TransCode Therapeutics Reports Third Quarter 2023 Results; Provides Business Update

BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported financial results for the third quarter ended September 30, 2023, and recent business progress.

“In the third quarter of 2023, we successfully completed a follow-on public offering in a very difficult biotech market as we continue our clinical study with our lead therapeutic candidate, an RNA targeted therapeutic candidate for treating metastatic disease,” said Michael Dudley, co-founder, president and Chief Executive Officer of TransCode. “We were excited to dose our first patient in our Phase 0 clinical trial with TTX-MC138 in cancer patients with advanced solid tumors for which further enrollment is underway.

TransCode co-founder and Chief Technology Officer, Dr. Zdravka Medarova, commented, “We also announced encouraging preclinical data in glioblastoma multiforme (GBM) with our lead candidate. In addition, we published results of a preclinical study showing that inhibition of microRNA-10b, the therapeutic target of TTX-MC138, in breast cancer cells impaired the capacity of cancer stem cells to create new tumors and become metastatic. We believe these findings are important because cancer stem cells have long been known to play a critical role in cancer initiation, metastasis, recurrence, and resistance to therapy. Therefore, we believe that inhibiting the tumor-creating capacity of these cells using TTX-MC138 has the potential to improve outcomes in patients with breast cancer that is recurrent and resistant to treatment.”

Recent Business Highlights

• In July, the company announced the results of a pre-clinical study of its lead therapeutic candidate, TTX-MC138, in non-human primates, effectively engaging its target and showing favorable pharmacokinetics and tissue distribution. In the study, non-human primates (n = 4) were injected with a microdose of radiolabeled TTX-MC138 and imaged by positron emission tomography-magnetic resonance imaging (PET-MRI) to determine the pharmacokinetics and tissue distribution of the therapeutic candidate. In addition, the pharmacodynamic activity of radiolabeled TTX-MC138 following a microdose injection was determined by measuring inhibition of its target, miRNA-10b, using qRT-PCR. TTX-MC138 demonstrated a long circulation half-life and tissue distribution consistent with hepatic clearance. Importantly, even at a microdose, the therapeutic candidate showed lasting activity and significantly inhibited miRNA-10b, known to be a driver of metastatic progression in a number of cancers.
• In August, the company dosed the first patient in its First-in-Human Phase 0 clinical study. The Phase 0 trial is an open-label, single-center, microdose study intended to demonstrate delivery of the radiolabeled version of TTX-MC138 to radiographically-confirmed metastases in subjects with advanced solid tumors. Preliminary data showed that radioactivity consistent with accumulation of TTX-MC138 was detected by noninvasive imaging in the regions of the metastatic lesions previously identified by fluorodeoxyglucose (FDG)/positron emission tomography (PET) (FDG/PET). In addition, radiolabeled TTX-MC138 had pharmacokinetic behavior consistent with that expected based on non-clinical IND-enabling studies. The patient tolerated the dosing with no reported adverse reactions. Metabolite analysis indicated circulation of intact radiolabeled TTX-MC138 for more than 20 hours, equivalent to that predicted by Drug Metabolism and Pharmacokinetics (DMPK) modelling, and that the drug candidate analyzed in the blood was identical to that of the manufactured drug candidate, demonstrating in vivo stability. Complete analysis of data from this first patient is in process and will be included in the final report for all patients enrolled in the study.
• In September, the company announced the results of a pre-clinical study of TTX-MC138 in murine models bearing human glioblastoma multiforme (GBM) tumors. In this study, the therapeutic candidate was delivered to brain tumors where it effectively engaged its target. In the study reported by TransCode, mice implanted with tumors derived from human GBM patients were treated with TTX-MC138 and imaged by magnetic resonance imaging (MRI) to determine delivery of the therapeutic candidate to the tumors. In addition, the pharmacodynamic activity of TTX-MC138 was determined by measuring inhibition of miRNA-10b using qRT-PCR. TTX-MC138 was injected intravenously and accumulated efficiently in the tumors. Importantly, the therapeutic candidate showed lasting activity and significantly inhibited miRNA-10b, known to be a driver of tumor progression in glioblastoma.
• Also, in September, the company closed an underwritten public offering of an aggregate of 16,863,000 shares of its common stock (or pre-funded warrants in lieu thereof), including the partial exercise of the underwriter’s over-allotment option. Each share of common stock (or pre-funded warrant) was sold at a public offering price of $0.51 per share (inclusive of the pre-funded warrant exercise price of $0.01 per share). All of the shares and pre-funded warrants in the offering were sold by the company. Gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $8.5 million.

Planned Milestones