TransCode Therapeutics and Quantum Leap Announce Submission of IND Amendment for Phase 2a Clinical Trial with TTX-MC138

Rhea-AI Summary

TransCode (NASDAQ: RNAZ) and Quantum Leap submitted an IND amendment to the FDA for a planned Phase 2a dose-expansion trial of TTX-MC138 in colorectal cancer (NCT05868226).

The PRE-I-SPY platform trial will enroll up to 45 ctDNA-positive patients post‑curative therapy, aims to start in H1 2026, and will be led by Dr. Paula Pohlmann.

Positive

• IND amendment submitted for Phase 2a dose-expansion
• Trial targets up to 45 ctDNA-positive colorectal cancer patients
• Planned start in H1 2026, led by MD Anderson investigator
• First PRE-I-SPY expansion into colorectal cancer, leveraging platform sites

Negative

• Submission is an IND amendment, not an FDA approval or cleared trial start
• Small planned cohort size (45) limits near-term commercial signal
• Timeline conditional on FDA review and site activation, start date not guaranteed

Key Figures

Planned enrollment: up to 45 patients Trial timing: first half of 2026

2 metrics

Planned enrollment up to 45 patients Phase 2a PRE-I-SPY colorectal cancer trial

Trial timing first half of 2026 Planned start of Phase 2a trial

Market Reality Check

Price: $8.58 Vol: Volume 8,502 vs 23,507 20...

low vol

$8.58 Last Close

Volume Volume 8,502 vs 23,507 20-day average (relative volume 0.36) ahead of this news. low

Technical Price at $8.58, trading below 200-day MA at $9.75 before the IND amendment update.

Peers on Argus

RNAZ was down 4.45% pre-news while only one tracked peer (APRE) appeared in mome...

1 Down

RNAZ was down 4.45% pre-news while only one tracked peer (APRE) appeared in momentum scans, down 5.82%. Other peers in Biotechnology were mixed, suggesting stock-specific factors rather than a broad sector move.

Previous Clinical trial Reports

5 past events · Latest: Dec 11 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 11	Phase 2a collaboration	Positive	+20.7%	Announced Phase 2a PRE-I-SPY colorectal cancer collaboration with Quantum Leap.
May 08	Phase 1a dosing update	Positive	-1.4%	Reported Cohort 4 initial dosing with no dose-limiting toxicities in Phase 1a.
May 01	Phase 1a progress	Positive	+38.7%	Highlighted continued positive safety and PK/PD data in metastatic cancer trial.
Mar 27	Cohort 4 initiation	Positive	-5.8%	Announced first patient dosed in Cohort 4 with higher dosing level cleared.
Mar 13	SRC cohort approval	Positive	-27.3%	Safety Review Committee approved opening Cohort 4 after favorable safety data.

Pattern Detected

Clinical trial updates for TTX-MC138 have generally been positive, but market reactions are inconsistent, with both strong rallies and sharp selloffs on favorable safety and progress news.

Recent Company History

Over the past year, TransCode’s key catalysts have centered on clinical progress for TTX-MC138. Multiple Phase 1 cohorts advanced with no dose‑limiting toxicities, and the Safety Review Committee repeatedly cleared higher dosing and expansion. A December 2025 update with Quantum Leap outlined the planned Phase 2a colorectal cancer trial, which reacted strongly positively. Today’s IND amendment submission for that same Phase 2a program builds directly on this progression toward MRD-directed efficacy testing.

Historical Comparison

clinical trial

+5.0 %

Average Historical Move

Historical Analysis

Past clinical-trial headlines for TTX-MC138 produced an average move of about 5%, with both strong gains and notable selloffs on positive safety and dosing updates.

Typical Pattern

The clinical story shows steady advancement: SRC approval to open Cohort 4, initial Cohort 4 dosing, expanded positive Phase 1a data, and then collaboration to run a Phase 2a MRD trial in colorectal cancer, now followed by the IND amendment submission.

Market Pulse Summary

This announcement advances TransCode’s program by moving TTX-MC138 toward a Phase 2a trial in ctDNA-...

Analysis

This announcement advances TransCode’s program by moving TTX-MC138 toward a Phase 2a trial in ctDNA-positive colorectal cancer within the PRE-I-SPY platform. It follows earlier Phase 1 progress and a December 2025 collaboration update with Quantum Leap. Historically, clinical milestones for this asset have produced volatile reactions in both directions, so upcoming data readouts and protocol execution will likely be key markers for how the story evolves.

Key Terms

investigational new drug (ind) application, phase 2a, circulating tumor dna (ctdna), minimal residual disease (mrd), +2 more

6 terms

investigational new drug (ind) application regulatory

"announced the submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application amendment"

An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.

phase 2a medical

"for a planned Phase 2a clinical trial with TransCode's lead therapeutic candidate, TTX-MC138."

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.

circulating tumor dna (ctdna) medical

"patients with colorectal cancer who have completed standard curative-intent therapy and have positive markers for circulating tumor DNA (ctDNA)."

Circulating tumor DNA (ctDNA) are tiny fragments of genetic material shed by cancer cells into the bloodstream, detectable with a blood test often called a liquid biopsy. For investors, ctDNA matters because it can enable earlier, less invasive detection of cancer, track how well treatments are working, and guide drug development and diagnostic products—factors that can drive demand, regulatory decisions, and company valuations in oncology-related markets.

minimal residual disease (mrd) medical

"presence of minimal residual disease (MRD) that could be amenable to early interventions."

The presence of minimal residual disease (MRD) means a very small number of cancer cells remain in the body after treatment, too few to cause symptoms or show up on routine scans but detectable with sensitive tests. For investors it matters because MRD status is a strong early indicator of whether a patient is likely to relapse and is increasingly used as a trial endpoint and regulatory signal, affecting a therapy’s market prospects and valuation much like finding glowing embers after a fire signals risk of re-ignition.

principal investigator medical

"will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center."

A principal investigator is the lead person responsible for overseeing a research project or study, ensuring it stays on track and meets its goals. In the context of investments, this role can be likened to the person in charge of a team or initiative, making key decisions and managing resources. Understanding who the principal investigator is can help investors assess the reliability and credibility of a project or research effort.

clinicaltrials.gov technical

"Information on the PRE-I-SPY program and the Phase 2a trial can be found at clinicaltrials.gov (NCT05868226)."

clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

AI-generated analysis. Not financial advice.

BOSTON, Feb. 5, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) (TransCode), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancers, in collaboration with Quantum Leap Healthcare Collaborative (Quantum Leap), today announced the submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application amendment for a planned Phase 2a clinical trial with TransCode's lead therapeutic candidate, TTX-MC138. The study will be conducted by Quantum Leap within their PRE-I-SPY program, a leading platform for innovative oncology clinical trials, and represents the program's first expansion into colorectal cancer.

As part of the PRE-I-SPY platform, the TTX-MC138 Phase 2a dose-expansion portion of the trial will enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have positive markers for circulating tumor DNA (ctDNA). Recent studies have demonstrated that ctDNA is a prognostic marker of cancer recurrence and may be indicative of the presence of minimal residual disease (MRD) that could be amenable to early interventions. The Phase 2a 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 MRD setting, where we believe the therapeutic intervention may have the greatest opportunity to improve long-term outcomes.

"This IND submission marks a pivotal step in TransCode's clinical development program, positioning TTX-MC138 where its mechanism of action has the potential to deliver meaningful benefit to patients," said Sue Duggan, TransCode's Senior VP, Operations. "We are pleased to partner with Quantum Leap's PRE-I-SPY program to evaluate TTX-MC138 and to support the expansion of this platform into new indications such as colorectal cancer," added Duggan.

The clinical trial will be performed at several clinical sites of the PRE-I-SPY Platform Network, many of which are members of the National Cancer Center Network. Additionally, the program is focused on partnering with the Colorectal Cancer Alliance, a leading advocacy organization. Information on the PRE-I-SPY program and the Phase 2a trial can be found at clinicaltrials.gov (NCT05868226).

About TransCode Therapeutics 

TransCode Therapeutics is a clinical stage company pioneering immuno-oncology and RNA therapeutic treatments for 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.

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 did TransCode (RNAZ) submit to the FDA on February 5, 2026?

They submitted an IND amendment for a Phase 2a dose-expansion study of TTX-MC138. According to the company, the amendment supports enrolling ctDNA-positive colorectal cancer patients within the PRE-I-SPY platform.

How many patients will the RNAZ TTX-MC138 Phase 2a trial enroll and when will it start?

The dose-expansion will enroll up to 45 patients with ctDNA-positive disease. According to the company, the trial is planned to begin in H1 2026 pending regulatory and site readiness.

What is the target patient population for TransCode's TTX-MC138 Phase 2a (RNAZ)?

The study targets colorectal cancer patients who completed curative-intent therapy and are ctDNA-positive. According to the company, this population represents minimal residual disease at risk of recurrence.

Where will the RNAZ PRE-I-SPY Phase 2a trial be conducted and who leads it?

The trial will run at PRE-I-SPY platform network sites, many in the National Cancer Center Network. According to the company, Dr. Paula Pohlmann of MD Anderson will serve as Principal Investigator.

Does the IND amendment mean FDA approval for TransCode's RNAZ trial to start immediately?

No, an IND amendment is a regulatory submission but not approval to start. According to the company, trial initiation depends on FDA review, site activation, and other operational steps.