Business
Tenaya Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
Commenced Patient Dosing in MyPeak-1TM Phase 1b Trial of TN-201 in MYBPC3-Associated Hypertrophic Cardiomyopathy Presented Positive Phase 1 Data for TN-301
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"Commenced Patient Dosing in MyPeak-1TM Phase 1b Trial of TN-201 in MYBPC3-Associated Hypertrophic Cardiomyopathy Presented Positive Phase 1 Data for TN-301 for the Potential Treatment of Heart Failure with Preserved Ejection Fraction at HFSA 2023 TN-401 for PKP2-Associated ARVC Received FDA Clearance to Begin First-in-Human Clinical Testing and Fast Track Designation SOUTH SAN FRANCISCO, Calif., Nov. 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 and provided a corporate update for the third quarter ended September 30, 2023. “The successful execution across all of our program milestones slated for 2023, including two gene therapy INDs cleared and the dosing of the first patient in our TN-201 clinical trial, represents the strong commitment and capabilities of our team,” said Faraz Ali, Chief Executive Officer of Tenaya. “We have momentum as we head into 2024, with three clinical-stage programs for the treatment of rare and prevalent heart conditions and unmatched capabilities focused on the discovery of precision heart disease medications.” Business and Program UpdatesTN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) In October 2023, Tenaya dosed the first patient in the MyPeak-1 Phase 1b clinical trial of TN-201 for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). MyPeak-1 (NCT05836259) is a multi-center, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201. Tenaya anticipates sharing initial data from the MyPeak-1 trial in 2024. In October 2023, Tenaya shared interim results from its ongoing seroprevalence study indicating that patients with MYBPC3-associated HCM have low levels of preexisting neutralizing antibodies to adeno-associated virus serotype 9 (AAV9) and the majority of patients could be eligible for TN-201 treatment in clinical trials. The seroprevalence study is being conducted across 10 clinic sites. As of the data cut off in August 2023, 76 patients with MYBPC3-associated HCM were enrolled. These data were presented at the HCM ...