Wugen's WU-CART-007 Gains RMAT and PRIME, Set to Present Phase 2 Results at EHA 2024

Wugen, Inc., a biotechnology company focused on developing allogeneic, off-the-shelf cell therapies for hematological and solid tumor malignancies, announced significant advancements with their investigational CAR-T cell therapy, WU-CART-007. The company has received two new regulatory designations that are expected to expedite the therapy's review process in both the United States and the European Union.

The U.S. Food and Drug Administration (FDA) granted WU-CART-007 the Regenerative Medicine Advanced Therapy (RMAT) designation, while the European Medicines Agency (EMA) awarded it the PRIME (Priority Medicines) designation. These designations are significant as they are given to therapies that show substantial potential in addressing serious unmet medical needs. WU-CART-007 is being developed for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

These regulatory milestones were achieved following a review of data from Wugen's global Phase 1/2 clinical trial focused on these conditions. The data will also be presented during the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain. Dr. Ibrahim Aldoss from City of Hope will present the latest findings on June 14.

Kumar Srinivasan, Wugen's president and CEO, emphasized the importance of these designations in accelerating the regulatory review process. He noted that the company aims to bring this allogeneic CAR-T treatment to patients swiftly as they conclude Phase 1/2 trials and gear up for pivotal studies. Chief Medical Officer Dr. Jan Davidson-Moncada highlighted that the designations were granted based on the robustness of the data and the potential of WU-CART-007 to fulfill critical patient needs.

WU-CART-007 has already received several other designations from the FDA, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations, all aimed at treating relapsed/refractory T-ALL and T-LBL. This investigational therapy utilizes CRISPR/Cas9 gene editing to modify T-cells, making them resistant to fratricide and reducing the risk of graft-versus-host disease (GvHD). These genetically edited cells are derived from healthy donors, eliminating the risk associated with malignant cell contamination in autologous CAR-T therapies.

During the EHA 2024 meeting, Wugen will present several studies. In an oral presentation, Dr. Ibrahim Aldoss will discuss the efficacy of WU-CART-007 against relapsed/refractory T-ALL and T-LBL. Additionally, poster presentations will cover topics such as the impact of enhanced lymphodepletion on WU-CART-007 and the efficacy of WU-NK-101, a memory natural killer (NK) cell therapy.

WU-NK-101 is another promising therapy from Wugen’s pipeline. This therapy leverages memory NK cells, known for their enhanced anti-tumor activity and longer lifespan. Wugen is advancing this therapy for the treatment of acute myelogenous leukemia (AML) and plans to explore its efficacy in solid tumors in combination with cetuximab. Early studies have demonstrated that WU-NK-101 retains robust anti-cancer activity in various tumor models, resists immune suppression, and displays an enhanced effect when used with checkpoint inhibitors. It has also received Orphan Drug Designation from the FDA for the treatment of AML.

Wugen continues to innovate in the field of cell therapy, developing next-generation CAR-T and memory NK cell therapies aimed at tackling both hematological and solid tumor malignancies. These advancements underscore Wugen’s commitment to providing effective therapeutic options for patients with hard-to-treat cancers.

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