TCBP Announces Dosing of 5 New Patients in ACHIEVE
TC BioPharm (NASDAQ: TCBP) has announced significant progress in its ACHIEVE Phase 2b trial for TCB008, a potential monotherapy for blood cancers. The company has dosed 6 patients at a higher dose level, with 5 patients receiving their second dose and 2 patients receiving their third dose. Each 5mL dose contains up to 230 million gamma delta T cells, with patients expected to receive approximately 1 billion cells over four doses.
The trial's rapid progression and strong enrollment reflect clinician interest in TCB008. TCBP has implemented process improvements and protocol amendments, resulting in improved patient recruitment and retention. The company is prepared to continue executing its clinical trial plans for ACHIEVE and ACHIEVE2 through 2024 and into 2025, alongside expanded manufacturing capabilities.
TC BioPharm (NASDAQ: TCBP) ha annunciato progressi significativi nel suo studio clinico di fase 2b ACHIEVE per il TCB008, una potenziale monoterapia per i tumori del sangue. L'azienda ha trattato 6 pazienti a un livello di dose più elevato, con 5 pazienti che hanno ricevuto la seconda dose e 2 pazienti che hanno ricevuto la terza dose. Ogni dose da 5mL contiene fino a 230 milioni di cellule T gamma delta, con i pazienti che si aspettano di ricevere circa 1 miliardo di cellule in quattro dosi.
La rapida progressione dello studio e il forte interesse degli iscritti riflettono l'interesse dei clinici per il TCB008. TCBP ha implementato miglioramenti nei processi e modifiche ai protocolli, portando a un miglioramento nel reclutamento e nella retention dei pazienti. L'azienda è pronta a continuare a realizzare i suoi piani di sperimentazione clinica per ACHIEVE e ACHIEVE2 fino al 2024 e nel 2025, insieme a capacità di produzione ampliate.
TC BioPharm (NASDAQ: TCBP) ha anunciado avances significativos en su ensayo de fase 2b ACHIEVE para el TCB008, una potencial monoterapia para los cánceres sanguíneos. La compañía ha tratado a 6 pacientes con un nivel de dosis más alto, con 5 pacientes recibiendo su segunda dosis y 2 pacientes recibiendo su tercera dosis. Cada dosis de 5 mL contiene hasta 230 millones de células T gamma delta, con la expectativa de que los pacientes reciban aproximadamente 1 mil millones de células en cuatro dosis.
El rápido progreso del ensayo y la fuerte inscripción reflejan el interés de los clínicos en el TCB008. TCBP ha implementado mejoras en los procesos y en los protocolos, lo que ha resultado en un mejor reclutamiento y retención de pacientes. La compañía está preparada para continuar ejecutando sus planes de ensayos clínicos para ACHIEVE y ACHIEVE2 a lo largo de 2024 y hasta 2025, junto con capacidades de fabricación ampliadas.
TC BioPharm (NASDAQ: TCBP)는 혈액암에 대한 잠재적인 단독 요법인 TCB008의 ACHIEVE 2b 단계 시험에서 상당한 진전을 발표했습니다. 이 회사는 6명의 환자에게 고용량을 투여했습니다, 이 중 5명의 환자는 두 번째 용량을 받았고 2명의 환자는 세 번째 용량을 받았습니다. 각 5mL 용량에는 최대 2억 3000만 개의 감마 델타 T 세포가 포함되어 있으며, 환자는 약 4회의 투여 동안 10억 개의 세포를 받을 것으로 예상됩니다.
시험의 빠른 진행과 높은 등록은 TCB008에 대한 임상의의 관심을 반영합니다. TCBP는 프로세스 개선 및 프로토콜 수정을 구현하여 환자 모집 및 유지가 개선되었습니다. 이 회사는 2024년과 2025년까지 ACHIEVE 및 ACHIEVE2에 대한 임상 시험 계획을 계속 실행할 준비가 되어 있으며, 제조 능력도 확장할 예정입니다.
TC BioPharm (NASDAQ: TCBP) a annoncé des progrès significatifs dans son essai de phase 2b ACHIEVE pour le TCB008, une potentielle monothérapie pour les cancers du sang. L'entreprise a traité 6 patients à un niveau de dose plus élevé, avec 5 patients recevant leur seconde dose et 2 patients recevant leur troisième dose. Chaque dose de 5 mL contient jusqu'à 230 millions de cellules T gamma delta, avec une attente que les patients reçoivent environ 1 milliard de cellules en quatre doses.
La progression rapide de l'essai et le grand nombre d'inscriptions reflètent l'intérêt des cliniciens pour le TCB008. TCBP a mis en œuvre des améliorations de processus et des modifications de protocole, conduisant à une meilleure recrutement et fidélisation des patients. L'entreprise est prête à continuer d'exécuter ses plans d'essai clinique pour ACHIEVE et ACHIEVE2 jusqu'en 2024 et dans le courant de 2025, ainsi qu'à accroître ses capacités de fabrication.
TC BioPharm (NASDAQ: TCBP) hat bedeutende Fortschritte in seiner ACHIEVE Phase 2b-Studie für TCB008 bekannt gegeben, eine potenzielle Monotherapie gegen Blutkrankheiten. Das Unternehmen hat 6 Patienten mit einer höheren Dosis behandelt, wobei 5 Patienten ihre zweite Dosis erhielten und 2 Patienten ihre dritte Dosis erhielten. Jede 5mL-Dosis enthält bis zu 230 Millionen gamma delta T-Zellen, wobei von den Patienten erwartet wird, dass sie insgesamt 1 Milliarde Zellen über vier Dosen erhalten.
Der schnelle Fortschritt der Studie und die starke Anwerbung spiegeln das Interesse der Kliniker an TCB008 wider. TCBP hat Prozessverbesserungen und Protokolländerungen implementiert, was zu einer besseren Rekrutierung und Bindung der Patienten geführt hat. Das Unternehmen ist bereit, seine klinischen Studienpläne für ACHIEVE und ACHIEVE2 bis 2024 und darüber hinaus in 2025 fortzusetzen, zusammen mit erweiterten Produktionskapazitäten.
- Successful dosing of 6 patients at higher dose level in ACHIEVE Phase 2b trial
- 5 patients received second dose, 2 patients received third dose
- Strong patient recruitment and retention rates
- Expanded manufacturing capabilities to enhance operational and economic efficiencies
- None.
Insights
The dosing progress in TCBP's ACHIEVE Phase 2b trial is encouraging. With 6 patients receiving their first dose at a higher level and 5 patients reaching their second dose, the trial is showing strong recruitment and retention. This suggests potential efficacy and tolerability of TCB008.
The step-wise approach to process improvements and protocol amendments seems to be paying off, as evidenced by the accelerated patient enrollment. The higher dose level of up to
However, it's important to await efficacy data and monitor for any adverse events, especially with the increased dosage. The trial's progress is promising, but final results will be key in determining TCB008's potential as a monotherapy for AML and MDS/AML.
TCBP's announcement demonstrates positive momentum in their clinical pipeline. The rapid enrollment and patient retention in the ACHIEVE trial suggest strong interest from clinicians, which could translate to market potential if TCB008 proves successful.
The company's ability to implement process improvements and protocol amendments efficiently is a good sign of operational agility. This could be important for accelerating development timelines and potentially reducing costs.
Investors should note the expanded manufacturing capabilities mentioned, which could improve operational efficiencies and potentially reduce production costs. However, it's important to consider that TCBP is still in the clinical stage and significant hurdles remain before commercialization. Financial resources to complete trials and potential future capital needs should be closely monitored.
- 5 New patients dosed, bringing total to 6 patients dosed in ACHIEVE at higher dose level
- 5 Patients received second dose
- 2 Patients received third dose
Currently, the trial has successfully dosed 6 patients with their first of 4 possible doses at the higher dose level. Each 5mL dose contains up to 230 million gamma delta T cells, and a patient is expected to receive up to an approximate 1 billion gamma delta T cells over four doses. Five patients have received their second dose, with 2 of these patients having also received their third dose. This correlates with TCBP's step-wise approach to process improvements, as implemented in Q4 2023, and further steps taken to amend the trial protocol in the first quarter of 2024. New patients will continue to be identified, screened, and enrolled into the study.
"TCBP is excited to announce our rapid progression in the ACHIEVE Phase 2b trial with very strong enrolment in the second part of the trial using the higher dose," stated, Bryan Kobel, CEO of TC BioPharm. "TCB008 is potentially a game-changing monotherapy for blood cancers, and the strong recruitment and patient retention rates are testament to clinician/physician interest in TCB008 as a monotherapy in leukemia. We're proud of the milestones accomplished to date, having rapidly dosed 6 patients with an additional 10 patients lined up. It is encouraging to see re-dosing of several patients, which we believe reflects positively on the steps the organization took in 2023 and early 2024. TCBP remains poised to execute on our clinical trial plans in 2024 and into 2025, including ACHIEVE and ACHIEVE2, as well as our expanded manufacturing capabilities to enhance our operational capabilities and our economic efficiencies."
The ACHIEVE
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company's intent or ability to affect any budget savings or execute on any M&A or capital raising strategy. These statements are based on management's current assumptions and are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Current Report on Form 8-K, please see the risks and uncertainties identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company's Investor Relations website at www.tcbiopharm.com and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company's beliefs and assumptions only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue.
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial in treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.
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FAQ
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