an application.

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