On May 28, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that it will present a poster describing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2025) being held May 30-June 3, 2025 in Chicago (Press release, Azitra, MAY 28, 2025, View Source [SID1234653429]).
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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 (Free ASCO Whitepaper) 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 (ASCO) (Free ASCO Whitepaper) Annual Meeting
Location:
McCormick Place, Chicago, IL
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