(RTTNews) - Pyxis Oncology (PYXS), a clinical-stage biopharmaceutical company, announced on Wednesday that its lead drug candidate, PYX-201, has shown promising results in an ongoing Phase 1 clinical trial for solid tumors. PYX-201 is an antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a non-cellular component in the tumor extracellular matrix.
The Phase 1 trial, which includes patients with multiple solid tumor types, showed significant clinical responses in Head and Neck Squamous Cell Carcinoma (HNSCC). Among six evaluable HNSCC patients treated at doses ranging from 3.6 mg/kg to 5.4 mg/kg, the trial observed a 50% overall response rate (ORR), including one complete response (CR) and two partial responses (PR), based on RECIST 1.1 criteria.
The trial also demonstrated encouraging results across five additional solid tumor types: ovarian cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma, with dose-dependent responses.
The treatment was generally well tolerated, with a favorable safety profile and low incidence of severe treatment-related adverse events.
In addition, Pyxis Oncology announced that it has entered into a Clinical Trial Collaboration Agreement with Merck to evaluate the combination of PYX-201 with KEYTRUDA (pembrolizumab), Merck's anti-PD-1 immunotherapy, for patients with HNSCC, HR+/HER2- breast cancer, TNBC, and sarcoma. Dosing for these combination studies is scheduled to begin in the first quarter of 2025.
These promising Phase 1 results, along with the upcoming collaboration with Merck, highlight the potential of PYX-201 as a new treatment option for patients with challenging cancers.
PYXS closed Wednesday's trading at $3.82, down 8.17%. In premarket trading today, the stock is down by 40.83 % at $2.26.
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