TTX-MC138 / TransCode - LARVOL DELTA

PRE-I-SPY-PI: PRE-ISPY Phase I/II Oncology Platform Program (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: QuantumLeap Healthcare Collaborative | Phase classification: P1 ➔ P1/2 | N=124 ➔ 280 | Trial completion date: Dec 2029 ➔ Dec 2031 | Trial primary completion date: Dec 2028 ➔ Dec 2030

Biomarker • Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Phase 1a Clinical Trial of TTX-MC138, a First-in-Class AntagomiR against Advanced Solid Tumors (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor

TransCode Therapeutics Announces Patent Advancements in…Japan Strengthening Global IP Position in RNA-Based Immuno-Oncology (PRNewswire) - "In Japan, the Japan Patent Office (JPO) issued a Notice of Allowance, and subsequently granted and issued Japanese Patent No. 7886877, for Patent Application No. 2023-540752, titled 'Template Directed Immunomodulation for Cancer Therapy.' The application is directed to novel RNA-based immunomodulatory compositions, including single-stranded 5′ triphosphate-modified RNA oligonucleotides designed to selectively activate innate immune pathways such as RIG-I within tumors and the tumor microenvironment. The allowed Japanese claims are related to compositions targeting cancers expressing miR-21, as well as nanoparticle-enabled delivery approaches incorporating magnetic or polymer-coated systems to enhance tumor targeting and cellular uptake....These developments further strengthen TransCode's global IP estate which encompasses its RNA-based therapeutic candidates, including TTX-MC138..."

Patent • Solid Tumor

TransCode Therapeutics Announces Patent Advancements in Australia… (PRNewswire) - "IP Australia issued a Notice of Acceptance for Patent Application No. 2019349817, titled 'Compositions and Methods for Immune Checkpoint Inhibition'. The application covers therapeutic nanoparticle compositions designed to deliver small interfering RNA (siRNA) molecules for the treatment of cancer. The allowed claims encompass nanoparticles comprising an iron oxide core, a dextran polymer coating, and a recited covalently linked siRNA, along with pharmaceutical compositions and methods of use across a broad range of cancers, including colon, lung, breast, pancreatic, and ovarian cancers....The Australian patent application is expected to proceed to grant with a projected expiry date of September 6, 2039....These developments further strengthen TransCode's global IP estate which encompasses its RNA-based therapeutic candidates, including TTX-MC138..."

Patent • Breast Cancer • Colon Cancer • Lung Cancer • Ovarian Cancer • Pancreatic Cancer

TransCode Therapeutics…announced the publication of a peer-reviewed article in Cancers titled, 'Targeting miR-10b in Breast Cancer Bone Colonization Model Using Image-Guided Nucleic Acid-Based Therapeutics' (PRNewswire) - "The study reports that TransCode's lead therapeutic candidate, TTX-MC138, produced significant survival benefits in a preclinical model of breast cancer bone metastasis while demonstrating favorable tolerability and no observed systemic toxicity....Animals treated with anti-miR-10b therapeutics demonstrated significant survival benefits compared with controls. Repeated dosing was well tolerated, with no evidence of systemic toxicity observed during the study."

Preclinical • Breast Cancer

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 Initiates Phase 2a Clinical Trial with TTX-MC138 in Patients with ctDNA Positive Colorectal Cancer (PRNewswire) - "The Phase 2a clinical trial is expected to enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have no radiographic evidence of disease, but remain or become ctDNA-positive, indicating the presence of minimal residual disease."

Trial status • Colorectal Cancer

Phase 1 clinical trial of a first-in-class antagomir therapeutic against advanced solid tumors (AACR 2026) - 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 • First-in-human • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • MIR10B • TG

Nanotherapy Targeting miR-10b Improves Survival in Orthotopic Glioblastoma Models. (PubMed, J Funct Biomater) - "In therapeutic studies in orthotopic models of GBM presented here we used MN-anti-miR10b as well as TTX-MC138, a clinically tested anti-miR10b nanotherapeutic now in Phase I trials in patients with solid (non-GBM) cancers. Both formulations showed efficient delivery, as demonstrated by imaging and improved survival, leading to target inhibition and increased apoptosis. This approach may offer a novel strategy for delivering therapeutics to GBM and improving patient outcomes in one of the most aggressive and treatment-resistant forms of brain cancer."

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MIR10B

TransCode Therapeutics Announces Publication of Preclinical Data Supporting Therapeutic Potential of TTX-MC138 in Glioblastoma (PRNewswire) - "The article was published in the peer-reviewed Journal of Functional Biomaterials (Volume 17, Issue 1)....TTX-MC138 is delivered to glioblastoma tumors in murine models of the disease, following intravenous injection. TTX-MC138 demonstrated suppression of miR-10b target and extended survival in aggressive glioblastoma models. Study supports future clinical development of TTX-MC138 for patients with glioblastoma...A Phase 2a clinical trial anticipated to begin in the first half of 2026..."

New P2a trial • Preclinical • Glioblastoma

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

TransCode Therapeutics Inc. and Quantum Leap Healthcare Collaborative announced a collaboration to evaluate TransCode’s lead therapeutic candidate TTX-MC138 in the PRE-I-SPY Phase 2a clinical trial platform. (City Buzz) - "he study plans to enroll up to 45 colorectal cancer patients who are ctDNA positive following standard curative-intent therapy, beginning in the first half of 2026."

Commercial • Colorectal Cancer

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