Clinical Trial News

IceCure Medical announces FDA Advisory Panel on ProSense® cryoablation for early-stage low risk breast cancer, expected to decide on marketing authorization by early 2025.

Sernova Corp. presented positive interim data from its Phase I/II clinical trial, showing sustained insulin independence in T1D patients with the Cell Pouch Transplant System. Histological data confirmed well-vascularized, functioning islets secreting insulin, glucagon, and somatostatin for over 5 years, with no detrimental fibrotic tissue. The Cell Pouch also demonstrated retrievability and safety.

Sinopia Biosciences awarded $2.2M Phase II SBIR grant from NIDCR to advance oral mucositis program using LEADS® platform, combining AI/ML and high-throughput screening for therapeutic target identification.

GSK's mRNA seasonal flu vaccine showed positive immune responses in younger and older adults, supporting progression to phase III trials. The mRNA platform demonstrated strong antibody titres and acceptable safety profiles.

Bright Minds Biosciences initiates BREAKTHROUGH Study, a Phase 2 trial evaluating BMB-101, a 5-HT2C agonist, for drug-resistant epilepsy. The trial targets 20 adult participants with Absence Epilepsy or Developmental Epileptic Encephalopathy, aiming to assess safety, tolerability, and efficacy. BMB-101, designed for chronic treatment, demonstrated safety and target engagement in Phase 1 studies.

Vironexis launches with $26M seed financing, focusing on AAV-delivered T-cell immunotherapy for safer, more effective cancer treatments. Their TransJoin™ platform supports over 10 product candidates, including VNX-101 for CD19+ acute lymphoblastic leukemia, set for Phase 1/2 trials in Q4 2024.

Summit Therapeutics secured $235 million in a private stock sale, selling over 10 million shares at $22.70 each, equal to the closing price. Major internal figures and biotech investors participated, indicating strong confidence. Funds will advance clinical trials for ivonescimab, an investigational cancer treatment.

Florey MND researchers received a $5 million grant to screen potential MND treatments using world-first iPSC technology, aiming to improve drug trial quality and find effective treatments for the disease.

Losmapimod failed to improve reachable workspace (RWS) in FSHD patients at week 48, leading Fulcrum to suspend its development. Despite this, Fulcrum maintains a robust cash position to advance other therapies, including pociredir for sickle cell disease.

Switching JIA patients from anti-TNF originators to biosimilars showed similar disease activity and drug persistence, with low switching back rates, supporting biosimilar safety and effectiveness.