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Wugen Secures $115 Million to Advance First-in-Class Off-the-Shelf CAR-T Therapy for T-Cell Malignancies

CAR-TOncology
  • Wugen raised $115 million in financing led by Fidelity Management & Research to advance its pivotal T-RRex trial of WU-CART-007, an off-the-shelf CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
  • WU-CART-007 demonstrated exceptional efficacy in Phase 1/2 trials with a 91% overall response rate and 73% complete remission rate, substantially outperforming current standard-of-care therapies for these aggressive malignancies.
  • The company aims to file a Biologics License Application in 2027, positioning WU-CART-007 as the potential first approved allogeneic CAR-T therapy for T-cell malignancies.
  • The therapy uses CRISPR gene editing technology and donor-derived cells to create an accessible, scalable treatment that eliminates the need for patient-specific cell extraction and manipulation.

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

NCT06514794RecruitingPhase 2
Wugen, Inc.
Posted 1/31/2025

A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

NCT04984356CompletedPhase 1
Wugen, Inc.
Posted 1/14/2022

Charles River Laboratories Joins EU-Backed EASYGEN Consortium to Accelerate Bedside CAR-T Manufacturing

CAR-TOncology
  • Charles River Laboratories has joined the EASYGEN Consortium, a European Union-backed initiative aimed at developing fully automated, hospital-based CAR-T cell therapy manufacturing within 24 hours.
  • The company will leverage its 3D screening technologies and patient-derived xenograft bank to create an ex vivo platform for rapid safety and efficacy screening of CAR-T cell candidates.
  • Currently, fewer than 20 percent of eligible patients receive CAR-T therapy due to complex, time-intensive manufacturing processes and limited capacity at specialized facilities.
  • The five-year research project involves 18 academic, research, industry and clinical partners across eight countries, targeting reduced costs and expanded patient access to personalized cell therapies.

NCI Funding Cut Forces Pediatric Brain Tumor Consortium to Halt Clinical Trial Enrollment

CAR-T
  • The National Cancer Institute has paused funding for the Pediatric Brain Tumor Consortium, forcing children's hospitals and cancer centers to halt enrollment in six active pediatric brain tumor trials.
  • The PBTC, which includes more than a dozen children's hospitals across the U.S. and Canada, will lose its $4 million annual funding when the current award expires in March 2026.
  • Five trials evaluating novel therapies for pediatric brain cancers, including a CAR T-cell therapy for ependymoma, are now suspended despite brain tumors being the leading cause of cancer-related death in children.
  • While the NCI plans to transfer some studies to the Pediatric Early Phase Clinical Trials Network, advocates warn this transition will reduce trial access and slow progress for families facing limited treatment options.

Kite Acquires Interius BioTherapeutics for $350M to Advance In Vivo CAR-T Platform

CAR-TOncology
  • Kite, a Gilead Company, has entered into a definitive agreement to acquire Interius BioTherapeutics for $350 million to advance in vivo CAR-T cell therapy development.
  • Interius's innovative platform generates CAR-T cells directly within the patient's body through a single intravenous infusion, eliminating the need for preconditioning chemotherapy and complex cell processing.
  • The acquisition aims to expand access to cell therapies for patients with rapidly progressing diseases who previously could not benefit from traditional CAR-T treatments.
  • The transaction is expected to reduce Gilead's 2025 earnings per share by approximately $0.23-$0.25 and will create a center of excellence in Philadelphia for next-generation in vivo therapies.

Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment

NCT06539338RecruitingPhase 1
Interius BioTherapeutics Inc.
Posted 10/7/2024

Wistar Institute Launches $17 Million Personalized HIV Cure Initiative with Six-Component Therapy Approach

CAR-T
  • The Wistar Institute received a five-year, $17 million NIH grant to launch the iCure Consortium, developing individualized cure regimens for HIV through personalized medicine approaches.
  • The innovative six-part therapy combines neutralizing antibodies, mRNA therapy, viral binders, engineered CAR-T and NK cells, and precision latency drugs tailored to each patient's unique virus.
  • The consortium aims to eliminate persistent viral reservoirs that remain after antiretroviral therapy, targeting durable drug-free remission for HIV patients.
  • Led by Nobel Laureate Drew Weissman and Luis Montaner, the initiative represents the first comprehensive personalized approach to HIV cure research.

Qihan Biotech Receives FDA Clearance for QT-019B, First Universal Dual-Target CAR-T Therapy for Refractory Lupus

CAR-TGene Editing
  • The FDA has cleared Qihan Biotech's IND application for QT-019B, enabling a Phase 1/2 clinical trial for refractory systemic lupus erythematosus in the United States.
  • QT-019B is an off-the-shelf allogeneic CAR-T therapy targeting both CD19 and BCMA antigens, engineered with gene editing to reduce immune rejection and enhance persistence.
  • The therapy has shown promising results in investigator-initiated clinical studies in China against multiple refractory autoimmune diseases, including systemic lupus erythematosus.
  • Qihan Biotech is developing next-generation CAR-T therapies that will not require lymphodepletion, potentially transforming treatment paradigms for autoimmune diseases.

Oman Achieves Medical Milestone with First Successful CAR-T Cell Therapy Implementation

CAR-TPrecision Medicine
  • The University Medical City in Oman successfully implemented the first CAR-T cell therapy in the Sultanate, positioning the country among regional leaders in advanced blood cancer treatment.
  • The therapy has demonstrated remarkable response rates in patients with B-cell Acute Lymphoblastic Leukemia and Diffuse Large B-cell Lymphoma, particularly for those unresponsive to conventional treatments.
  • This achievement results from collaboration between national medical teams and international partners, marking a significant step toward medical self-sufficiency and reduced overseas treatment costs.
  • The implementation represents a pioneering milestone in localizing cutting-edge immunotherapy previously available only at select international centers.

CHOP Researchers Discover Novel RNA Fragments as Immunotherapy Targets for Pediatric Brain Tumors

CAR-TMonoclonal Antibody
  • Researchers at Children's Hospital of Philadelphia identified missing messenger RNA fragments called microexons in pediatric high-grade glioma tumors that could enhance immunotherapy effectiveness.
  • The study revealed that glioma cells skip specific NRCAM microexons, creating a tumor-specific protein variant essential for cancer cell migration and invasion.
  • Scientists developed a monoclonal antibody targeting the glioma-specific NRCAM protein that successfully marks tumor cells for destruction by T cells in preclinical studies.
  • The findings could lead to safer CAR-T cell therapies for brain tumors and may apply to other solid tumors including glioblastoma multiforme.

Allogene Therapeutics Reports Narrowed Q2 Loss Despite Clinical Trial Delays for CAR-T Programs

CAR-TOncology
  • Allogene Therapeutics narrowed its GAAP net loss to $0.23 per share in Q2 2025, beating estimates of $0.27 per share while maintaining a strong cash position of $302.6 million.
  • The company delayed key clinical trial timelines for its lymphoma and autoimmune disease programs by approximately two quarters due to operational challenges at trial sites.
  • Over 250 patients have been consented for screening across trials, with the ALPHA3 futility analysis for cema-cel now expected in the first half of 2026.
  • The company's cash runway is projected to extend into the second half of 2027, supporting continued development of its off-the-shelf CAR-T therapy pipeline.

CIT Therapeutics Secures $2.5M Partnership with IFLI to Advance Novel SUMOylation-Targeted Cancer Therapy

CAR-TOncology
  • CIT Therapeutics has formed a strategic partnership with the Institute for Follicular Lymphoma Innovation (IFLI), securing up to $2.5 million in funding to advance its lead candidate SB-4826 into Phase I/Ib clinical trials.
  • SB-4826 is a first-in-class, orally bioavailable small molecule that selectively inhibits the SUMO E1 enzyme through an allosteric covalent mechanism, targeting SUMOylation pathways in cancer treatment.
  • The upcoming clinical trial will evaluate SB-4826 in patients with Non-Hodgkin Lymphoma, including those with relapsed or refractory follicular lymphoma.
  • This partnership represents part of IFLI's broader 2025 strategy to support multiple innovative programs, including CAR T-cell therapies and real-world data initiatives for follicular lymphoma treatment advancement.

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