Clinical Trial News

The FDA has approved Amtagvi, the first tumor-infiltrating lymphocyte (TIL) therapy, for patients with metastatic melanoma unresponsive to other treatments. This innovative therapy uses the patient's own immune cells to fight cancer, showing promising results in clinical trials.

IMUNON, Inc. announces Memorial Sloan Kettering Cancer Center's participation in a Phase 1/2 trial for IMNN-001 combined with bevacizumab in advanced ovarian cancer patients. The trial aims to assess minimal residual disease and progression-free survival, with initial results expected within a year. IMNN-001, a DNA-based IL-12 immunotherapy, shows promise in transforming ovarian cancer treatment.

A 16-week course of the monoclonal antibody omalizumab has shown to significantly increase the amount of peanut, tree nuts, egg, milk, and wheat that multi-food allergic children can consume without an allergic reaction, offering a new protective measure against accidental exposure.

The ARASENS trial highlights the efficacy of darolutamide combined with androgen-deprivation therapy and docetaxel, showing a significant reduction in the risk of death for patients with metastatic hormone-sensitive prostate cancer.

A groundbreaking study published in the New England Journal of Medicine reveals that CAR-T cell therapy can effectively treat severe autoimmune diseases by rebooting the immune system, eliminating the need for long-term immune-suppressive drugs.

The FDA will not enforce stricter measures against clinical trial sponsors and investigators failing to register studies or report results, citing resource constraints. It prefers voluntary compliance and regulatory discretion, while agreeing to create a dashboard for non-compliance notices.

The FDA issued a clinical hold on zelnecirnon trials due to a patient's liver failure, potentially linked to the drug. Dosing and new enrollments are paused, except for RAPT's tivumecirnon oncology trial. No liver toxicity was found in other participants or nonclinical studies. RAPT investigates the case, emphasizing patient safety and FDA collaboration.

Spectral Medical extends its exclusive supply and distribution agreement with Baxter Healthcare for 10 years post U.S. FDA approval of PMX, a therapeutic device for septic shock. Baxter's commitment supports Spectral's commercialization strategy, with plans to transfer rights to a new Kidney Care company upon separation. Spectral's Tigris Trial progresses, aiming to enhance treatment for endotoxic septic shock.

Immuneering's stock rose 13% to $7.49 in premarket trading after receiving FDA fast-track designation for IMM-1-104, a treatment for pancreatic ductal adenocarcinoma, aimed at patients who have failed one line of treatment.

Mabwell's B7-H3 targeting ADC, 7MW3711, approved by FDA for advanced malignant solid tumor trials, shows promising tumor-killing effects and safety. Developed using IDDC™ platform, it features innovative components for specific tumor targeting and apoptosis induction. Mabwell, with a robust R&D system, focuses on innovative medicines across various therapeutic areas.