XyloCor Therapeutics & SmartCella Seal Deal On Heart Gene Therapy System

XyloCor Therapeutics, Inc. (“XyloCor”), a clinical-stage biopharmaceutical company focused on innovative gene therapies for cardiovascular disease, has formed a licensing agreement with SmartWise, a division of SmartCella Holding AB (“SmartCella”). Under this agreement, XyloCor gains access to the Extroducer® Infusion Catheter System®, a pioneering endovascular device designed for delivering advanced therapies directly to the heart and challenging-to-reach tissues. XyloCor intends to utilize the Extroducer for catheter-based endocardial delivery of its leading gene therapy candidate, XC001 (encoberminogene rezmadenovec), in upcoming clinical trials and for future commercial applications.

AI Gianchetti, President & CEO of XyloCor, said “This agreement with SmartCella will enable XyloCor to build upon its robust foundation of efficacy and safety data for XC001 by offering the potential for improved safety and ease of delivery without surgery via this novel catheter. Teaming up with SmartCella will help in our effort to optimize patient safety and tolerability while maintaining accurate delivery of XC001 to target areas in the heart for patients with refractory angina. It also opens up the potential to develop XC001 earlier in the coronary artery disease progression for even larger patient groups.”

XC001 aims to alleviate ischemic burden by promoting the formation of new blood vessels in the heart through the localized expression of various isoforms of vascular endothelial growth factor (VEGF). By employing the Extroducer catheter, XyloCor can provide patients with a superior delivery method for administering XC001 directly to the heart. This approach is less invasive and mitigates the potential risks linked to surgical procedures.

Timothy D. Henry MD, Interventional Cardiologist and Director of the Lindner Center, The Christ Hospital, Cincinnati, Ohio, said “We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina. Preclinical models provide strong evidence that this approach will maintain, or even improve the efficacy when compared to surgical delivery and it should lower the risk of complications that may arise from surgical administration. I am looking forward to initiating the Phase 2b trial of XC001 in patients with refractory angina using this innovative administration approach.”

A recent publication on the EXACT Phase 1/2 trial explored the potential of XC001, a one-time gene therapy, as a novel treatment for refractory angina—a chronic and debilitating condition affecting over a million people in the United States with rising prevalence. In this trial, 42 patients with class II-IV angina underwent direct heart administration of XC001 through minimally invasive surgery. The findings revealed that XC001 can be safely administered, leading to sustained clinical improvements in exercise duration and reduced angina frequency, attributed to decreased ischemic burden as measured by Positron Emission Tomography (PET) imaging. Remarkably, six months post-treatment, 43% of patients experienced no chest pain during regular activities, and at the 12-month follow-up, 58% reported no angina episodes. XC001 was well tolerated, with no serious adverse events linked to the therapy. The upcoming Phase 2b trial will be a randomized, double-blind study.