PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)
PureTech Health (PRTC) announced that the FDA has granted Fast Track designation to LYT-200, their first-in-class anti-galectin-9 monoclonal antibody, for treating acute myeloid leukemia (AML). This follows previous FDA recognitions including Orphan Drug designation for AML and Fast Track designation for head and neck cancers.
LYT-200 is currently being evaluated in two Phase 1/2 clinical trials: one for hematological malignancies (AML and high-risk myelodysplastic syndrome) and another for advanced/metastatic solid tumors. The drug has shown favorable safety profiles in both trials, with early signals of clinical activity both as a monotherapy and in combination with other treatments.
The treatment works by directly killing cancer cells through apoptosis and DNA damage while reactivating the immune system's anti-cancer mechanisms. PureTech plans to advance LYT-200 through its Founded Entity, Gallop Oncology.
PureTech Health (PRTC) ha annunciato che la FDA ha concesso la designazione Fast Track a LYT-200, il loro anticorpo monoclonale anti-galectina-9 di prima classe, per il trattamento della leucemia mieloide acuta (LMA). Questo segue il riconoscimento precedente da parte della FDA, inclusa la designazione di Farmaco Orfano per LMA e la designazione Fast Track per i tumori della testa e del collo.
Attualmente, LYT-200 è in fase di valutazione in due trial clinici di Fase 1/2: uno per le neoplasie ematologiche (LMA e sindrome mielodisplastica ad alto rischio) e un altro per tumori solidi avanzati/metastatici. Il farmaco ha dimostrato profili di sicurezza favorevoli in entrambi i trial, con segnali iniziali di attività clinica sia come monoterapia che in combinazione con altri trattamenti.
Il trattamento agisce uccidendo direttamente le cellule cancerose attraverso l'apoptosi e i danni al DNA, mentre riattiva i meccanismi antitumorali del sistema immunitario. PureTech prevede di far avanzare LYT-200 tramite la sua Entità Fondatrice, Gallop Oncology.
PureTech Health (PRTC) anunció que la FDA ha otorgado la designación de Vía Rápida a LYT-200, su anticuerpo monoclonal anti-galectina-9 de primera clase, para el tratamiento de la leucemia mieloide aguda (LMA). Esto sigue a reconocimientos previos de la FDA, incluyendo la designación de Medicamento Huérfano para LMA y la designación de Vía Rápida para cánceres de cabeza y cuello.
Actualmente, LYT-200 se está evaluando en dos ensayos clínicos de Fase 1/2: uno para malignidades hematológicas (LMA y síndrome mielodisplásico de alto riesgo) y otro para tumores sólidos avanzados/metastásicos. El fármaco ha mostrado perfiles de seguridad favorables en ambos ensayos, con señales tempranas de actividad clínica tanto como monoterapia como en combinación con otros tratamientos.
El tratamiento funciona al matar directamente las células cancerosas a través de la apoptosis y el daño al ADN, mientras reactiva los mecanismos anticancerígenos del sistema inmunológico. PureTech planea avanzar LYT-200 a través de su Entidad Fundadora, Gallop Oncology.
PureTech Health (PRTC)은 FDA가 LYT-200, 그들의 첫 번째가 되는 anti-galectin-9 단일클론 항체에 대해 신속 승인(Fast Track designation)을 부여했다고 발표했습니다. 이 약물은 급성 골수성 백혈병(AML) 치료를 위한 것입니다. 이는 AML을 위한 희귀의약품 지정을 포함한 이전 FDA 인정을 따르는 것입니다. 또한 두경부암에 대한 신속 승인도 포함됩니다.
LYT-200은 현재 두 개의 1/2상 임상 시험에서 평가되고 있습니다: 하나는 혈액 악성종양(AML 및 고위험 골수형성이상증후군)에 대한 것이고, 다른 하나는 진행성/전이성 고형 종양을 위한 것입니다. 이 약물은 두 시험 모두에서 안전성 프로파일이 유리하게 나타났으며, 단독 치료와 타 치료와의 병행 사용 모두에서 초기 임상 활성을 나타내는 신호가 보였습니다.
이 치료법은 세포자멸사(apoptosis)와 DNA 손상을 통해 암세포를 직접 죽이는 방식으로 작용하며, 동시에 면역 체계의 항암 메커니즘을 재활성화합니다. PureTech는 LYT-200을 설립된 법인인 Gallop Oncology를 통해 발전시킬 계획입니다.
PureTech Health (PRTC) a annoncé que la FDA a accordé la désignation Fast Track à LYT-200, leur anticorps monoclonal anti-galectine-9 de première classe, pour le traitement de la leucémie myéloïde aiguë (LMA). Cela fait suite à des reconnaissances antérieures de la FDA, y compris la désignation de médicament orphelin pour la LMA et la désignation Fast Track pour les cancers de la tête et du cou.
LYT-200 est actuellement évalué dans deux essais cliniques de Phase 1/2 : l'un pour les maladies malignes hématologiques (LMA et syndrome myélodystrophique à haut risque) et l'autre pour les tumeurs solides avancées/métastatiques. Le médicament a montré des profils de sécurité favorables dans les deux essais, avec des signes précoces d'activité clinique tant en monothérapie qu'en combinaison avec d'autres traitements.
Le traitement fonctionne en tuant directement les cellules cancéreuses par apoptose et dommages à l'ADN, tout en réactivant les mécanismes anticancéreux du système immunitaire. PureTech prévoit de faire avancer LYT-200 par le biais de son entité fondatrice, Gallop Oncology.
PureTech Health (PRTC) gab bekannt, dass die FDA die Fast-Track-Phase für LYT-200, ihren ersten monoklonalen Antikörper gegen Galectin-9, zur Behandlung von akuter myeloischer Leukämie (AML) gewährt hat. Dies folgt auf frühere Anerkennungen durch die FDA, darunter die Auszeichnung als Arzneimittel für seltene Erkrankungen für AML und die Fast-Track-Phase für Kopf- und Halskrebs.
LYT-200 wird derzeit in zwei klinischen Studien der Phase 1/2 evaluiert: eine für hämatologische Malignome (AML und hochrisikofreie myelodysplastische Syndrom) und eine andere für fortgeschrittene/metastatische Tumoren. Das Medikament hat in beiden Studien positive Sicherheitsprofile gezeigt, mit frühen Anzeichen von klinischer Aktivität sowohl als Monotherapie als auch in Kombination mit anderen Behandlungen.
Die Behandlung wirkt, indem sie Krebszellen direkt durch Apoptose und DNA-Schäden abtötet, während sie die antitumoralen Mechanismen des Immunsystems reaktiviert. PureTech plant, LYT-200 über ihre gegründete Entität, Gallop Oncology, voranzubringen.
- FDA Fast Track designation received for AML treatment
- Additional FDA Orphan Drug designation for AML obtained
- Favorable safety and tolerability profile demonstrated in clinical trials
- Early signals of clinical activity observed in both monotherapy and combination treatments
- Multiple ongoing Phase 1/2 trials showing promising results
- None.
Insights
The FDA Fast Track designation for LYT-200 in AML treatment represents a significant regulatory milestone that could accelerate the development timeline. The dual mechanism of action - direct cancer cell killing and immune system reactivation - positions LYT-200 as a potentially versatile therapeutic option. Early clinical data showing favorable safety profiles and activity signals in both monotherapy and combination settings is particularly noteworthy.
The galectin-9 targeting approach is innovative in the AML space, where current treatment options are The combination strategy with venetoclax and hypomethylating agents aligns with current standard-of-care protocols, potentially offering an easier path to clinical adoption. Recent data from ASH 2024 suggesting broad patient applicability adds substantial value to the program.
This triple regulatory recognition - Fast Track designations for both AML and head/neck cancers, plus Orphan Drug status for AML - significantly de-risks the regulatory pathway. Fast Track designation provides several key advantages:
- More frequent FDA interactions for rapid issue resolution
- Rolling review eligibility for the future NDA submission
- Potential qualification for Accelerated Approval and Priority Review
For a company with a market cap of
Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment
LYT-200 is currently being evaluated in two Phase 1/2 trials for the potential treatment of AML/MDS and head and neck cancers
“Fast Track designation from the FDA reinforces our belief in the potential for LYT-200 to address the urgent needs of AML patients,” said Luba Greenwood, J.D., Entrepreneur-in-Residence at PureTech who is leading the Gallop Oncology work. “This milestone builds on the FDA’s recognition of LYT-200’s promise, including Orphan Drug designation for AML and a second Fast Track designation for head and neck cancers, both of which were granted last year. By targeting galectin-9, a key driver of cancer proliferation and immune suppression, LYT-200 represents a novel and promising approach for patients in need, and we look forward to the continued development of this program.”
LYT-200 exerts its therapeutic effects in AML by killing cancer cells directly via apoptosis and DNA damage as well as reactivating central anti-cancer effectors of the immune system. LYT-200 is the most advanced clinical program against galectin-9 and is being evaluated in two ongoing clinical trials, including:
- Phase 1/2 clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including AML and high-risk myelodysplastic syndrome (MDS). In this trial, LYT-200 has demonstrated a favorable safety and tolerability profile as well as early signals of clinical activity as single agent and in combination.
- Phase 1/2 trial in advanced/metastatic solid tumors, including head and neck cancers. In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. To date, LYT-200 has demonstrated a favorable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene's tislelizumab, and shown disease control and suggestions of initial anti-tumor activity.
The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML as well as a separate Fast Track designation for the treatment of recurrent/metastatic head and neck squamous cell carcinomas ("head and neck cancers”), in combination with anti-PD1 therapy. PureTech previously announced that it intends to advance LYT-200 via its Founded Entity, Gallop Oncology.
About LYT-200
LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational oncogenic and immunosuppressive protein, galectin-9, for the potential treatment of hematological malignancies and locally advanced metastatic solid tumors, including head and neck cancers, with otherwise poor survival rates. A wide variety of preclinical data support the potential clinical efficacy of LYT-200 and the importance of galectin-9 as a target and suggest a potential opportunity for biomarker development. PureTech has presented data demonstrating high expression of galectin-9 across various solid tumor types and blood cancers and has found that, in several cancers, galectin-9 levels correlate with shorter time to disease relapse and poor survival. Preclinical work also demonstrates single mechanistic and anti-tumor efficacy of LYT-200 in multiple animal and patient-derived tumor cell models. For example, LYT-200 outperforms anti-PD-1 in solid tumor models as a single agent. LYT-200 also synergizes with anti-PD-1 in activating CD4 and CD8 T cells in in vivo cancer models. LYT-200 is currently being evaluated in two ongoing Phase 1/2 adaptive design trials for the potential treatment of AML/MDS and head and neck cancers.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the
For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to development plans for LYT-200, potential benefits to patients, and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
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