Deux essais cliniques impliquant l’ADC recrutent actuellement des participants. Cr\u00e9dits : PeopleImages.com \u2013 Yuri A\/Shutterstock.<\/p>\n
La Food and Drug Administration (FDA) des \u00c9tats-Unis a accord\u00e9 la d\u00e9signation de voie rapide \u00e0 l’anticorps-m\u00e9dicament conjugu\u00e9 (ADC) de Pyxis Oncology, PYX-201, pour traiter les adultes atteints de carcinome \u00e9pidermo\u00efde de la t\u00eate et du cou r\u00e9current ou m\u00e9tastatique (R\/M HNSCC). <\/p>\n
Ce traitement est destin\u00e9 aux personnes dont la maladie a progress\u00e9 apr\u00e8s un traitement par chimioth\u00e9rapie \u00e0 base de platine et un anticorps anti-ligand de la mort cellulaire programm\u00e9e (PD-L). PYX-201 cible le composant structurel non cellulaire Extradomain-B Fibronectin (EDB+FN) dans la matrice extracellulaire de la tumeur.<\/p>\n
Deux essais cliniques sont en cours de recrutement pour l’ADC. Le premier, PYX-201-101, \u00e9value l’ADC en tant qu’agent unique chez des patients atteints de cette condition. Le second, PYX-201-102, examine l’ADC en combinaison avec Keytruda (pembrolizumab) de MSD, chez des patients atteints de R\/M HNSCC ainsi que d’autres tumeurs solides avanc\u00e9es. Cet essai fait partie d’un accord de partenariat avec la soci\u00e9t\u00e9 biopharmaceutique MSD.<\/p>\n
Lara Sullivan, pr\u00e9sidente et PDG de Pyxis Oncology, a d\u00e9clar\u00e9 : \u00ab Recevoir la d\u00e9signation de voie rapide pour PYX-201 de la FDA marque une \u00e9tape importante pour Pyxis Oncology, reconnaissant notre potentiel \u00e0 r\u00e9pondre \u00e0 un besoin m\u00e9dical important dans le R\/M HNSCC. Cette d\u00e9signation souligne l’urgence d’apporter des options de traitement diff\u00e9renci\u00e9es aux patients et aidera \u00e0 acc\u00e9l\u00e9rer le d\u00e9veloppement de PYX-201 alors que nous recrutons des patients pour notre essai. Nous sommes impatients de travailler avec la FDA pour avancer cette th\u00e9rapie prometteuse aussi efficacement que possible. \u00bb<\/p>\n
Cette d\u00e9signation d\u00e9pend des donn\u00e9es montrant le potentiel du m\u00e9dicament \u00e0 r\u00e9pondre \u00e0 un besoin m\u00e9dical non satisfait pour la condition cibl\u00e9e.<\/p>\n
Le carcinome \u00e9pidermo\u00efde, un sous-type de cancer de la t\u00eate et du cou, provient de la muqueuse de la cavit\u00e9 buccale.<\/p>\n
En mai 2023, Pyxis a conclu un accord d\u00e9finitif pour acheter Apexigen dans le cadre d’un accord de 16 millions de dollars.<\/p>\n
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