Foundation Medicine Partners with Syndax to Develop a Companion Diagnostic in Hematology and Support Efforts to Pursue Regulatory Approval for an Assay Based on the FoundationOne®Heme Platform
Foundation Medicine has partnered with Syndax Pharmaceuticals to develop a companion diagnostic for identifying acute myeloid leukemia (AML) patients with NPM1 mutations. This collaboration aims to support regulatory approval for an assay based on the FoundationOne®Heme platform. NPM1 mutations occur in about 30% of newly diagnosed AML cases, with no currently approved targeted treatments. The partnership focuses on advancing Syndax's menin inhibitor, revumenib, as a potential targeted therapy for NPM1-mutated AML.
If approved, this assay could become the first next-generation sequencing companion diagnostic for detecting genomic alterations in hematologic neoplasms. Foundation Medicine, a leader in companion diagnostic approvals, sees this collaboration as a critical step in expanding precision medicine options for blood cancer patients.
Foundation Medicine ha stretto una collaborazione con Syndax Pharmaceuticals per sviluppare un diagnostico companion volto all'identificazione dei pazienti con leucemia mieloide acuta (LMA) e mutazioni NPM1. Questa collaborazione mira a supportare l'approvazione regolatoria di un'assay basata sulla piattaforma FoundationOne®Heme. Le mutazioni NPM1 si riscontrano in circa il 30% dei casi di LMA appena diagnosticati, senza trattamenti mirati attualmente approvati. Il partnership si concentra sul progresso dell'inibitore di menin di Syndax, revumenib, come potenziale terapia mirata per LMA con mutazioni NPM1.
Se approvato, questo assay potrebbe diventare il primo diagnostico companion di sequenziamento di nuova generazione per la rilevazione delle alterazioni genomiche nelle neoplasie ematologiche. Foundation Medicine, leader nell'approvazione di diagnostici companion, considera questa collaborazione un passo fondamentale nell'espansione delle opzioni di medicina di precisione per i pazienti affetti da cancro del sangue.
Foundation Medicine se ha asociado con Syndax Pharmaceuticals para desarrollar un diagnóstico companion destinado a identificar a pacientes con leucemia mieloide aguda (LMA) que presentan mutaciones NPM1. Esta colaboración tiene como objetivo apoyar la aprobación regulatoria de un ensayo basado en la plataforma FoundationOne®Heme. Las mutaciones NPM1 ocurren en aproximadamente el 30% de los casos de LMA recién diagnosticados, sin tratamientos dirigidos actualmente aprobados. La colaboración se centra en impulsar el inhibidor de menin de Syndax, revumenib, como una posible terapia dirigida para la LMA con mutaciones NPM1.
Si se aprueba, este ensayo podría convertirse en el primer diagnóstico companion de secuenciación de nueva generación para detectar alteraciones genómicas en neoplasias hematológicas. Foundation Medicine, un líder en la aprobación de diagnósticos companions, ve esta colaboración como un paso crítico para expandir las opciones de medicina de precisión para los pacientes con cáncer de sangre.
Foundation Medicine는 Syndax Pharmaceuticals와 협력하여 NPM1 돌연변이가 있는 급성 골수성 백혈병 (AML) 환자를 식별하기 위한 동반 진단을 개발하고 있습니다. 이 협력은 FoundationOne®Heme 플랫폼을 기반으로 한 검사의 규제 승인을 지원하는 것을 목표로 합니다. NPM1 돌연변이는 새로 진단된 AML 사례의 약 30%에서 발생하며, 현재 승인된 표적 치료법은 없습니다. 파트너십은 NPM1 변이가 있는 AML 환자를 위한 잠재적인 표적 치료법으로서 Syndax의 메닌 억제제인 revumenib를 발전시키는 데 초점을 맞추고 있습니다.
승인될 경우, 이 검사는 혈액 종양에서 유전적 변화를 감지하기 위한 첫 번째 차세대 시퀀싱 동반 진단이 될 수 있습니다. 동반 진단 승인에서 선두 주자인 Foundation Medicine은 이 협업을 혈액암 환자를 위한 정밀 의료 옵션 확대에 있어 중대한 단계로 보고 있습니다.
Foundation Medicine s'est associé à Syndax Pharmaceuticals pour développer un diagnostic compagnon destiné à identifier les patients atteints de leucémie myéloïde aiguë (LMA) avec mutations NPM1. Cette collaboration vise à soutenir l'approbation réglementaire d'un test basé sur la plateforme FoundationOne®Heme. Les mutations NPM1 surviennent dans environ 30 % des cas de LMA nouvellement diagnostiqués, sans traitements ciblés actuellement approuvés. Le partenariat se concentre sur la promotion de l'inhibiteur de menin de Syndax, revumenib, comme une thérapie ciblée potentielle pour la LMA avec mutations NPM1.
Si approuvé, ce test pourrait devenir le premier diagnostic compagnon de séquençage de nouvelle génération pour détecter les altérations génomiques dans les néoplasies hématologiques. Foundation Medicine, leader des approbations de diagnostics compagnons, voit cette collaboration comme une étape cruciale pour élargir les options de médecine de précision pour les patients atteints de cancer du sang.
Foundation Medicine hat sich mit Syndax Pharmaceuticals zusammengetan, um ein Begleitdiagnosetests zu entwickeln, um Patienten mit akuter myeloischer Leukämie (AML) und NPM1-Mutationen zu identifizieren. Diese Zusammenarbeit hat zum Ziel, die behördliche Zulassung eines Tests auf der Grundlage der FoundationOne®Heme-Plattform zu unterstützen. NPM1-Mutationen treten bei etwa 30 % der neu diagnostizierten AML-Fälle auf, ohne derzeit zugelassene zielgerichtete Behandlungen. Der Schwerpunkt der Partnerschaft liegt auf der Weiterentwicklung des Menin-Inhibitors von Syndax, revumenib, als potenzielle zielgerichtete Therapie für NPM1-mutierte AML.
Wenn genehmigt, könnte dieser Test der erste Begleitdiagnosetest mit neuer Generation Sequenzierung zur Auffindung genomischer Veränderungen bei hämatologischen Neoplasien werden. Foundation Medicine, ein führendes Unternehmen bei der Genehmigung von Begleitdiagnosen, sieht in dieser Zusammenarbeit einen entscheidenden Schritt zur Erweiterung der Möglichkeiten der Präzisionsmedizin für Patienten mit Blutkrebs.
- Potential development of the first next-generation sequencing companion diagnostic for hematologic neoplasms
- Partnership with Syndax Pharmaceuticals to advance targeted therapy for NPM1-mutated AML
- Expansion of Foundation Medicine's leadership in companion diagnostic approvals
- Potential to improve treatment options for AML patients with NPM1 mutations
- None.
Insights
This partnership between Foundation Medicine and Syndax marks a significant step in advancing precision medicine for acute myeloid leukemia (AML) patients. The development of a companion diagnostic for NPM1 mutations, present in
The potential approval of an assay based on the FoundationOne®Heme platform could be groundbreaking as the first next-generation sequencing companion diagnostic for hematologic neoplasms. This would not only aid in identifying eligible patients for Syndax's menin inhibitor, revumenib, but also pave the way for more personalized treatment approaches in blood cancers overall.
The collaboration between Foundation Medicine and Syndax is a promising development in the field of hematology-oncology. As an oncologist, I'm particularly excited about the potential of menin inhibitors like revumenib for NPM1-mutated AML. Currently, we have no targeted treatments for this specific mutation, which significantly limits our therapeutic options.
The development of a companion diagnostic will be important in identifying patients who may benefit from this targeted therapy. Moreover, the broader implications of advancing the FoundationOne®Heme platform could lead to more precise diagnoses and treatments across various hematologic malignancies, potentially improving patient outcomes and quality of life.
This partnership has significant market implications. Foundation Medicine, already a leader in companion diagnostics with
For Syndax (NASDAQ: SNDX), this collaboration could accelerate the development and adoption of revumenib, potentially leading to increased market share in the AML treatment landscape. Investors should note that this partnership aligns with the growing trend towards precision medicine in oncology, which is expected to drive market growth in the coming years.
NPM1 mutations are unique to AML patients and are the most frequently found genetic alteration at approximately
“Blood cancers have a devastating impact on the lives of so many patients and their families,” said Ashley Yocum, PhD, Executive Research Lead at The Leukemia & Lymphoma Society. “Thanks to advancements in comprehensive genomic profiling, and decades of scientific research for new treatments, we are seeing a paradigm shift in how many types of blood cancer are diagnosed and treated, allowing more patients to benefit from the promise of precision medicine with access to more personalized treatment options.”
If approved, the assay could be the first next-generation sequencing companion diagnostic to detect genomic alterations in hematologic neoplasms, including enhancing the identification of patients with NPM1 mutations who may be eligible for revumenib.
“As the number of biomarkers with targeted therapies in hematologic malignancies reaches a critical inflection point, it is essential for physicians to have access to high-quality tests to make informed treatment decisions for their patients,” said Troy Schurr, Chief Biopharma Officer at Foundation Medicine. “We are incredibly excited to work with Syndax to advance the FoundationOne Heme platform as a companion diagnostic, a potential first for the FoundationOne Heme platform, and if approved, help patients with AML access this potential therapy.”
Foundation Medicine’s portfolio of FDA-approved diagnostic tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Foundation Medicine is the global leader in companion diagnostic approvals, with approximately
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X.
About FoundationOne®Heme
FoundationOne®Heme is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne Heme has not been cleared or approved by the
The test employs RNA sequencing in addition to DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions.
About Revumenib
Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed by Syndax Pharmaceuticals for the treatment of KMT2A-rearranged (KMT2Ar), also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including ALL and AML, and mutant nucleophosmin (mNPM1) AML. Revumenib was granted Orphan Drug Designation for the treatment of AML, ALL and MPAL by the FDA and for the treatment of AML by the European Commission, and Fast Track designation by the FDA and is currently under review for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation. A New Drug Application (NDA) for revumenib for the treatment of adult and pediatric R/R KMT2Ar acute leukemia is currently under review by the
1 Swaminathan M, Bourgeois W, Armstrong SA, Wang ES. Menin inhibitors in acute myeloid leukemia—What does the future hold?. The Cancer J. 2022;28(1):62-66. https://doi.org/10.1097/PPO.0000000000000571
2 Ranieri R, Pianigiani G, Sciabolacci S, et al. Current status and future perspectives in targeted therapy of NPM1-mutated AML. Leukemia. 2022;36(10):2351-2367. https://doi.org/10.1038/s41375-022-01666-2
3 Angenendt L, Röllig C, Montesinos P, et al. Chromosomal abnormalities and prognosis in NPM1-mutated acute myeloid leukemia: A pooled analysis of individual patient data from nine international cohorts. J Clin Oncol. 2019;37(29):2632-2642. https://doi.org/10.1200/JCO.19.00416
4 List of Cleared or Approved Companion Diagnostic Devices. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.
5 Multiple secondary sources used to cross validate information, including Trialtrove, clinicatrials.gov, EudraCT, ChiCTR; FDA approval timeline estimation based on Ph3 PCD + 8 months review; analysis based on current Phase 1/2, Phase 2 and Phase 3 trials with inclusion criteria requiring patient selection based on alterations to specific biomarkers.
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Source: Foundation Medicine
FAQ
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