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TransCode Therapeutics Announces Orphan Drug Designation Status for TTX-MC138 for Treatment of Pancreatic Cancer
BOSTON, Feb. 28, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology CompanyTM committed to more effectively treating
About this update from Transcode Therapeutics, Inc.
[{"type":"text","content":"BOSTON, Feb. 28, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology CompanyTM committed to more effectively treating cancer using RNA therapeutics, announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its lead therapeutic candidate, TTX-MC138, in pancreatic cancer. Pancreatic cancer is the seventh leading cause of cancer-related deaths worldwide and fourth in the United States. The survival rate of pancreatic cancer is less than 10%, with exocrine pancreatic adenocarcinoma (PDAC), having a 5-year survival rate of only 1% when diagnosed at an advanced inoperable stage, which occurs in 80% of cases. Despite continued research, the prognosis for people with this malignancy has not improved in over 40 years. “We are pleased to have received Orphan Drug Designation from FDA with our lead therapeutic candidate in pancreatic cancer,” said TransCode’s Chief Executive Officer and Co-founder, Michael Dudley. “This is the second drug in our pipeline to receive such status. In June 2022, FDA granted ODD status for our checkpoint inhibitor, TTX-siPDL1, also for treatment of pancreatic cancer,” added Dudley. The Company believes that TTX-MC138 has the potential to dramatically improve clinical outcomes in patients with pancreatic cancer. TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode believes that TTX-MC138 could be used as a treatment for many of these cancers. In a preclinical model of pancreatic adenocarcinoma, administration of TTX-MC138 as monotherapy resulted in complete responses, manifested as regression without recurrence, in 40% of treated animals. This study comes on the heels of studies in breast cancer demonstrating complete regressions of metastatic disease. In addition to murine models of cancer, TTX-MC138 was successfully delivered and demonstrated preliminary efficacy in a case study of spontaneous feline mammary carcinoma. Dudley further stated, “ODD status provides several potential benefits including seven years of marketing exclusivity if the designated candidate subsequently receives FDA marketing approval, tax credits for qualified R&D expenses, and an exemption from payment of the Prescription Drug U...