TransCode Therapeutics and Quantum Leap Healthcare Collaborative Launch a Phase 2a dose-expansion trial with TTX-MC138, following positive readouts from TransCode's Phase 1 trial

Rhea-AI Summary

TransCode Therapeutics (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative announced a collaboration to evaluate TTX-MC138 in the Quantum Leap PRE-I-SPY Phase 2a dose-expansion trial for colorectal cancer.

The Phase 2a will enroll up to 45 patients with ctDNA-positive minimal residual disease who completed curative-intent therapy, is planned to begin in H1 2026, and will be led by Dr. Paula Pohlmann at MD Anderson. The move follows TransCode's Phase 1a observation of an encouraging safety profile and durable anti-tumor effects, which the companies say support further efficacy testing in the MRD setting where recurrence risk is high.

Positive

• Phase 2a to begin in H1 2026
• Planned enrollment of up to 45 patients in MRD colorectal cancer
• Phase 1a reported safety and durable clinical benefit supporting expansion

Negative

• Phase 2a limited to up to 45 patients, restricting sample size

Key Figures

Phase 2a patients up to 45 patients Dose-expansion colorectal cancer trial in PRE-I-SPY platform

Trial phase Phase 2a Dose-expansion study of TTX-MC138 in MRD setting

Trial start window first half of 2026 Planned initiation of Phase 2a portion

Market Reality Check

$10.42 Last Close

Volume Volume 15,095 is 1.7x the 20-day average of 8,877, indicating elevated interest pre-announcement. high

Technical Shares at $8.63 were trading below the 200-day MA of $13.60, reflecting a longer-term downtrend.

Peers on Argus 2 Up 1 Down

Select biotech peers showed mixed moves, with INAB up 4.12% and BOLT up 2.86%, while APRE and CYCCP declined. RNAZ’s setup appears more company-specific than broad sector-driven.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 17	Management change	Positive	+1.8%	Senior Development Officer added to guide late-stage trials and strategy.
Oct 14	Clinical data update	Positive	+5.6%	Phase 1a completion with safety endpoint met and Phase 2a planning.
Oct 08	Acquisition/financing	Positive	+21.1%	Acquisition of Polynoma plus $25M equity investment to fund pipeline.

Pattern Detected

Recent company-specific milestones, including clinical progress and strategic deals, have generally coincided with positive 24-hour price reactions.

Recent Company History

Over recent months, TransCode has steadily advanced its pipeline and strategic positioning. On Feb 6, 2025, positive Cohort 3 safety data with TTX‑MC138 preceded a 27.18% move. Subsequent clinical trial updates in March and May showed mixed but often strong reactions, including a 38.71% move on May 1. An October 8 acquisition and $25 million financing coincided with a 21.11% gain. The completion of the Phase 1a trial on Oct 14 was followed by a 5.62% rise, framing today’s Phase 2a launch as a continuation of this trajectory.

Market Pulse Summary

This announcement details a collaboration to run a Phase 2a dose-expansion trial of TTX‑MC138 in MRD-stage colorectal cancer, enrolling up to 45 ctDNA-positive patients starting in the first half of 2026. It builds directly on prior Phase 1 safety and pharmacodynamic results and fits a pattern of stepwise clinical advancement. Investors may watch for trial initiation, enrollment progress, and subsequent efficacy and safety data, alongside any additional regulatory or financing updates tied to advancing this program.

Key Terms

phase 2a medical

"The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

ctdna medical

"therapy and are ctDNA positive. The Phase 2a portion of the trial"

Circulating tumor DNA (ctDNA) is tiny fragments of genetic material shed by cancer cells into the bloodstream, like breadcrumbs that can reveal a tumor’s presence and genetic makeup without needing a biopsy. For investors, ctDNA matters because tests and technologies that detect and analyze these fragments can speed diagnosis, track treatment response, and signal relapse, creating commercial opportunities in diagnostics, personalized therapies, and monitoring services.

minimal residual disease medical

"activity of TTX-MC138 in the Minimal Residual Disease (MRD) setting"

Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.

metastatic disease medical

"action specifically targeting metastatic disease combined with an excellent safety"

Metastatic disease is cancer that has spread from its original site to other parts of the body, where new tumors form and behave like the original cancer. It matters to investors because spread makes treatment harder, often requires more complex and costly therapies, changes clinical trial goals and regulatory hurdles, and can greatly affect the size and urgency of the market for new drugs — like a fire that jumps rooms and needs a larger response.

circulating tumor dna medical

"response following standard-of-care therapy but have evidence of circulating tumor DNA (ctDNA)"

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

AI-generated analysis. Not financial advice.

BOSTON, Dec. 11, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative ("Quantum Leap") today announce a new collaboration to evaluate TransCode's lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform.

The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and are ctDNA positive. The Phase 2a portion of the trial is planned to begin in the first half of 2026 and will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center.

This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the Minimal Residual Disease (MRD) setting, where the therapeutic intervention may have the greatest opportunity to improve long-term outcomes. The decision to test TTX-MC138 in patients who have demonstrated a pathological complete response following standard-of-care therapy but have evidence of circulating tumor DNA (ctDNA) is based on the high degree of recurrence in those patients and the lack of effective therapies in that setting. TTX-MC138 offers a therapeutic option in that setting because of the drug's mechanism of action specifically targeting metastatic disease combined with an excellent safety profile.

"The safety and durable clinical benefit observed in TransCode's Phase 1a trial with TTX-MC138 provide the basis for TransCode's decision to proceed with Phase 2a clinical testing", noted Daniel Vlock, MD, TransCode's Consulting Clinician. "The observed safety profile, coupled with the durability of TTX-MC138's anti-tumor effects, is particularly encouraging. These findings are consistent with the drug's mechanism of action and provide a basis for a more rigorous efficacy evaluation. This positions us to potentially intervene earlier in the patient's disease, offering a new therapeutic option for patients at risk of developing metastatic disease."

"Detecting and treating micrometastatic disease before it becomes visible is one of the biggest unmet challenges in cancer," said Laura Esserman, M.D., co-founder of Quantum Leap, and Professor of Surgery and Radiology at the University of California, San Francisco. "The PRE-ISPY Trial is uniquely positioned to rapidly evaluate agents like TTX-MC138 that may eradicate minimal residual disease and prevent recurrence in colorectal and eventually other cancer. We are excited to collaborate with TransCode to accelerate this program, with the goal of advancing effective, less toxic precision therapies into Phase 2 and beyond—where the potential to truly cure patients exists."

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode's Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO 2025.

About TransCode Therapeutics 

TransCode Therapeutics is a clinical stage company pioneering immunoncology and RNA therapeutic treatments of high risk and advanced cancers.  The company's lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. For more information, visit www.transcodetherapeutics.com.

About the I-SPY TRIALs

The I-SPY ("Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis") Trials were designed to rapidly screen promising experimental treatments and identify those most effective for biologically defined patient subgroups. The trials represent a unique collaboration among the U.S. Food and Drug Administration, industry partners, patient advocates, philanthropic sponsors, and clinicians across leading U.S. cancer research centers. Quantum Leap Healthcare Collaborative is the trial sponsor and oversees all operational, regulatory, and data-integration activities. The PRE-ISPY platform extends I-SPY into early feasibility testing to accelerate biologically targeted therapies into the I-SPY 2.2 high-risk curative setting. For more information, visit www.ispytrials.org.

About Quantum Leap Healthcare Collaborative

Quantum Leap Healthcare Collaborative is a 501(c)(3) nonprofit organization founded in 2005 by UCSF researchers and Silicon Valley innovators. Its mission is to integrate clinical care with research, advance high-impact platform trials, and improve patient outcomes through adaptive learning systems, enhanced data infrastructure, and widespread trial accessibility. Quantum Leap sponsors and manages the I-SPY Trial programs. For additional information, visit www.quantumleaphealth.org.

Forward-Looking Statements 

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the timing, conduct and results of TransCode's collaborations with Quantum Leap, TransCode's Phase 1a clinical trial, TransCode's planned Phase 2a clinical trial, and the incorporation of TTX-MC138 into the PRE-I-SPY program for a Phase 2a dose-expansion clinical trial, statements about microRNAs and their involvement in cancer, and statements concerning the therapeutic potential of TransCode's TTX-MC138 and other therapeutic candidates. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risks associated with drug discovery and development; the risk that the results of clinical trials will not be consistent with TransCode's preclinical studies or expectations or with results from previous clinical trials; risks associated with the conduct of clinical trials; risks associated with TransCode's financial condition and its need to obtain additional funding to support its business activities, including TransCode's ability to continue as a going concern; risks associated with the timing and outcome of TransCode's planned regulatory submissions; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks of competition from other companies developing products for similar uses; risks associated with TransCode's dependence on third parties; and risks associated with geopolitical events and pandemics, including the COVID-19 coronavirus and military actions. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode's actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled "Risk Factors" in TransCode's Annual Report on Form 10-K for the year ended December 31, 2024, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the Securities and Exchange Commission. All information in this press release is as of the date of this release; TransCode undertakes no duty to update this information unless required by law. 

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SOURCE TransCode Therapeutics, Inc.

FAQ

What is TransCode and Quantum Leap announcing for RNAZ on December 11, 2025?

They announced a collaboration to test TTX-MC138 in a PRE-I-SPY Phase 2a dose-expansion trial in ctDNA-positive colorectal cancer patients.

When will the RNAZ-sponsored Phase 2a trial with TTX-MC138 start?

The Phase 2a dose-expansion is planned to begin in the first half of 2026.

How many patients will the RNAZ Phase 2a trial enroll with TTX-MC138?

The trial will enroll up to 45 patients with ctDNA-positive minimal residual disease after curative-intent therapy.

What evidence from RNAZ supports moving TTX-MC138 into Phase 2a?

TransCode cited an observed safety profile and durable anti-tumor effects in its Phase 1a trial as the basis for expansion.

Who will lead the RNAZ Phase 2a TTX-MC138 study?

The Phase 2a portion will be led by Dr. Paula Pohlmann of MD Anderson Cancer Center.

What patient population will RNAZ's TTX-MC138 Phase 2a target?

Patients with colorectal cancer who completed standard curative-intent therapy and are ctDNA positive (minimal residual disease setting).