News

XyloCor Therapeutics Achieves Target Enrollment in Phase 2 EXACT Study of XC001 Novel Gene Therapy for Ischemic Heart Disease

Wayne, PA, June 28, 2022 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced it has achieved enrollment of target number of subjects in the Phase 2 portion of its ongoing Phase 1/2 clinical trial (EXACT) for refractory angina. Topline results from the Phase 2 study are expected in February 2023 with interim results in the second half of this year.

– Positive Phase 1 results reported at the American Association for Thoracic Surgery (AATS) and the American Society of Gene and Cell Therapy (ASGCT) revealed XC001 is well tolerated at all dose levels –

– Phase I data support XC001 therapeutic effect and potential dose response –

– Topline Phase 2 data readout expected in February 2023 with interim results in the second half of this year –

Wayne, PA, June 28, 2022 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced it has achieved enrollment of target number of subjects in the Phase 2 portion of its ongoing Phase 1/2 clinical trial (EXACT) for refractory angina. Topline results from the Phase 2 study are expected in February 2023 with interim results in the second half of this year.

“Achievement of this important milestone in the Phase 2 portion of the study is a testament to the clinical need in this patient population and I am eager to see the Phase 2 results as they emerge,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “Patients with refractory angina have no treatment options, and the results from the Phase 1 portion of the EXACT trial suggest a dose response and therapeutic potential which is encouraging for the development of XC001 as a treatment to improve these patients’ quality of life. We are very excited to see this more definitive evaluation of the safety and efficacy of this approach.”

“We are pleased to announce this important milestone in enrollment for our Phase 2 study especially during this unprecedented and challenging time,” said Al Gianchetti, President and CEO of XyloCor. “An estimated one million people suffer from refractory angina in the United States, and we are encouraged that XC001 may address the high unmet need in this patient group. XyloCor also plans to study XC001 in other patient groups as well, including as adjunctive therapy in patients undergoing bypass surgery.”

Individuals with refractory angina experience pressure or intense pain in the chest due to insufficient blood flow to the heart muscle. These symptoms can severely impact quality of life and may worsen comorbidities.

XyloCor’s lead investigational drug, XC001 (encoberminogene rezmadenovec) is a locally administered, single‑dose gene therapy currently in development as a novel approach to treating patients with refractory angina who have no other medical and surgical options. The treatment strategy is to use local administration to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects. XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open‑label, single‑arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial with target enrollment of 27 additional subjects at the highest tolerated dose (1 x 1011 vps, the highest tested dose). The investigational gene therapy is administered directly to the heart muscle through a mini‑thoracotomy by an experienced cardiac surgeon at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain.

About XyloCor

XyloCor Therapeutics is a private, clinical‑stage biopharmaceutical company developing potential best‑in‑class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Corporate and Investor Relations

A. Brian Davis, XyloCor Therapeutics
brian.davis@xylocor.com
610-541-2056

Media Contact

Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

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XyloCor Therapeutics Announces Presentation of Preliminary Clinical Data from Phase 1 Portion of the EXACT Phase 1/2 Study of XC001 Novel Gene Therapy for Refractory Angina at AATS and ASGCT

Wayne, PA, May 18, 2022 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced presentation of initial clinical data from the Phase 1 portion of its ongoing Phase 1/2 clinical trial (EXACT) for refractory angina at the American Association for Thoracic Surgery (AATS) Annual Meeting on May 15, 2022, and at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting on May 18, 2022.

– Data from the Phase 1 dose‑escalation portion of the Phase 1/2 EXACT study demonstrate XC001 was well‑tolerated at all dose levels tested; highest dose level evaluated selected for ongoing Phase 2 portion of the study –

– Preliminary efficacy data highlight XC001 potential for patients with refractory angina with no other treatment options –

– Treatment strategy is to use local administration to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects –

– Completion of Phase 2 enrollment is expected by the end of May 2022 –

Wayne, PA, May 18, 2022 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced presentation of initial clinical data from the Phase 1 portion of its ongoing Phase 1/2 clinical trial (EXACT) for refractory angina at the American Association for Thoracic Surgery (AATS) Annual Meeting on May 15, 2022, and at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting on May 18, 2022.

XC001: Locally administered, single‑dose gene therapy candidate to address the unmet need in refractory angina

XyloCor’s lead investigational drug, XC001 (encoberminogene rezmadenovec), is under development as a novel approach to treating patients with refractory angina who have exhausted other medical and surgical options. This investigational gene therapy is designed to activate naturally occurring biological pathways by creating new vessels to improve blood flow to areas of the heart not receiving adequate blood supply. This restored blood supply could potentially improve patients’ quality of life by enabling them to resume physical activities and it could reduce episodes of chest pain associated with refractory angina.

In the Phase 1 portion of the EXACT study, 12 subjects with Canadian Cardiovascular Society (CCS) angina class 2‑4 without revascularization options were divided into four escalating dose groups with three subjects each. Each subject received 15 epicardial injections of XC001 at one of the four dosage levels. Safety, efficacy and tolerability evaluations were measured as adverse events (AEs), serious adverse events (SAEs) and change from baseline from three to six months post‑treatment in exercise capacity, ischemic burden by positron emission tomography (PET) imaging, and patient‑reported symptomatology.

No drug‑related SAEs, bleeding complications or ventricular arrhythmias were observed in this Phase 1 dose‑escalation study. Over a six‑month follow up there were a total of 17 SAEs in seven subjects. Eleven SAEs were related to the underlying disease process or other causes. The other six SAEs which occurred in four subjects were judged to be related to the administration procedure, with none of those being unexpected nor resulting in patient death.

“The administration of XC001 appears to have been well‑tolerated at all tested doses,” said Nahush Mokadam, M.D., presenting author at AATS, Division Director, Cardiac Surgery, The Ohio State University Wexner Medical Center and Associate Director of the Heart and Vascular Center and site Principal Investigator for this study. “Objective criteria, including results from exercise tolerance tests and PET scans, suggest therapeutic potential.”

Although the Phase 1 portion of the study was primarily focused on safety and Phase 2 dose selection, initial clinical efficacy data appeared promising. Notably, the data showed positive trends in total exercise duration and reductions in patient symptoms and ischemic burden. Although patient numbers are small, preliminary data suggest that response may be correlated to administered dose.

“The preliminary efficacy evaluation suggests a dose response which is encouraging for the development of XC001 as a therapeutic strategy,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “We anticipate that the Phase 2 expansion portion of this study, which is testing the highest and most efficacious dose from Phase I, will complete enrollment this month. We are incredibly excited by the potential for this investigational therapy to improve the quality of life for these cardiac patients.”

“In many other gene therapy trials, safety concerns arose due to systemic administration of high viral particle loads,” added Dr. Povsic. “In contrast, because we can inject XC001 directly into the heart, we can dramatically reduce overall viral particle loads and systemic exposure while increasing efficacy.”

EXACT Phase 1/2 Study Data Presentations at AATS and ASGCT

Lead author, Dr. Mokadam presented three‑month data from the Phase 1 study in the presentation, Dose Escalation Study of Encoberminogene Rezmadenovec (Adenoviral Vector with Multiple Isoforms of Vascular Endothelial Growth Factor) in Refractory Angina: Phase 1 Results at the AATS Annual Meeting.

Dr. Povsic will present six‑month data from the Phase 1 study in the presentation, Preliminary Safety, Tolerability and Efficacy of Direct Epicardial Administration of Encoberminogene Rezmadenovec to Ischemic Myocardium in Patients with Refractory Angina: Six Month Phase 1 Data at the ASGCT 25th Annual Meeting.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open‑label, single‑arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, to be followed by an expansion phase of the trial with 27 additional subjects at the highest tolerated dose. The trial is designed to assess the preliminary safety and efficacy of XC001. The investigational gene therapy is administered directly to the heart muscle through a mini‑thoracotomy by an experienced cardiac surgeon. The EXACT trial is being conducted at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain. An estimated one million people suffer from refractory angina in the United States.

About XyloCor

XyloCor Therapeutics is a private, clinical‑stage biopharmaceutical company developing potential best‑in‑class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

click here to download the PDF

Read More >>

XyloCor Therapeutics Expands Leadership Team with Accomplished Pharmaceutical Executives to Accelerate Clinical Development Programs and Drive Corporate Growth

Wayne, PA, January 18, 2022 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced that it has appointed Elizabeth Tarka, M.D. as Chief Medical Officer and A. Brian Davis as Chief Financial Officer. These experienced pharmaceutical industry executives will enhance the company’s clinical development, operational, and financial capabilities and drive its ongoing growth.

– Elizabeth Tarka, M.D. appointed Chief Medical Officer –

– A. Brian Davis named Chief Financial Officer –

Wayne, PA, January 18, 2022 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced that it has appointed Elizabeth Tarka, M.D. as Chief Medical Officer and A. Brian Davis as Chief Financial Officer. These experienced pharmaceutical industry executives will enhance the company’s clinical development, operational, and financial capabilities and drive its ongoing growth.

“I am delighted to welcome Liz and Brian to the leadership team at XyloCor,” said Al Gianchetti, President and Chief Executive Officer. “Liz is a proven R&D leader who brings a strong track record managing late‑stage clinical development programs with particular expertise in cardiovascular medicine. Brian will leverage his extensive management and finance experience in both private and public biotech companies to accelerate Xylocor’s strategic and corporate objectives. Their collective experience will drive XyloCor toward our objectives as we focus on advancing our pipeline of transformative gene therapies intended to improve the lives of people with cardiovascular disease.”

Dr. Tarka is a cardiologist with over 20 years of experience in the pharmaceutical and biotechnology industry. She has dedicated her career to the development of innovative therapies that improve human health. Dr. Tarka’s experience includes leadership roles across all phases of late‑stage clinical development and a track record of effectively partnering with stakeholders to enable the successful execution of clinical trials. She joins the company from Idera Pharmaceuticals where she served as CMO. Before that, Dr. Tarka was Vice President, Clinical Development at Complexa, Inc., a clinical stage biopharmaceutical company focused on life‑threatening fibrosis and inflammatory diseases. Earlier in her career, she served as Clinical Program Leader for Xarelto® (rivaroxaban) at Janssen Pharmaceuticals, where she was responsible for the design, implementation, and medical oversight for large multinational trials. Prior to her tenure at Janssen, Dr. Tarka worked at GlaxoSmithKline in the Metabolic Pathways and Cardiovascular Therapeutic Area. She has been on the faculty and had numerous major teaching and clinical responsibilities at the University of Pennsylvania and affiliated hospitals. She is trained in Cardiology and Internal Medicine and has published in a number of peer‑reviewed journals. Dr. Tarka earned a BA in Biochemistry and an MD from the University of Pennsylvania where she also completed her residency and fellowship training.

Mr. Davis joins XyloCor with a proven background as a seasoned financial executive, including over 15 years of experience as a CFO for publicly traded, commercial- and clinical‑stage biopharmaceutical companies, and nearly 30 years as a financial professional in the life sciences industry. He has extensive expertise in fundraising, financial strategy, negotiating strategic transactions involving acquisition and disposition of commercial and clinical‑stage assets, shareholder relations, and SEC accounting, reporting, and compliance. Mr. Davis has raised over $600 million in public and private equity financings, including leading an initial public offering, and nearly $200 million in debt financings. Most recently, he was CFO at Verrica Pharmaceuticals, where he held managerial responsibility for executing equity and debt financings, analyst and shareholder relations, financial aspects of commercial launch preparation, business development, finance, accounting, tax, and treasury. Before that, Mr. Davis had similar duties as CFO at Strongbridge Biopharma plc, Tengion, Inc., and Neose Technologies, Inc. Mr. Davis is a Certified Public Accountant. He earned an MBA from The Wharton School, University of Pennsylvania and an undergraduate degree in Accounting from Trenton State College.

About XyloCor

XyloCor Therapeutics is a private, clinical‑stage biopharmaceutical company developing potential best‑in‑class gene therapies to transform outcomes for patients with cardiovascular disease. The company’s lead product candidate, XC001, is currently being investigated in a Phase 2 clinical trial for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Corporate and Investor Relations:

A. Brian Davis
XyloCor Therapeutics
brian.davis@xylocor.com
610-541-2056

Media Contact

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

click here to download the PDF

Read More >>

XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

Wayne, PA, July 27, 2021 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced the completion of the Phase 1 dose‑escalation component of its Phase 1/2 clinical trial (EXACT) of XC001 (encoberminogene rezmadenovec), its lead investigational gene therapy candidate for patients with refractory angina who have no further treatment options.

– Independent Data Monitoring Committee authorized proceeding to Phase 2 at highest dose level tested following review of clinical safety data from the Phase 1 dose escalation –

– Phase 2 clinical data readouts on safety and efficacy of XC001 anticipated in 2022 –

– Company plans to commence study startup of XC001 as an adjunct to CABG in 2H21, and clinical studies in additional cardiovascular indications are under discussion –

– Progress highlights potential of gene therapy in cardiovascular disease –

Wayne, PA, July 27, 2021 — XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced the completion of the Phase 1 dose‑escalation component of its Phase 1/2 clinical trial (EXACT) of XC001 (encoberminogene rezmadenovec), its lead investigational gene therapy candidate for patients with refractory angina who have no further treatment options.

Following a review of clinical data from the Phase 1 dose escalation component of the study, the Independent Data Monitoring Committee (IDMC) authorized proceeding to the Phase 2 component of the study at the highest dose tested. Since the IDMC authorization, three patients have been dosed in the Phase 2 expansion cohort. This progress highlights the potential for gene therapy to go beyond rare diseases and to address larger patient populations with significant unmet needs, such as chronic cardiovascular diseases.

XyloCor also confirms that it plans to submit an additional Phase 2 clinical study to the U.S. Food and Drug Administration (FDA) for XC001 as adjunctive therapy to coronary artery bypass grafting (CABG) in 2H21. The company also plans other clinical studies in additional cardiovascular indications, including heart failure caused by ischemic heart disease and as adjunctive therapy to percutaneous coronary intervention.

“Patients with refractory angina are forced to live with the ongoing burden of a disease that limits their activities on a daily basis due to chest pain,” said Thomas Povsic, M.D., Ph.D., Duke University cardiologist and National Principal Investigator for the EXACT study. “With a unique mechanism of action that restores blood flow to the heart via the creation of new blood vessels, XC001 represents a novel therapeutic approach for patients who have exhausted other medical and surgical options. It is very exciting to now move forward with exploring XC001’s potential in the Phase 2 portion of EXACT as a one‑time therapy for patients with refractory angina.”

“In our mission to deliver safe and effective gene therapies that transform the lives of people with cardiovascular disease, we are excited to achieve this important milestone and advance into the Phase 2 portion of our study,” said Al Gianchetti, President and Chief Executive Officer of XyloCor Therapeutics. “XC001 has enormous potential to significantly improve the lives of patients with refractory angina. We are grateful for the support of patients and their families, as well as the EXACT trial investigators as we continue to study the safety and efficacy of XC001 and look forward to reporting results in 2022.”

About XC001

XC001 (encoberminogene rezmadenovec) is a novel, investigational gene therapy designed to stimulate the growth of new blood vessels in the heart, in order to bypass diseased vessels and improve coronary blood flow. XC001 delivers the gene for vascular endothelial growth factor (VEGF), a naturally occurring protein, in targeted myocardial cells, thus stimulating the creation of new blood vessels via a process called angiogenesis. XC001 employs a proprietary multi‑isoform VEGF expression cassette that has been optimized to maximize expression of VEGF. XC001 has been granted Fast Track designation by the FDA for study in refractory angina. XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina, in 2020.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open‑label, single‑arm, dose‑escalation trial. 12 subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, to be followed by an expansion phase of the trial with 21 additional subjects at the highest tolerated dose. The trial is designed to assess the preliminary safety and efficacy of XC001. The investigational gene therapy is administered directly to the heart muscle through a mini‑thoracotomy by an experienced cardiac surgeon. The EXACT Trial is being conducted at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain. An estimated one million people suffer from refractory angina in the United States.

About XyloCor

XyloCor Therapeutics is a private, clinical‑stage biopharmaceutical company developing potential best‑in‑class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

click here to download the PDF

Read More >>

XyloCor Therapeutics Completes Oversubscribed $41.9 Million Series A Financing To Advance Novel Gene Therapy Pipeline For Coronary Artery Disease

Malvern, PA, March 22, 2021 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for the significant unmet patient needs in advanced coronary artery disease, today announced the closing of an additional $22.6 million financing. Fountain Healthcare Partners led the oversubscribed financing joined by new investors Longwood Fund and Lumira Ventures. All existing institutional investors including Sofinnova Investments and LSP (Life Sciences Partners) participated in the financing. The additional financing builds upon XyloCor’s 2018 Series A financing round, bringing total investment in the company to $41.9 million to date. XyloCor’s lead product candidate, XC001, is an investigational gene therapy currently being studied in a Phase 1/2 clinical trial (EXACT) for patients with refractory angina, a chronic condition for which there are no treatment options.

– Company closes additional $22.6 million in new financing –

– Proceeds will fund initiation of new clinical trial for lead gene therapy candidate XC001 as adjunctive therapy for patients undergoing coronary artery bypass graft surgery –

Malvern, PA, March 22, 2021 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for the significant unmet patient needs in advanced coronary artery disease, today announced the closing of an additional $22.6 million financing. Fountain Healthcare Partners led the oversubscribed financing joined by new investors Longwood Fund and Lumira Ventures. All existing institutional investors including Sofinnova Investments and LSP (Life Sciences Partners) participated in the financing. The additional financing builds upon XyloCor’s 2018 Series A financing round, bringing total investment in the company to $41.9 million to date. XyloCor’s lead product candidate, XC001, is an investigational gene therapy currently being studied in a Phase 1/2 clinical trial (EXACT) for patients with refractory angina, a chronic condition for which there are no treatment options.

The financing will enable XyloCor to expand its clinical development program for XC001, including the initiation of a new trial of XC001 as a potential adjunctive therapy to augment the effectiveness of coronary artery bypass graft surgery (CABG). XyloCor is at the forefront of scientific research and clinical study in the application of gene therapy to address vast unmet treatment needs in large patient populations with cardiovascular disease. In both its initial potential indication in refractory angina, and as an adjunctive therapy for patients undergoing CABG, XC001 represents a novel therapeutic approach.

“We greatly appreciate the recognition by Fountain Healthcare Partners, Longwood Fund, and Lumira Ventures of the value we have created since our initial funding and in XC001’s enormous potential for improving the lives of patients with advanced coronary disease,” said Al Gianchetti, president and chief executive officer of XyloCor Therapeutics. “With the support of our investors, we can build on the progress we have made since our initial funding to pursue, with a sense of urgency, new clinical indications where XC001 has promise for addressing unmet medical needs.”

“XyloCor has created significant value with XC001 with the progress the team has achieved on clinical and CMC milestones. Based on our experience, excellence on both fronts is critical to success in the gene therapy field,” said Aidan King, managing partner and co‑founder, Fountain Healthcare Partners, who also joined XyloCor’s board of directors. “We are gratified that this additional capital accelerates XC001’s development and expands its potential impact to the significant unmet need among CABG patients who are at high risk for incomplete revascularization.”

Board of Directors Additions

Joining Mr. King as a member of the XyloCor board of directors is Daniel Hétu, M.D., managing director, Lumira Ventures, and Perry Nisen, M.D., Ph.D., executive partner, Sofinnova Investments. Alan Colowick, M.D., MPH, will now serve an independent board member of XyloCor.

About XC001

XC001 is an investigational gene therapy designed to promote the growth of new blood vessels in the heart, with these new blood vessels bypassing diseased blood vessels and improving blood flow in the heart. XC001 deposits the gene for vascular endothelial growth factor (VEGF) in targeted heart cells. VEGF is a naturally occurring protein and it is believed that XC001 enables the heart cells to produce more VEGF, thus stimulating the creation of new blood vessels, a process called angiogenesis. XC001 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for study in refractory angina. An Investigational New Drug (IND) application for XC001 is open with the FDA. XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina in 2020.

The EXACT Trial

The EXACT clinical trial is a Phase 1/2 multicenter, open-label, single arm, dose escalation trial. Approximately 12 subjects (n=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion phase of the trial with 21 additional subjects at the highest tolerated dose. The trial is designed to assess the safety and efficacy of XC001. The investigational gene therapy will be administered directly to the muscle tissue of the heart by an experienced cardiac surgeon. The EXACT Trial was initiated in 2020 and is ongoing at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

Chronic angina pectoris occurs when the heart muscle does not receive as much oxygen as it needs for the amount of work it is performing, and this often results in chest pain. This is usually due to coronary artery disease. Patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and CABG have refractory angina and currently have no treatment options. These patients often become sedentary because of their symptoms, which in turn can exacerbate comorbidities and severely impact quality of life causing further deterioration of their health status. An estimated one million people suffer from refractory angina in the United States.

About Coronary Artery Bypass Graft Surgery (CABG)

CABG is a procedure used to treat coronary artery disease — the narrowing or blockage of the blood vessels that supply oxygen and nutrients to the heart muscle. During CABG, a healthy artery or vein from the body is connected, or grafted, to the blocked coronary artery. The grafted artery or vein bypasses the blocked portion of the coronary artery. This creates a new passage, and oxygen-rich blood is routed around the blockage to the heart muscle. Approximately 500,000 CABG procedures are performed annually in the United States, in which an estimated one-third of patients are at risk for incomplete coronary revascularization, often resulting in persistent angina. An adjunctive treatment to CABG, such as gene therapy with XC001, may reduce the incidence of incomplete revascularization.

About XyloCor

XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

click here to download the PDF

Read More >>

XyloCor Therapeutics Doses Patients in Phase 1/2 Trial Evaluating Novel Gene Therapy XC001 in Refractory Angina

Malvern, PA, July 21, 2020 — XyloCor Therapeutics today announced it has successfully dosed the first two patients in the EXACT Trial, a Phase 1/2 dose escalation trial evaluating the safety, tolerability and efficacy of its lead candidate XC001 in patients with refractory angina. The trial will enroll patients who are not responding to medication and are unsuitable for coronary artery bypass graft or percutaneous coronary intervention. XC001 is an investigational novel gene therapy designed to activate naturally occurring biological pathways to improve blood flow to areas of the heart not receiving adequate blood supply. One patient was dosed at The Christ Hospital Health Network and a second at Minneapolis Heart Institute Foundation.

Malvern, PA, July 21, 2020 — XyloCor Therapeutics today announced it has successfully dosed the first two patients in the EXACT Trial, a Phase 1/2 dose escalation trial evaluating the safety, tolerability and efficacy of its lead candidate XC001 in patients with refractory angina. The trial will enroll patients who are not responding to medication and are unsuitable for coronary artery bypass graft or percutaneous coronary intervention. XC001 is an investigational novel gene therapy designed to activate naturally occurring biological pathways to improve blood flow to areas of the heart not receiving adequate blood supply. One patient was dosed at The Christ Hospital Health Network and a second at Minneapolis Heart Institute Foundation.

“People with refractory angina are forced to make many sacrifices in their lives as chest pain limits their ability to perform ordinary physical activities,” said Al Gianchetti, President and Chief Executive Officer of XyloCor Therapeutics. “Dosing the first patients in this clinical trial is an important milestone in XyloCor’s efforts to advance an innovative treatment that could reduce chest pain and enable people to resume the normal daily activities that improve their overall quality of life.”

“XC001 has the potential as a one‑time gene therapy that will relieve chest pain by restoring blood flow to the heart,” said Rickey Reinhardt, MD, PhD, Chief Medical Officer of XyloCor Therapeutics. “The EXACT trial will provide us with vital data on the safety and efficacy of XC001 and we believe it will confirm evidence seen in previous pre‑clinical and clinical programs with this mechanism of action.”

“Therapeutic treatments for refractory angina are limited and thus results in poor health including frequent angina with an extremely diminished quality of life. There is a tremendous need to explore gene therapy as a viable treatment option for advanced coronary artery disease, especially for patients who have exhausted all other medication and surgical options,” concluded Mr. Gianchetti.

About the EXACT Trial

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) is a Phase 1/2 first‑in‑human, multicenter, open‑label, single arm dose escalation trial evaluating the safety, tolerability and efficacy of XC001 at six months in patients who suffer from chronic angina caused by coronary artery disease with no other treatment options. The trial will enroll 12 patients (n=3 per cohort) who will receive one of four ascending intramyocardial doses of XC001, followed by an expansion cohort of 17 patients of the highest tolerated dose. Secondary endpoints at six months include efficacy measures of improvement in exercise capacity, reduction in angina episodes, improvement in coronary blood flow and improvement in quality of life.

More information about the EXACT trial is available at https://clinicaltrials.gov/ct2/show/NCT04125732.

About XyloCor

XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a secondary product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. Co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, XyloCor has an exclusive license agreement with Cornell University for the worldwide rights to develop, manufacture and commercialize XC001. For more information, visit www.xylocor.com.

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Sam Brown Inc.
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XyloCor Therapeutics Names Alexander Gaidamaka, PhD, Senior Vice President of Technology, Manufacturing & Quality

Philadelphia, PA, June 9, 2020 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, strengthens its leadership team with the appointment of Alexander Gaidamaka, PhD, as Senior Vice President of Technology, Manufacturing & Quality. Dr. Gaidamaka brings a wealth of product development, regulatory and manufacturing experience across multiple technology platforms and GMP quality design and operations from his tenures with Sanofi Group, AmpliPhi Biosciences, Personalized OncoTherapeutics Inc. and several other companies.

Philadelphia, PA, June 9, 2020 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, strengthens its leadership team with the appointment of Alexander Gaidamaka, PhD, as Senior Vice President of Technology, Manufacturing & Quality. Dr. Gaidamaka brings a wealth of product development, regulatory and manufacturing experience across multiple technology platforms and GMP quality design and operations from his tenures with Sanofi Group, AmpliPhi Biosciences, Personalized OncoTherapeutics Inc. and several other companies.

“At this critical time in our growth, we are excited to have Alexander join our team. His broad therapeutics experience from pre‑clinical and clinical development through manufacturing processes will be invaluable to both our clinical and pre‑clinical gene therapy programs,” said Al Gianchetti, President and Chief Executive Officer of XyloCor Therapeutics. “Quality manufacturing is imperative when developing gene therapies, and his insights and skillset, developed from experience both in the US and globally, will bring XyloCor Therapeutics one step closer to helping patients with refractory angina who currently have no treatment options.”

With more than 25 years of experience in the pharmaceutical industry, Dr. Gaidamaka previously served as Vice President of Chemistry, Manufacturing & Controls for AmpliPhi Biosciences where he led and defined CMC strategy and application, implemented GMP production of clinical trial material and completed several IND submissions to the U.S. Food and Drug Administration for clinical trials and compassionate use. As Chief Executive Officer and Chief Scientific Officer at Personalized OncoTherapeutics, he developed a scalable technology concept for a personalized therapeutic cancer vaccine platform and conducted early research studies within cross-functional international projects. As Director of Biologics Development at Merial (Sanofi) and Senior Manager of QC Immunochemistry at Sanofi Pasteur, he executed on a broad spectrum of tasks from development to product approval, manufacturing and all aspects of GMP quality systems.

Dr. Gaidamaka began his career in pharmaceuticals by developing a series of generic and brand medicines when serving as the Head of the Department of Immunopharmacology & Allergology at State Scientific Center of Drugs, Ukraine. He then founded Biopharm LLC (Ukraine) and served as Chief Executive Officer. He also served as a subject matter expert for biologics at Ukrainian Pharmacopeia Committee. He received his PhD in immunology and microbiology and a Doctor of Veterinary Medicine from Kharkov Veterinary Academy. He is also an author of 42 publications and holds two patents.

About XyloCor

XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a secondary product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. Co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, XyloCor has a licensing agreement with Weill Cornell Medicine for the worldwide rights to develop, manufacture and commercialize XC001. For more information, visit www.xylocor.com.

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Mike Beyer
Sam Brown Inc. Healthcare Communications
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XyloCor Therapeutics Names Rickey Reinhardt, MD, PhD, Chief Medical Officer

Philadelphia, PA, August 7, 2019 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, strengthens its leadership team with the appointment of Rickey Reinhardt, MD, PhD, as Chief Medical Officer. Dr. Reinhardt formerly served as Chief Medical Officer for Comet Therapeutics where he led the strategy and execution of clinical development programs and provided oversight of regulatory affairs.

– Recognized industry leader to head clinical development programs –

Philadelphia, PA, August 7, 2019 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, strengthens its leadership team with the appointment of Rickey Reinhardt, MD, PhD, as Chief Medical Officer. Dr. Reinhardt formerly served as Chief Medical Officer for Comet Therapeutics where he led the strategy and execution of clinical development programs and provided oversight of regulatory affairs.

“Dr. Reinhardt’s broad and deep experience as a scientist and clinical drug developer will be invaluable to XyloCor as we advance our novel gene therapy programs,” said Al Gianchetti, President and Chief Executive Officer of XyloCor. “His proven success in driving drug development from discovery through phase 4 in areas such as oncology, cardiometabolics and rare diseases, including several clinical-stage gene therapy programs, will be a tremendous asset to our company.”

With more than 22 years of experience in the pharmaceutical industry, Dr. Reinhardt will focus on clinical development of XyloCor’s pipeline and its lead candidate, XC001, for the treatment of refractory angina. During his tenure at Comet Therapeutics, Dr. Reinhardt led the company’s clinical development efforts focused on inborn errors of metabolism. Previously, he served as Vice President of Clinical Research and Development at REGENXBIO where he led the cross‑functional team in charge of driving multiple gene therapy programs for the treatment of rare metabolic genetic and ophthalmology diseases.

Prior to joining REGENXBIO, Dr. Reinhardt served as Vice President and Head of Clinical and Alternative Development Programs at GlaxoSmithKline where he directed the development and successful global approvals of Tanzeum/Eperzan for the treatment of diabetes. While at GSK, he also led the European approval of the first ex‑vivo gene therapy for the treatment of severe combined immunodeficiency, Strimvellis, and expanded the label for Nucala to include the treatment of eosinophilic granulomatosis with polyangiitis (EGPA). Dr. Reinhardt has also held senior positions at Covance and Novo Nordisk. At Novo Nordisk, he spent 11 years in the Clinical Pharmacology, Clinical Research and Medical Affairs departments in which several biologics for the treatment of diabetes and obesity were brought to commercialization.

“I am excited to join XyloCor to lead the clinical development team as we work to uncover the potential of our pipeline,” said Dr. Reinhardt. ”XyloCor is poised to be a leader in cardiovascular gene therapy, and I am proud to be part of our effort to bring new advances in the treatment of coronary artery disease.”

Dr. Reinhardt began his career in pharmaceuticals at Merck in the clinical pharmacology group where he contributed to the development and approval of EMEND®. Prior to entering the industry, he spent 11 years as a bench scientist and in academia, which included serving as Clinical Assistant Professor of Medicine in the Division of Endocrinology, Metabolism and Nutrition at Robert Wood Johnson Medical School of Rutgers University, and as a Senior Medical Staff Fellow at the National Institutes of Health (NIH).

He received both his medical degree and PhD from Louisiana State University and holds a BS in biochemistry from the University of California - Los Angeles. He completed his endocrinology fellowship at the NIH and his residency in internal medicine at George Washington Hospital in Washington, DC. Dr. Reinhardt has published more than 80 papers, abstracts, reviews and book chapters. He holds board certifications in both internal medicine and endocrinology.

About XyloCor

XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a secondary product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. Co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, XyloCor has a licensing agreement with Weill Cornell Medicine for the worldwide rights to develop, manufacture and commercialize XC001. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

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XyloCor Therapeutics Raises $17 Million in Series A Financing to Advance Gene Therapy Portfolio in Cardiovascular Disease

Philadelphia, PA, December 6, 2018 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, today announced the close of a $17 million Series A financing which was co-led by Sofinnova Ventures and LSP (Life Sciences Partners). Proceeds from the financing will be used to advance the development of lead product candidate XC001, a cardiovascular angiogenic gene therapy, and expand the company’s business and operational structure. XyloCor is led by pharmaceutical industry veteran and former GlaxoSmithKline (GSK) executive, Al Gianchetti as Chief Executive Officer and has expanded its Board of Directors to include a number of leading industry experts.

– Novel gene therapy for patients with treatment-resistant angina who have no remaining treatment options is ready to enter clinical development –

– Pharmaceutical industry veteran and former GSK executive Al Gianchetti leads company as CEO –

Philadelphia, PA, December 6, 2018 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, today announced the close of a $17 million Series A financing which was co‑led by Sofinnova Ventures and LSP (Life Sciences Partners). Proceeds from the financing will be used to advance the development of lead product candidate XC001, a cardiovascular angiogenic gene therapy, and expand the company’s business and operational structure. XyloCor is led by pharmaceutical industry veteran and former GlaxoSmithKline (GSK) executive, Al Gianchetti as Chief Executive Officer and has expanded its Board of Directors to include a number of leading industry experts.

“XyloCor was created to develop a proprietary gene therapy for patients with refractory angina who have no remaining treatment options. This significant raise enables the research and development for our lead investigational product XC001, which has the potential to provide new hope for patients who suffer from this chronic and debilitating disease,” said Al Gianchetti, President and Chief Executive Officer of XyloCor. “We are grateful for the support and confidence demonstrated by our investors who bring highly valued contributions to XyloCor beyond the financial resources. Sofinnova and LSP are leaders in helping companies bring innovative therapeutics to patients who need them, and both have extensive experience in cardiovascular disease.”

The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to the company’s lead investigational product XC001, for clinical studies as a one‑time treatment for the improvement of exercise tolerance in patients with chronic angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures including coronary artery bypass surgery, percutaneous coronary intervention and stents. An Investigational New Drug (IND) application for XC001 is open with the FDA and XyloCor intends to commence clinical trials in 2019. XyloCor also has a secondary product, XC002, in discovery stage being investigated for the regeneration of cardiac tissue in patients with cardiac damage from heart attacks.

Chronic angina pectoris or chest pain occurs when the heart muscle does not receive as much oxygen as it needs for the amount of work it is performing. This is usually due to coronary artery disease. Patients with chronic angina who become resistant to current standard of care, whether medical or surgical, are considered refractory and often become sedentary because of their symptoms, which in turn can exacerbate comorbidities causing further deterioration of their health status.

“Gene therapy is an exciting and newly emerging area of medicine. With a robust scientific foundation and an experienced team, XyloCor is poised to address serious unmet medical needs in cardiovascular disease,” said co‑founder and advisor, Ronald Crystal, MD, the Bruce Webster Professor of Internal Medicine and Chairman, Department of Genetic Medicine, Weill Cornell Medicine and Director of its Belfer Gene Therapy Core Facility.

“XC001 has been designed to stimulate the formation of new coronary blood vessels to serve areas of the heart that are not receiving adequate blood supply, which may allow patients to increase their daily activities and improve their quality of life,” said co‑founder and board member, Todd Rosengart, MD, Professor and DeBakey-Bard Chair of the Michael E. DeBakey Department of Surgery, Baylor College of Medicine.

XyloCor is being led by Al Gianchetti who has more than 25 years of drug development and commercialization experience. He has served in a number of executive-level management positions at GSK and leadership roles with small biotech and specialty pharma companies. Mr. Gianchetti has extensive experience in both commercial strategy/operations and R&D, including involvement in Phase 1 through 3 clinical programs and several product launches.

XyloCor Expands and Formalizes Board of Directors

In conjunction with the financing, XyloCor has expanded its Board of Directors. New board members include Fouad Azzam, PhD, MBA, General Partner, LSP and Alan Colowick, MD, MPH, Partner, Sofinnova. They will serve alongside existing Board members Glenn Batchelder, Executive Chairman; Todd Rosengart, MD, Founder and Advisor; and Al Gianchetti, XyloCor President and CEO. Ronald Crystal, MD, Founder and Advisor and John de Koning, PhD, Partner, LSP will participate as board observers.

About Sofinnova

Founded in 1974, Sofinnova specializes in clinical and late preclinical investments in biopharmaceutical products. Their goal is to actively partner with entrepreneurs across all stages of company development. The firm seeks to build world class companies that aspire to dramatically improve the current state of medical care and the lives of patients through bringing innovative products to market. For more information, visit www.sofinnova.com.

About LSP

LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, the LSP team has invested in about 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over € 2 billion ($2.3 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is Europe’s leading life sciences investor. LSP also invests in public companies through its Euronext-listed LSP Life Sciences Fund (Bloomberg: LSP NA). XyloCor Therapeutics is the second investment of LSP’s latest flagship fund, LSP 6. For more information, please visit www.lspvc.com.

About XyloCor

XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a secondary product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. Co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, XyloCor has a licensing agreement with Weill Cornell Medicine for the worldwide rights to develop, manufacture and commercialize XC001. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

click here to download the PDF

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FDA Grants Fast Track designation to XyloCor Therapeutics Lead Candidate XC001

Newtown Square, PA, May 8, 2017 — XyloCor Therapeutics Inc., a privately held biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate XC001 (AdVEGF‑All6A+), a cardiovascular angiogenic gene therapy. XC001 is a one‑time treatment being investigated for improving exercise tolerance in patients who have chronic angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures such as coronary artery bypass surgery and percutaneous coronary intervention and stents.

Newtown Square, PA, May 8, 2017 — XyloCor Therapeutics Inc., a privately held biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate XC001 (AdVEGF‑All6A+), a cardiovascular angiogenic gene therapy. XC001 is a one‑time treatment being investigated for improving exercise tolerance in patients who have chronic angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures such as coronary artery bypass surgery and percutaneous coronary intervention and stents.

“Achieving Fast Track status validates the need for XC001, which has the potential to be a unique treatment for this serious condition with high unmet need — chronic, refractory angina,” said Al Gianchetti, President and Chief Executive Officer of XyloCor. “This designation is supported by strong scientific evidence for XC001 and clinical validation of this mechanism of action in refractory angina. This important designation is intended to contribute to an expedited development and regulatory review process, which can get the drug sooner to patients who can benefit from it.”

The FDA Fast Track designation is designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and that demonstrate the potential to address an unmet medical need.

XC001 is a novel gene therapy that promotes angiogenesis, the formation of new vessels that can provide arterial blood flow to myocardial regions with inadequate blood supply. Enhancing myocardial blood flow with therapeutic angiogenesis is intended to relieve myocardial ischemia, improve regional and global left ventricular performance, alleviate angina symptoms and disability and potentially improve prognosis.

“There are many patients in the United States with refractory angina and there are no available treatment options,” said Magnus Ohman, Professor of Medicine, The Kent and Siri Rawson Director, Duke Program for Advanced Coronary Disease, Duke University School of Medicine. “These patients have significant limitations in terms of their daily activities because of the chest pain associated with their ischemic disease and XC001 could be an important new option for them.”

An IND for XC001 is open with the FDA and XyloCor intends to commence clinical trials upon funding.

About XyloCor

XyloCor Therapeutics is a private biopharmaceutical company developing novel gene therapy for people with unmet medical need from advanced coronary artery disease. XyloCor is focused on developing its lead product, XC001, for patients with refractory angina with no treatment options and its secondary product, XC002, for patients with cardiac tissue damage from heart attacks. XyloCor was founded by Dr. Ronald Crystal and Dr. Todd Rosengart, who both sit on XyloCor’s advisory board. Dr. Crystal is the Bruce Webster Professor and Chairman, Department of Genetic Medicine, Weill Cornell Medicine and Director of the Belfer Gene Therapy Core Facility. Dr. Rosengart is Professor and Chairman, DeBakey Bard Chair of Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine. XyloCor has a licensing agreement with Cornell University granting the company worldwide rights to develop, manufacture and commercialize XC001. With a strong scientific foundation, compelling preclinical and clinical evidence and an experienced team, XyloCor is poised for success and to help patients lead better, healthier lives. For more information, visit www.xylocor.com.

Company Contact: Al Gianchetti, President and Chief Executive Officer, info@xylocor.com

Media Contact: Mike Beyer, Sam Brown Inc., mikebeyer@sambrown.com, 312-961-2502

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