Notable Labs Receives FDA Clearance to Proceed Further with Volasertib Phase 2 Study
Notable Labs (NASDAQ: NTBL) has received FDA clearance to proceed with its Phase 2 study of volasertib for relapsed/refractory acute myeloid leukemia (R/R AML). The company plans to initiate patient enrollment in the coming months, following agreement on the dosing plan. The study will evaluate volasertib in combination with decitabine, utilizing Notable's Predictive Medicine Platform (PMP) to enhance patient outcomes.
The Phase 2 trial will begin with a dose optimization lead-in, incorporating body-surface area dosing and prophylactic antibiotic treatment. Notable expects initial data from this phase in Q4 2024, followed by selective enrollment of PMP-predicted responders. Initial efficacy results are anticipated in H1 2025. This progress marks a significant step in addressing the unmet need for R/R AML patients, particularly those who have received venetoclax-based therapies.
Notable Labs (NASDAQ: NTBL) ha ricevuto l'autorizzazione dalla FDA per procedere con il suo studio di Fase 2 su volasertib per leucemia mieloide acuta relascente/refrattaria (R/R AML). La società prevede di avviare l'arruolamento dei pazienti nei prossimi mesi, dopo aver concordato il piano di dosaggio. Lo studio valuterà volasertib in combinazione con decitabina, utilizzando la piattaforma di medicina predittiva (PMP) di Notable per migliorare gli esiti per i pazienti.
Il trial di Fase 2 inizierà con un'introduzione per l'ottimizzazione del dosaggio, incorporando il dosaggio in base all'area di superficie corporea e il trattamento profilattico con antibiotici. Notable si aspetta dati iniziali da questa fase nel quarto trimestre del 2024, seguiti da un arruolamento selettivo dei rispondenti previsti dalla PMP. I risultati iniziali di efficacia sono previsti nel primo semestre del 2025. Questo progresso segna un passo significativo nell'affrontare le esigenze insoddisfatte dei pazienti R/R AML, in particolare di coloro che hanno ricevuto terapie a base di venetoclax.
Notable Labs (NASDAQ: NTBL) ha recibido la aprobación de la FDA para proceder con su estudio de Fase 2 sobre volasertib para leucemia mieloide aguda en recaída/refractaria (R/R AML). La empresa planea iniciar la inscripción de pacientes en los próximos meses, luego de acordar el plan de dosificación. El estudio evaluará volasertib en combinación con decitabina, utilizando la Plataforma de Medicina Predictiva (PMP) de Notable para mejorar los resultados en los pacientes.
El ensayo de Fase 2 comenzará con una introducción para la optimización de la dosis, incorporando la dosificación basada en el área de superficie corporal y el tratamiento profiláctico con antibióticos. Notable espera datos iniciales de esta fase en el cuarto trimestre de 2024, seguido de un reclutamiento selectivo de los respondedores previstos por la PMP. Se anticipan resultados iniciales de eficacia en la primera mitad de 2025. Este avance marca un paso significativo para abordar la necesidad insatisfecha de los pacientes con R/R AML, especialmente aquellos que han recibido terapias basadas en venetoclax.
Notable Labs (NASDAQ: NTBL)는 재발/내성 급성 골수성 백혈병(R/R AML)을 위한 volasertib의 2상 연구를 진행할 수 있도록 FDA 승인을 받았습니다. 회사는 용량 계획에 대해 합의한 후, 향후 몇 달 내에 환자 등록을 시작할 계획입니다. 이 연구는 Notable의 예측 의학 플랫폼(PMP)을 활용하여 환자 결과를 개선하면서 decitabine과 함께 volasertib을 평가할 것입니다.
2상 시험은 체표 면적 용량 및 예방 항생제 치료를 포함한 용량 최적화 준비로 시작됩니다. Notable은 2024년 4분기 이 단계의 초기 데이터를 기대하고 있으며, PMP 예측 응답자의 선택적 등록이 이어질 것입니다. 초기 효능 결과는 2025년 상반기에 예상됩니다. 이 발전은 특히 venetoclax 기반 요법을 받은 환자들의 R/R AML에 대한 충족되지 않은 요구를 해결하는 데 중요한 단계입니다.
Notable Labs (NASDAQ: NTBL) a reçu l'approbation de la FDA pour poursuivre son étude de phase 2 sur volasertib pour la leucémie myéloïde aiguë récurrente/réfractaire (R/R AML). L'entreprise prévoit de commencer le recrutement des patients dans les mois à venir, suite à un accord sur le plan de dosage. L'étude évaluera le volasertib en combinaison avec la décitabine, en utilisant la plateforme de médecine prédictive (PMP) de Notable pour améliorer les résultats des patients.
L'essai de phase 2 débutera par une optimisation de la dose, intégrant une posologie en fonction de la surface corporelle et un traitement prophylactique aux antibiotiques. Notable s'attend à des données initiales de cette phase au quatrième trimestre 2024, suivies d'un recrutement sélectif des répondants prévus par la PMP. Les premiers résultats d'efficacité sont attendus au premier semestre 2025. Cette avancée représente une étape significative pour répondre aux besoins non satisfaits des patients atteints de R/R AML, en particulier ceux ayant reçu des thérapies basées sur le venetoclax.
Notable Labs (NASDAQ: NTBL) hat die Genehmigung der FDA erhalten, um mit der Phase-2-Studie zu volasertib bei rezidivierten/refraktären akuten myeloischen Leukämie (R/R AML) fortzufahren. Das Unternehmen plant, in den kommenden Monaten mit der Rekrutierung von Patienten zu beginnen, nachdem der Dosierungsplan genehmigt wurde. Die Studie wird volasertib in Kombination mit Decitabin bewerten und dabei die Predictive Medicine Platform (PMP) von Notable nutzen, um die Ergebnisse für die Patienten zu verbessern.
Die Phase-2-Studie wird mit einer Dosisoptimierung beginnen, die eine Dosierung basierend auf der Körperoberfläche und eine prophylaktische Antibiotikabehandlung umfasst. Notable erwartet erste Daten aus dieser Phase im vierten Quartal 2024, gefolgt von einer selektiven Rekrutierung der von der PMP prognostizierten Ansprechenden. Erste Wirksamkeitsdaten werden für das erste Halbjahr 2025 erwartet. Dieser Fortschritt stellt einen bedeutenden Schritt dar, um den ungedeckten Bedarf bei R/R AML-Patienten zu decken, insbesondere bei jenen, die venetoclax-basierte Therapien erhalten haben.
- FDA clearance received for Phase 2 volasertib study in R/R AML
- Agreement reached on Phase 2 dosing plan
- Patient enrollment to begin in coming months
- Potential to enhance patient clinical outcomes and tolerability
- Initial data from dose optimization expected in Q4 2024
- Initial efficacy results anticipated in H1 2025
- None.
Phase 2 dosing plan, agreed with FDA, paves the way to initiate patient enrollment
FOSTER CITY, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable”, “Notable Labs” or the “Company”), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), today announced progress for the Phase 2 volasertib program following receipt of “Clearance to Proceed” from the FDA and agreement on the dosing plan for its Phase 2 clinical trial. With trial start-up activities launched in the first quarter of this year, Notable intends to initiate enrollment in the Phase 2 study for PMP-enabled development of volasertib for relapsed refractory (R/R) acute myeloid leukemia (AML) in the coming months.
“We are pleased to report positive progress in our clinical development program to evaluate the use of volasertib, in combination with decitabine, for patients with R/R AML. Receiving FDA’s clearance and agreement on a Phase 2 dosing plan positions us to move forward to activate study sites,” said Thomas Bock, M.D., Chief Executive Officer of Notable. “AML remains a devastating and life-threatening unmet need, especially for patients whose disease has progressed after first-line treatment, and especially in those who have received venetoclax-based therapies. Advancing the volasertib program through the next Phase 2 implementation steps represents meaningful progress for the Company. We are excited about the potential of volasertib, our predictive platform, and our carefully designed clinical program to enhance patient clinical outcomes and tolerability. We look forward to updating our investors and key stakeholders as we proceed.”
Glenn Michelson, M.D., Chief Medical Officer of Notable commented, “Our study design and enrollment strategy for volasertib has been informed by our robust clinical validation trials conducted at Stanford University, the University of Texas MD Anderson Cancer Center and other recognized institutions. In addition, our program incorporates learnings from the agent’s originator, Boehringer Ingelheim, and leverages their extensive post-hoc analysis of the initial Phase 3 AML study. These valuable data guided our decision to in-license volasertib and the overall development strategy. We are enthusiastic to advance a promising new treatment option for patients with R/R AML, building on our platform.”
Amer Zeidan, MBBS, Associate Professor of Medicine (Hematology), Chief of Hematologic Malignancies at Yale Cancer Center and study co-chair shared, “As a clinical researcher with experience in acute myeloid leukemia, I am excited about the potential of volasertib, in combination with Notable’s platform and the enhanced trial design, to overcome some of the problems experienced in prior trials of this agent. This study will allow us to understand if volasertib could offer promise to advance care for patients with acute myeloid leukemia.”
The Phase 2 study will begin with a dose optimization lead-in and incorporate body-surface area (BSA) dosing, prophylactic antibiotic treatment and best supportive care. The second part of the study is planned to enroll patients with R/R AML who are PMP-predicted responders. The Company is working towards initiating dosing of the first subjects in the Phase 2 trial. Based on our plan, Notable expects to have initial data from the dose optimization lead-in during the fourth quarter of 2024, initiate selective enrollment of PMP-predicted responders after that, and start to report initial efficacy results during H1 2025.
Disclosure: Amer Zeidan declared consulting fees from Notable.
About Volasertib
Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, with significant unmet medical need. Building on the performance of volasertib on PMP, an important and proprietary step during Notable’s targeted in-licensing strategy and decision making, Notable will utilize its PMP to predict volasertib-responsive patients prior to their treatment, with the goal of selectively enrolling and treating those predicted responders, increasing volasertib’s response rates and overall patient outcomes, and fast-tracking volasertib’s remaining clinical development in this patient population. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously granted Breakthrough Therapy designation by the FDA. Notable in-licensed volasertib and obtained exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers.
About Notable Labs, Ltd.
Notable Labs, Ltd. is a clinical-stage platform therapeutics company developing predictive medicines for patients with cancer. Through its proprietary Predictive Medicine Platform (PMP), Notable aims to predict whether or not a patient is likely to respond to a specific therapeutic. The PMP is designed to identify and select clinically responsive patients prior to their treatment, potentially fast-tracking clinical development. By continually advancing and expanding the reach of the PMP across diseases and predicted medical outcomes, Notable aims to be the leader in predictive medicine and revolutionize the way patients seek and receive treatments that work best for them.
Notable believes it has created a targeted and de-risked in-licensing strategy to deliver a product’s medical impact and commercial value faster, with a greater likelihood of success, than traditional drug development. By transforming historical standards of care, Notable aims to create a dramatically positive impact for patients and the healthcare community. Notable is headquartered in Foster City, California. Learn more at our website and follow us @notablelabs.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding Notable’s future operations and goals; the potential benefits of any therapeutic candidates or platform technologies of Notable; the timing of any clinical milestones of Notable’s therapeutic candidates; the cash runway of the company; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they were first issued, and are based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Notable’s control. Notable’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) uncertainties associated with Notable’s platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (ii) risks related to the inability of Notable to obtain sufficient additional capital to continue to advance these product candidates and any preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) risks associated with Notable’s future financial and operating results, including its ability to become profitable; (vi) Notable’s ability to retain key personnel; (vii) Notable’s ability to manage the requirements of being a public company; (viii) uncertainties relating to the Israel-Hamas war; (ix) Notable’s ability to obtain orphan drug designation, and the associated benefits, for any of its drug candidates; (x) Notable’s inability to obtain regulatory approval for any of its drug candidates; and (xi) changes in, or additions to international, federal, state or local legislative requirements, such as changes in or additions to tax laws or rates, pharmaceutical regulations, and other regulations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including the factors described in the section titled “Risk Factors” in the Annual Report on Form 10-K of Notable Labs, Ltd. for the year ended December 31, 2023 as filed with the SEC, and in other subsequent filings with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Notable expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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