TransCode Therapeutics Announces Phase 1 Clinical Trial Initiation
TransCode Therapeutics (NASDAQ: RNAZ) has initiated its Phase 1 clinical trial for TTX-MC138, its lead RNA therapeutic candidate for cancer treatment. Two clinical trial sites have been activated, with patient enrollment expected to begin this quarter. The trial, designed to evaluate the safety and preliminary anti-tumor activity of TTX-MC138, may include up to five sites in total.
The study comprises a dose-escalation phase followed by a dose-expansion phase. It aims to assess the safety, tolerability, and potential clinical activity of TTX-MC138 in patients with various metastatic solid cancers. This marks a significant milestone for TransCode in advancing RNA therapeutics in oncology.
TransCode Therapeutics (NASDAQ: RNAZ) ha avviato il suo studio clinico di Fase 1 per TTX-MC138, il suo principale candidato terapeutico a RNA per la cura del cancro. Due siti di prova clinica sono stati attivati, con l'ingresso dei pazienti previsto per iniziare in questo trimestre. Lo studio, progettato per valutare la sicurezza e l'attività antitumorale preliminare di TTX-MC138, potrebbe includere fino a cinque siti in totale.
La ricerca comprende una fase di aumento dei dosaggi seguita da una fase di espansione dei dosaggi. L'obiettivo è valutare la sicurezza, la tollerabilità e il potenziale effetto clinico di TTX-MC138 in pazienti con vari tumori solidi metastatici. Questo rappresenta una tappa significativa per TransCode nell'avanzamento delle terapie a RNA in oncologia.
TransCode Therapeutics (NASDAQ: RNAZ) ha iniciado su ensayo clínico de Fase 1 para TTX-MC138, su principal candidato terapéutico de ARN para el tratamiento del cáncer. Se han activado dos sitios de ensayo clínico, y se espera que la inscripción de pacientes comience en este trimestre. El ensayo, diseñado para evaluar la seguridad y la actividad antitumoral preliminar de TTX-MC138, podría incluir hasta cinco sitios en total.
El estudio comprende una fase de escalamiento de dosis seguida de una fase de expansión de dosis. Su objetivo es evaluar la seguridad, tolerabilidad y posible actividad clínica de TTX-MC138 en pacientes con varios cánceres sólidos metastásicos. Este es un hito significativo para TransCode en el avance de las terapias de ARN en oncología.
TransCode Therapeutics (NASDAQ: RNAZ)는 암 치료를 위한 RNA 치료 후보물질인 TTX-MC138에 대한 1상 임상 시험을 시작했습니다. 두 개의 임상 시험 사이트가 활성화되었습니다, 환자 등록은 이번 분기에 시작될 것으로 예상됩니다. 이 시험은 TTX-MC138의 안전성과 초기 항종양 활성을 평가하기 위해 설계되었으며, 총 5개의 사이트가 포함될 수 있습니다.
이번 연구는 용량 증가 단계 후용량 확장 단계로 구성되어 있습니다. 다양한 전이성 고형 암 환자에서 TTX-MC138의 안전성, 내약성 및 잠재적 임상 활성을 평가하는 것을 목표로 하고 있습니다. 이는 종양학에서 RNA 치료제를 발전시키는 TransCode에 중요한 이정표가 됩니다.
TransCode Therapeutics (NASDAQ: RNAZ) a lancé son essai clinique de Phase 1 pour TTX-MC138, son principal candidat thérapeutique à ARN pour le traitement du cancer. Deux sites d'essai clinique ont été activés, et l'inscription des patients est prévue pour débuter ce trimestre. L'essai, conçu pour évaluer la sûreté et l'activité antitumorale préliminaire de TTX-MC138, pourrait inclure jusqu'à cinq sites au total.
L'étude se compose d'une phase d'escalade de dose suivie d'une phase d'expansion de dose. Elle vise à évaluer la sécurité, la tolérance et la potentielle activité clinique de TTX-MC138 chez des patients atteints de différents cancers solides métastatiques. Cela marque une étape importante pour TransCode dans l'avancement des thérapeutiques à ARN en oncologie.
TransCode Therapeutics (NASDAQ: RNAZ) hat mit seiner Phase-1-Studie für TTX-MC138, sein führendes RNA-Therapeutikum zur Krebsbehandlung, begonnen. Zwei klinische Studienstandorte wurden aktiviert, die Patienteneinschreibung wird voraussichtlich in diesem Quartal beginnen. Die Studie, die darauf abzielt, die Sicherheit und die vorläufige antitumorale Aktivität von TTX-MC138 zu bewerten, könnte insgesamt bis zu fünf Standorte umfassen.
Die Studie besteht aus einer Dosissteigerungsphase, gefolgt von einer Dosiserweiterungsphase. Ziel ist es, die Sicherheit, Verträglichkeit und potenzielle klinische Aktivität von TTX-MC138 bei Patienten mit verschiedenen metastasierenden soliden Tumoren zu bewerten. Dies stellt einen bedeutenden Meilenstein für TransCode im Fortschritt der RNA-Therapeutika in der Onkologie dar.
- Initiation of Phase 1 clinical trial for lead candidate TTX-MC138
- Two clinical trial sites activated with potential for up to five sites
- Patient enrollment expected to begin in the current quarter
- Trial designed to evaluate safety and preliminary anti-tumor activity
- None.
Insights
The initiation of TransCode Therapeutics' Phase 1 clinical trial for TTX-MC138 marks a significant milestone in RNA oncology. This trial, designed to evaluate safety and preliminary anti-tumor activity, could potentially revolutionize cancer treatment using RNA therapeutics. The two-phase approach - dose-escalation followed by dose-expansion - is a strategic method to thoroughly assess the drug's safety profile and efficacy.
The activation of two clinical sites, with plans for up to five, indicates strong interest from the medical community. This enthusiasm suggests potential for rapid patient enrollment, which could accelerate the trial's progress. However, investors should note that Phase 1 trials primarily focus on safety and
TTX-MC138's potential to target metastatic solid cancers is particularly noteworthy. Metastasis remains a critical challenge in oncology, often rendering treatments ineffective. If successful, this RNA therapeutic could address a significant unmet need in cancer treatment.
The trial's design, allowing for evaluation across various tumor types, is commendable. This approach could uncover unexpected efficacy in certain cancers, potentially broadening the drug's application. However, it's important to temper expectations; many promising cancer therapies fail in early-stage trials. The preliminary anti-tumor activity data from this trial will be important in gauging TTX-MC138's potential, but definitive efficacy conclusions will require larger, later-phase studies.
For TransCode Therapeutics (NASDAQ: RNAZ), this clinical trial initiation is a pivotal moment. It transitions the company from preclinical to clinical stage, potentially enhancing its valuation. However, investors should be aware that clinical-stage biotech companies often face increased cash burn rates due to trial expenses.
The company's focus on RNA therapeutics places it in a growing, competitive field. Success could position TransCode as a leader in RNA oncology, but failure could significantly impact its stock price. With patient enrollment expected this quarter, we may see increased market attention on RNAZ. Investors should closely monitor trial progress and any interim data releases, as these could cause significant stock volatility.
- Two clinical trial sites activated
- Patient enrollment expected this quarter
- Trial designed to evaluate the safety and preliminary anti-tumor activity of TTX-MC138
BOSTON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced initiation of its Phase 1 multicenter, open-label, clinical study of its lead therapeutic candidate, TTX-MC138.
Two clinical trial sites have been activated with patient enrollment expected to begin during the current quarter. TransCode may activate a total of up to five clinical trial sites, all of which are expected to be activated this quarter.
The Phase 1 clinical trial is designed to generate critical data to support evaluation of the safety of TTX-MC138 in patients with a variety of metastatic solid cancer. It may provide early evidence of TTX-MC138 clinical activity. 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.
“We are thrilled to have garnered such high interest in TTX-MC138 from eminent oncologists working in some of the most respected clinical trial sites in the country,” commented Sue Duggan, Senior Vice President, Operations, at TransCode. “Advancing breakthrough RNA therapeutics science in the clinic is our primary goal as a biotechnology company at the cusp of innovative technology,” added Duggan.
Active and recruiting sites can be found at:
https://clinicaltrials.gov/study/NCT06260774?spons=transcode&rank=1
About TransCode Therapeutics
TransCode Therapeutics 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 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 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 our clinical trials will not be consistent with our pre-clinical studies or expectations or with previous clinical trials; risks associated with the timing and outcome of TransCode’s planned regulatory submissions; risks associated with TransCode’s conduct of clinical trials; 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 the 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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