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TransCode Therapeutics Announces Initial Dosing in Fourth Cohort of Phase 1 Clinical Trial with TTX-MC138
Prnewswire· 2025-03-27 20:37
Core Insights - TransCode Therapeutics has initiated treatment for the first patient in Cohort 4 of its Phase I clinical trial for TTX-MC138, a therapeutic candidate targeting microRNA-10b, which is associated with metastatic cancer [1][3] - The trial has shown no significant safety or dose-limiting toxicities among the ten patients treated so far, with seven remaining on study for continued treatment [2][8] - The ongoing analysis of pharmacokinetic and pharmacodynamic data suggests that TTX-MC138 aligns with preclinical results, indicating a promising safety profile [2][4] Company Overview - TransCode Therapeutics is focused on developing RNA therapeutics to treat metastatic diseases, utilizing its proprietary TTX nanoparticle platform [7] - TTX-MC138 is the lead candidate designed to inhibit microRNA-10b, which is believed to drive metastatic disease [4][7] - The company aims to address challenges in RNA delivery to unlock therapeutic access to various genetic targets relevant for cancer treatment [9] Clinical Trial Details - The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study aimed at evaluating the safety and tolerability of TTX-MC138 in patients with metastatic solid cancers [5] - The trial consists of an initial dose-escalation phase followed by a dose-expansion phase, with the primary objective of assessing safety and tolerability [5] - Cohort 4's treatment is expected to provide insights for dose expansion and initial evidence of clinical activity as the trial progresses [3][5]
TransCode Therapeutics, Inc. Announces Closing of Registered Direct Offering
Prnewswire· 2025-03-25 22:24
Company Overview - TransCode Therapeutics, Inc. is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics [5] - The company's lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [5] - TransCode has a portfolio of first-in-class RNA therapeutic candidates designed to improve RNA delivery and access novel genetic targets for cancer treatment [5] Recent Offering - The company announced the closing of a sale of 10,250,000 shares of common stock and warrants, generating gross proceeds of approximately $10 million at a price of $0.98 per share [1][2] - Proceeds from the offering will primarily be used for product development activities, including clinical trials for TTX-MC138 and general corporate purposes [2] - ThinkEquity acted as the sole placement agent for the offering [2] Regulatory Compliance - The offering was conducted under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) [3] - The final prospectus supplement related to the offering is available on the SEC's website [3]
TransCode Therapeutics, Inc. Announces Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Prnewswire· 2025-03-24 03:11
Core Viewpoint - TransCode Therapeutics, Inc. has announced a public offering of 10,250,000 shares of common stock and warrants, aiming to raise approximately $10 million for product development and working capital [1][2]. Group 1: Offering Details - The shares are priced at $0.98 each, with warrants having an exercise price of $0.86, immediately exercisable for five years [1]. - The offering is expected to close on March 25, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to product development activities, including clinical trials for TTX-MC138, the company's lead therapeutic candidate, and for general corporate purposes [2]. Group 3: Company Overview - TransCode is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics, utilizing its proprietary TTX nanoparticle platform [6]. - The lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker associated with metastasis [6].
TransCode Therapeutics Announces Safety Review Committee Approval to Open Fourth Cohort in Phase I/II Clinical Trial
Prnewswire· 2025-03-13 11:47
Core Insights - TransCode Therapeutics has received unanimous approval from the Safety Review Committee (SRC) to open the fourth cohort of its Phase I clinical trial for TTX-MC138, a first-in-class RNA therapeutic targeting metastatic cancers [1][3] - The fourth cohort will receive a dose approximately fifty percent higher than that administered in the third cohort, indicating a planned escalation in dosage [1][2] - The trial has shown no dose limiting toxicities or disease progression in the first three cohorts, with six out of nine patients continuing treatment [2][7] Company Overview - TransCode Therapeutics is focused on developing RNA therapeutics for cancer treatment, particularly targeting metastatic diseases through its proprietary TTX nanoparticle platform [8] - TTX-MC138 specifically targets microRNA-10b, which is associated with metastatic disease, and has shown promising results in preclinical and early clinical trials [4][8] Clinical Trial Details - The Phase I clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study aimed at evaluating the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5] - The trial consists of an initial dose-escalation stage followed by a dose-expansion stage, with the primary objective of assessing safety and tolerability [5] - Preliminary pharmacokinetic (PK) and pharmacodynamic (PD) analyses from Cohorts 1 and 2 are consistent with preclinical results, suggesting an efficacious dose range of 0.8-1.6 mg/kg [2][7]
TransCode Therapeutics, Inc. Announces Results of Special Meeting
Prnewswire· 2025-02-25 21:15
Company Overview - TransCode Therapeutics, Inc. is a clinical-stage oncology company focused on treating metastatic disease using RNA therapeutics [3] - The company utilizes its proprietary TTX nanoparticle platform for the intelligent design and effective delivery of RNA therapeutics [3] - The lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [3] - TransCode has a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for various cancers [3] Special Meeting Outcomes - The Special Meeting held on February 25, 2025, resulted in the approval of two proposals by a majority of votes cast [5] - Proposal One involved the approval of the full issuance of shares of Common Stock upon the exercise of Series C and Series D Warrants, adjustments to the exercise price, and an alternative cashless exercise feature [5] - Proposal Two allowed for the adjournment of the Special Meeting to solicit further votes if necessary, which was also approved by a majority [5]
TransCode Therapeutics Announces Completion of Cohort 3 Initial Dosing with Lead Candidate in Phase 1 Clinical Trial
Prnewswire· 2025-02-06 13:00
Core Insights - TransCode Therapeutics, Inc. has initiated Cohort 3 of its Phase 1 clinical trial for TTX-MC138, with three patients enrolled and dosed, following unanimous approval from the Safety Review Committee based on prior cohorts' safety and pharmacokinetic data [1][2] - The trial has shown no significant safety or dose-limiting toxicities across the nine patients in the first two cohorts, with ongoing analyses indicating a pharmacokinetic and pharmacodynamic profile consistent with preclinical results [2][7] - TTX-MC138 is designed to inhibit microRNA-10b, which is implicated in the progression of metastatic cancers, and has demonstrated pharmacodynamic activity in previous trials, suggesting a broad therapeutic window [3][6] Company Overview - TransCode Therapeutics is a clinical-stage oncology company focused on RNA therapeutics for treating metastatic diseases, utilizing its proprietary TTX nanoparticle platform [6] - The lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis [6] - The Phase 1 clinical trial is structured as a multicenter, open-label, dose-escalation and dose-expansion study aimed at evaluating the safety and tolerability of TTX-MC138 in various metastatic solid cancers [4]
TransCode Therapeutics, Inc. Announces Adjournment of Special Meeting and Information for Adjourned Special Meeting
Prnewswire· 2025-02-04 21:15
Core Viewpoint - TransCode Therapeutics has adjourned its Special Meeting originally scheduled for February 4, 2025, to February 25, 2025, to solicit additional votes on key proposals related to the issuance of shares and adjustments to warrants [1][3]. Group 1: Special Meeting Details - The Special Meeting was adjourned due to a lack of quorum, with only approximately 29.94% of the outstanding shares represented [2]. - The Adjourned Special Meeting will be held virtually, allowing stockholders to participate and vote online [3]. - Stockholders are encouraged to vote their shares by February 24, 2025, at 11:59 p.m. Eastern time [4][9]. Group 2: Proposals Overview - Proposal One seeks approval for the full issuance of shares of Common Stock upon the exercise of Series C and Series D Warrants, including adjustments to the exercise price and an alternative cashless exercise feature [6]. - Proposal Two is to adjourn the Special Meeting to allow further solicitation of proxies if there are insufficient votes for Proposal One [6]. Group 3: Voting Instructions - Stockholders can vote by mail, online, or by telephone, with all votes needing to be received by February 24, 2025, to be counted [7][14]. - Those who have already voted and do not wish to change their vote need not take any action [5]. Group 4: Company Overview - TransCode Therapeutics is focused on treating metastatic disease through RNA therapeutics, utilizing its proprietary TTX nanoparticle platform [10]. - The lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [10]. - The company has a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges [10].
TransCode Therapeutics Announces First Patient Dosed in Third Cohort with Lead Candidate in Phase 1 Clinical Trial
Prnewswire· 2025-01-14 13:00
Core Insights - TransCode Therapeutics has initiated dosing of the first patient in Cohort 3 of its Phase 1 clinical trial for TTX-MC138, following approval from the Safety Review Committee based on positive safety data from earlier cohorts [1][2][3] - The dosing in Cohort 3 is approximately double that of Cohort 2, with ongoing analyses indicating a favorable pharmacokinetic and pharmacodynamic profile consistent with preclinical results [2][4] - TTX-MC138 is designed to inhibit microRNA-10b, which is implicated in the progression of metastatic cancers, and has shown promising results in previous trials [4][7] Company Overview - TransCode Therapeutics is focused on developing RNA therapeutics for treating metastatic diseases, utilizing its proprietary TTX nanoparticle platform [7] - The company’s lead candidate, TTX-MC138, targets tumors that overexpress microRNA-10b, a known biomarker for metastasis [7] - TransCode has a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for cancer treatment [7] Clinical Trial Details - The Phase 1 clinical trial is a multicenter, open-label study designed to evaluate the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5] - The trial consists of a dose-escalation stage followed by a dose-expansion stage, with the primary objective of assessing safety and tolerability [5] - Preliminary results from the trial may provide early evidence of clinical activity for TTX-MC138, although this is not a primary endpoint [5]
TransCode Therapeutics Announces Safety Review Committee Approval of Opening Third Cohort and Preliminary Results from First Cohort in Phase 1 TTX-MC138 Clinical Trial
Prnewswire· 2024-12-18 13:00
Core Viewpoint - TransCode Therapeutics has received approval to open the third cohort of its Phase 1 clinical trial for TTX-MC138, a therapeutic candidate targeting microRNA-10b, after a favorable safety review of Cohort 2 data [1][3] Group 1: Clinical Trial Progress - The Safety Review Committee (SRC) has unanimously approved the opening of Cohort 3 based on the safety data from Cohort 2, which reported no significant safety or dose-limiting toxicities [1][3] - New patients are currently being evaluated for eligibility in Cohort 3, with the dose for this cohort being approximately double that of Cohort 2 [1] - Several patients from Cohort 1 and Cohort 2 remain on study for continued treatment, with ongoing analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data [2] Group 2: Pharmacokinetic and Pharmacodynamic Data - Cohort 1 data suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results, showing 66% inhibition of miR-10b at 24 hours post-infusion [2] - The concentration of TTX-MC138 in blood plasma was found to be higher than in nonclinical studies, indicating a favorable pharmacokinetic profile [2] Group 3: About TTX-MC138 - TTX-MC138 is a first-in-class therapeutic candidate targeting microRNA-10b, which is believed to drive metastatic disease [4] - The Phase 0 clinical trial provided evidence of the drug's delivery to metastatic lesions and pharmacodynamic activity, even at microdoses, suggesting a broad therapeutic window [4] Group 4: Trial Design - The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study aimed at evaluating the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5] - The trial includes an initial dose-escalation phase followed by a dose-expansion phase, with the primary objective of assessing safety and tolerability [5]
TransCode Therapeutics Announces Effective Date for 1-for-33 Reverse Stock Split
GlobeNewswire News Room· 2024-11-29 21:25
Core Viewpoint - TransCode Therapeutics, Inc. has announced a 1-for-33 reverse stock split effective December 4, 2024, to increase its stock price and meet Nasdaq listing requirements [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will convert thirty-three current shares into one new share, reducing the number of outstanding shares from 17,265,658 to approximately 696,233 [2]. - No fractional shares will be issued; instead, stockholders will have fractional shares rounded up to the nearest whole number [2]. - The reverse stock split will also adjust the exercise prices of outstanding stock options and warrants, as well as the number of shares under stock incentive plans [2]. Group 2: Company Information - TransCode is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics, utilizing its proprietary TTX nanoparticle platform [5]. - The lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [5]. - The company is developing a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for cancer treatment [5]. Group 3: Administrative Details - Vstock Transfer LLC will serve as the exchange agent for the reverse stock split, and stockholders will not need to take action to receive post-split shares [3]. - The CUSIP number for the company will change to 89357L402 as of the effective time of the reverse stock split [4].