Azitra, Inc. Announces Presentation at ASCO 2025 Highlighting Clinical Trial Investigating ATR-04 for EGFRi-Associated Rash
Azitra (NYSE: AZTR) announced it will present a poster at ASCO 2025 detailing its Phase 1/2 clinical trial of ATR04-484, a treatment for EGFR inhibitor-associated rash. The presentation will take place at McCormick Place, Chicago, from May 30-June 3, 2025.
ATR04-484 is a live biotherapeutic product using an engineered Staphylococcus epidermidis strain, designed to treat dermal toxicity in patients using EGFRi cancer therapies. The FDA has granted Fast Track designation for this indication. The treatment addresses a significant side effect of EGFRi therapies, commonly used in non-small cell lung cancer and colorectal cancer treatment, where patients often reduce or discontinue treatment due to severe skin reactions.
Azitra (NYSE: AZTR) ha annunciato che presenterà un poster al ASCO 2025 in cui illustrerà il suo studio clinico di Fase 1/2 su ATR04-484, un trattamento per l'eruzione cutanea associata agli inibitori EGFR. La presentazione si terrà al McCormick Place di Chicago, dal 30 maggio al 3 giugno 2025.
ATR04-484 è un prodotto bioterapeutico vivo che utilizza un ceppo ingegnerizzato di Staphylococcus epidermidis, progettato per trattare la tossicità cutanea nei pazienti sottoposti a terapie oncologiche con inibitori EGFR. La FDA ha concesso la designazione Fast Track per questa indicazione. Il trattamento affronta un effetto collaterale significativo delle terapie EGFRi, comunemente usate nel trattamento del carcinoma polmonare non a piccole cellule e del cancro del colon-retto, dove i pazienti spesso riducono o interrompono la terapia a causa di gravi reazioni cutanee.
Azitra (NYSE: AZTR) anunció que presentará un póster en el ASCO 2025 detallando su ensayo clínico de Fase 1/2 sobre ATR04-484, un tratamiento para la erupción cutánea asociada a inhibidores de EGFR. La presentación tendrá lugar en McCormick Place, Chicago, del 30 de mayo al 3 de junio de 2025.
ATR04-484 es un producto bioterapéutico vivo que utiliza una cepa modificada de Staphylococcus epidermidis, diseñado para tratar la toxicidad dérmica en pacientes que reciben terapias contra el cáncer con inhibidores de EGFR. La FDA ha otorgado la designación Fast Track para esta indicación. El tratamiento aborda un efecto secundario significativo de las terapias EGFRi, comúnmente usadas en el cáncer de pulmón de células no pequeñas y cáncer colorrectal, donde los pacientes a menudo reducen o suspenden el tratamiento debido a reacciones cutáneas graves.
Azitra (NYSE: AZTR)는 ASCO 2025에서 EGFR 억제제 관련 발진 치료제인 ATR04-484의 1/2상 임상시험 결과를 포스터로 발표할 예정입니다. 발표는 2025년 5월 30일부터 6월 3일까지 시카고 맥코믹 플레이스에서 진행됩니다.
ATR04-484는 유전자 조작된 Staphylococcus epidermidis 균주를 이용한 생물 치료제로, EGFR 억제제 암 치료를 받는 환자의 피부 독성을 치료하기 위해 개발되었습니다. FDA는 이 적응증에 대해 신속 심사(Fast Track) 지정을 승인했습니다. 이 치료법은 비소세포폐암과 대장암 치료에 흔히 사용되는 EGFR 억제제 치료의 주요 부작용인 심각한 피부 반응으로 인해 환자들이 치료를 중단하거나 줄이는 문제를 해결합니다.
Azitra (NYSE: AZTR) a annoncé qu'elle présentera un poster lors de l'ASCO 2025 détaillant son essai clinique de phase 1/2 sur ATR04-484, un traitement contre l'éruption cutanée associée aux inhibiteurs de l'EGFR. La présentation aura lieu au McCormick Place, Chicago, du 30 mai au 3 juin 2025.
ATR04-484 est un produit biothérapeutique vivant utilisant une souche modifiée de Staphylococcus epidermidis, conçu pour traiter la toxicité cutanée chez les patients sous thérapies anticancéreuses par inhibiteurs de l'EGFR. La FDA a accordé la désignation Fast Track pour cette indication. Ce traitement cible un effet secondaire important des thérapies EGFRi, couramment utilisées dans le traitement du cancer du poumon non à petites cellules et du cancer colorectal, où les patients réduisent souvent ou arrêtent leur traitement en raison de réactions cutanées sévères.
Azitra (NYSE: AZTR) gab bekannt, dass es auf der ASCO 2025 ein Poster präsentieren wird, das seine Phase-1/2-Studie zu ATR04-484 vorstellt, einer Behandlung für durch EGFR-Inhibitoren verursachten Hautausschlag. Die Präsentation findet vom 30. Mai bis 3. Juni 2025 im McCormick Place in Chicago statt.
ATR04-484 ist ein lebendes biotherapeutisches Produkt, das einen gentechnisch veränderten Stamm von Staphylococcus epidermidis verwendet und zur Behandlung von Hauttoxizität bei Patienten entwickelt wurde, die EGFRi-Krebstherapien erhalten. Die FDA hat für diese Indikation die Fast-Track-Zulassung erteilt. Die Behandlung richtet sich gegen eine bedeutende Nebenwirkung der EGFRi-Therapien, die häufig bei der Behandlung von nicht-kleinzelligem Lungenkrebs und Darmkrebs eingesetzt werden, bei der Patienten aufgrund schwerer Hautreaktionen oft die Therapie reduzieren oder abbrechen.
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Insights
Azitra's upcoming ASCO presentation about its Phase 1/2 trial for EGFRi rash treatment shows promising pipeline progress but lacks efficacy data.
Azitra's announcement about presenting their ATR04-484 clinical trial at ASCO 2025 represents a modest step forward in the company's clinical development pipeline. The presentation will focus on their Phase 1/2 trial investigating a novel live biotherapeutic product for treating rashes caused by EGFR inhibitor cancer therapies - a common and problematic side effect that can lead patients to discontinue potentially life-saving cancer treatments.
The technology behind ATR04-484 is particularly innovative - it's a specially engineered strain of Staphylococcus epidermidis with genetic modifications for safety, including deletion of antibiotic resistance genes and engineered auxotrophy to control bacterial growth. This represents a novel approach to managing dermatologic toxicities associated with cancer therapies.
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The addressable market for this treatment could be substantial, as EGFRi therapies are widely used for multiple cancer types including non-small cell lung cancer and colorectal cancer. A successful treatment for the associated skin toxicities could improve patient quality of life and potentially lead to better adherence to cancer treatment regimens, addressing an unmet medical need in supportive cancer care.
The presentation titled, "Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound," will highlight Azitra's multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical trial investigating the safety and tolerability of ATR04-484 for the treatment of EGFRi-induced dermal toxicity in adult 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. Azitra has received Fast Track designation from the FDA for EGFRi-associated rash.
Multiple cancers, including non-small cell lung cancer (NSCLC) and colorectal cancer, are treated with EGFRi therapies that work by blocking the activity of the EGFR protein, which plays a crucial role in cell growth and survival. However, EGFRis are also associated with unique dermatologic toxicities that can hamper treatment efforts and cause significant physical and psychological discomfort for patients, leading some to reduce or even stop these effective treatments.
"We believe topical ATR04-484 has the potential to be an important advance in the treatment of EGFRi-associated skin rash, which is a painful and debilitating condition that often leads patients to suspend use of these life-saving cancer therapies," said Mary Spellman MD, CMO of Azitra. "As we prepare to dose the first patient in the Phase 1/2 clinical trial of ATR04-484, we are excited to present an overview of the study at ASCO 2025, which is the preeminent global oncology meeting. The product represents a unique and novel method for treating EGFRi-associated skin toxicities, and we look forward to presenting this technology to leaders in the cancer research community."
Details of the presentation are as follows:
Event: | 2025 American Society of Clinical Oncology Annual Meeting |
Location: | McCormick Place, |
Track: | Symptom Science and Palliative Care |
Poster Title: | Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound |
Presenter: | Mary Spellman, MD, Chief Medical Officer |
Poster Number | 162b |
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
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 (i) our provision of initial safety data and topline results for the phase 1b trial for our ATR-12, (ii) the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program and (iii), 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 experience delays in the provision of initial safety data and topline results for ATR-12 or, if we do, that such data may not be favorably received, 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 and our quarterly report on Form 10-Q filed on May13, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
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SOURCE Azitra, Inc.
FAQ
What is Azitra's ATR04-484 treatment and what is it designed to treat?
When and where will AZTR present their clinical trial results at ASCO 2025?
What phase is Azitra's ATR04-484 clinical trial currently in?
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