MedPath

Tagged News

Chengdu UCELLO Biotech's UC101 Becomes First Allogeneic Universal CAR-T Therapy to Receive FDA IND Approval

CAR-TOncology
  • Chengdu UCELLO Biotech's CD19-targeted allogeneic universal CAR-T therapy UC101 received FDA IND approval on January 11, 2025, marking a historic milestone as the first such product worldwide.
  • The therapy represents a significant advancement in CAR-T technology by utilizing allogeneic universal T cells rather than patient-specific autologous cells, potentially reducing manufacturing time and costs.
  • Challenge IM provided critical ultrafiltration technology and automated cross-flow filtration systems to support UC101's manufacturing processes, demonstrating the importance of specialized bioprocessing equipment in cell therapy development.

Liv Hospital Partners with University of Pennsylvania to Establish Local CAR-T Cell Manufacturing in Turkey

CAR-T
  • Liv Hospital and Istinye University have signed a comprehensive collaboration with the University of Pennsylvania's Perelman School of Medicine to develop CAR-T cell therapy and proton therapy capabilities in Turkey.
  • The partnership will establish good-manufacturing-practice cell production laboratories in Istanbul to produce CAR-T therapies locally, potentially reducing treatment delays and shipping costs.
  • Early-stage trials will focus on relapsed or refractory multiple myeloma, diffuse large B-cell lymphoma, and acute lymphoblastic leukemia, with plans to expand to autoimmune disorders.
  • A multi-room proton therapy center is planned at Liv's oncology campus to serve regional needs and reduce patient travel to other countries for advanced cancer treatment.

Multiple Myeloma Treatment Landscape Shows Promise with Novel Combination Therapies in Recent Clinical Trials

OncologyCAR-T
  • Recent clinical trials demonstrate positive outcomes for multiple myeloma patients using combination therapies including pomalidomide, daratumumab, and novel agents like belantamab mafodotin.
  • Phase 3 studies comparing standard therapies with CAR-T cell therapy (ciltacabtagene autoleucel) are ongoing, with enrollment of 419 patients expected to complete by May 2025.
  • Belantamab mafodotin combinations showed manageable safety profiles in lenalidomide-refractory multiple myeloma patients, with ocular events being controllable through dose modifications.
  • Selinexor-based triplet therapies demonstrated varying response rates, with the 60mg weekly dosing showing superior efficacy compared to 40mg dosing in recent Phase 2 trials.

FDA Lifts Clinical Hold on Allogene's AlloCAR T Studies After Safety Investigation Clears Manufacturing Process

CAR-TOncology
• The FDA has removed a clinical hold on all five of Allogene Therapeutics' AlloCAR T studies that was imposed in October 2021 following a chromosomal abnormality in a single patient. • A three-month investigation concluded that the chromosomal abnormality was unrelated to Allogene's manufacturing process and had no clinical significance for the patient. • The pivotal phase II trial of ALLO-501A in relapsed/refractory large B-cell lymphoma is scheduled to commence in mid-2022. • Allogene's stock rose over 4% in premarket trading following the announcement of the clinical hold removal.

Sana Biotechnology Schedules June 2025 Investor Conference Presentations to Update on Engineered Cell Therapy Pipeline

CAR-T
  • Sana Biotechnology will present at two major investor conferences in June 2025, including the Jefferies Global Healthcare Conference and Goldman Sachs 46th Annual Global Healthcare Conference.
  • The presentations will feature business overviews and updates on the company's engineered cell therapy programs focused on treating diabetes, autoimmune diseases, and cancer.
  • The company is developing innovative therapies including UP421 for diabetes and SC291 for autoimmune disorders, with key clinical data expected in 2025.
  • Sana's approach involves creating engineered cells as medicines to repair genes, replace damaged cells, and make therapies broadly available to patients.

Ruxolitinib Shows Promise in Treating CAR T-Cell Therapy-Induced Parkinsonism in Multiple Myeloma

CAR-TNeurologyOncology
  • Researchers report successful treatment of ciltacabtagene autoleucel-induced parkinsonism in multiple myeloma patients using the JAK inhibitor ruxolitinib, offering a potential solution for this serious complication.
  • Both patients developed immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) alongside parkinsonism, suggesting a possible connection between these conditions in CAR T-cell therapy recipients.
  • The findings are particularly significant as CAR T-cell therapy expands to earlier treatment lines for multiple myeloma, highlighting the urgent need for effective management strategies for neurological complications.

Vyloy Leads Claudin 18.2 Targeted Therapy Revolution with 60+ Drug Candidates in Pipeline

Monoclonal AntibodyCAR-TDrug Approval
  • Vyloy (zolbetuximab) has emerged as the first approved Claudin 18.2-targeted therapy for HER2-negative gastric and gastroesophageal junction adenocarcinoma, marking a significant milestone in precision oncology.
  • The global Claudin 18.2 therapy market is rapidly expanding with over 60 drug candidates in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates.
  • China has become a major innovation hub for Claudin 18.2-targeted therapies, with companies like Innovent, MabWorks, and Biotheus leading development efforts as research expands beyond gastric cancers to other solid tumors.

A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06238843RecruitingPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 6/30/2024

Elicera's iTANK-Armed CAR T-Cell Therapy Shows Complete Response in Lymphoma Patients

CAR-TOncology
  • Elicera Therapeutics reports that two out of three patients in the first cohort of the CARMA study achieved complete metabolic response with ELC-301, an iTANK-armed CD20-targeting CAR T-cell therapy.
  • The promising results were achieved despite using only one-tenth of the planned maximum dose in a challenging patient population, including one patient who had previously failed standard CD19 CAR T-cell therapy.
  • The Phase I/IIa CARMA study has already progressed to its second cohort, where patients are receiving a dose three times higher than the initial cohort, with further data expected as the trial advances.

NUS Researchers Develop NExT: A Revolutionary Gene Delivery Platform for Cancer Immunotherapy

CAR-TOncology
  • Researchers at the National University of Singapore have developed Nanostraw Electro-actuated Transfection (NExT), a non-viral technology that efficiently delivers genetic material into immune cells with minimal disruption.
  • The NExT platform can transfect over 14 million immune cells in a single run with up to 94% efficiency for proteins and 80% for mRNA, while maintaining essential tumor-fighting characteristics.
  • This breakthrough could significantly reduce manufacturing costs and improve accessibility of CAR-T cell therapies, which currently cost approximately S$670,000 per infusion in Singapore.

Pharmacists Take Central Role in Managing Novel Cancer Therapies as CAR-T and Bispecific Antibodies Transform Treatment Landscape

CAR-TOncology
  • Pharmacists have evolved from traditional dispensing roles to comprehensive patient management in cancer care, particularly with novel therapies like CAR-T cell therapy and bispecific antibodies.
  • Patient selection has become a critical pharmacist responsibility, as not every patient qualifies for these advanced therapies and multiple treatment options require careful evaluation.
  • Pharmacists now proactively manage toxicities by monitoring lab results and patient symptoms, enabling dose adjustments and prophylactic interventions to maintain treatment continuity.
  • The expanded role includes value-based care participation, medication adherence monitoring, and close collaboration with multidisciplinary teams to optimize patient outcomes.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.