TransCode Therapeutics Announces FDA Clearance To Initiate Phase 1/2 Clinical Trial with TTX-MC138 in Patients with Advanced Solid Tumors

Clinical trial expected to commence in mid-2024 to evaluate the safety and preliminary anti-tumor activity of TTX-MC138

BOSTON, April 15, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company’s Investigational New Drug (IND) application and concluded that the company may proceed with its Phase 1/2 multicenter, open-label, dose-escalation and dose-expansion study of its lead therapeutic candidate, TTX-MC138, in patients with advanced solid tumors.

“We are thrilled to have obtained FDA authorization to advance TTX-MC138 into the clinic. FDA’s clearance of our IND application represents a significant milestone for our company,” commented Sue Duggan, Senior Vice President, Operations, at TransCode. “Activation of the IND opens the door for continued development of TTX-MC138 in the clinical setting. The Phase 1/2 clinical trial is designed to generate critical data to support evaluation of the safety of TTX-MC138 and may provide early evidence of its clinical activity in patients with metastatic disease.”

The Phase 1/2 clinical trial includes an initial dose-escalation phase followed by a dose-expansion phase. The dose-escalation portion of the trial is designed to include patients with a variety of metastatic solid cancers. The primary objective of this phase is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion phase, certain tumor types will be evaluated based on preliminary results from the dose-escalation phase. The primary objective of the dose-expansion phase is to further evaluate safety as well as tolerability and anti-tumor activity of TTX-MC138 in cancer patients.

The company believes that TTX-MC138 has the potential to positively affect patient outcomes in a range of cancers, including breast, pancreatic, ovarian, colon, glioblastomas and others. In multiple animal models of cancer, treatment with TTX-MC138 led to statistically significant reductions of metastatic burden and longer animal survival relative to animals given control treatments. Successful clinical development of TTX-MC138 potentially represents a novel solution for patients with metastatic cancer.