TransCode Therapeutics, Inc. engages in the development and commercializing of diagnostics and therapeutics for the detection and treatment of cancer. The company was founded by Robert Michael Dudley, Zdravka Medarova, and Anna Moore in January 2016 and is headquartered in Newton, MA.
Clinical Trials
2
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2016
Active, not recruiting
1
50.0%
Completed
1
50.0%
No approval data available
- Intranasal RIG-101 was well tolerated at all tested doses in healthy volunteers and asthma patients, including up to seven days of daily dosing. - Biomarker analyses in asthma patients confirmed induction of type I and type III interferons and interferon-stimulated genes, matching the intended mechanism. - A two-part, randomized, placebo-controlled Phase I/II trial targeting 82 participants at two UK sites is now recruiting, with Part B testing rhinovirus RV-A16 challenge. - Leyden Labs also disclosed it acquired RIGImmune in spring 2026, adding stem-loop RNA therapeutics and the NEED delivery platform to its mucosal protection pipeline.
- TransCode Therapeutics is developing RNA-based therapies for metastatic cancer, with lead candidate TTX-MC138 targeting microRNA-10b using a proprietary iron oxide nanoparticle delivery system. - The global metastatic cancer treatment market was estimated at $116.1 billion in 2024 and is projected to reach $168.0 billion by 2029, growing at a CAGR of 7.7%. - The company's platform includes TTX-RIGA for immune stimulation, TTX-CRISPR for gene editing, and TTX-mRNA for cancer vaccines, alongside siRNA candidates TTX-siPDL1 and TTX-siLIN28B. - A key challenge in RNA therapeutics—extrahepatic delivery—is addressed by TransCode's iron oxide nanocarrier that avoids liver uptake and preferentially targets tumor cells via dextran coating.
- TransCode Therapeutics has initiated a Phase 2a clinical trial for TTX-MC138 in ctDNA-positive colorectal cancer patients following successful completion of Phase 1a studies. - The Phase 1a trial demonstrated strong safety profile with no dose-limiting toxicities and achieved 64% stable disease rate in evaluable metastatic cancer patients. - TTX-MC138 represents a first-in-class therapeutic targeting microRNA-10b, with three patients continuing treatment for over 14 cycles showing durable disease control. - The Phase 2a trial will enroll up to 45 colorectal cancer patients with minimal residual disease, conducted through the PRE-I-SPY platform in collaboration with leading cancer centers.
- The Minimal Residual Disease pipeline features over five therapeutic candidates from companies including Genentech, AmMax Bio, and Precigen Inc, spanning multiple clinical stages. - Immunotherapy-based approaches such as monoclonal antibodies, bispecific antibodies, and CAR T-cell therapies are at the forefront of MRD-directed innovation. - The FDA released draft guidance in January 2026 regarding MRD and complete response as primary endpoints for accelerated approval in multiple myeloma trials. - Advanced diagnostics including NGS, PCR, and flow cytometry are enhancing MRD detection, with Ultima Genomics' ppmSeq technology demonstrating low single-digit parts-per-million sensitivity.
- CK Life Sciences has established Sequencio Therapeutics as a wholly-owned subsidiary dedicated to advancing therapeutic cancer vaccines, marking the third pillar of a strategic reorganization following transactions with TransCode and Dogwood Therapeutics. - Sequencio's preclinical portfolio includes investigational cancer vaccines targeting TROP2, which demonstrated 100% tumor growth inhibition in preclinical breast and colorectal cancer mouse studies, along with candidates targeting PRAME, PD-L1, B7-H3, and Claudin 6. - The company will present five research abstracts at the AACR Annual Meeting 2026, showcasing advancements in next-generation cancer vaccine technologies based on their proprietary TrueHLA™ Epitope-to-Efficacy™ translational design framework. - Sequencio is prioritizing its most promising programs for IND-enabling studies with the goal of accelerating select vaccine candidates into early-stage clinical development through strategic partnerships.
- TransCode Therapeutics published preclinical research in Molecular Imaging and Biology demonstrating a novel template-directed RIG-I agonist approach that selectively activates innate immune signaling within cancer cells. - The innovative strategy uses overexpressed oncogenic microRNAs like miRNA-21 as intracellular assembly templates to drive tumor-specific RIG-I activation while minimizing systemic toxicity. - The approach addresses longstanding challenges with RIG-I agonists including off-target immune activation and inefficient systemic delivery, while enabling non-invasive imaging of drug delivery. - The findings support the translational potential of TransCode's TTX nanoparticle delivery platform, which is currently being evaluated in clinical trials.
- TransCode Therapeutics, a clinical-stage immuno-oncology and RNA therapeutics company, has appointed Jack E. Stover to its Board of Directors effective December 22, 2025. - Stover brings over three decades of executive leadership experience across life sciences companies, including successful exits such as leading Antares Pharma's sale to Halozyme for over $900 million. - The appointment strengthens TransCode's leadership as the company advances its RNA and immuno-oncology pipeline for treating high-risk and advanced cancer patients. - Stover will join the Audit and Nominating Committees as the company enters what leadership describes as an exciting stage of development.
- TransCode Therapeutics and Quantum Leap Healthcare Collaborative announced a Phase 2a dose-expansion trial for TTX-MC138, enrolling up to 45 colorectal cancer patients with minimal residual disease. - The first-in-class therapeutic candidate targets microRNA-10b and demonstrated safety and durable clinical benefit in Phase 1a trials, establishing a recommended Phase 2 dose. - The trial will evaluate TTX-MC138 in patients who completed standard therapy but remain ctDNA positive, addressing a critical unmet need in preventing cancer recurrence. - The PRE-I-SPY platform collaboration aims to accelerate development of precision therapies for minimal residual disease, with trial initiation planned for the first half of 2026.
- TransCode Therapeutics acquired Polynoma LLC from CK Life Sciences in a strategic transaction valued at approximately $165 million on a fully diluted basis, with CK Life Sciences obtaining approximately 91% ownership. - The acquisition brings seviprotimut-L, a novel polyvalent shed antigen vaccine for stage IIB and IIC melanoma that has been safely administered in over 1,000 patients and is Phase 3-ready. - CK Life Sciences concurrently invested $25 million to advance TransCode's lead microRNA therapeutic TTX-MC138 into Phase 2 clinical trials, targeting microRNA-10b as a master regulator of metastatic cancer. - The combined pipeline creates potential synergies between seviprotimut-L's melanoma focus and TTX-MC138's micrometastases targeting capabilities in the same patient population.
- The global CRISPR-Cas9 therapy market is rapidly expanding with over 25 therapies currently in clinical trials, many of which are expected to receive regulatory approval and enter the market within the next 5-7 years. - Casgevy, the first approved CRISPR-Cas9 therapy for sickle cell anemia and beta thalassemia, is currently available in the US, EU, UK, Saudi Arabia, and Bahrain at approximately $2 million per treatment course. - Applications of CRISPR-Cas9 technology are expected to expand beyond genetic disorders and cancers to include cardiovascular, neurodegenerative, and CNS diseases, potentially transforming into a multi-billion-dollar industry.
