TransCode Submits IND Amendment for TTX-MC138 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3d ago
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Should l Buy RNAZ?
TransCode Therapeutics, in collaboration with Quantum Leap Healthcare Collaborative, announced the submission to the U.S. FDA of an Investigational New Drug 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.
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About RNAZ
TransCode Therapeutics, Inc. is a clinical-stage oncology company focused on treating metastatic disease. It is defeating cancer through the intelligent design and effective delivery of RNA therapeutics based on its proprietary TTX nanoparticle platform. Its lead candidate, TTX-MC138, targets metastatic tumors overexpressing microRNA-10b, a biomarker of metastasis. The Company is also developing a portfolio of RNA therapeutic candidates to overcome delivery challenges and unlock access to novel genetic targets. Its preclinical programs include TTX-siPDL1 (siRNA modulator of PD-L1), TTX-RIGA (RNA agonist of RIG-I for innate immunity activation), and TTX-siMYC (siRNA inhibitor of c-MYC). Additionally, R&D efforts are exploring the combination of TTX-MC138 and seviprotimut-L technologies to enhance therapeutic impact.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
TransCode Publishes TTX-MC138 Research for Glioblastoma Treatment
- Research Publication: TransCode Therapeutics, in collaboration with Michigan State University, published preclinical research on TTX-MC138 for glioblastoma treatment, demonstrating significant survival improvements, marking a crucial advancement in addressing treatment-resistant cancers.
- Efficacy Validation: The study showed that TTX-MC138 effectively delivered to human glioblastoma in murine models, inducing a five-fold increase in apoptotic activity, further validating its potential to overcome drug delivery barriers.
- Clinical Trial Progress: TTX-MC138 has completed IND studies and toxicity testing, showing good safety in Phase I trials for non-CNS cancers, with a Phase II trial anticipated to begin in the first half of 2026, advancing its clinical application.
- Strategic Implications: This research not only provides robust biological support for TransCode's RNA therapeutic platform but also showcases its broad potential in treating metastatic tumors, potentially transforming the treatment landscape for glioblastoma.
See More
TransCode's TTX-MC138 Significantly Extends Survival in Glioblastoma Mouse Models
- Survival Extension: TTX-MC138 successfully delivered via intravenous injection in glioblastoma mouse models significantly extends survival, indicating its potential in treating this highly aggressive cancer.
- Target Mechanism Validation: The study demonstrates that TTX-MC138 effectively suppresses miR-10b, resulting in a five-fold increase in apoptotic activity in tumors, thereby enhancing therapeutic efficacy and supporting its clinical development.
- Preclinical Research Findings: Conducted in collaboration with Michigan State University and published in the Journal of Functional Biomaterials, this study lays the groundwork for the clinical application of TTX-MC138, which is expected to drive future clinical trials.
- Future Clinical Trial Plans: Currently undergoing Phase 1 clinical trials, TTX-MC138 is anticipated to enter Phase 2 trials in the first half of 2026, further validating its potential application in metastatic diseases.
See More
TransCode Appoints Jack E. Stover to Board of Directors, Enhancing Leadership Experience
- Leadership Enhancement: TransCode Therapeutics appoints Jack E. Stover to its Board, bringing over 30 years of leadership experience in the life sciences sector, which is expected to drive the company's strategic development in RNA and immuno-oncology.
- Audit Committee Adjustment: Stover will join the Audit and Nominating Committees, succeeding Dr. Magda Marquet, thereby optimizing the company's governance structure and enhancing financial transparency and compliance.
- Rich Industry Experience: Having served as CEO and director for multiple biopharmaceutical companies, Stover has successfully led various financings and mergers, which is anticipated to provide crucial support for TransCode's capital formation and market expansion.
- Future Development Outlook: Stover expressed eagerness to help advance the mission of a cancer-free future, indicating alignment with the company's vision, which may enhance investor confidence and attract greater attention.
See More
TransCode Appoints Jack E. Stover to Board, Enhancing Oncology Expertise
- Board Appointment: TransCode Therapeutics has appointed Jack E. Stover to its Board of Directors, bringing over 30 years of leadership experience in the life sciences sector, particularly in drug development and capital formation, which is expected to significantly bolster the company's advancements in RNA and immuno-oncology.
- Audit Committee Changes: Stover will join the Audit and Nominating Committees, succeeding Dr. Magda Marquet, thereby enhancing the board's financial and strategic capabilities, which will improve the company's compliance and transparency in a complex regulatory environment.
- Industry Leadership Experience: Stover has served as CEO for multiple biotech firms, including Interpace Biosciences and Antares Pharma, where his successful integration efforts led to a sale for over $900 million, showcasing his exceptional ability to drive company growth.
- Future Development Vision: Stover expressed enthusiasm for helping TransCode achieve its mission of a cancer-free future, indicating the company's long-term commitment and strategic vision in cancer treatment, which may attract increased investor interest in its R&D potential.
See More
TransCode's TTX-MC138 Set to Begin Phase 2a Trial Within Quantum Leap PRE-I-SPY Initiative
Collaboration Announcement: TransCode Therapeutics and Quantum Leap Healthcare Collaborative are collaborating to evaluate TTX-MC138 in a Phase 2a dose-expansion trial, following positive results from a Phase 1 study.
Therapeutic Candidate Details: TTX-MC138 is designed to inhibit microRNA-10b, a biomarker associated with metastatic cancers, and has shown safety and a recommended dose in its initial trials.
Phase 2a Study Plans: The upcoming Phase 2a study will involve up to 45 colorectal cancer patients with minimal residual disease, aiming to assess the drug's biological and clinical activity in this critical treatment setting.
Market Reaction: Following the announcement, TransCode's stock rose by 20.74% to $10.42 but experienced a decline in pre-market trading, dropping to $9.92.
See More
TransCode Partners with Quantum Leap for TTX-MC138 Phase 2a Clinical Trial
- Collaboration Launch: TransCode Therapeutics and Quantum Leap Healthcare Collaborative are set to initiate a Phase 2a clinical trial for TTX-MC138 in the first half of 2026, aiming to enroll 45 colorectal cancer patients to evaluate the drug's biological and clinical activity in the Minimal Residual Disease (MRD) setting.
- Trial Design: The trial will focus on patients who have completed standard therapy and are ctDNA positive, addressing the lack of effective treatments in this area and potentially providing new therapeutic options for high-recurrence-risk patients, thereby improving long-term outcomes.
- Safety Validation: TTX-MC138 achieved its primary safety endpoint in the Phase 1 trial, demonstrating a favorable safety profile and anti-tumor effects, which lays the groundwork for Phase 2 clinical testing and may enable earlier intervention in patient care.
- Precision Therapy Outlook: The PRE-I-SPY trial platform by Quantum Leap will accelerate the evaluation of TTX-MC138's potential, aiming to provide more effective and less toxic precision therapies for colorectal cancer and other cancers, advancing the field of cancer treatment.
See More
TransCode Publishes TTX-MC138 Research for Glioblastoma Treatment
- Research Publication: TransCode Therapeutics, in collaboration with Michigan State University, published preclinical research on TTX-MC138 for glioblastoma treatment, demonstrating significant survival improvements, marking a crucial advancement in addressing treatment-resistant cancers.
- Efficacy Validation: The study showed that TTX-MC138 effectively delivered to human glioblastoma in murine models, inducing a five-fold increase in apoptotic activity, further validating its potential to overcome drug delivery barriers.
- Clinical Trial Progress: TTX-MC138 has completed IND studies and toxicity testing, showing good safety in Phase I trials for non-CNS cancers, with a Phase II trial anticipated to begin in the first half of 2026, advancing its clinical application.
- Strategic Implications: This research not only provides robust biological support for TransCode's RNA therapeutic platform but also showcases its broad potential in treating metastatic tumors, potentially transforming the treatment landscape for glioblastoma.
See More
TransCode's TTX-MC138 Significantly Extends Survival in Glioblastoma Mouse Models
- Survival Extension: TTX-MC138 successfully delivered via intravenous injection in glioblastoma mouse models significantly extends survival, indicating its potential in treating this highly aggressive cancer.
- Target Mechanism Validation: The study demonstrates that TTX-MC138 effectively suppresses miR-10b, resulting in a five-fold increase in apoptotic activity in tumors, thereby enhancing therapeutic efficacy and supporting its clinical development.
- Preclinical Research Findings: Conducted in collaboration with Michigan State University and published in the Journal of Functional Biomaterials, this study lays the groundwork for the clinical application of TTX-MC138, which is expected to drive future clinical trials.
- Future Clinical Trial Plans: Currently undergoing Phase 1 clinical trials, TTX-MC138 is anticipated to enter Phase 2 trials in the first half of 2026, further validating its potential application in metastatic diseases.
See More
TransCode Appoints Jack E. Stover to Board of Directors, Enhancing Leadership Experience
- Leadership Enhancement: TransCode Therapeutics appoints Jack E. Stover to its Board, bringing over 30 years of leadership experience in the life sciences sector, which is expected to drive the company's strategic development in RNA and immuno-oncology.
- Audit Committee Adjustment: Stover will join the Audit and Nominating Committees, succeeding Dr. Magda Marquet, thereby optimizing the company's governance structure and enhancing financial transparency and compliance.
- Rich Industry Experience: Having served as CEO and director for multiple biopharmaceutical companies, Stover has successfully led various financings and mergers, which is anticipated to provide crucial support for TransCode's capital formation and market expansion.
- Future Development Outlook: Stover expressed eagerness to help advance the mission of a cancer-free future, indicating alignment with the company's vision, which may enhance investor confidence and attract greater attention.
See More
TransCode Appoints Jack E. Stover to Board, Enhancing Oncology Expertise
- Board Appointment: TransCode Therapeutics has appointed Jack E. Stover to its Board of Directors, bringing over 30 years of leadership experience in the life sciences sector, particularly in drug development and capital formation, which is expected to significantly bolster the company's advancements in RNA and immuno-oncology.
- Audit Committee Changes: Stover will join the Audit and Nominating Committees, succeeding Dr. Magda Marquet, thereby enhancing the board's financial and strategic capabilities, which will improve the company's compliance and transparency in a complex regulatory environment.
- Industry Leadership Experience: Stover has served as CEO for multiple biotech firms, including Interpace Biosciences and Antares Pharma, where his successful integration efforts led to a sale for over $900 million, showcasing his exceptional ability to drive company growth.
- Future Development Vision: Stover expressed enthusiasm for helping TransCode achieve its mission of a cancer-free future, indicating the company's long-term commitment and strategic vision in cancer treatment, which may attract increased investor interest in its R&D potential.
See More
TransCode's TTX-MC138 Set to Begin Phase 2a Trial Within Quantum Leap PRE-I-SPY Initiative
Collaboration Announcement: TransCode Therapeutics and Quantum Leap Healthcare Collaborative are collaborating to evaluate TTX-MC138 in a Phase 2a dose-expansion trial, following positive results from a Phase 1 study.
Therapeutic Candidate Details: TTX-MC138 is designed to inhibit microRNA-10b, a biomarker associated with metastatic cancers, and has shown safety and a recommended dose in its initial trials.
Phase 2a Study Plans: The upcoming Phase 2a study will involve up to 45 colorectal cancer patients with minimal residual disease, aiming to assess the drug's biological and clinical activity in this critical treatment setting.
Market Reaction: Following the announcement, TransCode's stock rose by 20.74% to $10.42 but experienced a decline in pre-market trading, dropping to $9.92.
See More
TransCode Partners with Quantum Leap for TTX-MC138 Phase 2a Clinical Trial
- Collaboration Launch: TransCode Therapeutics and Quantum Leap Healthcare Collaborative are set to initiate a Phase 2a clinical trial for TTX-MC138 in the first half of 2026, aiming to enroll 45 colorectal cancer patients to evaluate the drug's biological and clinical activity in the Minimal Residual Disease (MRD) setting.
- Trial Design: The trial will focus on patients who have completed standard therapy and are ctDNA positive, addressing the lack of effective treatments in this area and potentially providing new therapeutic options for high-recurrence-risk patients, thereby improving long-term outcomes.
- Safety Validation: TTX-MC138 achieved its primary safety endpoint in the Phase 1 trial, demonstrating a favorable safety profile and anti-tumor effects, which lays the groundwork for Phase 2 clinical testing and may enable earlier intervention in patient care.
- Precision Therapy Outlook: The PRE-I-SPY trial platform by Quantum Leap will accelerate the evaluation of TTX-MC138's potential, aiming to provide more effective and less toxic precision therapies for colorectal cancer and other cancers, advancing the field of cancer treatment.
See More
