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Tenaya Therapeutics Announces TN-201 IND Clearance and Anticipated 2023 Milestones
Phase 1b Clinical Trial for TN-201 in MYBPC3-associated HCM Patients Expected to Begin Dosing in Third Quarter 2023; Data Anticipated in 2024 Data from
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"Phase 1b Clinical Trial for TN-201 in MYBPC3-associated HCM Patients Expected to Begin Dosing in Third Quarter 2023; Data Anticipated in 2024 Data from First-in-Human Clinical Trial of TN-301 Anticipated in Second Half 2023 TN-401 IND Submission Planned in Second Half 2023 Cash Runway Extended into First Half 2025 SOUTH SAN FRANCISCO, Calif., Jan. 09, 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, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of its Investigational New Drug (IND) application to initiate clinical testing of TN-201. In addition, Tenaya shared anticipated 2023 program milestones and updated cash runway guidance. “Tenaya had a momentous year in 2022 in which we filed two INDs, transitioned into a clinical-stage company, launched operations of our Genetic Medicines Manufacturing Center - where we successfully produced clinical drug supply for TN-201 - and significantly extended our cash runway,” said Faraz Ali, Chief Executive Officer of Tenaya. “We are pleased to start 2023 with clearance of the IND for our TN-201 gene therapy program and look forward to dosing patients with MYBPC3-associated HCM in our Phase 1b study in the coming months. We are also starting 2023 with confirmation of target engagement in our TN-301 Phase 1 study and look forward to reporting clinical data for this program later this year. We are enrolling patients across three non-interventional studies for our gene therapy programs and plan to file an IND for TN-401. Taken altogether, we are making tremendous strides on our mission and are solidifying our leadership position in the field of precision medicine therapies for heart disease.” TN-201 IND Clearance and Phase 1 ProtocolTenaya received notification from the FDA indicating that, following review of the company’s IND package, clinical testing of TN-201 may proceed. TN-201 is Tenaya’s first-in-class adeno-associated virus (AAV)-based investigational gene therapy product candidate for the treatment of hypertrophic cardiomyopathy (HCM) caused by mutations in the MYBPC3 gene, the most common genetic cause of HCM. TN-201 is designed to deliver a fully functional MYB...