TTX-MC138 / TransCode - LARVOL DELTA

Phase 1 Clinical Testing of a First-in-Class Antisense Oligonucleotide Therapeutic against Advanced Solid Tumors of Multiple Tissue Origins (SABCS 2025) - P1, P1/2 | "The process leading to use of TTX-MC138 in the clinic is critically dependent on the innate tropism of the TTX drug design engine to tumors and represents a first step towards developing effective nucleic-acid based therapeutics against cancer. Clinical Study: NCT06260774."

Clinical • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • MIR10B

Phase I/II clinical study of a first-in-class antisense oligonucleotide (TTX-MC138) therapeutic against advanced solid tumors of multiple tissue origins (ESMO 2025) - P1/2 | "Clinical Study: NCT06260774. Conclusions The process leading to use of TTX-MC138 in the clinic is critically dependent on the innate tropism of TransCode's TTX drug design engine to tumors and represents a first step towards developing effective nucleic-acid based therapeutics against cancer."

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • MIR10B

TransCode Therapeutics presents preliminary data from its completed Phase 1a study with TTX-MC138 in metastatic disease at ESMO (PRNewswire) - "Safety primary endpoint achieved. Median treatment duration of 4 months with a range of 2 to 12 months and three patients remain on trial. RECIST data with apparent stable disease lasting over 4 months in 44% of patients (7 out of 16). Safety and durability profile consistent with known mechanism of action."

P1 data • Solid Tumor

TTX-MC138-002: Study of TTX-MC138 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=16 | Active, not recruiting | Sponsor: TransCode Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2026 ➔ Sep 2025

Enrollment closed • Trial primary completion date • Solid Tumor

...TransCode announced a $25 million investment from CK Life Sciences Int'l., (Holdings) Inc. ("CK Life Sciences") to be used primarily to advance clinical development of TransCode's lead microRNA asset, TTX-MC138, into a Phase 2 clinical trial. (PRNewswire)

Financing • Solid Tumor

TransCode Therapeutics Reports Further Progress on Phase 1a Clinical Trial with No Dose Limiting Toxicities Reported in Patients with Metastatic Cancer (PRNewswire) - P1/2 | N=20 | NCT06260774 | Sponsor: TransCode Therapeutics | "TransCode Therapeutics...announced further progress in its Phase 1a clinical trial of TTX-MC138 in patients with metastatic cancer....Eight patients remain on study for continued treatment, receiving an additional dose of TTX-MC138 during each 28 day treatment cycle and may remain on study absent any significant safety observations or disease progression. To date, the two patients who have remained on study the longest have received seven doses of TTX-MC138 over the course of approximately seven months and have demonstrated stable disease. No significant safety or dose limiting toxicities have been reported to date in any of the trial's 13 patients....Analysis of PD activity from cycle 1 treatments in Cohorts 1 and 2, treated with a dose of 0.8 mg/kg and 1.6 mg/kg respectively, demonstrates miR-10b target engagement at 24 hours post-infusion in 5 out of the 6 patients analyzed to date."

P1 data • Solid Tumor

TransCode Therapeutics Announces Initial Dosing in Fourth Cohort of Phase 1 Clinical Trial with TTX-MC138 (PRNewswire) - P1/2 | N=20 | NCT06260774 | Sponsor: TransCode Therapeutics | "TransCode Therapeutics...announced that the first patient in Cohort 4 of its Phase I clinical trial has received their initial dose. TransCode also reported that two additional patients in Cohort 4 are scheduled to receive TTX-MC138....No significant safety or dose limiting toxicities have been reported. The dose administered to the fourth cohort, as originally planned in the clinical protocol, is approximately fifty percent higher than the dose administered in the third cohort....Of the ten patients treated with TTX-MC138 in the first four cohorts, seven remain on study for continued treatment....Further, data analysis of both pharmacokinetic (PK) and pharmacodynamic (PD) activity from Cohorts 1, 2 and 3 is ongoing and suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode's Phase 0 clinical trial."

P1 data • Trial status • Solid Tumor

TransCode Therapeutics, Inc. Announces Registered Direct Offering Priced At-the-Market Under Nasdaq Rules (PRNewswire) - "TransCode Therapeutics...announced that it has agreed to sell an aggregate of 10,250,000 shares of its common stock and warrants to purchase up to 10,250,000 shares of common stock priced at-the-market under Nasdaq rules, at a purchase price of $0.98 per share and associated warrant....The gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, including related IND-enabling studies, and for working capital and other general corporate purposes."

Commercial • Solid Tumor

TransCode Therapeutics Announces Safety Review Committee Approval to Open Fourth Cohort in Phase I/II Clinical Trial (PRNewswire) - "TransCode Therapeutics, Inc...today announced that the Safety Review Committee (SRC) monitoring its Phase I clinical trial has unanimously approved opening of the fourth cohort of patients based on the SRC's favorable review of Cohort 3 safety data. The therapeutic candidate being evaluated, TTX-MC138, is a first-in-class therapeutic designed to treat multiple metastatic cancers using antisense technology. The dose administered to the fourth cohort, as originally planned in the clinical protocol, will be approximately fifty percent higher than the dose administered in the third cohort."

Clinical protocol • DSMB • Oncology • Solid Tumor

TransCode Therapeutics Announces Completion of Cohort 3 Initial Dosing with Lead Candidate in Phase 1 Clinical Trial (PRNewswire) - "TransCode Therapeutics...announced that Cohort 3 of its Phase 1 clinical trial enrolled three patients and all have been dosed with TTX-MC138, its lead candidate. The Safety Review Committee monitoring the clinical trial unanimously approved opening of the third cohort based on its review of Cohort 1 and 2 safety and pharmacokinetic (PK) data and is monitoring Cohort 3 as preliminary data becomes available. The dose administered to patients in the third cohort is approximately double the dose administered in the second cohort."

DSMB • Trial status • Solid Tumor

TransCode Therapeutics Announces First Patient Dosed in Third Cohort with Lead Candidate in Phase 1 Clinical Trial (PRNewswire) - "TransCode Therapeutics, Inc...announced that the first patient in Cohort 3 of its Phase 1 clinical trial has been dosed with TTX-MC138, its lead candidate...Additional Cohort 3 patients have been scheduled. The dose administered to patients in the third cohort is approximately double the dose administered to those in the second cohort....No significant safety or dose limiting toxicities have been reported. Analyses of PK data and pharmacodynamic (PD) activity from Cohorts 1 and 2 is ongoing."

Trial status • Solid Tumor

TransCode Therapeutics Announces Safety Review Committee Approval of Opening Third Cohort and Preliminary Results from First Cohort in Phase 1 TTX-MC138 Clinical Trial (PRNewswire) - P1 | N=20 | NCT06260774 | Sponsor: TransCode Therapeutics | "TransCode Therapeutics, Inc...announced that the Safety Review Committee (SRC) monitoring its Phase 1 clinical trial has unanimously approved opening of the third cohort of patients based on its favorable review of Cohort 2 safety data....Several patients in the first and second cohort remain on study for continued treatment. No significant safety or dose limiting toxicities have been reported. Analysis of Cohort 1 data for pharmacokinetic (PK) and pharmacodynamic (PD) activity is ongoing and to date suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from the previous Phase 0 clinical trial. Specifically, results from Cohort 1 confirmed the Phase 0 observation that TTX-MC138 shows evidence of pharmacodynamic activity in the presence of high baseline expression of miR-10b, reaching a 66% inhibition at 24 hours after infusion."

P1 data • Trial status • Oncology • Solid Tumor

Early Clinical Experience with TTX-MC138, a First-in-Class Therapeutic Candidate for Metastatic Breast Cancer (SABCS 2024) - "Remarkably, even at a 100 microgram microdose, the drug showed robust PD activity with a 70% inhibition of the miR-10b target in blood over the full time course of the study. The process leading to the implementation of TTX-MC138 in the clinic is critically dependent on the innate tropism of the TTX delivery platform to tumors and represents a first step towards developing effective nucleic-acid based therapeutics against cancer."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • MIR10B

TransCode Therapeutics Announces Safety Review Committee Approval of Second Cohort Opening in Phase 1 TTX-MC138 Clinical Trial Following Favorable Review of Cohort 1 Safety Data (GlobeNewswire) - "TransCode Therapeutics, Inc...announced that the Safety Review Committee (SRC) monitoring its Phase 1 clinical trial has unanimously approved opening of the second cohort of patients based on its favorable review of Cohort 1 safety data....The therapeutic candidate being evaluated, TTX-MC138, is TransCode’s lead candidate designed to inhibit microRNA-10b, a microRNA critical to the emergence and progression of metastatic cancer. All patients in the first cohort remain on study for continued treatment. No significant safety or dose limiting toxicities have been reported. The dose administered to the second cohort will be approximately double the dose administered to the first cohort."

Trial status • Oncology • Solid Tumor

TransCode Therapeutics Completes Initial Dosing of First Cohort in Phase 1 Clinical Trial with TTX-MC138, a microRNA-Targeted Technology (GlobeNewswire) - "TransCode Therapeutics, Inc...today announced that it has dosed all patients in the first cohort of its Phase 1a dose-escalation clinical trial. The therapeutic candidate being evaluated, TTX-MC138, is TransCode’s lead candidate designed to inhibit microRNA-10b, a microRNA critical to the emergence and progression of metastatic cancer. All patients in the cohort received their first dose of TTX-MC138 and remain on study for continued treatment. No significant safety or dose limiting toxicities have been reported."

Trial status • Solid Tumor

Clinical experience with TTX-MC138: A first-in-class therapy against metastatic cancer (ESMO 2024) - "The process leading to the implementation of TTX-MC138 in the clinic is critically dependent on the innate tropism of the TTX delivery platform to tumors and represents a first step towards developing effective nucleic-acid based therapeutics against cancer."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • MIR10B

TransCode Therapeutics Announces First Patients Treated in Phase 1 Clinical Trial with First-in-Class Lead Therapeutic Candidate (GlobeNewswire) - "TransCode Therapeutics, Inc...announced dosing of the first two patients in its Phase 1 clinical trial with its lead candidate, TTX-MC138. Several additional patients have been screened for enrollment in the trial, a multicenter, open-label, dose-escalation and dose-expansion study of TTX-MC138. Several additional patients have been screened for enrollment in the trial, a multicenter, open-label, dose-escalation and dose-expansion study of TTX-MC138."

Trial status • Oncology • Solid Tumor

TransCode Therapeutics Announces Publication of Study with Lead Therapeutic Candidate Revealing Mechanisms Behind Candidate’s Preclinical Efficacy Against Metastatic Cancer (GlobeNewswire) - "TransCode Therapeutics...in collaboration with Michigan State University, published an article in the journal Oncotarget titled, Inhibition of miR-10b treats metastatic breast cancer by targeting stem cell-like properties....In this study, the authors show that stem-like breast cancer cells increase expression of miR-10b, the molecule targeted by TTX-MC138. The study also demonstrates that treatment of breast cancer cells with TTX-MC138 reduces their stemness, confirming that these properties make metastatic cells susceptible to the therapeutic candidate’s actions."

Preclinical • Breast Cancer

TransCode Therapeutics Awarded $2 Million NIH Grant to Support Clinical Evaluation of Lead Candidate (GlobeNewswire) - "TransCode Therapeutics, Inc...today announced that it has been awarded a $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support clinical evaluation of TTX-MC138, TransCode’s lead therapeutic candidate...Funds under the grant are expected to be received over two years."

Financing • Oncology • Solid Tumor

TransCode Therapeutics Announces Phase 1 Clinical Trial Initiation (GlobeNewswire) - "TransCode Therapeutics, Inc...today announced initiation of its Phase 1 multicenter, open-label, clinical study of its lead therapeutic candidate, TTX-MC138. Two clinical trial sites have been activated with patient enrollment expected to begin during the current quarter. TransCode may activate a total of up to five clinical trial sites, all of which are expected to be activated this quarter."

Trial status • Oncology • Solid Tumor

TTX-MC138-002: Study of TTX-MC138 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: TransCode Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

TransCode Therapeutics, Inc. Announces Closing of Public Offering (GlobeNewswire) - "TransCode Therapeutics...announced the closing of its previously announced public offering of 10,000,000 shares of its common stock at a public offering price of $0.30 per share, for gross proceeds of $3,000,000, before deducting placement agent fees and offering expenses. The Company intends to use the net proceeds from the offering primarily for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, and related investigational new drug (IND) enabling studies, and for working capital and other general corporate purposes."

Commercial • Solid Tumor

TransCode Therapeutics, Inc. Announces Proposed Public Offering of Common Stock (GlobeNewswire) - "TransCode Therapeutics...announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ('Pre-funded Warrants') in lieu thereof) in a best efforts public offering. All of the shares of common stock (and/or Pre-funded Warrants) are to be sold by the Company....The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The Company intends to use the net proceeds from the offering primarily for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, and related investigational new drug (IND) enabling studies, and for working capital and other general corporate purposes."

Commercial • Solid Tumor

Initial clinical experience with the first-in-class anti-metastasis therapeutic TTX-MC138. (ASCO 2024) - P1 | "The results of the non-clinical studies and Phase 0 clinical study have the potential to address the question of delivery to the target tissue. The process leading to the implementation of TTX-MC138 in the clinic is critically dependent on the innate tropism of the TTX delivery platform to tumors and represents a first step towards developing effective nucleic-acid based therapeutics against cancer. Clinical trial information: NCT05908773."

Clinical • Oncology • MIR10B

TransCode Therapeutics Reports Positive Data from First-in-Human Clinical Study Using Novel Lead Therapeutic Candidate, TTX-MC138 (GlobeNewswire) - Early P1 | N=01 | NCT05908773 | Sponsor: TransCode Therapeutics | "New results from the patient dosed in this trial indicate that a microdose of radiolabeled TTX-MC138 resulted in significant inhibition of the drug candidate’s molecular target, miRNA-10b, in the patient’s blood. Specifically, after injection, the amount of miR-10b in the patient’s blood was significantly reduced compared to levels prior to administration of radiolabeled TTX-MC138, reaching a reduction of 66% at 24 hours following dosing....Full data analysis is ongoing and will be included in the final study report."

Clinical data • Oncology • Solid Tumor