TeraImmune Extends CRADA for Development of Treg Expansion for Clinical Use
GERMANTOWN, Md., Jan. 04, 2023 (GLOBE NEWSWIRE) — TeraImmune, Inc., a biotechnology company focused on the discovery and development of novel regulatory T-cell-(Treg)-based cell therapies for autoimmune diseases, announced today the extension of a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The CRADA is entitled “Developing the process of human regulatory T cells for clinical use.”
Under the agreement, TeraImmune continues to develop cGMP-compliant manufacturing protocol for its lead candidate, TI-168, and clinical laboratory manuals designed to provide relevant tactical support for the upcoming clinical trial. NIAID provides scientific advice on the therapeutic use of Tregs and on establishing cGMP-grade Treg manufacturing processes, as well as assists in the development of standard operating procedures for the preclinical and clinical stage development of cGMP-grade Treg cell therapy.
TeraImmune licensed one of its key technologies for a stable expansion of functional regulatory T cells from NIAID. The CRADA will extend an existing collaboration with NIAID researcher Ethan Shevach, M.D., who made significant contributions towards understanding the function of Tregs in mediating the immune response and identified Helios, a key marker of functional human Tregs.
“We are excited to continue our cooperative research with Dr. Shevach,” said Yong Chan Kim, PhD, Chief Executive Officer of TeraImmune. “Based on this collaborative teamwork, we will further maturate the clinical manufacturing processes for human Treg that are feasible for various indications, including our key pipeline candidates TI-168 for a refractory hemophilia A, TI-235 for multiple sclerosis and TI-620 atopic dermatitis. Through our R&D efforts, we observed that TREGable™ stabilizes multiple key markers/drivers of Tregs, including Foxp3 and Helios.”
About TeraImmune, Inc.
TeraImmune, Inc. is a biotechnology company that develops innovative immune-cell therapies. The Company is leveraging a dual Treg manufacturing platform consisting of both natural regulatory T cells (Tregs) isolated from patients (TREGable™) and induced Tregs converted from a patient’s T-effector (Teff) cells (TREGing™). TeraImmune has received FDA IND clearance to initiate a Phase 1/2a clinical trial of TI-168 for the treatment of congenital Hemophilia A with refractory inhibitors. Its Treg platform technology is designed for conditions that suppress unwanted immune reactions. The Company has expanded its pipeline to include the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of the skin disease such as Atopic Dermatitis. Increased selectivity of Tregs with target-specific receptors can enable to suppress the unwanted immune reactions without side effects in the patients with autoimmune diseases.
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