Pyxis Oncology Announces Dosing of First Subject in Phase 1 Trial of PYX-201, a Novel ADC for Solid Tumors
Milestone marks transition of
Preliminary data anticipated in early 2024
“PYX-201 has the potential to offer a new approach to targeting multiple tumor types via a multipronged mechanism of action that may benefit patients with solid tumors. We expect to see preliminary data from this study, including biomarker results and potential early signs of clinical activity, in early 2024,” said
The Phase 1 trial, referred to as PYX-201-101, is an open-label, multicenter, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PYX-201 and identify recommended doses for further study. Patients with relapsed or refractory solid tumors, including non-small cell lung cancer (NSCLC), hormone receptor-positive breast cancer, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma, soft tissue sarcoma, hepatocellular carcinoma or kidney cancer are eligible to enroll.
About the Flexible Antibody Conjugation Technology (FACT) Platform
The FACT platform, licensed from Pfizer, Inc. in 2021, is designed to facilitate creation of next-generation ADCs like PYX-201 that have the potential for improved anti-tumor activity, safety and tolerability. Compared to traditional ADC approaches, the FACT platform is based upon technical improvements to allow site-specific payload conjugation, linker stability and payload potency.
PYX-201-101 (NCT05720117) is an open-label, multicenter, Phase 1 dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. Patients with relapsed or refractory solid tumors known to have significant expression of EDB of fibronectin, including with relapsed or refractory solid tumors, including non-small cell lung cancer, hormone receptor positive breast cancer, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma, soft tissue sarcoma, hepatocellular carcinoma or kidney cancer are eligible to enroll.
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Source: Pyxis Oncology