Skip to main content
Premium Trial:

Request an Annual Quote

Pyxis Oncology Gets FDA Permission to Start Phase I Trials of Anti-EDB Drug, Immunotherapy

NEW YORK – Pyxis Oncology on Thursday said the US Food and Drug Administration has cleared two investigational new drug applications, which allows the firm to begin Phase I trials of the anti-extradomain-B (EDB) fibronectin therapy candidate PYX-201 and the immunotherapy PYX-106.

The Phase I study of PYX-201 will involve patients with solid tumors— specifically breast, head and neck, lung, and thyroid cancers — with significant expression of EDB-FN, an alternatively spliced isoform of fibronectin. The dose-escalation trial will determine the recommended Phase II dose and evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the drug.

In March 2021, Pyxis licensed PYX-201 from Pfizer, along with another DNA damaging agent, PYX-203, and an antibody-drug conjugate development platform.

Meanwhile, the Phase I trial of PYX-106 is also a dose-escalation study to evaluate safety and preliminary efficacy of that drug. The trial will enroll patients with tumors that have significant infiltration of M2 macrophages and expression of Siglec-15, including bladder, cholangiocarcinoma, colorectal, and kidney cancer.

Pyxis Chief Medical Officer Jay Feingold said in a statement that Siglec-15, the target of PYX-106, has little overlap with the most common immunotherapy targets, PD-1 or PD-L1. "The antibody's strong activity and its target's unique expression suggest that PYX-106 could be valuable in both mono and combination treatment settings for a broad range of tumors," Feingold said.

The Cambridge, Massachusetts-based Pyxis expects to start the first-in-human trials for PYX-201 and PYX-106 in early 2023. Pyxis CEO Lara Sullivan also said in a statement that the firm has enough cash to fund operations into the first half of 2025. Last year, Pyxis went public with a $168 million initial public offering.