— Data Support Start of First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy in Pediatric and Adult Patients —
ST. LOUIS, MO and SAN DIEGO, CA, Dec. 5, 2024 – Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced upcoming scientific presentations, including updates from the company’s Phase 1/2 study of WU-CART-007. Researchers will present Phase 1/2 updates and studies for its investigational cell therapies this week at the American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 7-10 in San Diego.
Results from Phase 1/2 showed continued anti-leukemic activity and clinically manageable safety in adults and adolescents. WU-CART-007 is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy under evaluation for treatment of patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL).
Based on findings to date with WU-CART-007, including this week’s data, Wugen will initiate the first pivotal Phase 2 study for an off-the-shelf CD7-targeted CAR-T cell therapy.
“Maturing evidence, including the Phase 1/2 study being presented, suggest WU-CART-007 has the potential to improve current standard of care for patients with these blood cancers. T-ALL/LBL are malignancies associated with high rates of relapse and mortality in patients, many of whom are young,” said Armin Ghobadi, M.D, professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) at the Washington University School of Medicine in St. Louis.
“At this year’s ASH meeting, we will present clinical data from adult and adolescent patients that support our soon to open pivotal trial for patients with relapsed or refractory T-ALL/LBL,” said Wugen Chief Medical Officer, Cherry Thomas, M.D. “We are looking forward to working with experienced investigators to provide meaningful clinical benefit to patients with limited treatment options.”
The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will involve two groups: a R/R cohort and subsequently an exploratory minimal residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia.
Wugen Presentations at ASH
Presenter: Armin Ghobadi, M.D., Washington University School of Medicine, St. Louis
Presentation type: Poster
Time/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,H
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II
Presenter: Shannon L. Maude, M.D., Division of Oncology, Center for Childhood Cancer Research and Cancer Immunotherapy Program, Children’s Hospital of Philadelphia, Philadelphia
Presentation type: Poster
Time/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,H
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II
Wugen researchers will also present the following abstracts for the company’s investigational memory natural killer cell therapy, WU-NK-101:
Presenter: Tom Leedom, Wugen, Inc., St. Louis
Presentation type: Oral
Time/location: Monday, Dec. 9, 3:30 p.m. PT; Marriott Grand Ballroom 8-9, Marriott Marquis San Diego Marina
Session: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Enhancing NK Cell Therapeutics Hematology Disease Topics & Pathways: Research, Translational Research 2:45-4:15 p.m. PT
Presenter: Amanda F. Cashen, M.D., Washington University School of Medicine, St. Louis
Presentation type: Poster
Time/location: Monday, Dec. 9, 6:00-8:00 p.m. PT; Halls G, H
Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III
Hematology Disease Topics & Pathways: Research, Clinical trials, Translational Research, Clinical Research
Investigator-initiated research
Presenter: Michael H. Kramer, M.D., Ph.D., Washington University School of Medicine, Saint Louis
Presentation type: Poster
Time/location: Sat., Dec. 7, 5:30-7:30 p.m. PT; Halls G, H
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I;
About WU-CART-007
WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794.
WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.
About Wugen
Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com and follow Wugen’s LinkedIn page.
Investor Contact:
Mark Lewis
Wugen
314-501-1968
Media Contact:
Christine Fanelle
Scient PR
215-595-5211
