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Allogene Therapeutics Modifies ALPHA3 Trial Design Following Patient Death, Adopts Standard Lymphodepletion Protocol

CAR-T
  • Allogene Therapeutics has discontinued the FC plus ALLO-647 lymphodepletion arm in its ALPHA3 trial after a patient death from hepatic failure attributed to disseminated adenovirus infection.
  • The company will proceed with standard fludarabine and cyclophosphamide (FC) lymphodepletion for cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma.
  • This strategic shift eliminates ALLO-647 from all current trials and accelerates focus on the company's next-generation Dagger Platform Technology for future CAR-T development.
  • The modified ALPHA3 trial continues as a two-arm randomized study comparing cema-cel after standard FC to observation, with futility analysis scheduled for first half 2026.

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

NCT06500273RecruitingPhase 2
Allogene Therapeutics
Posted 6/18/2024

Everest Medicines Invests $30.9M in I-Mab Following Promising 83% Response Rate for Gastric Cancer Bispecific Antibody

CAR-T
  • Everest Medicines has made a strategic $30.9 million equity investment in I-Mab, bringing its total ownership to 16.1% of the U.S.-based biotech company.
  • I-Mab's lead bispecific antibody givastomig demonstrated an impressive 83% overall response rate in combination with immunotherapy in a Phase 1b trial for first-line gastric cancer.
  • The strategic partnership combines I-Mab's 4-1BB receptor targeting platform with Everest's mRNA cancer vaccines and CAR-T therapies, creating synergistic development opportunities.
  • The collaboration leverages I-Mab's clinical translational capabilities in the U.S. with Everest's strong presence in Asian markets for accelerated global expansion.

UCLA Scientists Achieve First-in-Human Reprogramming of Stem Cells to Generate Renewable Cancer-Fighting T Cells

CAR-T
  • UCLA researchers successfully demonstrated the first-in-human reprogramming of blood-forming stem cells to continuously produce cancer-targeting T cells in a groundbreaking clinical trial.
  • The approach creates an "internal factory" that generates tumor-targeting immune cells over time, potentially offering longer-lasting protection against cancer recurrence.
  • One patient with aggressive sarcoma showed tumor regression and maintained detectable levels of engineered immune cells for months following treatment.
  • The therapy targets NY-ESO-1, a cancer-testis antigen found in approximately 80% of synovial sarcomas but rarely in healthy adult tissues.

Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer

NCT03240861TerminatedPhase 1
Jonsson Comprehensive Cancer Center
Posted 7/26/2017

ZUMA-7 Trial Demonstrates Survival Advantage for Second-Line CAR-T Therapy in Refractory DLBCL

CAR-T
  • The ZUMA-7 trial remains the only randomized CAR-T therapy study to demonstrate an overall survival benefit compared to standard of care in primary refractory diffuse large B-cell lymphoma.
  • Patients who received CAR-T therapy in second-line treatment showed superior outcomes compared to those who delayed treatment until third-line, highlighting the importance of early intervention.
  • CAR-T patients experienced faster recovery and return to baseline quality of life compared to those undergoing high-dose chemotherapy and autologous transplant.
  • Long-term follow-up data from pivotal trials show approximately 35% of patients achieve durable responses, suggesting potential cure in this subset with manageable long-term toxicity profiles.

Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma

NCT05459571Active, Not RecruitingPhase 2
Kite, A Gilead Company
Posted 8/9/2022

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

ViroCell Biologics Partners with AvenCell Therapeutics to Advance Dual-Targeted Allogeneic CAR-T Therapy

CAR-TOncology
  • ViroCell Biologics has delivered a novel retroviral vector to AvenCell Therapeutics for their investigational CD19/CD20 dual-targeted CAR-T therapy AVC-203, designed for B cell malignancies and autoimmune diseases.
  • AVC-203 is an allogeneic "off-the-shelf" CAR-T cell therapy engineered to mitigate graft-versus-host disease and graft rejection, incorporating AvenCell's RevCAR receptor for additional antigen targeting with in vivo "off/on" capability.
  • The therapy is expected to enter a phase I clinical trial for relapsed/refractory B cell lymphoma in the second half of 2025, with potential advantages of improved efficacy, immediate treatment availability, and reduced cost compared to existing CAR-T therapies.

ImmunoACT Achieves Profitability with India's First CAR-T Therapy, Treating Over 350 Cancer Patients

CAR-TDrug Approval
  • ImmunoACT reported ₹62 crore in revenue and ₹12 crore profit before tax in FY25, marking rare profitability for an Indian biotech startup in its first full year of operations.
  • The company's NexCAR19 therapy, priced 90% lower than US and European counterparts, has been administered to over 350 patients across 70 hospitals since its April 2024 launch.
  • NexCAR19 demonstrated significant clinical benefits with 40% progression-free survival in B-cell non-Hodgkin lymphoma and 60% in B-cell acute lymphoblastic leukemia patients.
  • The therapy's cost has decreased from ₹42 lakh to ₹30 lakh per dose, with further price reductions expected as production scales and demand increases.

Leveragen and Propeller Bio Form Strategic Partnership to Advance Next-Generation Antibody Discovery Platform

CAR-T
  • Leveragen, a Boston-based biotech company, has announced a strategic collaboration with newly launched Propeller Bio to advance antibody and protein-based therapeutics development.
  • The partnership provides Propeller Bio access to Leveragen's proprietary Singularity Sapiens Mouse platform, which produces fully human single-domain antibodies with strong developability and diverse epitope coverage.
  • Propeller Bio is led by David Shen, former CEO of Proteologix, which was acquired by Johnson & Johnson for $850 million upfront in 2024.
  • The Singularity Sapiens Mouse platform supports multiple therapeutic formats including bispecifics, antibody-drug conjugates, CAR-T therapies, and mRNA-encoded antibodies.

Lyell Immunopharma Secures $100 Million Private Placement to Advance CAR T-Cell Therapy Development

CAR-T
  • Lyell Immunopharma announced a private placement agreement for up to $100 million in gross proceeds to advance its next-generation CAR T-cell therapy programs.
  • The funding includes an initial $50 million closing at $13.32 per share, with potential for an additional $50 million upon achieving clinical milestones related to the LYL314 PiNACLE pivotal trial.
  • The proceeds will fund two pivotal-stage clinical trials of LYL314 and extend the company's cash runway into mid-2027, supporting a planned Biologics License Application submission for large B-cell lymphoma treatment.
  • LYL314 is a dual-targeting CD19/CD20 CAR T-cell therapy designed to improve complete response rates and duration compared to approved CD19-targeted therapies.

Everest Medicines Raises HK$1.57 Billion to Accelerate AI+mRNA Platform and Pipeline Development

CAR-TOncology
  • Everest Medicines completed a significantly oversubscribed share placement raising approximately HK$1.57 billion to fund global R&D and commercialization efforts.
  • The company will allocate 50% of proceeds to advance its AI+mRNA platform, including EVM14 and EVM16 cancer vaccines that have achieved regulatory milestones.
  • EVM14 became Everest's first mRNA therapeutic vaccine to receive dual IND acceptance from both China's NMPA and the U.S. FDA.
  • The funding will also support commercialization of existing products including NEFECON for IgA nephropathy and the anticipated approval of VELSIPITY for ulcerative colitis.

UK Becomes First Country to Enable Point-of-Care Manufacturing for Personalized Therapies

CAR-T
  • The UK has enacted world-first legislation allowing personalized medicines to be manufactured at hospitals, clinics, and near patients' homes, reducing treatment delivery times from months to days.
  • The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 covers cell and gene therapies, tissue-engineered treatments, 3D-printed products, blood products, and medicinal gases.
  • The framework supports mobile manufacturing units and enables final manufacturing steps at the point of care, potentially preventing patients from becoming too unwell to receive CAR-T therapies due to extended wait times.
  • This legislation represents a significant advancement toward truly personalized medicine and is part of the NHS 10-year plan announced by the UK government.

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