EXCLUSIVE: TransCode Therapeutics Reports Progress In Early-Stage Study For Lead Cancer Drug

TransCode Therapeutics, Inc. RNAZ announced further progress on Thursday in its Phase 1a clinical trial of TTX-MC138 in patients with metastatic cancer.

To date, 13 patients have received at least one dose of TTX-MC138 at four separate dose levels ranging from 0.8 mg/kg to 4.8 mg/kg. Two patients have been treated in the expanded enrollment.

Eight patients remain on the study for continued treatment, receiving an additional dose of TTX-MC138 during each 28-day treatment cycle, and may remain on the study absent any significant safety observations or disease progression.

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To date, the two patients who have remained on study the longest have received seven doses of TTX-MC138 over approximately seven months and have demonstrated stable disease.

No significant safety or dose-limiting toxicities have been reported in the trial's 13 patients.

Ongoing analyses of PK activity from Cohorts 1, 2, and 3 suggest that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode's Phase 0 clinical trial.

Specifically, the preliminary PK data follow a predictable dose-response relationship.

Analysis of PD activity from cycle one treatments in Cohorts 1 and 2, treated with a dose of 0.8 mg/kg and 1.6 mg/kg, respectively, demonstrates miRNA-10b target engagement at 24 hours post-infusion in 5 out of the six patients analyzed.

The observed tolerability profile and the available PK/PD results thus far support the advancement of the clinical trial to evaluate the safety and potential anti-tumor activity of TTX-MC138 in the planned dose expansion (Phase 1b) portion of the trial.

At the highest dose administered, TTX-MC138 was well tolerated with no significant toxicities noted.

In January, TransCode Therapeutics dosed the first patient in Cohort 3 of its Phase 1 clinical trial with its lead candidate, TTX-MC138.

The company's Safety Review Committee approved the progression to the third cohort following a favorable review of safety and pharmacokinetic data from Cohorts 1 and 2. No significant safety or dose-limiting toxicities have been reported in the earlier cohorts.

The pharmacokinetic data from these cohorts has been consistent with preclinical and Phase 0 trial results. Patients from the earlier cohorts remain in the study and are continuing to receive additional doses of TTX-MC138.

Price Action: RNAZ stock is up 4.89% at $0.43 during the premarket session at the last check Thursday.