TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia
TC BioPharm (NASDAQ: TCBP) has announced the dosing of the sixth patient in its ACHIEVE UK clinical trial for acute myeloid leukemia (AML) on July 16, 2024. This marks the first patient treated with a higher dose of TCB-008 following an amendment approved by the MHRA in February 2024. The trial, now in Phase II, aims to evaluate the efficacy of TCB-008 in patients with AML or MDS/AML who have relapsed or refractory disease.
The study consists of two cohorts: Cohort A for relapsed/refractory patients and Cohort B for patients with detectable residual disease after remission. The new dosage contains up to 230 million cells per dose, increased from the previous 35 million. Eligible patients may receive up to four doses, totaling approximately 1 billion cells. TC BioPharm expects to dose up to 10 more patients in 2024 and plans to open an additional clinical trial site in Q3.
TC BioPharm (NASDAQ: TCBP) ha annunciato il trattamento del sesto paziente nel suo studio clinico ACHIEVE UK per leucemia mieloide acuta (AML) il 16 luglio 2024. Questo segna il primo paziente trattato con una dose più alta di TCB-008, a seguito di un emendamento approvato dalla MHRA nel febbraio 2024. Lo studio, ora nella fase II, mira a valutare l'efficacia di TCB-008 nei pazienti con AML o MDS/AML che hanno avuto recidive o malattia refrattaria.
Lo studio consiste in due coorti: Coorte A per pazienti recidivanti/refrattari e Coorte B per pazienti con malattia residua rilevabile dopo remissione. La nuova dose contiene fino a 230 milioni di cellule per dose, aumentata rispetto ai precedenti 35 milioni. I pazienti idonei possono ricevere fino a quattro dosi, per un totale di circa 1 miliardo di cellule. TC BioPharm prevede di trattare fino a 10 pazienti in più nel 2024 e pianifica di aprire un ulteriore sito di sperimentazione clinica nel terzo trimestre.
TC BioPharm (NASDAQ: TCBP) ha anunciado el tratamiento del sexto paciente en su ensayo clínico ACHIEVE UK para leucemia mieloide aguda (AML) el 16 de julio de 2024. Esto marca el primer paciente tratado con una dosis más alta de TCB-008, tras una modificación aprobada por la MHRA en febrero de 2024. El ensayo, ahora en fase II, tiene como objetivo evaluar la eficacia de TCB-008 en pacientes con AML o MDS/AML que han recaído o tienen enfermedad refractaria.
El estudio consta de dos cohortes: la Cohorte A para pacientes en recaída/refractarios y la Cohorte B para pacientes con enfermedad residual detectable después de la remisión. La nueva dosis contiene hasta 230 millones de células por dosis, aumentada de los anteriores 35 millones. Los pacientes elegibles pueden recibir hasta cuatro dosis, totaling aproximadamente 1 mil millones de células. TC BioPharm espera tratar hasta 10 pacientes más en 2024 y planea abrir un sitio adicional de ensayo clínico en el tercer trimestre.
TC BioPharm (NASDAQ: TCBP)는 2024년 7월 16일 급성 골수성 백혈병 (AML)을 위한 ACHIEVE UK 임상 시험에서 여섯 번째 환자의 투약을 발표했습니다. 이는 2024년 2월 MHRA의 승인을 받은 후 TCB-008의 더 높은 용량으로 치료된 첫 환자를 의미합니다. 현재 2상에 있는 이 시험은 재발 또는 불응성 질환을 가진 AML 또는 MDS/AML 환자에서 TCB-008의 효과를 평가하는 것을 목표로 하고 있습니다.
이 연구는 두 개의 코호트로 구성됩니다: 재발/불응성 환자를 위한 A코호트와 관해 후 잔여 질환이 있는 환자를 위한 B코호트입니다. 새로운 용량은 이전의 3500만에서 증가된 2억 3000만 세포를 포함합니다. 자격을 갖춘 환자는 최대 네 번의 투약을 받아서 총 약 10억 세포를 받을 수 있습니다. TC BioPharm은 2024년에 최대 10명의 추가 환자를 투약하고, 3분기에 추가 임상 시험 장소를 열 계획입니다.
TC BioPharm (NASDAQ: TCBP) a annoncé la dose du sixième patient dans son essai clinique ACHIEVE UK pour leucémie myéloïde aiguë (AML) le 16 juillet 2024. Cela marque le premier patient traité avec une dose plus élevée de TCB-008 suite à un amendement approuvé par la MHRA en février 2024. L'essai, qui est maintenant en phase II, vise à évaluer l'efficacité de TCB-008 chez des patients atteints d'AML ou de MDS/AML ayant une maladie récurrente ou réfractaire.
l'étude se compose de deux cohortes : la Cohorte A pour les patients en rechute/réfractaires et la Cohorte B pour les patients ayant une maladie résiduelle détectable après rémission. La nouvelle dose contient jusqu'à 230 millions de cellules par dose, augmentée par rapport aux précédents 35 millions. Les patients éligibles peuvent recevoir jusqu'à quatre doses, totalisant environ 1 milliard de cellules. TC BioPharm s'attend à traiter jusqu'à 10 patients supplémentaires en 2024 et prévoit d'ouvrir un site d'essai clinique supplémentaire au troisième trimestre.
TC BioPharm (NASDAQ: TCBP) hat die Dosierung des sechsten Patienten in seiner klinischen Studie ACHIEVE UK für akute myeloische Leukämie (AML) am 16. Juli 2024 bekannt gegeben. Dies markiert den ersten Patienten, der mit einer höheren Dosis von TCB-008 behandelt wird, nach einer im Februar 2024 von der MHRA genehmigten Änderung. Die Studie, die sich jetzt in der Phase II befindet, zielt darauf ab, die Wirksamkeit von TCB-008 bei Patienten mit AML oder MDS/AML zu bewerten, die ein rezidiviertes oder refraktäres Krankheitsbild haben.
Die Studie besteht aus zwei Kohorten: Kohorte A für rezidivierte/refraktäre Patienten und Kohorte B für Patienten mit nach Remission nachweisbarer Residualerkrankung. Die neue Dosierung enthält bis zu 230 Millionen Zellen pro Dosis, erhöht von den vorherigen 35 Millionen. Berechtigte Patienten können bis zu vier Dosen erhalten, was insgesamt etwa 1 Milliarde Zellen entspricht. TC BioPharm erwartet, bis 2024 bis zu 10 weitere Patienten zu dosieren und plant, im dritten Quartal einen weiteren klinischen Prüfstandort zu eröffnen.
- Dosing of 6th patient in ACHIEVE study, first with higher dose of TCB-008
- No drug-related Serious Adverse Events reported in initial 5-patient safety cohort
- Increased dose size from 35 million to 230 million cells per dose
- Potential for interim data announcement in next 6-9 months
- Plans to dose up to 10 more patients in 2024
- Expected opening of additional clinical trial site in Q3 2024
- Trial still in early stages with patient data
- Efficacy of increased dose yet to be determined
Insights
The dosing of the sixth patient in the ACHIEVE Study marks a important milestone for TC BioPharm's (TCBP) clinical development of TCB-008, particularly as it involves an increased dose level. This phase II study targets a challenging patient population with acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (MDS/AML). The absence of drug-related serious adverse events in the first five patients is highly encouraging. This not only demonstrates TCB-008's potential safety profile but also sets a positive precedent for further dose escalation in both Cohort A and B.
Moreover, the ability to advance either cohort to an independent Phase III Pivotal Trial upon meeting primary efficacy endpoints provides flexibility and could expedite the clinical development timeline. This is especially critical given the urgent need for new therapies in refractory or relapsed AML patients who have limited treatment options. Investors should watch closely for interim data in the next six to nine months, as positive results could significantly de-risk the clinical program and enhance TCBP's market valuation.
The restart and dosing of additional patients in the ACHIEVE clinical trial is a significant event for TC BioPharm, as it indicates progress and potential for further investment. The news suggests that TCBP is on track with its clinical milestones, which could lead to increased investor confidence and potential stock price appreciation. The upcoming interim data announcement within the next six to nine months is particularly crucial. If the efficacy and safety data continue to be positive, it could attract more funding and partnership opportunities, thereby boosting the company's financial health and long-term prospects.
From a financial perspective, investors should also consider the rigorous regulatory environment TCBP is navigating. Successfully increasing the dose from 35,000,000 to 230,000,000 cells per dose without adverse effects is a positive indicator of the drug's potential scalability and market readiness. This could lead to a quicker route to market for TCB-008, thereby providing a faster return on investment.
For oncologists, the report that the sixth patient in the ACHIEVE study has been successfully dosed with an increased quantity of TCB-008 is a noteworthy development. The study addresses a critical gap in the treatment of refractory or relapsed AML patients who lack effective therapeutic options. The absence of serious adverse events in the safety cohort is promising, suggesting that TCB-008 may offer a viable new treatment pathway.
Furthermore, the flexibility of advancing either cohort to a Phase III trial, based on efficacy endpoints, is highly advantageous. This approach allows for a more efficient and targeted route to therapeutic validation. Given that the increased dose is aligned with the medium dose cohort in the FDA trial, the findings from this study will be pivotal for both regulatory submissions and clinical practice. If successful, TCB-008 could redefine the treatment landscape for AML, offering new hope for patients who currently face a grim prognosis.
- 5 patients treated in "safety cohort" showed no drug related Serious Adverse Events
- Restart of trial after amendment approved by MHRA to increase dose level
The ACHIEVE
Cohort A represents relapsed/refractory patients who have been unable to attain remission and are in palliative care as they are unable to tolerate further chemotherapy. Initially, 5 patients were treated at the lower dose. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort A for a total of 24 patients.
Cohort B represents patients who have attained remission following prior treatment, however, continue to have a detectable residual disease. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort B for a total of 24 patients.
Interim data review is not reliant on the completion of either Cohort, and consequently the Company is not required to complete investigation of both Cohorts prior to advancing to a Pivotal Phase 3 study in one or both Cohorts simultaneously.
Enrolled patients will be treated with an increased dose of TCB-008, containing up to 230,000,000 cells per dose compared to the previous dose of 35,000,000. The increased dose is commensurate with the proposed medium dose cohort in the Company's FDA trial in AML. Eligible patients will receive up to three additional infusions of TCB008, starting 14 days after the previous infusion and administered every subsequent 14 days, representing a total of 4 doses of TCB-008 or approximately 1,000,000,000 cells. Details of the ACHIEVE Study can be found at https://www.clinicaltrials.gov/study/NCT05358808
"The dosing and restart of ACHIEVE represents an important milestone in our progress towards Phase 2b efficacy data in AML with an interim data announcement in the next six to nine months, as well as proof in our ability to successfully navigate potentially arduous regulatory and clinical trial environments in both ACHIEVE and ACHIEVE2," said Bryan Kobel, CEO of TC BioPharm. "In addition to dosing our 6th patient and restarting ACHIEVE, we've screened and enrolled additional patients into the trial and expect to dose up to 10 more in 2024 and expect to open at least one additional clinical trial site in Q3. These efforts, combined with additional refinement of TCB-008 over the last 6 months, escalating the dose size in the ACHIEVE trial and existing data, have us poised for inflection points in 2024 and confidence in our ability to continue to execute on our clinical trial plans. Based on the substantial clinical safety and efficacy data to date and encouraging tolerability information generated in the five-patient safety cohort of ACHIEVE, we are excited to realize the potential of TCB-008 as a mono-therapy and continue to pursue partners for combination therapies."
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 for OmnImmune® 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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SOURCE TC BioPharm
FAQ
What is the current status of TC BioPharm's ACHIEVE clinical trial for AML?
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When does TC BioPharm (TCBP) expect to announce interim data for the ACHIEVE trial?
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