XyloCor and SmartCella Sign License Agreement for XC001 Heart Gene Therapy Delivery System

XyloCor Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing innovative gene therapies for cardiovascular diseases, has partnered with SmartWise, a division of SmartCella Holding AB. This collaboration grants XyloCor the rights to use the Extroducer® Infusion Catheter System®, an advanced endovascular device designed for direct delivery of therapies to the heart. XyloCor will employ this technology to enhance the delivery of its leading gene therapy candidate, XC001 (encoberminogene rezmadenovec), in both upcoming clinical trials and eventual commercial applications.

Al Gianchetti, President and CEO of XyloCor, highlighted the significance of this partnership, stating that the agreement would enable the company to leverage its strong efficacy and safety data for XC001. The Extroducer catheter offers a less invasive method for delivering XC001, which could significantly improve patient safety and ease of administration. This catheter-based approach aims to optimize the targeted delivery of XC001 to patients suffering from refractory angina, a severe form of chest pain that persists despite available treatments.

XC001 works by promoting the growth of new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor (VEGF). This process helps reduce ischemic burden and provides patients with a less invasive alternative for gene therapy administration, eliminating the risks associated with surgical procedures.

Dr. Timothy D. Henry, an Interventional Cardiologist and Director of the Lindner Center at The Christ Hospital in Cincinnati, praised the Extroducer catheter's potential. He noted that preclinical models show this method could maintain or even enhance the efficacy of gene therapy while reducing complications compared to surgical delivery. Dr. Henry expressed enthusiasm for the upcoming Phase 2b trial, which will explore the safety and effectiveness of administering XC001 using this innovative catheter system.

The positive results from the recently published EXACT Phase 1/2 trial underscore the promise of XC001. This trial evaluated the safety and efficacy of one-time gene therapy with XC001 in patients with refractory angina, a chronic condition affecting over a million people in the U.S. The trial involved 42 patients who underwent minimally invasive procedures to receive XC001 directly into the heart. Results showed that XC001 could be safely administered and led to significant improvements in exercise duration and reduction in angina frequency. After six months, 43% of patients reported no chest pain during ordinary activities, and 58% experienced no angina episodes at the 12-month follow-up.

The Phase 2b study, which will be randomized and double-blinded, aims to further evaluate the safety and efficacy of XC001 delivered via the Extroducer® Infusion Catheter in patients with refractory angina.

Niklas Prager, CEO of SmartCella, emphasized the transformative potential of the Extroducer in delivering XC001 for patients with refractory angina. He noted that this collaboration with XyloCor represents a substantial advancement in treatment options and marks a significant milestone for SmartCella's global expansion efforts.

Under the terms of the agreement, XyloCor has secured a global license to use the Extroducer for administering XC001. SmartCella will supply the catheters for clinical trials and commercial use in exchange for an upfront payment, along with clinical, regulatory, and commercial milestones, and royalties on sales. The total value of the deal is approximately USD 130 million, with mid-single-digit royalties.

XC001 aims to improve blood flow in the heart by promoting new blood vessels, thereby reducing chest pain associated with refractory angina and enhancing patients' quality of life. The Extroducer® Infusion Catheter System facilitates direct-to-tissue drug delivery, addressing significant unmet needs in the treatment of solid tumors, genetic disorders, and tissue repair. SmartWise received FDA clearance for the Extroducer catheter in June 2022.

XyloCor Therapeutics continues to innovate in the field of cardiovascular gene therapy, with XC001 as its lead candidate. The company is also developing XC002 for cardiac tissue repair following heart attacks. SmartCella, founded in 2014, combines advanced delivery platforms with cutting-edge cell and mRNA therapies to maximize the potential of targeted treatments.