- Lead Program Targets the Underlying Protein Trafficking Defects in Heart Failure
- IND-Enabling Development for Non-Ischemic Dilated Cardiomyopathy (DCM) underway, with IND filing Anticipated in 2025
- Indication Expansion Pipeline for Additional High Unmet Need, Prevalent forms of Heart Failure
SALT LAKE CITY & SAN FRANCISCO--(BUSINESS WIRE)--TikkunLev Therapeutics, a biotechnology company developing precision therapies targeting the causal disease biology of failing heart muscle, today officially announced the company’s launch, lead program for non-ischemic DCM, seed financing from undisclosed investors, and the establishment of its Scientific Advisory Board. The proceeds from the seed financing have been supporting ongoing IND-enabling development and product manufacturing, in anticipation of the company’s first IND filing in 2025.
TikkunLev (Hebrew for repairing the heart) is leveraging the proprietary, ground-breaking research of Dr. Robin Shaw, Chief Scientific Officer and Co-Founder of TikkunLev, the Nora Eccles Harrison Presidential Endowed Chair and Professor of Medicine at the University of Utah, and Director of the Nora Eccles Harrison Cardiovascular Research and Training Institute (CVRTI) at the University of Utah. Dr. Shaw’s team discovered the underlying disease biology of failing heart muscle and used that information to develop first-in-class precision therapies for highly prevalent forms of heart failure that lack effective treatment options. TikkunLev’s platform is centered around cBIN1, an architectural protein that plays a vital role in the organization and function of cardiac muscle. The expression of cBIN1 is disrupted in every form of heart failure studied, which triggers the onset of failing heart muscle and poor clinical outcomes. TikkunLev also plans to leverage a clinically-validated cBIN1 blood-based biomarker to support the development of its pipeline.
Extensive preclinical studies have been completed, including studies in gold-standard large animal models of acquired heart failure, demonstrating unprecedented recovery of heart function and reverse remodeling of failing hearts, with a single low IV dose. The company’s lead program, TLT-101, is in IND-enabling development for non-ischemic DCM, with plans to file an IND application in 2025. TikkunLev also has a rich indication expansion pipeline, targeting additional common forms of heart failure, backed by extensive nonclinical data.
TikkunLev has entered into a collaboration agreement with the University of Utah’s CVRTI to leverage its proprietary large animal disease models, expertise in translational cardiology and advanced heart failure (the first permanent artificial heart implant took place at Utah), and its state-of-the-art R&D facility. TikkunLev will utilize these resources to accelerate the development of its lead program and support its pipeline.
“Our mission is to deliver potentially curative, first-in-class precision therapies to patients suffering from different forms of heart failure by targeting the molecular underpinnings of failing heart muscle,” said Matt Killeen, Ph.D., President of TikkunLev Therapeutics. “Leveraging over a decade of NIH-supported research, the companion cBIN1 blood-based biomarker, and our collaboration with the CVRTI, we’re uniquely positioned to rapidly advance to the clinic and revolutionize the treatment of heart failure.”
“When we first discovered cBIN1 we did not realize its potential to be a master regulator of cardiomyocyte organization and overall cardiac function,” said Robin Shaw, M.D., Ph.D., Chief Scientific Officer and Co-Founder. cBIN1 organizes the proteins of the calcium handling apparatus of heart muscle cells, and is decreased in failing hearts, reducing the strength of heart contraction and relaxation. Returning cBIN1 to hearts improves the function of failing heart muscle and reverses the syndrome of heart failure. “We have extensively evaluated our precision therapy in different gold-standard small and large animal models and demonstrated a consistent ability to recover heart function, reverse remodel failing hearts, and dramatically improve outcomes. We look forward to rapidly advancing our lead program to IND next year and into the clinic shortly thereafter.”
Scientific Advisory Board
TikkunLev’s scientific advisors include world-renowned experts in advanced heart failure, cardiology, and clinical development:
- Dr. James Fang, MD - President of the Heart Failure Society of America and Chief of Cardiovascular Medicine, University of Utah
- Dr. Adrian Hernandez, MD - Vice Dean of Medicine at Duke University and Executive Director of the Duke Clinical Research Institute
- Dr. Javed Butler, MD, MBA - President of Baylor Scott and White Research Institute and Distinguished Professor of Medicine, University of Mississippi
About TikkunLev Therapeutics
TikkunLev Therapeutics is pioneering the development of precision therapies to reverse heart failure by targeting the causal disease biology of failing heart muscle. With a lead program in IND-enabling development for non-ischemic DCM and a broad indication expansion pipeline focused on common, devastating forms of heart failure, TikkunLev is committed to transforming the treatment landscape for heart failure patients worldwide. For more information, visit www.tikkunlev.com and follow us on LinkedIn.
About the University of Utah’s CVRTI
The CVRTI is an independent 40,000 square foot cardiac research institute on the University of Utah Health Sciences campus that provides a highly integrated approach to the study of basic and translational cardiac biology. The Institute is the largest freestanding academic team of cardiac muscle biology, metabolism, and electrophysiology researchers in the country. Facilities include a fully equipped large animal operating room for preclinical studies and extensive on-site translational expertise.
Contacts
For more information, please contact: info@tikkunlev.com
