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TransCode Therapeutics, Inc. develops RNA and immuno-oncology therapeutics for high-risk and advanced cancers. News about RNAZ centers on its lead candidate TTX-MC138, an antagomiR targeting microRNA-10b, along with preclinical publications, IND-related clinical updates, research collaborations and sponsored research tied to RNA-targeted oncology.
Company updates also cover additions to its early-stage oncology pipeline, including adenovirus-based oncolytic immunotherapy candidates UIO-524, UIO-525 and UIO-526, as well as governance changes involving its board and scientific advisory structure. Capital-structure announcements, material agreements and operating or financial results are recurring disclosure themes for this clinical-stage biotechnology issuer.
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TransCode Therapeutics (NASDAQ: RNAZ) has received approval from the Dana Farber Cancer Institute Institutional Review Board (IRB) to advance its First-in-Human (FIH) Phase 0 clinical trial for TTX-MC138, targeting metastatic lesions in advanced solid tumors. The trial will assess delivery and pharmacokinetics of TTX-MC138 in up to 12 cancer patients. TTX-MC138 inhibits microRNA-10b, a key regulator of metastasis. Preclinical studies show promising results: complete elimination of local metastases in triple-negative breast cancer models and significant regression in pancreatic adenocarcinoma. This trial, conducted under an exploratory Investigational New Drug application, aims to generate critical data for future clinical studies, although it is not designed to demonstrate therapeutic effect. CEO Michael Dudley expressed optimism about the potential impact on cancer treatment.
TransCode Therapeutics (NASDAQ: RNAZ) announced the submission of a provisional patent application titled "Nanoparticles Comprising Payloads and Their In Vivo Delivery" (U.S. patent application 63/456,602) aimed at enhancing its TTX therapeutic delivery platform. This technology seeks to overcome challenges in delivering RNA therapeutics to tumors, which have been hindered by systemic inflammation and toxicity. The application expands the platform's capabilities to include gene editing and mRNA vaccines. CEO Michael Dudley emphasized that this innovation positions TransCode as a leader in targeted delivery systems. The new patent application aligns with the company's goal of providing personalized therapy for cancer patients and adds to its existing intellectual property portfolio, which includes several granted patents.
TransCode Therapeutics, Inc. (NASDAQ: RNAZ) announced a Common Stock Purchase Agreement with White Lion Capital, allowing the sale of up to approximately $1.08 million in common stock until May 31, 2023. The funds will be utilized for working capital and corporate purposes. The offering will occur under a previously filed shelf registration statement with the SEC. TransCode focuses on developing RNA therapeutics to treat various cancers, with their lead candidate, TTX-MC138, targeting metastatic cancers responsible for a significant portion of cancer deaths globally. Additional candidates include TTX-siPDL1 and TTX-siLIN28B, aimed at inhibiting tumor growth.
BOSTON, April 6, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics (NASDAQ: RNAZ), the RNA Oncology Company™, will present new results at the AACR Annual Meeting from April 14-19. Highlights include:
- A study showcasing the RNAi-based checkpoint inhibitor TTX-siPDL1 in pancreatic adenocarcinoma, indicating successful therapeutic efficacy.
- Preclinical data on TTX-MC138 demonstrating efficacy and mechanism in pancreatic adenocarcinoma models.
- A Phase 0 microdose study demonstrating delivery of radiolabeled TTX-MC138 in patients with advanced solid tumors.
Zdravka Medarova, CTO, emphasized the rapid progress toward clinical trials aimed at metastatic disease treatment. With recent FDA approval for TTX-MC138's First-in-Human Study, the company advances from animal studies to clinical trials.
TransCode Therapeutics (NASDAQ: RNAZ) has secured a third-year Fast-Track Small Business Innovation Research (SBIR) grant amounting to nearly $871,000 from the NIH. This funding will support clinical evaluations of TTX-MC138, the company's lead therapeutic candidate targeting advanced solid tumors, particularly those associated with metastatic disease. CEO Michael Dudley expressed gratitude for the NIH's ongoing support, emphasizing the potential of their TTX platform. The company is preparing for a first-in-human study and has shown promise in preclinical trials, specifically against micoRNA-10b in metastatic cancer models.
TransCode Therapeutics, Inc. (NASDAQ: RNAZ) announced that it will not complete the sale of Series A Convertible Preferred Stock originally valued at $500,000 due to the proposed purchaser's withdrawal from the agreement. The company will not issue any shares related to this transaction and has reserved its legal rights. TransCode aims to enhance cancer treatment through RNA therapeutics, with its lead candidate, TTX-MC138, targeting metastatic cancers linked to high mortality rates. The firm also explores several other drug candidates and gene-editing platforms to improve patient outcomes in oncology.
TransCode Therapeutics (Nasdaq: RNAZ) announced the sale of 60 shares of its Series A Convertible Preferred Stock to Triton Funds for $500,000. Each share has a stated value of $10,000 and is convertible at a price of $0.60 per share of common stock. This offering is part of a registered direct offering under a previously effective Form S-3 registration statement filed with the SEC. The securities will not be offered in jurisdictions where it would be unlawful prior to proper registration.
TransCode aims to improve cancer treatment through its RNA therapeutic platform, including candidates targeting various tumor types.
TransCode Therapeutics (NASDAQ: RNAZ) reported strong 2022 results, highlighting FDA approval for its Phase 0 clinical trial of TTX-MC138 in advanced solid tumors. Key milestones included a strategic alliance with MD Anderson Cancer Center and receiving Orphan Drug Designation for TTX-siPDL1. Financially, the company faced challenges, ending 2022 with $5.0 million in cash, down from $20.8 million in 2021. Research and development expenses rose to $10.5 million. Recent advancements include positive preclinical results for TTX-MC138, where 40% of treated animals showed complete response.
TransCode Therapeutics (NASDAQ: RNAZ) announced that the FDA granted Orphan Drug Designation for its lead candidate, TTX-MC138, aimed at treating pancreatic cancer. This designation is crucial due to pancreatic cancer's low survival rate, less than 10%. The designation may offer benefits such as seven years of marketing exclusivity, tax credits for qualified R&D, and an exemption from the PDUFA filing fee, estimated to save over $3 million. TTX-MC138 showed promise in preclinical models, achieving complete responses in 40% of subjects. A Phase 0 clinical trial is set to assess TTX-MC138 in patients with advanced solid tumors, aiming to inform future treatments.