TransCode Therapeutics Announces First Patients Treated in Phase 1 Clinical Trial with First-in-Class Lead Therapeutic Candidate
TransCode Therapeutics (NASDAQ: RNAZ) has announced the dosing of the first two patients in its Phase 1 clinical trial for TTX-MC138, a first-in-class therapeutic candidate designed to treat metastatic cancers. The trial, a multicenter, open-label, dose-escalation and dose-expansion study, aims to evaluate the safety and tolerability of TTX-MC138 in patients with metastatic cancer. Several additional patients have been screened for enrollment.
TTX-MC138 is an antisense oligonucleotide conjugated to TransCode's proprietary TTX delivery system, designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers. This Phase 1 trial follows a successful Phase 0 clinical trial that showed evidence of delivery and pharmacodynamic activity of a radiolabeled version of TTX-MC138.
TransCode Therapeutics (NASDAQ: RNAZ) ha annunciato la somministrazione ai primi due pazienti nel suo studio clinico di Fase 1 per TTX-MC138, un candidato terapeutico innovativo progettato per trattare i tumori metastatici. Lo studio, multicentrico, aperto, con escalation e espansione della dose, ha l'obiettivo di valutare la sicurezza e la tollerabilità di TTX-MC138 nei pazienti con cancro metastatico. Diversi altri pazienti sono stati selezionati per l'arruolamento.
TTX-MC138 è un oligonucleotide antisenso coniugato al sistema di somministrazione proprietario TTX di TransCode, progettato per inibire il microRNA-10b, un noto responsabile della metastasi in diversi tipi di cancro. Questo studio di Fase 1 segue un precedente studio clinico di Fase 0 che ha mostrato evidenze di somministrazione e attività farmacodinamica di una versione radiomarcata di TTX-MC138.
TransCode Therapeutics (NASDAQ: RNAZ) ha anunciado la dosificación de los primeros dos pacientes en su ensayo clínico de Fase 1 para TTX-MC138, un candidato terapéutico de primera clase diseñado para tratar cánceres metastásicos. El ensayo, un estudio multicéntrico, abierto, de escalación y expansión de dosis, tiene como objetivo evaluar la seguridad y tolerabilidad de TTX-MC138 en pacientes con cáncer metastásico. Varios pacientes adicionales han sido seleccionados para su inclusión.
TTX-MC138 es un oligonucleótido antisense conjugado al sistema de administración patentado TTX de TransCode, diseñado para inhibir el microARN-10b, un conocido impulsor de la metástasis en múltiples tipos de cáncer. Este ensayo de Fase 1 sigue a un exitoso ensayo clínico de Fase 0 que mostró evidencia de entrega y actividad farmacodinámica de una versión radiomarcada de TTX-MC138.
TransCode Therapeutics (NASDAQ: RNAZ)는 전이성 암 치료를 위해 설계된 최초의 치료 후보물질인 TTX-MC138에 대한 1상 임상시험에서 첫 번째 환자 두 명의 용량 투여를 발표했습니다. 이 연구는 다기관, 개방형, 용량 증량 및 확장 연구로, 전이성 암 환자에서 TTX-MC138의 안전성 및 내약성을 평가하는 것을 목표로 합니다. 여러 추가 환자들이 등록을 위해 선별되었습니다.
TTX-MC138은 전이를 유도하는 것으로 알려진 미세RNA-10b를 억제하도록 설계된 TransCode의 독점 TTX 전달 시스템에 접합된 안티센스 올리고뉴클레오타이드입니다. 이 1상 시험은 TTX-MC138의 방사성 표지 버전의 전달 및 약리역학적 활동의 증거를 보여준 성공적인 0상 임상시험을 따릅니다.
TransCode Therapeutics (NASDAQ: RNAZ) a annoncé l'administration des premiers deux patients dans son essai clinique de Phase 1 pour TTX-MC138, un candidat thérapeutique de première classe conçu pour traiter les cancers métastatiques. L'essai, une étude multicentrique, ouverte, d'escalade et d'expansion de dose, vise à évaluer la sûreté et la tolérance de TTX-MC138 chez les patients atteints de cancer métastatique. Plusieurs autres patients ont été sélectionnés pour une inclusion.
TTX-MC138 est un oligonucléotide antisens couplé au système de délivrance propriétaire TTX de TransCode, conçu pour inhiber le microARN-10b, un acteur bien connu de la métastase dans plusieurs types de cancer. Cet essai de Phase 1 suit un essai clinique de Phase 0 réussi qui a montré des preuves de délivrance et d'activité pharmacodynamique d'une version radiomarquée de TTX-MC138.
TransCode Therapeutics (NASDAQ: RNAZ) hat die Dosierung der ersten beiden Patienten in seiner Phase 1-Studie für TTX-MC138 angekündigt, einen therapeutischen Kandidaten der ersten Klasse, der zur Behandlung von metastasierenden Krebserkrankungen entwickelt wurde. Die Studie, eine multizentrische, offene, Dosissteigerungs- und Dosisexpansionsstudie, zielt darauf ab, die Sicherheit und Verträglichkeit von TTX-MC138 bei Patienten mit metastasierenden Tumoren zu bewerten. Mehrere zusätzliche Patienten wurden für die Einschreibung gescreent.
TTX-MC138 ist ein Antisense-Oligonukleotid, das an das proprietäre TTX- Liefer系统 von TransCode gekoppelt ist und darauf abzielt, mikroRNA-10b zu inhibieren, ein bekannter Treiber der Metastasierung bei mehreren Krebsarten. Diese Phase-1-Studie folgt auf eine erfolgreiche Phase-0-Studie, die Hinweise auf die Lieferung und die pharmakodynamische Aktivität einer radioaktiv markierten Version von TTX-MC138 gezeigt hat.
- First two patients dosed in Phase 1 clinical trial for TTX-MC138
- Successful completion of Phase 0 clinical trial showing evidence of delivery and pharmacodynamic activity
- TTX-MC138 has potential to treat multiple types of metastatic cancers
- First-in-class therapeutic candidate targeting a molecule responsible for metastatic disease
- Early stage of clinical development (Phase 1) with uncertain outcomes
- Safety and efficacy of TTX-MC138 yet to be established in Phase 1 trial
The initiation of TransCode's Phase 1 clinical trial for TTX-MC138 marks a significant milestone in the development of RNA-based cancer therapeutics. This first-in-class candidate targets microRNA-10b, a known driver of metastasis, potentially offering a novel approach to treating metastatic cancers across multiple indications.
The trial's focus on safety and tolerability is crucial, as it builds upon the evidence of delivery and pharmacodynamic activity observed in the previous Phase 0 trial. The ability to target metastatic lesions, as demonstrated earlier, is particularly promising. However, it's important to note that Phase 1 trials primarily assess safety and efficacy data will come in later stages.
While the news is encouraging, investors should remain cautious. The path from Phase 1 to market approval is long and often challenging, especially for novel therapeutics. The broad potential across various cancer types is exciting but will require extensive further testing.
The commencement of TransCode's Phase 1 trial for TTX-MC138 is an intriguing development in oncology. Targeting microRNA-10b as a driver of metastasis represents a novel approach that could potentially address a critical unmet need in cancer treatment.
The broad applicability across multiple cancer types, including breast, pancreatic, ovarian, colon and lung cancers, is particularly noteworthy. If successful, this could offer a paradigm shift in treating metastatic disease, which remains the primary cause of cancer-related deaths.
However, it's important to temper excitement with caution. While the Phase 0 results showing delivery to metastatic lesions are promising, the therapeutic efficacy and long-term safety of this approach remain to be established. The complexity of RNA therapeutics and the challenges of drug delivery make this an ambitious but high-risk endeavor.
TransCode's advancement to Phase 1 clinical trials with TTX-MC138 represents a significant milestone for the company and potentially for the field of RNA oncology. This progress could positively impact investor sentiment, as it demonstrates the company's ability to move from preclinical to clinical stages.
However, it's important to consider that TransCode (NASDAQ: RNAZ) is still in the early stages of clinical development. The company will likely require substantial capital to fund further trials, which could lead to dilution for current shareholders. Additionally, the timeline to potential commercialization is long and success is far from guaranteed.
Investors should closely monitor the trial's progress, particularly safety data and any early efficacy signals. The broad potential across multiple cancer types could represent significant market opportunity if successful, but also increases the complexity and potential costs of development.
- Two patients dosed; several additional patients screened for enrollment
- Trial to evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer
- TTX-MC138 is an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers
- Phase 1 clinical trial follows evidence of delivery and pharmacodynamic activity in prior first-in-human Phase 0 clinical trial with radiolabeled TTX-MC138
BOSTON, Sept. 17, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced dosing of the first two patients in its Phase 1 clinical trial with its lead candidate, TTX-MC138. Several additional patients have been screened for enrollment in the trial, a multicenter, open-label, dose-escalation and dose-expansion study of TTX-MC138.
“We are thrilled to announce the first two patients were administered TTX-MC138 in our Phase 1 clinical trial. This is a significant milestone for the TTX-MC138 clinical development program with our novel approach to treating metastatic cancers,” commented Sue Duggan, Senior Vice President of Operations, at TransCode. Duggan added, “TTX-MC138 is a first-in-class therapeutic candidate that showed evidence of delivery to metastatic lesions in our Phase 0 clinical trial.”
TransCode believes that TTX-MC138 is the first therapeutic candidate in clinical development designed to specifically target a molecule responsible for metastatic disease across multiple indications and irrespective of the site of metastasis. It has the potential to positively affect patient outcomes in a range of cancers, including breast, pancreatic, ovarian, colon, lung and others. Successful clinical development of TTX-MC138 could represent a breakthrough approach to effectively treating patients with metastatic cancer.
About the Trial
The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study, designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation phase followed by a dose-expansion phase. The primary objective of the dose-escalation phase is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion phase, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase.
Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).
About TransCode Therapeutics
TransCode is a clinical-stage oncology company focused on treating metastatic disease. The company is committed to defeating cancer through the intelligent design and effective delivery of RNA therapeutics based on its proprietary TTX nanoparticle platform. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors which overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode is developing a portfolio of other first-in-class RNA therapeutic candidates designed to overcome the challenges of RNA delivery and thus unlock therapeutic access to a variety of novel genetic targets that could be relevant to treating a variety of cancers.
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 therapeutic potential of TransCode’s TTX-MC138 and the timing, conduct and results of the planned Phase 1 clinical trial. 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 risk associated with drug discovery and development; the risk that the results of clinical trials will not be consistent with TransCode’s pre-clinical studies or expectations or with results from previous clinical trials; risks associated with the conduct of clinical trials; 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 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 TransCode’s dependence on third parties; and risks associated with geopolitical events and pandemics, including the COVID-19 coronavirus. 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, 2023, 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.
For more information, please contact:
TransCode Therapeutics, Inc.
Tania Montgomery-Hammon, VP of Business Development
tania.montgomery@transcodetherapeutics.com
FAQ
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