TransCode Therapeutics Advances Clinical Trial with New Dose for TTX-MC138 in Patients
TransCode Therapeutics, Inc., a company dedicated to advancing cancer treatment through RNA-based therapies, has made significant strides in its clinical trials for TTX-MC138, a pioneering candidate targeting metastatic cancers. On February 6, 2025, the company announced that it had successfully completed the initial dosing for Cohort 3 of its Phase 1 clinical trial, a notable step that underscores their commitment to effective cancer therapies.
This latest cohort included three patients who received TTX-MC138 at approximately double the dose administered in the previous cohort. The decision to escalate the dose was supported unanimously by the Safety Review Committee after thorough evaluations of the safety and pharmacokinetic (PK) data from Cohorts 1 and 2. Thus far, clinical data has demonstrated that patients have tolerated the drug without significant adverse effects or dose-limiting toxicities. In total, nine patients have received TTX-MC138 across the trial’s first three cohorts, with ongoing analyses showing promising results in terms of safety and pharmacodynamics (PD).
The therapeutic model behind TTX-MC138 focuses on inhibiting miR-10b, a microRNA involved in the progression of various metastatic cancers. Initial results from the first cohort revealed a potent pharmacodynamic response, with a substantial 66% inhibition observed within 24 hours post-infusion, consistent with findings from a prior Phase 0 trial. Such results not only validate earlier investigations but also showcase TTX-MC138's potential for managing cancer effectively by targeting critical pathways involved in tumor growth and metastasis.
As part of its structure, this Phase 1 trial is designed in two stages—dose escalation followed by dose expansion—to gather essential data on both safety and therapeutic efficacy among patients diagnosed with a range of metastatic solid tumors. The primary focus during the dose-escalation phase is to assess the safety and tolerability of increasing doses, while future dose-expansion efforts will aim to evaluate the treatment’s effects on specific cancer types identified based on primary trial outcomes.
Encouragingly, TransCode's portfolio extends beyond TTX-MC138, as the company is also advancing several other unique RNA therapeutic candidates. Each is designed to address the challenges inherent to RNA delivery mechanisms, potentially expanding the scope of therapeutic applications across various cancer types. This innovation lies at the core of TransCode's mission to improve patient outcomes in the battle against cancer.
With cancer remains one of the leading causes of morbidity and mortality worldwide, initiatives like those by TransCode Therapeutics signify vital progress within oncology. As additional data emerges from ongoing trials, the hope is that TTX-MC138 will pave the way for new standards of care in the fight against cancer.
For those interested in following the developments related to this trial, further details can be found on clinical trial registries such as www.clinicaltrials.gov under the NCT Identifier NCT06260774. As the fight against cancer continues, companies like TransCode Therapeutics exemplify the potential of cutting-edge research in transforming the future of cancer care.
This latest cohort included three patients who received TTX-MC138 at approximately double the dose administered in the previous cohort. The decision to escalate the dose was supported unanimously by the Safety Review Committee after thorough evaluations of the safety and pharmacokinetic (PK) data from Cohorts 1 and 2. Thus far, clinical data has demonstrated that patients have tolerated the drug without significant adverse effects or dose-limiting toxicities. In total, nine patients have received TTX-MC138 across the trial’s first three cohorts, with ongoing analyses showing promising results in terms of safety and pharmacodynamics (PD).
The therapeutic model behind TTX-MC138 focuses on inhibiting miR-10b, a microRNA involved in the progression of various metastatic cancers. Initial results from the first cohort revealed a potent pharmacodynamic response, with a substantial 66% inhibition observed within 24 hours post-infusion, consistent with findings from a prior Phase 0 trial. Such results not only validate earlier investigations but also showcase TTX-MC138's potential for managing cancer effectively by targeting critical pathways involved in tumor growth and metastasis.
As part of its structure, this Phase 1 trial is designed in two stages—dose escalation followed by dose expansion—to gather essential data on both safety and therapeutic efficacy among patients diagnosed with a range of metastatic solid tumors. The primary focus during the dose-escalation phase is to assess the safety and tolerability of increasing doses, while future dose-expansion efforts will aim to evaluate the treatment’s effects on specific cancer types identified based on primary trial outcomes.
Encouragingly, TransCode's portfolio extends beyond TTX-MC138, as the company is also advancing several other unique RNA therapeutic candidates. Each is designed to address the challenges inherent to RNA delivery mechanisms, potentially expanding the scope of therapeutic applications across various cancer types. This innovation lies at the core of TransCode's mission to improve patient outcomes in the battle against cancer.
With cancer remains one of the leading causes of morbidity and mortality worldwide, initiatives like those by TransCode Therapeutics signify vital progress within oncology. As additional data emerges from ongoing trials, the hope is that TTX-MC138 will pave the way for new standards of care in the fight against cancer.
For those interested in following the developments related to this trial, further details can be found on clinical trial registries such as www.clinicaltrials.gov under the NCT Identifier NCT06260774. As the fight against cancer continues, companies like TransCode Therapeutics exemplify the potential of cutting-edge research in transforming the future of cancer care.
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