MAIA Biotechnology Receives USAN Council Approval for “Ateganosine” as Nonproprietary Name for Anticancer Agent THIO
MAIA Biotechnology (NYSE: MAIA) announced that the United States Adopted Names (USAN) Council has approved 'ateganosine' as the nonproprietary name for its lead molecule THIO, a telomere-targeting anticancer agent in development for advanced non-small cell lung cancer (NSCLC).
The USAN Council, comprising experts from the American Medical Association, U.S. Pharmacopeial Convention, and FDA, is responsible for selecting standardized generic drug names. The name ateganosine was chosen to reflect the drug's mechanism of action in altering telomeric guanosine of cancer cells.
This approval represents a significant milestone in MAIA's regulatory pathway as the company progresses with Phase 2 and 3 clinical trials. The company will continue using the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).
MAIA Biotechnology (NYSE: MAIA) ha annunciato che il Consiglio dei Nomi Adottati negli Stati Uniti (USAN) ha approvato 'ateganosina' come nome non proprietario per la sua molecola principale THIO, un agente anticancro mirato ai telomeri in fase di sviluppo per il trattamento del carcinoma polmonare non a piccole cellule avanzato (NSCLC).
Il Consiglio USAN, composto da esperti dell'American Medical Association, della U.S. Pharmacopeial Convention e della FDA, è responsabile della selezione dei nomi standardizzati per i farmaci generici. Il nome ateganosina è stato scelto per riflettere il meccanismo d'azione del farmaco nell'alterare la guanosina telomerica delle cellule tumorali.
Questa approvazione rappresenta una pietra miliare significativa nel percorso regolatorio di MAIA mentre l'azienda avanza con gli studi clinici di Fase 2 e 3. L'azienda continuerà a utilizzare il nome THIO nelle sue designazioni di studio clinico (THIO-101, THIO-102, THIO-103, THIO-104).
MAIA Biotechnology (NYSE: MAIA) anunció que el Consejo de Nombres Adoptados de Estados Unidos (USAN) ha aprobado 'ateganosina' como el nombre no propietario para su molécula líder THIO, un agente anticancerígeno dirigido a los telómeros en desarrollo para el cáncer de pulmón no microcítico avanzado (NSCLC).
El Consejo USAN, compuesto por expertos de la Asociación Médica Americana, la Convención Farmacopea de EE. UU. y la FDA, es responsable de seleccionar nombres genéricos estandarizados para medicamentos. El nombre ateganosina fue elegido para reflejar el mecanismo de acción del fármaco en la alteración de la guanosina telomérica de las células cancerosas.
Esta aprobación representa un hito significativo en la trayectoria regulatoria de MAIA mientras la empresa avanza con los ensayos clínicos de Fase 2 y 3. La compañía continuará usando el nombre THIO en sus designaciones de ensayos clínicos (THIO-101, THIO-102, THIO-103, THIO-104).
MAIA Biotechnology (NYSE: MAIA)는 미국 채택 이름 위원회(USAN)가 'ateganosine'를 자사의 주요 분자인 THIO의 비독점 이름으로 승인했다고 발표했습니다. THIO는 진행된 비소세포폐암(NSCLC)을 위한 텔로미어 타겟 항암제입니다.
USAN 위원회는 미국 의학 협회, 미국 약전 협회, FDA의 전문가들로 구성되어 있으며, 표준화된 일반 약물 이름을 선택하는 책임이 있습니다. ateganosine이라는 이름은 암세포의 텔로미어 구아노신을 변화시키는 약물의 작용 메커니즘을 반영하기 위해 선택되었습니다.
이번 승인은 MAIA의 규제 경로에서 중요한 이정표를 나타내며, 회사는 2상 및 3상 임상 시험을 진행 중입니다. 회사는 THIO-101, THIO-102, THIO-103, THIO-104와 같은 임상 시험 명칭에서 THIO라는 이름을 계속 사용할 것입니다.
MAIA Biotechnology (NYSE: MAIA) a annoncé que le Conseil des Noms Adoptés des États-Unis (USAN) a approuvé 'ateganosine' comme nom non propriétaire pour sa molécule phare THIO, un agent anticancéreux ciblant les télomères en développement pour le cancer du poumon non à petites cellules avancé (NSCLC).
Le Conseil USAN, composé d'experts de l'American Medical Association, de la U.S. Pharmacopeial Convention et de la FDA, est responsable de la sélection des noms de médicaments génériques standardisés. Le nom ateganosine a été choisi pour refléter le mécanisme d'action du médicament dans l'altération de la guanosine télomérique des cellules cancéreuses.
Cette approbation représente une étape importante dans le parcours réglementaire de MAIA alors que l'entreprise progresse avec les essais cliniques de Phase 2 et 3. L'entreprise continuera d'utiliser le nom THIO dans ses désignations d'essai clinique (THIO-101, THIO-102, THIO-103, THIO-104).
MAIA Biotechnology (NYSE: MAIA) gab bekannt, dass der US-amerikanische Ausschuss für angenommene Namen (USAN) 'ateganosine' als den nicht proprietären Namen für ihr Hauptmolekül THIO, ein telomerzielendes Antikrebsmittel in der Entwicklung für fortgeschrittenes nicht-kleinzelliges Lungenkarzinom (NSCLC), genehmigt hat.
Der USAN-Ausschuss, der aus Experten der American Medical Association, der U.S. Pharmacopeial Convention und der FDA besteht, ist verantwortlich für die Auswahl standardisierter generischer Arzneimittelnamen. Der Name ateganosine wurde gewählt, um den Wirkmechanismus des Medikaments zu reflektieren, der die telomerische Guanosin von Krebszellen verändert.
Diese Genehmigung stellt einen bedeutenden Meilenstein im regulatorischen Weg von MAIA dar, da das Unternehmen mit den klinischen Studien der Phasen 2 und 3 fortschreitet. Das Unternehmen wird den Namen THIO weiterhin in seinen klinischen Studienbezeichnungen (THIO-101, THIO-102, THIO-103, THIO-104) verwenden.
- Achievement of key regulatory milestone with USAN approval
- Progress towards Phase 2 and 3 clinical trials
- Development of first-in-class cancer treatment
- None.
- Nonproprietary drug name approval marks essential step in FDA approval process
The USAN Council is responsible for selecting standardized, informative and unique nonproprietary (generic) drug names. It is made up of experts from the American Medical Association (AMA), the
“The designation of a new nonproprietary name for THIO is a key step along our development and regulatory pathway as we move forward with Phase 2 and 3 clinical trials,” said Vlad Vitoc, M.D., CEO of MAIA. “We chose a name inspired by the mechanism of action of our molecule: altering telomeric guanosine of the cancer cells. The generic name ateganosine is a unique and consistent identity that will support clear communication between healthcare providers, patients and researchers.”
Generic drug names are used in product information, drug regulation, labelling and prescribing as for promotional materials and scientific literature.
MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
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Source: MAIA Biotechnology, Inc.
FAQ
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