Wugen Garners New FDA and EMA Regulatory Designations for T-Cell Malignancy CAR-T WU-CART-007


The company also announced that it will be reporting new data at the European Hematology Association 2024 Hybrid Congress.

Wugen’s WU-CART-007, an investigational allogeneic CD7-directed chimeric antigen receptor T-cell (CAR-T) therapy intended to treat relapsed/refractory (r/r) T-cell acute lymphoblastic leukemia (T-ALL) and r/r T-cell lymphoblastic lymphoma (T-LBL), has been granted regenerative medicine advanced therapy (RMAT) designation by the FDA and priority medicines (PRIME) designation by the European Medicines Agency (EMA).1

Both the RMAT and PRIME designation were granted in relation to both aforementioned indications. The regulatory agencies based their decisions on data packages that included results from a phase 1/2 clinical trial (NCT04984356) evaluating the CAR-T in r/r T-ALL and r/r T-LBL.

Alongside the announcement of the new designations, Wugen also reported that it will be presenting new phase 2 trial data at the European Hematology Association (EHA) 2024 Hybrid Congress, which will be held from June 13 to 16, in Madrid, Spain. The company noted that its 2 presentations related to WU-CART-007 at the conference will cover data demonstrating safety and antileukemic activity along with additional findings.

“The FDA and EMA granted these designations for WU-CART-007 based on the rigor of our data and the potential of WU-CART-007 in addressing serious unmet needs of patients suffering from resistant blood cancers following treatment with current therapies,” Jan Davidson-Moncada, MD, PhD, the chief medical officer of Wugen, said in a statement.1

Wugen previously reported data from the phase 1/2 trial atthe the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition, held December 9-12, in San Diego, California.2 Among 18 of 22 evaluable patients who were treated at the trial’s second dose level or a greater dose, the Composite Complete Remission Rate (CRc) was 67%. Furthermore, patients treated at the recommended phase 2 dose level achieved a CRc of 73%. The safety profile for WU-CART-007 was characterized as “manageable”.

“For a disease that disproportionately affects younger individuals, the need to find better treatments feels especially urgent,” Armin Ghobadi, MD, an associate professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy in the Division of Medical Oncology at the Washington University School of Medicine in St. Louis, who presented the data at ASH, said in a statement.2 “It’s encouraging to see positive momentum—with favorable tolerability and efficacy data continuing to be reported as the study has expanded to include more patients with such difficult-to-treat blood cancers.”

WU-CART-007 was previously granted fast track and rare pediatric disease designations by the FDA for r/r T-ALL and r/r T-LBLin July 2022.3 The agency had also granted orphan drug designation to the CAR-T for the same indications in March 2022.4

In addition to the 2 presentations on WU-CART-007 slated for EHA’s 2024 Meeting, Wugen will also be giving a third presentation focused on WU-NK-101, its investigational allogeneic natural killer (NK) cell therapy.1 WU-NK-101, which is manufactured with the company’s Moneta platform, consists of NK cells derived from peripheral blood mononuclear cells with a cytokine-induced memory-like phenotype that Wugen expects will give an advantage in factors including antitumor activity, trafficking, proliferation capacity, and metabolic flexibility.5 WU-NK-101 is currently being evaluated in a first-in-human phase 1 clinical trial (NCT05470140) for patients with acute myeloid leukemia (AML). Wugen announced that the first patient in that trial was dosed in August 2023. The company has indicated that it is also seeking to evaluate WU-NK-101 in combination with cetuximab for the treatment of solid tumors.1

1. Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews and plans to present positive phase 2 study findings at European Hematology Association (EHA) 2024 in June. News release. Wugen, Inc. May 20, 2024. Accessed May 28, 2024. https://wugen.com/wugen-announces-rmat-and-prime-designations-for-wu-cart-007-to-accelerate-regulatory-reviews-and-plans-to-present-positive-phase-2-study-findings-at-european-hematology-association-eha-2024-in-june/
2.Wugen presents latest data from first-in-human phase 1/2 trial of WU-CART-007 in patients with difficult-to-treat blood cancers at American Society of Hematology Annual Meeting. News release. Wugen, Inc. December 11, 2023. Accessed May 28, 2024. https://wugen.com/wugen-presents-latest-data-from-first-in-human-phase-1-2-trial-of-wu-cart-007-in-patients-with-difficult-to-treat-blood-cancers-at-american-society-of-hematology-annual-meeting/
3. Wugen receives U.S. FDA fast track and rare pediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL. News release. Wugen, Inc. July 19,2022. Accessed May 28, 2024. https://finance.yahoo.com/news/wugen-receives-u-fda-fast-120000746.html
4. Wugen announces first patient dosed in phase 1/2 trial of WU-CART-007 for the treatment of patients with R/R T-ALL/LBL. News release. Wugen, Inc. March 15, 2022. Accessed May 28, 2024. https://www.businesswire.com/news/home/20220315005264/en/Wugen-Announces-First-Patient-Dosed-in-Phase-12-Trial-of-WU-CART-007-for-the-Treatment-of-Patients-with-RR-T-ALLLBL
5. Wugen begins first-in-human phase 1 clinical trial of WU-NK-101, its lead allogeneic memory natural killer (NK) cell therapy for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). News release. Wugen, Inc. August 15, 2023. Accessed May 28, 2024. https://wugen.com/wugen-begins-first-in-human-phase-1-clinical-trial-of-wu-nk-101-its-lead-allogeneic-memory-natural-killer-nk-cell-therapy-for-patients-with-relapsed-or-refractory-r-r-acute-myeloid-leukemia-aml-2/
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