US Market News
1週前
TransCode Therapeutics to Host R&D Webcast on June 18, 2026June 8, 2026 8:04 AM
PR Newswire (US) Live Webcast to Highlight TTX-MC138 Phase 2a Trial, Three-Platform Pipeline, and Investment ThesisBOSTON, June 8, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical-stage oncology company advancing a three-platform pipeline in RNA therapeutics and immuno-oncology, today announced it will host its first live virtual R&D Webcast on Thursday, June 18, 2026, at 10:00 a.m. Eastern Time. The webcast will provide strategic, scientific, and clinical program updates anchored by TransCode's recently-initiated Phase 2a clinical trial of TTX-MC138 — the Company's lead antagomiR program — in ctDNA-positive colorectal cancer, alongside portfolio and investment thesis updates across its development pipeline. A recording of the webcast will be made available on the Company's website following the event.Date:Thursday, June 18, 2026Time:10:00 -11:15 a.m. Eastern TimeFormat:Live webcast, open access Registration:Will be made available on www.transcodetherapeutics.com as of June 11, 2026 Replay:Webcast recording available on the Company's website following the eventThe webcast will cover:TTX-MC138 Phase 2a clinical development, including trial design and strategic path forwardPipeline and development strategy across the Company's other candidates and platformsCapital strategy, financial position, and long-term investment thesisFeatured speakers will include:Guest: Keith Flaherty, MD — Director of Clinical Research, Massachusetts General Hospital Cancer Center; Professor of Medicine, Harvard Medical School; Member, TransCode Scientific Advisory BoardPhilippe P Calais, PharmD, PhD — Chief Executive Officer and Chairman of the Board, TransCode TherapeuticsDan Vlock, MD — Consulting Oncology Clinician, TransCode TherapeuticsZdravka Medarova, PhD — Co-Founder and Chief Scientific Officer, TransCode TherapeuticsLouis Brenner, MD — Consulting Strategic Advisor, TransCode TherapeuticsMichel Janicot, PhD — Consulting Head of Translational Science, TransCode Therapeutics"With TTX-MC138 now beginning enrollment in Phase 2a, and with two additional platform assets advancing on capital-disciplined timelines, TransCode is at a meaningful inflection point. This webcast is an opportunity to share for the first time in our Company's history the scientific depth behind our programs, review the clinical data that supported our decision to move into the Phase 2a trial, and articulate the investment thesis underlying a three-platform pipeline. We look forward to engaging with our investors and the investment community."— Philippe P Calais, PharmD, PhD, Chief Executive Officer and Chairman of the Board, TransCode TherapeuticsAbout TransCode TherapeuticsTransCode Therapeutics is an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy. 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.Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the timing, conduct, and anticipated results of TransCode's clinical programs, the therapeutic potential of TTX-MC138, and the Company's development, capital strategy, investment thesis, and communications to the public. 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. 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, 2025, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the U.S. 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/transcode-therapeutics-to-host-rd-webcast-on-june-18-2026-302793483.htmlSOURCE TransCode Therapeutics, Inc. Original: TransCode Therapeutics to Host R&D Webcast on June 18, 2026
US Market News
2週前
TransCode Therapeutics Successfully Completes Phase 1a Clinical Trial, Reports Safety and Stabilization Data for TTX-MC138 in Metastatic CancerJune 3, 2026 8:04 AM
PR Newswire (US) TransCode reports no dose-limiting toxicities, durable disease stabilization in metastatic patients; advances to Phase 2 development in ctDNA-positive cancers using next-generation RNA therapeutics.BOSTON, June 3, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, today announced further results of the Phase 1a dose escalation clinical trial. The trial met its primary endpoint of safety, with positive tolerability, combined with disease stabilization in multiple patients, and the absence of dose-limiting toxicities with its lead therapeutic candidate TTX-MC138. TTX-MC138, an investigational inhibitor of the key metastatic driver, microRNA-10b, has shown durable disease control. These findings support advancing TTX-MC138 into Phase 2a clinical development to assess efficacy in patients with circulating tumor DNA (ctDNA) positive colorectal cancer following curative–intent therapy. TTX-MC138 has been administered to 16 patients who received 86 doses. The median treatment duration was 11.3 weeks, with a range of four to 52.4 weeks, representing 2 to 20 cycles of treatment.
Notably, three patients remain on trial, and continue to receive TTX-MC138. One patient is at 21 cycles of treatment, another is at 16 cycles, and the third one is at 14 cycles of treatment. (Table 1)Table 1: Trial demographics, met safety primary endpoint
CohortDoseNumber of PatientsDLT's110.8mg/kg30231.6mg/kg30333.2mg/kg270434.8mg/kg301 No significant treatment-related safety events or dose limiting toxicities were observed.
2 Optional backfill 3 with additional patients.
3 One patient in each of cohort 2, 3 and 4 currently on study.TransCode believes these results support its selection of the recommended Phase 2a dose (RP2D) of 4.8mg/kg.In addition, the assessment of the trial patient population underscored the potential for durable disease control in participants with metastatic cancer.Based on Response Evaluation Criteria in Solid Tumors (RECIST) standardized criteria to measure tumor response to treatment using imaging to categorize lesions and assess changes in size over time, 9 out of 14 (64%) of evaluable patients achieved stable disease lasting six months, demonstrating a durable disease activity. "From a clinical perspective, it is quite encouraging to see how well tolerated this agent has been at the exposures achieved through the Phase 1a dose-escalation study, without any dose-limiting toxicities. That, combined with the observation of disease stabilization in a population with such advanced disease supports continued clinical development" noted Keith Flaherty, MD, Director of Clinical Research at the Massachusetts General Hospital Cancer Center, Professor of Medicine at Harvard Medical School and TransCode's Advisory Board member.The pharmacokinetics profile from the analysis of plasma from patients receiving TTX-MC138 demonstrated evidence of drug bioavailability consistent with earlier preclinical studies.One patient diagnosed with metastatic thyroid cancer was noted to have a dramatic decrease in their thyroglobulin levels, a tumor marker associated with cancer progression. The patient has now had demonstrated stable disease for the last 12 months and is one of the three patients who remain on study. We believe that the patient's continued participation in the study, together with the decline in their thyroglobulin levels, provides further evidence of therapeutic activity from TTX-MC138.A clinical study report is in process. Several presentations are planned at future scientific congresses."As the safety and tolerability primary objectives of the trial were met, the encouraging rates of disease stabilization provide the rationale to advance TTX-MC138 clinical development in our recently initiated Phase 2a trial. We continue to believe that TTX-MC138 may offer a promising therapeutic option, if approved, for patients with metastatic disease who have limited treatment alternatives," said Daniel Vlock, MD, TransCode Consulting Clinician.Further information about the trial is available at www.clinicaltrials.gov, (NCT Identifier: NCT06260774).About TTX-MC138TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b (miR-10b), a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode's Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions. About TransCode Therapeutics TransCode Therapeutics is an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy. 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.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 Phase 1a and Phase 2a clinical trials, 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. 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, 2025, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the U.S. 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/transcode-therapeutics-successfully-completes-phase-1a-clinical-trial-reports-safety-and-stabilization-data-for-ttx-mc138-in-metastatic-cancer-302789380.htmlSOURCE TransCode Therapeutics, Inc. Original: TransCode Therapeutics Successfully Completes Phase 1a Clinical Trial, Reports Safety and Stabilization Data for TTX-MC138 in Metastatic Cancer
US Market News
3週前
TransCode Therapeutics Initiates Phase 2a Clinical Trial with TTX-MC138 in Patients with ctDNA Positive Colorectal CancerMay 27, 2026 8:04 AM
PR Newswire (US) BOSTON, May 27, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, today announced the initiation of its Phase 2a clinical trial. The study is to evaluate TransCode's lead therapeutic candidate, TTX-MC138, in patients with circulating tumor DNA (ctDNA) positive colorectal cancer following curative-intent therapy. The trial is being conducted in collaboration with Quantum Leap Healthcare Collaborative (QLHC), sponsor of the PRE-I-SPY clinical trial platform. The trial builds on growing clinical and scientific momentum supporting ctDNA-guided strategies targeting minimal residual disease (MRD) in colorectal cancer. The Phase 2a clinical trial is expected to enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have no radiographic evidence of disease, but remain or become ctDNA-positive, indicating the presence of minimal residual disease.Principal investigators are Dr. Emil Lou of the University of Minnesota and Dr. Zhaohui Jin of the Mayo Clinic Comprehensive Cancer Center. The trial is chaired by Dr. Paula Pohlmann of the MD Anderson Cancer Center.The trial leverages clinical sites currently participating and actively recruiting in QLHC's PRE-I-SPY platform trial. Several of those clinical sites are part of the National Comprehensive Cancer Network (NCCN). Those centers have considerable expertise and are at the forefront defining standard-of-care practices for the treatment of cancer.It is anticipated that the trial will produce new data about the importance of ctDNA testing and the role of TTX-MC138 in reducing the risk of cancer recurrence in this at-risk patient population. The trial has been submitted to the U.S. Food and Drug Administration and received Institutional Review Board approval, enabling site activation and commencement of patient enrollment.This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the minimal residual disease setting where therapeutic intervention may have the greatest opportunity to improve long-term outcomes. ctDNA testing is becoming increasingly important in oncology, particularly in colorectal cancer, because it provides a highly sensitive, real-time measure of residual disease and information about tumor biology that traditional methods often fail to detect. This approach has recently been successfully employed in the treatment of patients with muscle invasive bladder cancer."TTX-MC138's safety profile, coupled with the durability of its anti-tumor effects, observed in TransCode's Phase 1a clinical trial 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 TransCode and its collaborators to potentially intervene earlier in a patient's disease, and may in the future offer a new therapeutic option for patients at risk of developing metastatic disease" noted Daniel Vlock, MD, TransCode's Consulting Clinician.About TTX-MC138TTX-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 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.About the I-SPY TRIALsThe 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 curative setting. For more information, visit www.ispytrials.org.About Quantum Leap Healthcare CollaborativeQuantum 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, TransCode's Phase 1a clinical trial, and TransCode's planned Phase 2a 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, 2025, 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/transcode-therapeutics-initiates-phase-2a-clinical-trial-with-ttx-mc138-in-patients-with-ctdna-positive-colorectal-cancer-302782666.htmlSOURCE TransCode Therapeutics, Inc. Original: TransCode Therapeutics Initiates Phase 2a Clinical Trial with TTX-MC138 in Patients with ctDNA Positive Colorectal Cancer
US Market News
2月前
TransCode Therapeutics Appoints Dr. Anna Moore as Chair of Scientific Advisory Board; Announces Sponsored Research Agreement with Michigan State UniversityApril 27, 2026 8:02 AM
PR Newswire (US)
BOSTON, April 27, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering RNA and immuno-oncology therapeutics for the treatment of high risk and advanced cancers, today announced the appointment of Anna Moore, PhD, as Chair of its Scientific Advisory Board and the signing of a sponsored research agreement (SRA) with Michigan State University (MSU).
Dr. Moore, Associate Dean for Research Development, Director of the Precision Health Program and Professor in the Departments of Radiology and Physiology at Michigan State University, is a co-founder of TransCode Therapeutics and globally recognized expert in molecular imaging and RNA-targeted cancer therapeutics. Prior to joining MSU, she had a successful 26-year career at Massachusetts General Hospital (MGH) and Harvard Medical School, where she served as Professor of Radiology and Director of the Molecular Imaging Laboratory. Dr. Moore has played a foundational role in the scientific development of TransCode's RNA platform and pipeline, including the advancement of its lead therapeutic candidate, TTX-MC138, an antagomiR targeting microRNA-10b. As Chair of the Scientific Advisory Board, she will provide strategic guidance on the company's research and development efforts, with a focus on advancing innovative RNA-based approaches for the treatment of advanced cancers."I am honored and very much looking forward to assume this role and continue collaborating with the TransCode team to advance innovative RNA-based therapeutics targeting advanced metastatic disease, which remains one of the most significant unmet needs in oncology," said Dr. Moore. "Dr. Moore's contribution to the field of RNA therapeutics for cancer and her key role in launching TransCode Therapeutics attest to her unique value for the company's future growth," added Zdravka Medarova, PhD, TransCode's co-founder and Chief Scientific Officer.TransCode also announced the execution of a sponsored research agreement with Michigan State University. The agreement is designed to accelerate development of TransCode's pipeline candidates from the laboratory into clinical development. Research conducted at MSU will also focus on evaluation of TransCode's lead therapeutic candidate, TTX-MC138, in combination withSeviprotimut-L for potential synergies and in combination with standard-of-care therapies. TransCode acquired Seviprotimut-L through its acquisition of the parent company of Polynoma, LLC.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's portfolio includes 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 effectiveness of TransCode's TTX delivery platform, its drug candidates, TTX-MC138 and Seviprotimut-L, and its therapeutic approaches and strategies, statements concerning the timing, conduct and results of TransCode's preclinical and clinical studies, statements about microRNAs and their involvement in cancer, ongoing and future research collaborations and partnerships, and statements concerning the therapeutic potential of TransCode's 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, 2025, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the U.S. 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/transcode-therapeutics-appoints-dr-anna-moore-as-chair-of-scientific-advisory-board-announces-sponsored-research-agreement-with-michigan-state-university-302753057.htmlSOURCE TransCode Therapeutics, Inc.
Original: TransCode Therapeutics Appoints Dr. Anna Moore as Chair of Scientific Advisory Board; Announces Sponsored Research Agreement with Michigan State University
US Market News
4月前
TransCode Secures Exclusive, Worldwide, Fully Paid-Up Royalty-Free License to Develop and Commercialize a Next-Generation Oncolytic Immunotherapy Platform in an All-Stock Transaction Underscoring the Company's Dedication to Improving the Lives of Cancer PaMarch 3, 2026 8:01 AM
PR Newswire (US)
TransCode adds a unique adenovirus technology platform to its early-stage pipeline that has the potential to address a difficult to treat disease such as muscle-invasive bladder cancer.BOSTON, March 3, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, today announced that it has entered into an exclusive, worldwide, fully paid-up royalty-free license agreement with Unleash Immuno Oncolytics, Inc. ("Unleash"). TransCode obtained the rights to develop three Unleash drug candidates, UIO-524, UIO-525 and UIO-526, which includes a license of all in-licensed rights held by Unleash to the Unleash drug candidates together with the acquisition of all rights to the drug candidates owned by Unleash. Under the terms of the exclusive license agreement, Unleash will receive a one-time payment of 1,136,364 shares of a new series of non-voting convertible preferred stock of TransCode, convertible into an equal number of shares of common stock of TransCode (the "Preferred Stock"). The Preferred Stock represents 6.8% of TransCode's common stock on a fully diluted basis assuming conversion of all TransCode preferred stock outstanding.
The lead candidate UIO-524 complements and expands TransCode's oncology pipeline by introducing a next-generation, biology-driven oncolytic immunotherapy platform designed to address solid tumor indications with high-unmet medical need, beginning with muscle-invasive bladder cancer (MIBC).MIBC is a significant unmet medical need indication with poor outcomes, limited durable treatment options, and a highly immunosuppressive tumor microenvironment. Bladder cancer represents a multi-billion-dollar global market, with muscle-invasive disease accounting for a disproportionate share of treatment intensity and healthcare costs, creating what TransCode believes is a compelling opportunity for differentiated therapeutic approaches.Dr. Philippe P. Calais, Pharm.D., Ph.D., Chairman and CEO of TransCode, stated that "As we are advancing our lead asset, TTX-MC138, into a clinical Phase 2a trial, expanding our pipeline with an innovative preclinical technology such as UIO-524 provides us with an additional shot on goal using a next generation oncolytic immunotherapy candidate intended to address a large and attractive market in more aggressive settings such as MIBC."Tungsten Advisors acted as the exclusive financial advisor.About Unleash and the Licensing TransactionUIO-524 is a rationally designed oncolytic adenovirus engineered to selectively replicate within both malignant cells and cancer-associated stroma. The virus delivers a multi-cytokine immune-activating payload comprising CD40-L, 4-1BBL, and IL-21, intended to activate dendritic cells, T cells, and NK cells, and to drive a robust, systemic anti-tumor immune response. UIO-524 is regulated by a proprietary SPARC promoter that is highly active in malignant cells and cancer-associated stromal compartments and which enables biology-driven differentiation. This design enables selective viral replication and localized expression of immune-activating cytokines within the tumor microenvironment.UIO-524 builds on CG Oncology's CG0070, the most clinically advanced and successful oncolytic adenovirus to date, demonstrating meaningful activity in non–muscle-invasive bladder cancer (NMIBC). UIO-524 contains a structurally related oncolytic adenovirus backbone, incorporates tumor- and stroma-targeted replication and contains a more comprehensive, multi-cytokine immune payload. This design positions UIO-524 as a next-generation oncolytic immunotherapy candidate intended to address more aggressive disease settings such as MIBC.A more detailed description of the financing and licensing agreements can be found in TransCode's Form 8-K filed with the U.S Securities and Exchange Commission.About TTX-MC138TTX-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 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.About TransCode TherapeuticsTransCode Therapeutics, Inc. is a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer. 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.Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning TransCode's technology and collaborations, statements concerning the therapeutic potential of TransCode's TTX-MC138 and other therapeutic candidates, statements concerning the benefits of the licensing transaction and the opportunity in MIBC. 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/transcode-secures-exclusive-worldwide-fully-paid-up-royalty-free-license-to-develop-and-commercialize-a-next-generation-oncolytic-immunotherapy-platform-in-an-all-stock-transaction-underscoring-the-companys-dedication-to-improv-302701818.htmlSOURCE TransCode Therapeutics, Inc.
Original: TransCode Secures Exclusive, Worldwide, Fully Paid-Up Royalty-Free License to Develop and Commercialize a Next-Generation Oncolytic Immunotherapy Platform in an All-Stock Transaction Underscoring the Company's Dedication to Improving the Lives of Cancer Pa
US Market News
4月前
TransCode Therapeutics and Quantum Leap Announce Submission of IND Amendment for Phase 2a Clinical Trial with TTX-MC138February 5, 2026 8:04 AM
PR Newswire (US)
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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/transcode-therapeutics-and-quantum-leap-announce-submission-of-ind-amendment-for-phase-2a-clinical-trial-with-ttx-mc138-302679808.htmlSOURCE TransCode Therapeutics, Inc.
Original: TransCode Therapeutics and Quantum Leap Announce Submission of IND Amendment for Phase 2a Clinical Trial with TTX-MC138
tw0122
6月前
To the extent the Company raises additional funds by issuing equity securities, its stockholders may experience significant dilution. Any debt financing, if available, may include potentially dilutive features and include restrictive covenants that impact the Company’s ability to conduct business. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly scale back its planned operations or (ii) relinquish or otherwise dispose of rights to technologies on unfavorable terms.Going ConcernThese financial statements have been prepared under the assumption that the Company will continue as a going concern which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. Due to the Company’s recurring and expected continuing losses from operations, the Company has concluded there is substantial doubt concerning its ability to continue as a going concern within one year of the issuance of these financial statements without additional capital becoming available. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.To date, the Company has incurred substantial losses and negative cash flows from operations. It expects to continue to incur operating losses for the foreseeable future as it pursues development of its lead therapeutic candidate and other programs. Operating losses are expected to continue until such time, if ever, that the Company can generate significant revenue from product candidates currently in development. The Company is unable to predict the extent of any future losses or when the Company will become profitable, if ever.For the nine months ended September 30, 2025, net cash used in operating activities was approximately $ million and the Company’s net loss was approximately $ million. As of September 30, 2025, the Company had an accumulated deficit of approximately $ million and approximately $ million in cash.
tw0122
6月前
Concurrent with the Acquisition, the Company entered into an Investment Agreement (the “Investment Agreement”) with DEFJ. Pursuant to the Investment Agreement, DEFJ agreed to purchase, and the Company agreed to issue and sell in a private placement, an aggregate of shares of Series B Non-Voting Preferred Stock, par value $ per share, (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, the “Preferred Stock”) for a price per share of $, for an aggregate purchase price of approximately $ million. The aggregate purchase price consisted of a cash subscription amount of $ million paid on October 8, 2025, and a promissory note (the “Promissory Note”) in the aggregate principal amount of approximately $ million (together, the “October 2025 Investment”). The Promissory Note has a principal amount of approximately $ million and accrues interest at a rate of % per annum, calculated as simple interest on a 365-day year. The principal and accrued but unpaid interest are due and payable on January 1, 2026, and secured by shares of the Series B Preferred Stock issued to DEFJ. Each share of Series B Preferred Stock is convertible into shares of Common Stock. The Company has not generated revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. The Company is subject to those risks associated with any early-stage biopharmaceutical company that requires substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approvals, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital.The Company plans to expand development of its lead therapeutic candidate and other candidates, and to explore strategic partnerships. Management believes that its cash at September 30, 2025, along with the net proceeds from the October 2025 Investment, is sufficient to fund operations and capital requirements into the fourth quarter 2026
MartinLutherKing
7月前
New criminal fraudsters with massive money laundering experience have been elected in the dirtiest fraud artist pharmaceutical company in nasdaq history, Milk the cow dry boys and girls in management you made history.
TransCode Therapeutics Expands Executive Team with Appointment of Dr. Michel Janicot as Senior Development Officer
Accomplished drug development leader to advance TransCode's mission of defeating cancer through RNA innovation and translational excellence
BOSTON, Nov. 17, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy, announced today the appointment of Dr. Michel Janicot, Ph.D., as consultant Senior Development Officer. Dr. Janicot brings more than 35 years of experience in pharmaceutical research, preclinical, and early clinical drug development across oncology and other therapeutic areas. He will serve initially on a part-time basis.
"Michel's extensive leadership in drug development will strengthen and guide our efforts as TransCode advances its growing oncology pipeline," said Philippe P. Calais, Chief Executive Officer of TransCode Therapeutics. "His expertise in RNA biology and oncology strategy will be instrumental in advancing TTX-MC138 and Seviprotimut-L— our two lead programs in our mission to deliver transformative treatments for metastatic and recurrent cancers."
Dr. Janicot holds a Ph.D. in Biochemistry (Molecular and Cellular Biology) from Université Paris VII in France and completed postdoctoral research at The Johns Hopkins University in the Department of Biological Chemistry under Dr. M. Daniel Lane. He began his industry career at Rhône-Poulenc Rorer, followed by senior leadership positions at Janssen Pharmaceutica, where he led preclinical and translational development programs across oncology, immunology, inflammation, and fibrosis.
Since 2012, Dr. Janicot has served as Founder and Managing Director of JMi ONConsulting, a Brussels-based firm specializing in strategic support and portfolio management for early-stage pharmaceutical development. Through JMi ONConsulting, he has advised leading biotechnology companies in Europe and the U.S. on oncology R&D, preclinical and clinical strategy, and business development initiatives. He also co-founded the aPODD Foundation, a UK-based nonprofit dedicated to accelerating pediatric oncology drug development.
"I am thrilled to join TransCode at such a pivotal stage in its growth," said Dr. Janicot. "The company's pioneering pipeline and RNA platform offers a unique opportunity to intercept key drivers of advanced cancers."As Senior Development Officer Dr. Janicot will support strategic R&D initiatives and contribute to the clinical development strategy for TransCode's investigational oncology programs as they advance toward late stage clinical trials.
Dr. Janicot is also a member of multiple international scientific boards and has authored or co-authored over 360 invited lectures, patents, book chapters, and peer-reviewed publications. His professional expertise spans discovery, preclinical dossier preparation (CTA/IND), early clinical development, translational medicine, and strategic partnering.
Here Today
8月前
This is the only thing I like which in my opinion might be key:
Contingent Value Rights Agreement 20, 2025, including those holders receiving shares of Common Stock in connection with the Acquisition, is entitled to one contractual contingent value right (each, a “CVR”) issued by the Company, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of Common Stock held by such holder as of such time. The CVR Agreement has a term of seven years. 50% of the Net Proceeds (as defined in the CVR Agreement) from any Upfront Payment (as defined in the CVR Agreement) or Milestone Payment (as defined in the CVR Agreement) received by the Company in a given calendar quarter. The distributions in respect of the CVRs that become payable will be made on a quarterly basis and will be subject to a number of deductions, subject to certain exceptions or limitations, including but not limited to certain taxes and certain out-of-pocket expenses incurred by the Company. 40% of the CVRs then-outstanding have, certain rights to audit and enforcement on behalf of all Holders. The CVRs may not be sold, assigned, transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than as permitted pursuant to the CVR Agreement. The foregoing description of the CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the form of the CVR Agreement, a copy of which is included as Exhibit B to the Purchase Agreement, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.