-- FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports manufacturing readiness for therapies with expedited clinical development timelines
-- WU-CART-007 (Soficabtagene Geleucel “Sofi-cel”) is selected for participation enabling additional FDA engagement on CMC strategy ahead of a potential BLA submission
ST. LOUIS--(BUSINESS WIRE)--Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that the U.S. Food and Drug Administration (FDA) has selected Sofi-cel, an investigational allogeneic CAR-T cell therapy, to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. Wugen was invited by the FDA to participate in the CDRP program, which selects up to nine development programs annually across the FDA’s two product review centers for biologics and drugs.
The FDA established the CDRP program to facilitate CMC development for therapies with accelerated clinical development timelines based on the anticipated clinical benefits of earlier patient access to the therapy. The program promotes earlier and more structured engagement between sponsors and the FDA on CMC development strategies and goals. Participation in the CDRP program is expected to allow Wugen to engage frequently with the FDA on CMC strategy as the company continues to build manufacturing capabilities to advance Sofi-cel toward BLA submission.
Sofi-cel is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial (T-RRex) for patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Sofi-cel previously received Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of R/R T-ALL/T-LBL.
“Selection for the FDA’s CDRP program enables us to streamline and seamlessly integrate clinical progress with manufacturing readiness to rapidly advance the program towards BLA filing,” said Kumar Srinivasan, Chief Executive Officer of Wugen. “Building on our recent RMAT and Breakthrough Therapy designations, we welcome the opportunity to work closely with the FDA through this highly selective program as we advance Sofi‑cel along an accelerated clinical timeline. These additional CMC interactions will strengthen our manufacturing and regulatory capabilities with the goal of bringing Sofi‑cel to patients as quickly as possible.”
About Soficabtagene Geleucel (Sofi-cel)
Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD).
Sofi-cel is manufactured in the United States using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL. More information on the pivotal trial is available at ClinicalTrials.gov, identifier NCT06514794.
Sofi-cel has received Breakthrough Therapy Designation (BTD), Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased Agency support to expedite the development and review of promising therapies for patients with medical need.
About Wugen
Wugen, Inc., founded and headquartered in St. Louis, Missouri, is a clinical-stage biotechnology company focused on developing next-generation, allogeneic CAR-T cell therapies for cancer. Wugen’s proprietary gene-editing platform is designed to overcome key limitations of first-generation cell therapies, enabling scalable, off-the-shelf treatments with biologics-like cost of goods margins.
Contacts
Investor Contact:
Mark Lewis
Wugen
Mlewis@wugen.com
314-501-1968
