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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 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

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

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.

St. Jude Develops AI-Powered Tool to Accelerate Dual-Target CAR-T Cell Therapy Design

CAR-TAI
  • St. Jude researchers developed a computational tool that screens thousands of tandem CAR designs in days, dramatically accelerating development of dual-target immunotherapies.
  • The AI-informed algorithm successfully optimized CAR-T cells targeting pediatric brain tumor proteins B7-H3 and IL-13Rα2, completely clearing tumors in four out of five mice.
  • The computational approach overcame key challenges in tandem CAR design, including poor surface expression and suboptimal cancer-killing ability that have limited effectiveness against solid tumors.
  • The tool can screen approximately 1,000 CAR constructs in days versus the years required for traditional laboratory-based design approaches.

Sana Biotechnology Reports Breakthrough in Type 1 Diabetes Cell Therapy with 6-Month Clinical Data

CAR-T
  • Sana Biotechnology presented positive 6-month clinical results showing hypoimmune-modified pancreatic islet cells survived and functioned without immunosuppression in type 1 diabetes patients.
  • The New England Journal of Medicine published the company's 12-week clinical results, demonstrating stable C-peptide production and successful immune evasion.
  • The company raised $105 million in new capital and expects to file investigational new drug applications for SC451 and SG299 as early as 2026.
  • Clinical data from ongoing GLEAM and VIVID trials evaluating allogeneic CAR T cell therapies are expected to be reported in 2025.

Sartorius Stedim Biotech Partners with Nanotein Technologies to Enhance Cell Therapy Manufacturing with NanoSpark® Platform

CAR-T
  • Sartorius Stedim Biotech has entered into an exclusive global distribution agreement with Nanotein Technologies for NanoSpark® immune cell activation reagents, investing up to $3 million in a minority shareholding.
  • The partnership focuses on commercializing NanoSpark® STEM-T and GROW-NK soluble activators designed to enhance T cell and natural killer cell expansion for CAR-T and NK-based cancer therapies.
  • Nanotein's technology addresses critical manufacturing challenges by providing feeder-free solutions that generate higher yields of healthier immune cells with improved therapeutic functionality.
  • The collaboration aims to develop additional novel products for the rapidly expanding cell and gene therapy markets, with cGMP grade STEM-T expected in late 2025 and GROW-NK in 2026.

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