Azitra, Inc. to Present ATR-04 Program Update at ASCO 2025
Azitra (NYSE American: AZTR) announced that its ATR04-484 program for treating EGFR inhibitor-associated rash will be presented at the 2025 ASCO Annual Meeting in Chicago (May 30-June 3, 2025). The company plans to dose the first patient in their Phase 1/2 clinical trial during the first half of 2025.
ATR04-484 is a live biotherapeutic product using an engineered Staphylococcus epidermidis strain, developed to treat skin rashes caused by EGFR inhibitor cancer treatments. The product has received Fast Track designation from the FDA for this indication. These rashes occur due to suppressed skin immunity and inflammation, often showing elevated IL-36γ and S. aureus levels.
EGFR inhibitors are cancer drugs targeting the EGFR protein, commonly used in treating non-small cell lung cancer and colorectal cancer. The complete ASCO abstract will be available on May 22, 2025.
Azitra (NYSE American: AZTR) ha annunciato che il suo programma ATR04-484 per il trattamento dell'eruzione cutanea associata agli inibitori EGFR sarà presentato al 2025 ASCO Annual Meeting a Chicago (30 maggio - 3 giugno 2025). L'azienda prevede di somministrare la prima dose al primo paziente nella sperimentazione clinica di fase 1/2 nella prima metà del 2025.
ATR04-484 è un prodotto bioterapeutico vivo che utilizza un ceppo ingegnerizzato di Staphylococcus epidermidis, sviluppato per trattare le eruzioni cutanee causate dai trattamenti oncologici con inibitori EGFR. Il prodotto ha ottenuto la designazione Fast Track dalla FDA per questa indicazione. Queste eruzioni si verificano a causa della soppressione dell'immunità cutanea e dell'infiammazione, spesso con livelli elevati di IL-36γ e S. aureus.
Gli inibitori EGFR sono farmaci oncologici che agiscono sulla proteina EGFR, comunemente usati nel trattamento del carcinoma polmonare non a piccole cellule e del carcinoma colorettale. L'abstract completo dell'ASCO sarà disponibile il 22 maggio 2025.
Azitra (NYSE American: AZTR) anunció que su programa ATR04-484 para tratar la erupción cutánea asociada a inhibidores de EGFR será presentado en la Reunión Anual ASCO 2025 en Chicago (30 de mayo - 3 de junio de 2025). La compañía planea administrar la primera dosis al primer paciente en su ensayo clínico de fase 1/2 durante la primera mitad de 2025.
ATR04-484 es un producto bioterapéutico vivo que utiliza una cepa modificada de Staphylococcus epidermidis, desarrollado para tratar erupciones cutáneas causadas por tratamientos oncológicos con inhibidores de EGFR. El producto ha recibido la designación Fast Track de la FDA para esta indicación. Estas erupciones ocurren debido a la supresión de la inmunidad cutánea y la inflamación, con niveles elevados de IL-36γ y S. aureus.
Los inhibidores de EGFR son medicamentos contra el cáncer que actúan sobre la proteína EGFR, comúnmente usados para tratar el cáncer de pulmón no microcítico y el cáncer colorrectal. El resumen completo de ASCO estará disponible el 22 de mayo de 2025.
Azitra(NYSE American: AZTR)는 EGFR 억제제 관련 발진 치료를 위한 ATR04-484 프로그램이 2025년 5월 30일부터 6월 3일까지 시카고에서 열리는 2025 ASCO 연례회의에서 발표될 예정이라고 밝혔습니다. 회사는 2025년 상반기 중 1/2상 임상시험에서 첫 환자에게 투약할 계획입니다.
ATR04-484는 유전자 조작된 Staphylococcus epidermidis 균주를 이용한 생물치료제로, EGFR 억제제 암 치료로 인한 피부 발진을 치료하기 위해 개발되었습니다. 이 제품은 FDA로부터 이 적응증에 대해 패스트 트랙 지정을 받았습니다. 이러한 발진은 피부 면역 억제와 염증으로 인해 발생하며, 종종 IL-36γ와 S. aureus 수치가 높게 나타납니다.
EGFR 억제제는 EGFR 단백질을 표적으로 하는 암 치료제로, 비소세포폐암과 대장암 치료에 흔히 사용됩니다. ASCO 초록 전문은 2025년 5월 22일에 공개될 예정입니다.
Azitra (NYSE American : AZTR) a annoncé que son programme ATR04-484 destiné au traitement de l’éruption cutanée associée aux inhibiteurs de l’EGFR sera présenté lors du Congrès annuel ASCO 2025 à Chicago (du 30 mai au 3 juin 2025). La société prévoit d’administrer la première dose au premier patient dans le cadre de son essai clinique de phase 1/2 au cours du premier semestre 2025.
ATR04-484 est un produit biothérapeutique vivant utilisant une souche modifiée de Staphylococcus epidermidis, développé pour traiter les éruptions cutanées causées par les traitements anticancéreux par inhibiteurs de l’EGFR. Ce produit a obtenu la désignation Fast Track de la FDA pour cette indication. Ces éruptions surviennent en raison d’une immunité cutanée affaiblie et d’une inflammation, souvent associées à des niveaux élevés d’IL-36γ et de S. aureus.
Les inhibiteurs de l’EGFR sont des médicaments anticancéreux ciblant la protéine EGFR, couramment utilisés dans le traitement du cancer du poumon non à petites cellules et du cancer colorectal. Le résumé complet de l’ASCO sera disponible le 22 mai 2025.
Azitra (NYSE American: AZTR) gab bekannt, dass sein ATR04-484-Programm zur Behandlung von durch EGFR-Inhibitoren verursachtem Hautausschlag auf dem 2025 ASCO Jahreskongress in Chicago (30. Mai - 3. Juni 2025) vorgestellt wird. Das Unternehmen plant, den ersten Patienten in der Phase-1/2-Studie in der ersten Hälfte des Jahres 2025 zu dosieren.
ATR04-484 ist ein lebendes biotherapeutisches Produkt, das einen gentechnisch veränderten Stamm von Staphylococcus epidermidis verwendet und zur Behandlung von Hautausschlägen entwickelt wurde, die durch EGFR-Inhibitoren in der Krebstherapie verursacht werden. Das Produkt hat von der FDA die Fast Track-Zulassung für diese Indikation erhalten. Diese Ausschläge treten aufgrund einer unterdrückten Hautimmunität und Entzündungen auf und zeigen häufig erhöhte Werte von IL-36γ und S. aureus.
EGFR-Inhibitoren sind Krebsmedikamente, die das EGFR-Protein gezielt angreifen und häufig zur Behandlung von nicht-kleinzelligem Lungenkrebs und Darmkrebs eingesetzt werden. Das vollständige ASCO-Abstract wird am 22. Mai 2025 verfügbar sein.
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Azitra is developing ATR04-484 for the treatment of EGFR inhibitor-associated rash with plans to dose first patient in Phase 1/2 trial in the first half of 2025
BRANFORD, Conn., April 25, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that an abstract detailing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30-June 3, 2025 in
"We look forward to presenting an update on the ATR-04 program at ASCO as we plan to dose the first patient in the first half of 2025," said Francisco Salva, CEO of Azitra. "ASCO is widely regarded as the most prestigious cancer research conference in the world, and we are eager to educate leaders in the oncology community on the potential of ATR04-484 to treat the unique dermatologic toxicities that often accompany EGFRi treatments, which can hamper treatment efforts and cause significant physical and psychological discomfort for patients."
ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484. ATR04-484 is in development for EGFRi-associated skin rash, which is associated with the suppression of skin immunity by EGFR inhibitors and subsequent inflammation, often accompanied by elevated levels of IL-36γ and S. aureus. Azitra has received Fast Track designation from the FDA for EGFRi associated rash and has initiated a Phase 1/2 clinical study in patients with EGFRi rash with the first patient expected to be dosed in the first half of 2025.
EGFR inhibitors are a class of cancer drugs that target and block the activity of the EGFR protein, which plays a crucial role in cell growth and survival. They are primarily used to treat certain types of cancer, including non-small cell lung cancer (NSCLC) and colorectal cancer.
The full ASCO abstracts will be available on May 22, 2025, after 5 p.m. ET. Abstract titles are available at: https://www.asco.org/abstracts.
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies.
Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact
Norman Staskey
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staskey@azitrainc.com
Investor Relations
Tiberend Strategic Advisors, Inc.
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205-566-3026
jnugent@tiberend.com
Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
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cmcdonald@tiberend.com
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SOURCE Azitra, Inc.
FAQ
When will Azitra (AZTR) begin dosing patients with ATR04-484 for EGFR inhibitor rash?
What is ATR04-484's current FDA status for treating EGFR inhibitor-associated rash?
How does Azitra's ATR04-484 treatment work for EGFR inhibitor rash?
When and where will Azitra (AZTR) present their ATR04-484 program update?
What types of cancer are typically treated with EGFR inhibitors that can cause these rashes?
