On February 4, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported 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 (Press release, Pyxis Oncology, FEB 4, 2025, View Source [SID1234650030]).

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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:

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First-line (1L) and second line + (2L+) R/M HNSCC
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Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2- BC) breast cancer
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Advanced 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 Executive Officer of Pyxis Oncology. Dr. Sullivan continued, "Treatment options for many patients with advanced solid tumors remain limited, and we are eager to explore this promising therapeutic approach."

In addition, the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 PYX-201-101 study have begun enrolling patients. The expansion phase includes the following cohorts across sites in the US, EU and other countries:

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PYX-201 monotherapy for 2L and third line (3L) R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy
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PYX-201 monotherapy for 2L and 3L R/M HNSCC patients who have received prior EGFR and PD-1 inhibitor therapy

Pyxis Oncology is committed to delivering innovative therapies for cancer patients with limited treatment options. These ongoing trials represent a critical step forward in advancing PYX-201 as a potential breakthrough treatment for a broad range of cancers.

KEYTRUDAis a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About PYX-201-101 Clinical Study

PYX-201-101 (NCT05720117) is an ongoing Phase 1 dose escalation (Part 1) and dose expansion (Part 2) study evaluating PYX-201 monotherapy in participants with advanced solid tumors predicted to express EDB+FN, an extracellular matrix protein that is highly expressed in tumor stroma across several human cancer types.

About PYX-201-102 Clinical Study

PYX-201-102 (NCT06795412) is a Phase 1/2, open-label, global, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201 in combination with pembrolizumab in participants with advanced solid tumors. Patients with histologically or cytologically confirmed advanced solid tumors, including first-line (1L) R/M head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple-negative breast cancer (TNBC), hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) R/M HNSCC are eligible to enroll.

About PYX-201

PYX-201, an antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM), is the company’s lead clinical drug candidate.