The first cohort of participants has been dosed in a Phase I trial MTX-474, a human IgG1 antibody designed to neutralise EphrinB2 signalling to treat fibrosis. The study, taking place in Australia, is designed to assess the safety, tolerability, pharmacokinetics, and target engagement of MTX-474 in… Read More
The US Food and Drug Administration (FDA) has cleared GigaGen’s application to initiate a Phase I trial of its polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339. It is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic HBV infection. Carter Keller,… Read More
In a 12-week clinical trial, weekly doses of Altimmune’s pemvidutide resulted in up to 68.5% relative reduction in liver fat content (LFC), with up to 55.6% of subjects achieving LFC normalisation after 12 weeks of treatment. The results of the trial, investigating the GLP-1/glucagon dual receptor… Read More
Oncodesign Precision Medicine (OPM) has announced positive results of a Phase I trial testing the drug candidate OPM-101, administered orally in single ascending doses (SAD) and multiple ascending doses (MAD), in healthy volunteers (HV). OPM-101 is intended for the treatment of resistant and metastatic cancers. Read More
Every week, DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates in the DDW Highlights podcast. It is now also available in a concise vodcast format. Clinical trial news has caught… Read More
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. Clinical trial news has caught our attention this week. Despite the revelation… Read More
News round-up for 8-12 July by DDW Senior Digital Content Editor Diana Spencer. Clinical trial news has caught our attention this week. Despite the revelation from Phesi that a third of clinical trials fail at Phase II, DDW has reported positive human trial updates on therapeutics for myasthenia… Read More
Intellia Therapeutics has shared the first-ever clinical data demonstrating the potential for redosing with an investigational in vivo CRISPR-based therapy. The data from the ongoing Phase I study of NTLA-2001, a single-dose treatment in development for transthyretin (ATTR) amyloidosis, were presented at the Peripheral Nerve Society Annual Meeting. Read More
In a Phase I trial, patients with metastatic kidney cancer who took a live biotherapeutic product alongside immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes. City of Hope, US, researchers are now in discussions with the global SWOG Cancer Research Network to design a… Read More
EXO Biologics has completed dosing of the first cohort of patients in its EVENEW study, the first European Medicines Agency (EMA) authorised clinical trial involving mesenchymal stromal cell (MSC)-based exosomes. The Phase I/II clinical trial is testing the company’s lead candidate EXOB-001, developed to prevent bronchopulmonary… Read More
A team of investigators at City of Hope in the US funded by the Prostate Cancer Foundation (PCF) reports that patients with advanced prostate cancer can be safely treated with chimeric antigen receptor (CAR)-T cell therapy. The results of their first-in-human Phase I clinical trial, which… Read More
Swedish company IRLAB Therapeutics has initiated a Phase I study of IRL757, its drug candidate for apathy – a condition associated with Parkinson’s disease and other CNS diseases. IRL757 has shown positive effects in several preclinical models of cognitive function, including improved motivation. This… Read More
Biomica has revealed encouraging initial findings from an ongoing Phase I clinical trial of its microbiome-based immuno-oncology candidate, BMC128, in combination with an anti-PD1 immune checkpoint inhibitor. The trial is assessing the drug in patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell… Read More
Acepodia has announced promising preliminary data from its Phase I dose escalation clinical trial of ACE1831, an anti-CD20 antibody conjugated allogeneic gamma delta T cell therapy being evaluated in patients with non-Hodgkin’s lymphoma (NHL). One out of five patients demonstrated complete response (CR) and three out… Read More
Kynos Therapeutics has announced positive top line results from the first in human Phase I trial of its lead drug candidate, KMO inhibitor KNS366, for acute and chronic inflammatory disorders. KMO is an enzyme that acts at a key point in the kynurenine pathway of… Read More
The US Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for Tr1X’s TRX103 for the prevention of Graft versus Host Disease (GvHD) in patients undergoing HLA-mismatched haematopoietic stem cell transplantation (HSCT). The company plans to initiate a Phase I study of the investigational allogeneic off-the-shelf… Read More
