Pyxis Oncology, Inc. (NASDAQ:PYXS) announced on Thursday, a portfolio prioritization, focusing resources on advancing its lead clinical program, PYX-201.
Pyxis Oncology's second clinical program, PYX-106, is being deprioritized to allocate resources toward advancing the lead asset, PYX-201.
As a result, Pyxis Oncology has decided to suspend further clinical investment in PYX-106, which was in-licensed from Biosion Inc., with Biosion retaining rights for Greater China.
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In November, Pyxis Oncology reported preliminary data from the ongoing Phase 1 dose-escalation study of PYX-201, evaluating its safety and efficacy in multiple solid tumor types.
Among patients with HNSCC, PYX-201 achieved a confirmed 50% objective response rate (ORR), including one complete response and a disease control rate (DCR) of 100% in six heavily pretreated HPV-positive and HPV-negative evaluable patients with a median of four prior lines of therapy.
Across six solid tumor types of interest at therapeutically active dose levels, including HNSCC, ovarian, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC) and sarcoma, PYX-201 (n=31) achieved a 26% ORR in the Phase 1 trial, with dose-dependent responses observed.
The portfolio prioritization further supports a development plan for PYX-201 in several dose expansion studies, including monotherapy in 2/3L HNSCC, in combination with pembrolizumab in 1/2L+ HNSCC, and pembrolizumab combination studies in other solid tumors including HR+/HER2- and triple-negative breast cancer.
Preliminary data from these cohorts are expected in the second half of 2025 and the first half of 2026.
"Given the historical development challenges associated with anti-siglec-15 antibodies, we believe that the Street expectations were low heading into the initial data readout for PYX-106," said the William Blair analyst.
The company's current cash position is expected to fund its planned monotherapy and combination therapy trials of PYX-201 into the second half of 2026.
The analyst says it supports management's decision to stop investing in the program. While PYX-201 showed some activity, it likely won't significantly change head and neck cancer treatment.
PYXS Price Action: PYXS Oncology stock is up 1.30% at $1.56 at publication Friday.
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