XyloCor Therapeutics – a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease – announced the completion of a $67.5 million Series B financing. And the new investment will support a randomized, double-blind Phase 2b clinical trial (EXACT-2) of XC001 (encoberminogene rezmadenovec), in refractory angina, using a new non-surgical method of endocardial administration via a novel injection catheter.
The investment will also fund a second randomized, double-blind Phase 2 trial of XC001 as an adjunctive treatment to coronary artery bypass graft surgery (CABG). XC001 offers a new therapeutic approach for debilitating and chronic conditions that impact over one million people in the United States who have no treatment options.
New investor Jeito Capital led the Series B funding round, including existing institutional investors EQT, Fountain Healthcare Partners, and Lumira Ventures. Rachel Mears, Partner at Jeito Capital, will join the XyloCor Board of Directors.
XyloCor is pioneering the application of one-time gene therapy for addressing significant unmet treatment needs among underserved patients with cardiovascular disease. In its initial target indication in refractory angina, XC001 has demonstrated the potential to transform outcomes for patients who have exhausted available treatment options and have a debilitating quality of life. The positive results from the recently published Phase 1/2 clinical trial (EXACT-1) demonstrate the disease-modifying potential of XC001 to relieve chest pain in patients with refractory angina by reducing ischemic burden
Based on the foundation of efficacy and safety data for XC001 showed in EXACT-1, XyloCor plans to launch a randomized, double-blind Phase 2b in refractory angina in 2025 to further build upon the clinically meaningful evidence generated to date. And XyloCor intends to deploy a catheter‑based endocardial delivery of XC001 in the Phase 2b EXACT-2 study, eliminating the need for surgical administration in this population.
XyloCor looks to initiate a second Phase 2 trial of XC001 in 2025 as an adjunctive therapy to augment the effectiveness of CABG: a procedure used to treat coronary artery disease. CABG is generally recommended when there are significant blockages in the major coronary arteries to improve oxygen-rich blood flow, improve cardiovascular disease symptoms and quality of life, and reduce future cardiac events.
There are about 400,000 CABG procedures performed annually in the United States, in which an estimated one-third of procedures result in incomplete coronary revascularization, which can result in increased mortality, hospitalizations, repeat revascularizations, and angina symptoms. Administering XC001 during the CABG procedure is supposed to promote the growth of new blood vessels in the areas of the heart not treated by the bypass grafts and reduce symptoms and improve outcomes beyond the bypass alone. XyloCor plans to dose the first patient in the Phase 2 study by the end of the year.
KEY QUOTES:
“We are delighted to have Jeito Capital join our strong investor syndicate and Board of Directors. The support of this prominent group of life sciences investors is recognition of the progress we have made and confidence in our ability to reach important milestones in the path ahead. With this financing, we can accelerate our clinical development of XC001, completing two phase 2 clinical trials, and achieve our mission to help people with cardiovascular disease who have no treatment options.”
– Al Gianchetti, president and chief executive officer of XyloCor Therapeutics
“We are thrilled to support XyloCor as it advances its clinical trials to evaluate XC001 as a potential treatment for patients struggling with the burden of cardiovascular disease. The company has strong support from an experienced leadership team, world-class cardiologists and scientists, and has made impressive achievements in a short time in advancing its novel gene therapy approach. We look forward to collaborating with the company as it progresses to the next steps in its clinical program.”
– Rachel Mears, Partner at Jeito Capital
