Clinical Trial News

Sanofi’s Sarclisa, combined with standard care, significantly improves progression-free survival in newly diagnosed multiple myeloma patients eligible for stem cell transplant, as shown in a Phase III trial. It targets CD38, leading to cell death and immune-mediated destruction. Sarclisa, already approved for relapsed refractory multiple myeloma, aims for earlier treatment settings, competing with Johnson & Johnson’s Darzalex.

Lykos Therapeutics received a complete response letter from the FDA for midomafetamine capsules for PTSD, requesting an additional Phase 3 trial. The company plans to meet with the FDA to discuss resubmission and address concerns raised during the Advisory Committee meeting.

First patients enrolled in US pivotal study of AI-based image analysis module for lung cancer by Invenio Imaging, in collaboration with Johnson & Johnson and multiple cancer centers.

FDA approves neffy (epinephrine nasal spray) 2 mg for Type I Allergic Reactions, including anaphylaxis, in adults and children ≥30 kg, marking the first needle-free epinephrine treatment innovation in over 35 years.

FDA declined approval for MDMA as PTSD therapy, citing insufficient data and safety concerns, despite advocacy from veterans and mental health groups. Lykos Therapeutics plans to request reconsideration. This decision impacts the broader push for psychedelic treatments, with ongoing research into substances like psilocybin for mental health conditions.

FDA approves Lymphir (denileukin diftitox-cxdl) immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Lymphir targets the interleukin-2 (IL-2) receptor on malignant T-cells and Tregs, offering rapid skin relief without cumulative toxicity. The approval is based on a Phase 3 study showing a 36.2% Objective Response Rate (ORR) with 8.7% achieving Complete Response (CR), and a median time to response of 1.4 months.

WestGene Biopharma's mRNA therapeutic cancer vaccine, WGc-043, receives dual IND approvals from China's NMPA and the US FDA, marking the world's first for EBV-related cancers. Featuring AI-assisted antigen screening and an advanced delivery system, WGc-043 targets EBV-positive solid tumors and hematologic malignancies, with promising safety and efficacy data from previous trials.

NanoViricides, Inc. updates on NV-387, a broad-spectrum antiviral drug mimicking host cells to disable viruses. Demonstrated effectiveness in animal trials against Influenza, COVID, RSV, and orthopoxviruses. Plans Phase II trials for human effectiveness, aiming for regulatory approval and market entry. Exploring collaborations to accelerate development.

A federal mandate in 2022 required all state Medicaid programs to cover routine costs of clinical trial participation, aiming to improve equity in study participation. A study found that states with such mandates saw a 5% increase in Black or Hispanic patient enrollment in oncology trials after Medicaid expansion under the ACA. The study emphasizes the need for collaboration between states and frontline clinicians to ensure awareness and implementation of the policy change, potentially improving cancer clinical trial diversity.

Novartis receives FDA accelerated approval for Fabhalta (iptacopan) to reduce proteinuria in primary IgA nephropathy (IgAN), targeting the alternative complement pathway. Approval based on Phase III APPLAUSE-IgAN study interim analysis showing 44% reduction in proteinuria at 9 months vs. 9% with placebo. Continued approval contingent on eGFR data expected in 2025.