CT041

Robust Pipeline of 220+ Drugs Advancing for Gastric Cancer Treatment, Led by Major Pharmaceutical Companies

3 months ago

• DelveInsight's comprehensive analysis reveals over 200 companies actively developing 220+ pipeline therapies for gastric cancer treatment, indicating significant industry investment in addressing this disease. • Key players including BeiGene, Bristol-Myers Squibb, and AstraZeneca are advancing promising candidates like tislelizumab, relatlimab-nivolumab combination, and trastuzumab deruxtecan through clinical trials. • Multiple therapeutic approaches are being explored, from monoclonal antibodies to small molecules, with several drugs in late-stage development including Catumaxomab in Phase III and Tivumecirnon in Phase II trials.

Advancements and Challenges in Clinical Trials: A 2024 Overview

4 months ago

2024 has seen significant progress in clinical trials across various diseases, including neurodegenerative diseases, cancer, and eye diseases, with several treatments moving into pivotal Phase III trials. However, the year also witnessed challenges, including missed endpoints in trials targeting motor neurone disease and setbacks in depression treatment trials.

CARsgen's Satri-cel Shows Promise in Phase II Trial for Advanced Gastric and GEJ Cancers

5 months ago

• CARsgen Therapeutics' satri-cel significantly improved progression-free survival in patients with advanced gastric/gastroesophageal junction cancers. • The Phase II trial (CT041-ST-01) evaluated satri-cel in patients with Claudin18.2-positive tumors who had failed at least two prior lines of therapy. • CARsgen plans to submit a New Drug Application to China's NMPA in the first half of 2025, potentially marking the first CAR-T therapy for solid tumors. • Satri-cel has received Breakthrough Therapy Designation from China's NMPA and RMAT designation from the U.S. FDA, expediting its development and review.

FDA Approves Autolus' Obecabtagene Autoleucel (Aucatzyl) for R/R B-cell ALL

6 months ago

• The FDA has approved obecabtagene autoleucel (obe-cel), a CD19-directed CAR-T therapy, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-cell ALL). • Approval was based on the Phase 1b/2 FELIX trial, which demonstrated overall complete remission rates above 60% and durable remissions exceeding 12 months. • Clinical holds on CARsgen's BCMA-directed CAR-T therapy zevorcabtagene autoleucel and Claudin18.2-directed CAR-T satricabtagene autoleucel have been removed by the FDA.

Cell Therapy Advances in Gastric Cancer: CAR-T and Novel Combinations Show Promise

6 months ago

• CARsgen completed enrollment in a pivotal Phase 2 trial of satricabtagene autoleucel (satri-cel), a CLDN18.2-targeted CAR-T therapy, for advanced gastric/gastroesophageal cancer. • A Phase 2 trial has dosed its first patient with refractory gastroesophageal cancer, evaluating the combination of iNKT cell therapy agenT-797 with botensilimab and balstilimab. • Triumvira Immunologics' TAC01-CLDN18.2, a TAC T-cell therapy, is being evaluated in a Phase 1/2 trial for various solid tumors, including gastric cancer.

FDA Lifts Clinical Holds on CARsgen's CAR-T Therapies for Multiple Myeloma and Gastric/Pancreatic Cancers

6 months ago

• The FDA has removed clinical holds on three of CARsgen's CAR-T cell therapies, including zevorcabtagene autoleucel for multiple myeloma. • The holds were initially placed due to chemistry, manufacturing, and controls (CMC)-related questions following an inspection of CARsgen’s facility. • Zevor-cel is already approved in China for relapsed/refractory multiple myeloma after at least three prior lines of therapy. • The lifted holds allow CARsgen to continue clinical trials evaluating satricabtagene autoleucel for gastric/pancreatic cancers and CT071 for multiple myeloma.

FDA Lifts Clinical Holds on CARsgen's CAR-T Therapy Trials

7 months ago

• The FDA has lifted clinical holds on CARsgen Therapeutics' trials for zevor-cel, satri-cel, and CT071, allowing the resumption of these studies in the US. • The holds were initiated due to CMC concerns identified during an inspection of CARsgen's manufacturing facility in Durham, North Carolina. • Zevor-cel targets BCMA for relapsed/refractory multiple myeloma, satri-cel targets claudin 18.2 in solid tumors, and CT071 targets GPRC5D for RRMM and primary plasma cell leukemia.

Vironexis' VNX-101 Cleared for Phase 1/2 Trial in CD19+ Acute Lymphoblastic Leukemia

8 months ago

• Vironexis Biotherapeutics received FDA clearance for its IND application for VNX-101, an AAV-based gene therapy, enabling a Phase 1/2 trial for CD19+ acute lymphoblastic leukemia. • VNX-101 uses the TransJoin platform to express a bispecific T-cell engager, targeting CD19 on tumor cells and CD3 on T-cells to facilitate cancer cell killing. • The Phase 1/2 trial is anticipated to begin in Q4 2024, marking the first clinical trial of an AAV-delivered cancer immunotherapy, with Fast Track and Rare Pediatric Disease designations. • Vironexis' TransJoin technology aims to improve safety, efficacy, and durability compared to CAR-T therapy and bispecific antibodies, while streamlining manufacturing and reducing treatment burden.

CAR-T Therapies Gain Ground in China and Beyond: Regulatory Approvals and Clinical Advancements

9 months ago

• Legend Biotech's Carvykti (cilta-cel) receives approval in China for relapsed or refractory multiple myeloma after multiple lines of prior therapy. • JW Therapeutics' Carteyva (relma-cel) gains approval in China for treating relapsed or refractory mantle cell lymphoma in adult patients. • Galapagos' GLPG5101, a CD19-directed CAR-T therapy, receives FDA clearance for a Phase 1/2 trial in relapsed or refractory non-Hodgkin lymphoma.

Drug Development Updates