WU-NK-101

-- First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy to Begin in First Quarter 2025-- The Global Study Will Evaluate WU-CART-007 in Pediatric and Adult Patients ST. LOUIS, Mo. and SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- 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 it will initiate a pivotal Phase 2 study in the first quarter of 2025 for the company’s potential first-in-class, investigational, anti-CD7 CAR-T cell therapy, WU-CART-007, in patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). “T-ALL/LBL is an aggressive cancer with a significant need for new therapies given that many patients will progress on standard of care,” said Kumar Srinivasan, Ph.D., Wugen president and chief executive officer. “Wugen is well positioned for this critical stage of research and development for WU-CART-007. Recently, we generated positive Phase 1/2 results; received significant new regulatory designations – RMAT and PRIME – to expedite our clinical development path in the United States and Europe; and deepened our cell therapy expertise with Cherry T. Thomas, M.D. joining our team as chief medical officer.” 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 evaluate the efficacy of WU-CART-007 in two groups: an R/R cohort and an exploratory minimum residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia. “With a 20-year void of new medicines to treat patients with relapsed or refractory T-ALL/LBL, many of whom are young, we believe off-the-shelf allogeneic CD7-targeted CAR-T cell therapies may offer hope and innovation,” said Dr. Thomas, Wugen’s chief medical officer. “Wugen’s progress in advancing WU-CART-007 also includes a robust, scalable and efficient commercial manufacturing process, developed with our partners to create a CD7-targeted therapy for off-the-shelf use,” said Matt Cooper, Ph.D., Wugen’s co-founder and chief scientific officer, who invented WU-CART-007 as a researcher at Washington University in St. Louis, MO. Wugen previously announced positive results from a Phase 1/2 cohort expansion study showing clinically manageable safety and evidence of anti-leukemic activity (overall response rate of 91%) in heavily pre-treated patients with R/R T-ALL/LBL. Researchers will present a data update at the American Society of Hematology Annual Meeting (ASH) 2024, Dec. 7-10 in San Diego. Follow Wugen’s LinkedIn page to see abstracts to be presented at ASH 2024 for WU-CART-007 and for WU-NK-101, Wugen’s investigational off-the-shelf memory natural killer cell therapy. 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 LewisWugenMlewis@wugen.com314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com215-595-5211

-- Researchers Shared Findings Including a Clinically Manageable Safety Profile and Anti-leukemic Activity with WU-CART-007 in Patients with R/R T-ALL/LBL and Previously Treated with Existing Therapies -- U.S. Biotech Wugen to Initiate Follow-Up Study Exploring Its Anti-CD7, Off-the-Shelf, Allogeneic CAR-T Cell Therapy in Pediatric and Minimal Residual Disease (MRD) Patients in Q424 -- Company Presented Additional New Data at EHA on WU-CART-007 and WU-NK-101, Its Off-the-Shelf Investigational Memory Natural Killer Cell Therapy ST. LOUIS and SAN DIEGO, June 14, 2024 (GLOBE NEWSWIRE) -- 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, announces positive Phase 2 results for the company’s investigational anti-CD7 CAR-T therapy, WU-CART-007 (“W-T7”), in patients with relapsed/refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). In his presentation today at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, lead investigator Ibrahim Aldoss, M.D., City of Hope in Duarte, CA, shared data from this Phase 2 cohort expansion study showing a clinically manageable safety profile as well as evidence of anti-leukemic activity with WU-CART-007 (“W-T7”) in patients with R/R T-ALL/LBL previously treated with existing therapies for their cancers. “Relapsed and refractory T-ALL/LBL is a highly aggressive disease with high rates of relapse and mortality in both children and adults,” Dr. Aldoss said. “These results are exciting and support the potential of this allogeneic CAR-T as a new treatment for patients who still face a refractory illness despite having received the best medicines we have for T-ALL/LBL right now.” “The need for effective, allogeneic treatments that are available at the point of care without delays is urgent for patients with hard-to-treat blood cancers,” said Wugen Chief Medical Officer Jan Davidson-Moncada, M.D., Ph.D. “Wugen is confident we can overcome specific challenges that have existed for CAR-T therapies in targeting T-cell diseases. We are eager to conduct further studies of WU-CART-007, which was invented by Wugen’s Co-founder and Chief Scientific Officer Matt Cooper, Ph.D., to target CD7+ malignancies.” Key Phase 2 Findings The presentation at EHA featured results with the recommended dose (RP2D) of WU-CART-007 administered in 13 patients at a median age 30 years who were heavily pre-treated and had a high burden of disease at the start of the study. A substantial proportion of patients (38%) had progressed or relapsed after allogeneic stem cell transplant. Outcomes following WU-CART-007 treatment in the study surpassed current standard of care1 for R/R T-ALL/LBL and included: Composite complete remission rate (CRc) of 73% (8/11) (primary endpoint).Overall response rate of 91% (10/11; 2 partial response (PR) in patients with extramedullary disease, R/R T-LBL).Duration of response (DOR) (secondary endpoint): Median duration (mDOR) was 6.2 months (95% CI: 1.8, NE);Median follow up was 8.5 months (95% CI: 2.7, NE); 46% (5/11) patients remained in continuous remission at 4.3 to 8.6 months. Seven patients (5 at RP2D) successfully transplanted. Pharmacokinetic analysis exhibited rapid expansion and persistence of an allogeneic cell therapy: At RP2D, WU-CART-007 expansion peaked at Day 10 (223,799 copies/g of DNA) and can be detected out to Day 90. No patient developed drug product-specific anti-HLA antibodies.No anti-drug antibody detected on any patients to date. Phase 1 dose escalation data from this first-in-human global Phase 1/2 clinical trial of WU-CART-007 for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL) were presented last December at the American Society of Hematology meeting. See those findings here. Additional Wugen Data at EHA Researchers presented other new findings with WU-CART-007 and WU-NK 101 in these posters at EHA: Title: Preliminary Effect of Enhanced Lymphodepletion (ELD) on WU-CART-007 in T-ALL/LBLPresenters: Ouiam Bakkacha M.D. and Ben Capoccia Ph.D., Wugen, St. Louis, MOAbstract: P408 Title: WU-NK-101 is an Off-The-Shelf Memory NK Cell with a Time-Resilient, Anti-Tumor Phenotype that can be Detected in R/R AML Patient PBMC After InfusionPresenter: Laura Arthur, Ph.D., Wugen, St. Louis, MOAbstract: P1422 More information is available on the EHA 2024 Hybrid Congress website. About WU-CART-007WU-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). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356. WU-CART-007 has received Orphan Drug, Fast Track, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. Food and Drug Administration and received PRIME (“Priority Medicines”) 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 WU-NK-101WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This cell population has a superior phenotype, proliferation capacity, and metabolic fitness, making it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML). Wugen is planning to initiate solid tumor studies of WU-NK-101 in combination with cetuximab. Studies of WU-NK-101 to date have shown promising robust in vivo activity in various tumor indications, retention of anti-cancer activity in TME, resistance to immune suppression, and enhanced activity with checkpoint inhibitors. WU-NK-101 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. About Wugen A spin-out of Washington University in St. Louis, 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. Investor Contact:Mark LewisWugenMlewis@wugen.com+1 314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com+1 215-595-5211 1 Nelarabine USPI