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Tenaya Therapeutics Announces 2025 Strategic Priorities and Anticipated Milestones
Continued Focus on Driving Advancement of TN-201 and TN-401 Gene Therapies for Cardiomyopathies Dosing Initiated in Cohort 2 of the MyPEAK™-1 Phase 1b/2
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"Continued Focus on Driving Advancement of TN-201 and TN-401 Gene Therapies for Cardiomyopathies Dosing Initiated in Cohort 2 of the MyPEAK™-1 Phase 1b/2 Clinical Trial of TN-201 for Treatment of MYBPC3-Associated Hypertrophic Cardiomyopathy Additional Cohort 1 Data to be Reported in 1H25 Building on Promising Initial Data Initial Data from RIDGE™-1 Phase 1b Clinical Trial of TN-401 for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy Expected in 2H25 SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (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 provided an update on its clinical development programs and outlined its strategic priorities for 2025. “2024 was a pivotal year for Tenaya, marked by important operational execution across our clinical-stage pipeline of gene therapy candidates with the potential to target and address the underlying drivers of heart disease,” said Faraz Ali, Chief Executive Officer of Tenaya. “As we enter 2025, we are eager to build on this momentum to accelerate enrollment and report on safety, biopsy and initial clinical endpoints from both our TN-201 and TN-401 programs throughout the year.” Program Updates and Anticipated 2025 Milestones: TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) Tenaya anticipates reporting additional data from Cohort 1 from the ongoing MyPEAK-1 Phase 1b/2 clinical trial of TN-201 for the potential treatment of MYBPC3-associated HCM in the first half of 2025. These data are expected to include safety and available assessments from the first three patients dosed, 52-week biopsy data for Patient 2, and baseline and post-dose biopsy data for Patient 3. In December 2024, Tenaya announced initial interim data from Cohort 1, which showed TN-201 administered at the starting dose of 3E13 vg/kg was generally well-tolerated among the first three patients enrolled in the study. Among the first two patients, TN-201 achieved readily detectable vector DNA in the heart and evidence of transgene RNA expression. Serial biopsies at Week 8 and Week 52 for Patient 1 demonstrated increasing TN-201 mRNA and MyBP-C protein levels over time. Circulating biomarkers of cardiac...