Tagged News
Vyloy Leads Claudin 18.2 Targeted Therapy Revolution with 60+ Drug Candidates in Pipeline
• 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.
Elicera's iTANK-Armed CAR T-Cell Therapy Shows Complete Response in Lymphoma Patients
• 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
• 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.
Waters Acquires Halo Labs to Enhance Biologic Therapy Analysis Capabilities
• Waters Corporation has acquired Halo Labs, gaining specialized imaging technology that detects particles in cell, protein, and gene therapies with capabilities beyond standard methods.
• The Aura platform's subvisible particle technology provides critical insights for CAR T-cell therapies by detecting translucent process impurities that conventional methods miss.
• This strategic acquisition strengthens Waters' position in specialized analytical technologies for emerging biopharmaceuticals, particularly supporting quality control in advanced therapy development.
Poolbeg Pharma Secures £4.1 Million Fundraising to Advance Clinical Programs in Oncology and Obesity
• Poolbeg Pharma has announced a £4.1 million conditional fundraising to advance its POLB 001 Phase 2a trial for cancer immunotherapy-induced Cytokine Release Syndrome and oral GLP-1 proof of concept trial for obesity.
• The fundraising comprises a £2.655 million placing, £1.345 million in direct subscriptions, and up to £100,000 from a retail offer, with shares issued at 2.5 pence each, representing a 12% discount to the previous closing price.
• The proceeds will extend Poolbeg's cash runway into 2027, supporting multiple near-term clinical data catalysts including first patient dosing for POLB 001 in H2 2025 and topline data expected in H2 2026.
Aging Impairs CAR-T Cell Therapy Effectiveness Through Metabolic Decline, Swiss Study Reveals
• New research from Swiss institutions demonstrates that age-related immune decline significantly reduces the effectiveness of CAR-T cell cancer therapy by impairing mitochondrial function and metabolism.
• Scientists identified decreased levels of nicotinamide adenine dinucleotide (NAD) as the key factor behind reduced antitumor activity in CAR-T cells from older individuals.
• Researchers successfully rejuvenated aged CAR-T cells by restoring NAD levels in preclinical models, suggesting potential strategies to improve immunotherapy outcomes in older cancer patients.
Lymphodepletion Enhances MAR-T Cell Therapy Efficacy in Lymphoma Patients, Marker Therapeutics Reports
• Marker Therapeutics' Phase 1 APOLLO study shows lymphodepletion significantly improves expansion and persistence of MT-601 MAR-T cells in lymphoma patients, potentially enhancing anti-tumor activity.
• Early clinical data reveals promising efficacy with 78% objective response rate and 44.4% complete response rate in patients who relapsed after or are not candidates for anti-CD19 CAR-T therapy.
• The non-genetically modified MAR-T cell approach targets six different tumor antigens, demonstrating excellent safety with no dose-limiting toxicities while potentially offering manufacturing advantages over current engineered T cell therapies.
Related Clinical Trials:
Marker Therapeutics, Inc.
Posted 1/2/2023
Novel BAFF-R CAR-T Therapy Achieves Complete Response in Heavily Pretreated Follicular Lymphoma Patient
• PeproMene Bio's first-in-class BAFF-R targeted CAR-T cell therapy (PMB-CT01) has achieved complete remission in a heavily pretreated follicular lymphoma patient who had failed seven prior therapies including CD19 CAR-T.
• All seven patients with relapsed/refractory B-cell non-Hodgkin lymphoma treated with PMB-CT01 have achieved complete responses lasting from 1 to 29+ months, with minimal toxicity reported.
• PMB-CT01 targets the BAFF receptor, which is crucial for B-cell survival, potentially making it harder for tumor cells to escape therapy through antigen loss compared to CD19-targeted approaches.
Related Clinical Trials:
PeproMene Bio, Inc.
Posted 5/18/2021
PeproMene Bio, Inc.
Posted 6/13/2022
Tessera Therapeutics Reports Breakthrough Gene Editing Results for Multiple Genetic Diseases
• Tessera's RNA Gene Writer technology achieved 76% and 70% editing efficiency in hepatocytes for alpha-1 antitrypsin deficiency and phenylketonuria respectively, with high specificity and durability in non-human primate studies.
• Preclinical data for sickle cell disease demonstrated greater than 20% editing in long-term hematopoietic stem cells across multiple species, potentially reaching curative thresholds without requiring stem cell transplantation.
• The company's proprietary lipid nanoparticle delivery system showed high liver specificity with no off-target activity detected, advancing the potential for in vivo gene editing therapies for multiple genetic disorders.
Intermountain Health Pioneers First Remote CAR-T Cell Collection Site in Southern Utah
• Intermountain Health has established the nation's first remote CAR-T cell collection site at St. George Regional Hospital, bringing advanced cancer treatment closer to patients in Southern Utah and Nevada.
• The innovative satellite clinic eliminates the need for patients to travel hundreds of miles to Salt Lake City for initial collection procedures, significantly improving accessibility to this cutting-edge immunotherapy.
• CAR-T cell therapy, which reprograms patients' immune cells to target and destroy cancer cells, has shown remarkable success in treating various hematologic cancers including leukemia, lymphoma, and multiple myeloma.