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

Wugen
5 min read
0
WugenWugen
Wugen

-- Researchers to Present New Phase 2 Data Showing Safety and Anti-Leukemic Activity with WU-CART-007 and Additional New Findings for this Investigational, Off-the-Shelf Allogeneic CAR-T Cell Therapy

-- Company to Initiate Follow-Up Study in Q4 2024 with WU-CART-007 in Pediatric and Minimal Residual Disease (MRD) Patients

-- Will Share New Data for WU-NK-101, its Investigational Memory Natural Killer Cell Therapy, at EHA

ST. LOUIS and SAN DIEGO, May 20, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced receipt of two new regulatory designations for its investigational CAR-T cell therapy, WU-CART-007, that it anticipates will expedite regulatory reviews on two continents.

Specifically, Wugen received Regenerative Medicine Advanced Therapy (RMAT) designation in the United States and PRIME (“Priority Medicines”) designation in the European Union for WU-CART-007 for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). Both designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

Regulators granted Wugen these designations following their reviews of data including results from the global Phase 1/2 clinical trial for the treatment of R/R T-ALL/LBL. Additional information is available on clinicaltrials.gov, identifier NCT# 04984356. The newest data from the Phase 1/2 study will be presented by Ibrahim Aldoss, M.D., City of Hope, on June 14 during the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain.

“Our goal is to bring this investigational off-the-shelf allogeneic CAR-T treatment to patients as soon as possible,” said Kumar Srinivasan, Ph.D., M.B.A., Wugen president and chief executive officer. “These designations represent a significant opportunity to accelerate regulatory reviews for WU-CART-007 as we conclude Phase 1/2 trials and begin pivotal studies later this year.”

“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,” said Jan Davidson-Moncada, M.D., Ph.D., chief medical officer of Wugen.

About RMAT and PRIME Designations
The U.S. Food and Drug Administration’s Center for Biologic Research and Evaluation grants RMAT designation for regenerative medicine therapies intended to treat, modify, reverse, or cure a serious condition as well as having preliminary clinical evidence indicating their potential to address unmet medical needs for a serious condition. EMA’s PRIME scheme is designed for medicines that demonstrate the potential to address an unmet medical need.

WU-CART-007 previously received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration for the treatment of R/R T-ALL/LBL.

Wugen Presentations at EHA
These abstracts will be presented at the hybrid EHA 2024 meeting:

Oral Presentation
Title: WU-CART-007, an Allogeneic CAR-T Cell Targeting CD7, is Highly Effective Against Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL)
Presenter: Ibrahim Aldoss, M.D., City of Hope, Duarte, CA
Abstract/Presentation ID: S110
Date/time: Friday, June 14, 14:45-15:00 CEST (8:45-9:00 a.m. U.S. ET)

Poster Presentations
Title: Preliminary Effect of Enhanced Lymphodepletion (ELD) on WU-CART-007 in T-ALL/LBL
Presenters: Ouiam Bakkacha M.D. and Ben Capoccia Ph.D., Wugen, St. Louis, MO
Abstract: 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 Infusion
Presenter: Laura Arthur, Ph.D., Wugen, St. Louis, MO
Abstract: P1422

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). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356. WU-CART-007 has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration for the treatment of R/R T-ALL/LBL.

About WU-NK-101
WU-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
Wugen, Inc. is a clinical-stage 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 Lewis
Wugen
Mlewis@wugen.com
314-501-1968

Media Contact:
Christine Fanelle
Scient PR
christine@scientpr.com
215-595-5211


Advertisement

Recommended Stories

  • Moderna Stock Is Having Another Very Bad Day. Here’s Why.

    The stock’s drop comes as Moderna awaits important developments involving its experimental cancer treatment, a new respiratory vaccine, and a possible avian flu vaccine under development.Read the full ...

  • Pfizer Stock Is Near An 11-Year Low — But Is It A Buy On This 'Massive' Upside?

    Pfizer stock is now above its 50-day line on better-than-expected first-quarter sales. Is PFE stock a buy now?

  • Verona prepares for anticipated US launch of ensifentrine for COPD in Q3 2024

    Ensifentrine is a first-in-class dual phosphodiesterase 3/4 inhibitor for the treatment of chronic obstructive pulmonary disease.

  • Johnson & Johnson's Drug Seltorexant Aces Late-Stage Depression Trial

    Wednesday, Johnson & Johnson (NYSE:JNJ) announced topline results from Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms. Seltorexant is an investigational first-in-class selective antagonist of the human orexin-2 receptor being studied for the adjunctive treatment of MDD with insomnia symptoms. Also Read: Johnson & Johnso

  • Insmed stocks soar as Phase III lung disease drug exceeds expectations

    If Insmed’s brensocatib is given the green light, it would be the first therapy approved for patients with bronchiectasis.

  • Amgen Secures FDA Nod For Rare-Disease Treatment Biosimilar Based On AstraZeneca's Drug

    Tuesday, the FDA approved Amgen Inc (NASDAQ:AMGN) Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca Plc’s (NASDAQ:AZN) Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-medi

  • Prothena (PRTA), Bristol Myers Tie Up for Second Neuro Candidate

    Prothena (PRTA) announces that Bristol Myers is exercising its option for the second time, thereby in-licensing exclusive global rights for PRX019 to potentially treat neurodegenerative diseases.

  • Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag

    The FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

  • Analysis-Weight-loss drug forecasts jump to $150 billion as supply grows

    As millions seek access to weight-loss drugs from Novo Nordisk and Eli Lilly, increasing supplies, possible wider usage and a growing number of would-be rivals are leading some experts to raise annual global sales forecasts for the treatments to about $150 billion by the early 2030s. "It is very unusual to have a medicine that is capturing the imagination of millions of people," said Michael Kleinrock, senior research director at healthcare analytics firm IQVIA Institute for Data Science. Most insurers do not cover the new therapies with low co-payments, but an unprecedented percentage of people are paying themselves or with coupons from drug manufacturers, he said.

  • Gilead and Cartography enter deal to develop cancer therapies

    Cartography is entitled to receive $20m upfront, followed by additional near-term preclinical milestone payments.