Business
Tenaya Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
TN-201 IND Cleared in January; Plan to Begin Phase 1b Dosing in MYBPC3-associated HCM Patients in Third Quarter 2023 Dosing Commenced in Multiple-Ascending
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"TN-201 IND Cleared in January; Plan to Begin Phase 1b Dosing in MYBPC3-associated HCM Patients in Third Quarter 2023 Dosing Commenced in Multiple-Ascending Dose Stage of First-In-Human Clinical Trial of TN-301; Data Anticipated in Second Half 2023 2022 Year End Cash and Investments of $204 Million; Runway to Fund Operations into First Half 2025 SOUTH SAN FRANCISCO, Calif., March 08, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a corporate update. “Tenaya enters 2023 well capitalized and with meaningful milestones ahead,” said Faraz Ali, Chief Executive Officer of Tenaya. “This year, we look forward to beginning clinical testing of our lead gene therapy candidate, TN-201, sharing data from our first-in-human clinical trial of TN-301, and submitting an IND for our TN-401 gene therapy candidate, as well as presenting additional data detailing insights on current pipeline candidates and emerging platform innovations.” Business and Program Updates TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy (HCM) In January 2023, Tenaya received notification from the U.S. Food and Drug Administration (FDA) that clinical testing of TN-201 may proceed based on the agency’s review of the company’s Investigational New Drug (IND) application. TN-201 is designed to deliver a fully functional MYBPC3 gene to restore normal levels of MyBP-C protein and thereby potentially halt disease progression and reverse the course of genetic HCM after a single dose.Tenaya plans to commence a Phase 1b multi-center, open-label, dose-escalation study to assess the safety, tolerability and pharmacodynamics of a one-time intravenous infusion of TN-201 in symptomatic adults with MYBPC3-associated HCM in the third quarter of 2023. Initial data from the Phase 1b trial are anticipated in 2024. TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF) Tenaya commenced dosing of healthy participants in the multiple-ascending dose (MAD) stage of its ongoing Phase 1 trial evaluating the safety, tolerability, pharmac...