Tenaya Therapeutics Reports Early Data from MyPEAK-1 Clinical Trial of TN-201 Gene Therapy

On December 17, 2024, Tenaya Therapeutics, Inc. (NASDAQ: TNYA) shared insights from the first cohort of patients in the MyPEAK-1 clinical trial of TN-201 gene therapy. The preliminary data revealed TN-201’s positive reception, suggesting its potential for treating MYBPC3-associated hypertrophic cardiomyopathy (HCM), attributed to decreased MyBP-C levels.

The early findings from three patients in Cohort 1 displayed promising results. TN-201 exhibited good tolerability, showing detectable vector DNA in the heart, transgene RNA expression, and elevated TN-201 mRNA and MyBP-C protein levels over time. Although early markers of cardiac muscle strain remained stable, longer-term observations are essential to fully understand TN-201’s impact.

Furthermore, Tenaya is committed to monitoring the first three patients continuously and looks forward to additional data readouts from Cohort 1 and the higher dose Cohort 2 in 2025. The ongoing Phase 1b/2 My-PEAK-1 study concentrates on MYBPC3-associated nonobstructive HCM in symptomatic adults at risk of sudden cardiac death.

The patient outcomes have been encouraging, demonstrating stable or improved clinical markers. TN-201’s safety profile indicated manageable liver enzyme elevations and no significant cardiac toxicities. Interim observations also displayed robust transduction into cardiomyocytes and enhanced expression of TN-201 RNA and MyBP-C protein over time.

The report emphasized the crucial role of TN-201 in gene delivery and restoration of MyBP-C levels, essentially aiming to halt disease progression and enhance patient well-being. While the initial results appear promising, the company and regulators underscore the necessity for further comprehensive data analysis, patient follow-ups, and continuous assessments.

Tenaya acknowledged that the provided data is not filed for Securities Exchange Act of 1934 or Securities Act of 1933 purposes but serves to inform stakeholders on the evolving clinical developments.

The presented information remains aligned with Tenaya Therapeutics’ goal to advance healthcare solutions for MYBPC3-associated HCM, harnessing gene therapy to address underlying genetic abnormalities and enhance patient outcomes in the future.

Contact:
Tenaya Therapeutics, Inc.
171 Oyster Point Boulevard, Suite 500, South San Francisco, CA 94080
Phone: 650-825-6990

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Tenaya Therapeutics’s 8K filing here.

Tenaya Therapeutics Company Profile

Tenaya Therapeutics, Inc, a biotechnology company, discovers, develops, and delivers therapies for heart disease in the United States. It develops its products through gene editing, cellular regeneration, and gene addition. The company is developing TN-201, a gene therapy for myosin binding protein C3-associated hypertrophic cardiomyopathy which is in phase 1 clinical trial; TN-301, a small molecule for heart failure with preserved ejection fraction which is in phase 1 clinical trial; and TN-401, a gene therapy for plakophilin 2-associated arrhythmogenic right ventricular cardiomyopathy which is in preclinical stage.