Pyxis Oncology Announces FDA Clearance of Two IND Applications
FDA grants IND clearances of PYX-201, a novel antibody-drug conjugate (ADC) product candidate, and PYX-106, an immunotherapy product candidate
Phase 1 clinical trials of PYX-201 and PYX-106 will evaluate the safety and anti-tumor activity in patients with select solid tumors
Dual IND clearances represent achievement of significant 2022 milestones and executional pipeline advancement
Cash runway extended into first half 2025
“We are thrilled to receive two nearly simultaneous IND clearances from the FDA, representing a major moment as we transition to a clinical stage company demonstrating the operational prowess of our team,” said
The first-in-human trial of PYX-201 will be a dose escalation trial to determine the recommended phase 2 dose. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with solid tumors known to have significant expression of EDB of fibronectin.
The first-in-human trial of PYX-106 will be a dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with tumors known to have significant infiltration of M2 macrophages and expression of Siglec-15 in order to determine the recommended phase 2 dose.
PYX-201 is a non-internalizing ADC product candidate that binds to extradomain-B (EDB) fibronectin, an integral component of the extracellular matrix in the tumor that is overexpressed in many malignancies and is minimally expressed in most normal adult tissues. As shown in patient-derived xenograft (PDX) model studies of NSCLC and pancreatic cancer, its highly cell-permeable auristatin payload is enzymatically released after binding, which directly attacks cancer cells and other components that form the supportive tumor infrastructure. Auristatin elicits an antitumor immune response by inducing immunogenic cell death and dendritic cell maturation. While its effects are primarily due to its non-internalizing activity, a fraction of PYX-201 may also be internalized, further enhancing its antitumor activity.
PYX-106 is an immunotherapy product candidate in development that blocks the activity of Siglec-15, an emerging immune suppressor expressed across a broad range of tumors. Siglec-15 expression does not overlap with one of the most common targets in immuno-oncology, PD-1, supporting its potential use alone and in combination with current immunotherapies. PYX-106 may benefit patients who do not respond to current standards of care. In preclinical studies, PYX-106 has demonstrated broad immune activation, strong binding affinity, and a 7-day half-life. Cumulatively, these advantages may translate to superior anticancer activity and more flexible dosing regimens.
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Source: Pyxis Oncology