US-based biopharmaceutical company XyloCor has signed a licensing agreement with SmartWise, a company of SmartCella, to use the latter’s Extroducer Infusion Catheter System.
Under the licence agreement, XyloCor will obtain a global licence to Extroducer, in exchange for up to $130m in upfront payment, along with milestone payments and royalty on sales.
Extroducer is an endovascular device designed to deliver advanced therapeutics directly into the heart, along with other hard-to-reach tissues.
XyloCor intends to use the endovascular device to support the catheter-based endocardial delivery of its lead gene therapy candidate, XC001 (encoberminogene rezmadenovec).
XyloCor president and CEO Al Gianchetti 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 is designed to promote new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor (VEGF), to improve blood flow.
By restoring the blood flow, the drug will decrease chest pain, and improve the patients’ quality of life, allowing them to engage in daily physical activities that would otherwise cause pain.
In the recently published EXACT Phase 1/2 trial, XC001 directly administered to the heart in 42 participants showed safe administration and achieved durable clinical improvements.
XC001 was well tolerated in the study, with no serious adverse events related to the drug.
Using the Extroducer catheter, XyloCor can provide a better delivery option for local administration of XC001 directly to the heart, which is less invasive and prevents risks.
SmartCella CEO Niklas Prager said: “The collaboration underscores the transformative potential of the Extroducer in delivering XC001 therapy for patients with refractory angina.
“A great example of a powerful combination of delivery system and drug therapy representing a substantial advancement in treatment options.
“The collaboration with such a distinguished partner as XyloCor marks a significant milestone for our global expansion efforts and will also enable us to further explore and harness the future capabilities of the Extroducer, ultimately expanding the benefits to a greater number of patients in need.”