XRad Therapeutics announced first patient dosed in Phase 1a clinical trial of XRD-0394 for metastatic, locally advanced or recurrent solid tumours.
Manchester, U.K., 25 August 2021 – The dosing of the first patient into US-based XRad Therapeutics’ Phase 1a study of XRD-0394 in metastatic, locally advanced, or recurrent solid tumours, marks a major milestone for XRad and Aptus Clinical. For XRad, XRD-0394 is their first asset to reach clinical development, whilst for Aptus, this is the first study utilising their US-based CRA team. As part of Aptus’ full-service delivery capability, the US CRAs, working alongside their UK headquartered clinical operations and data management colleagues, now provide significant geographical extension to Aptus’ current experience delivering early phase oncology, cell & gene therapy and rare disease clinical trials in in the UK and EU.
This Phase 1a trial will evaluate the safety and tolerability of single ascending doses of XRD-0394 in combination with radiation therapy. The trial is being conducted at two world-renowned centres of excellence: Memorial Sloan Kettering Cancer Center in New York and the Stanford Cancer Institute in Palo Alto, California. XRD-0394 is a first-in-class, oral, dual kinase inhibitor of both ataxia-telangiectasia mutated and DNA-dependent protein kinase and based on preclinical studies is designed to enhance the effectiveness of radiation therapies. Results from this trial will inform the dosing regimen for the company’s planned Phase 1b study.
Tona Gilmer, PhD, President, Chief Executive Officer and co-founder of XRad, said in a statement: “We are delighted to be working with our clinical CRO partners at Aptus who are managing the delivery of this vital first study in our development programme. Successful completion will allow us to rapidly move to the next step in our clinical development”
Jonathan Lewis, co-founder and Chief Commercial Officer at Aptus Clinical commented “We are thrilled that the XRad team entrusted the clinical delivery of their first asset to Aptus. Having worked initially with members of our consulting team, recognition of the strength and depth of experience in our operational delivery organisation has been a great endorsement of our capabilities. We look forward to working alongside the XRad team to demonstrate the full benefits of this important potential addition to the cancer treatment armamentarium.”
For more information about the study, please visit www.clinicaltrials.gov (NCT05002140). XRD-0394 is not approved for any condition at this time.
About XRad Therapeutics
XRad Therapeutics is a privately held, clinical stage biopharmaceutical company focused on developing dual kinase inhibitors for treating cancer. The company’s lead candidate, XRD-0394, is a first-in-class dual inhibitor of ataxia-telangiectasia mutated (ATM) and DNA-dependent protein kinase (DNA-PK). Initial development efforts are focused on evaluating XRD-0394’s ability to enhance radiation therapy when used in combination. In parallel, the company is exploring the potential benefits of using XRad’s dual kinase inhibitors in combination with targeted radionuclides, checkpoint inhibitors, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors and antibody drug conjugates (ADCs).
About Aptus Clinical Ltd.
Aptus Clinical Limited is a UK headquartered, clinical Contract Research Organisation that specialises in the design, conduct and delivery of early phase clinical studies with a particular focus in oncology, rare diseases, cell and gene therapies. Projects are delivered by a team of highly experienced drug development experts utilising an extensive network of academic links. Aptus partners with clients to help them transform their promising therapies into valued medicines. For more information, visit www.aptusclinical.com
Read XRad’s press release here