TransCode and Quantum Leap search FDA approval for Section IIa TTX-MC138 examine
A partnership consisting of TransCode Therapeutics and Quantum Leap Healthcare Collaborative has filed an investigational new drug (IND) software for approval from the U.S. Meals and Drug Administration (FDA) for a deliberate Section IIa examine of lead colorectal most cancers candidate TTX-MC138.
The examine shall be performed inside Quantum Leap’s PRE-I-SPY program and marks the platform’s first growth into colorectal most cancers.
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The dose growth portion will enroll as much as 45 sufferers with colorectal most cancers who’ve accomplished customary healing remedy and have constructive circulating tumor DNA (ctDNA) markers.
Current analysis has proven that ctDNA could function a prognostic marker for most cancers recurrence and sign minimal residual illness (MRD) which will profit from early intervention.
The Section IIa scientific trial is predicted to start within the first half of 2026 and shall be led by principal investigator Dr. Paula Pohlmann of MD Anderson Most cancers Middle.
The purpose is to evaluate the organic and scientific exercise of TTX-MC138 in sufferers with MRD after major remedy.
Scientific trial actions will happen at a number of PRE-I-SPY Platform Community websites, lots of which belong to the Nationwide Most cancers Middle Community. This system additionally companions with the Colorectal Most cancers Alliance.
TransCode operations senior VP Sue Duggan mentioned: “This IND submission marks a important step in TransCode’s scientific growth program, positioning TTX-MC138 the place its mechanism of motion has the potential to ship significant advantages to sufferers.
“We’re happy to companion with Quantum Leap’s PRE-I-SPY program to judge TTX-MC138 and help the growth of this platform into new indications reminiscent of colorectal most cancers.”
In March 2025, TransCode obtained unanimous approval from the Security Assessment Committee (SRC) to open the fourth cohort in its Section I trial of TTX-MC138 for the remedy of a number of metastatic cancers.
