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Pyxis Oncology Initiates New PYX-201 Combination Trial and Initiates Cohort Expansions of Ongoing Monotherapy Trial
- Initiation of Phase 1/2 combination trial with PYX-201, an extracellular ADC targeting Extradomain-B Fibronectin (EDB+FN) and Merck’s KEYTRUDA®
About this update from Pyxis Oncology, Inc.
[{"type":"text","content":"- Initiation of Phase 1/2 combination trial with PYX-201, an extracellular ADC targeting Extradomain-B Fibronectin (EDB+FN) and Merck’s KEYTRUDA® (pembrolizumab) in multiple solid tumors - Phase 1 monotherapy trial expanded to include cohorts in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) - Ongoing commitment to innovative cancer therapies for patients with limited treatment options BOSTON, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM), which is highly expressed in various tumor types. Two PYX-201 trials are now actively recruiting and are designed to evaluate PYX-201 as monotherapy in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) and PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. The combination trial is part of a recently announced Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada). The Phase 1/2 combination study, PYX-201-102, is now actively recruiting and is on track to initiate dosing patients in Q1 2025 as planned. This Pyxis Oncology sponsored trial is investigating the novel extracellular targeting ADC PYX-201 in combination with pembrolizumab in multiple indications including but not limited to: First-line (1L) and second line + (2L+) R/M HNSCCHormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2- BC) breast cancerAdvanced or metastatic triple-negative breast cancer (TNBC) \"PYX-201 is designed to specifically deliver its AUR-0101 payload within the tumor microenvironment (TME) and has been shown to induce immunogenic cell death. When combined with pembrolizumab, PYX-201 may have the potential to enhance the oncologic responses observed with pembrolizumab, by allowing activated T cells to infiltrate TMEs that are often inaccessible and inhospitable,\" said Lara S. Sullivan, M.D., President and Chief Exec...