Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage research and development company focused on developing cancer treatments of the future, has announced the successful dosing of the first subject in a Phase 1 trial of its groundbreaking PYX-201. This novel antibody-drug conjugate, licensed from Pfizer, targets the extradomain-B (EDB) of fibronectin, a non-internalizing antigen found in the extracellular matrix of tumors. Overexpression of EDB fibronectin is common in solid tumors and is rarely seen in normal adult tissues. Pyxis Oncology anticipates the first results of this trial to be available in early 2024.
Pyxis Oncology is proud to announce the initiation of dosing in its first clinical trial for PYX-201, a promising new approach to targeting multiple tumor types with a multipronged mechanism of action that may benefit patients with solid tumors. Initial biomarker results and potential early signs of clinical activity are expected to be seen in early 2024, marking a significant achievement and important milestone for the transition of Pyxis Oncology to a clinical-stage company.
Dr. Alexander Spira, Director of NEXT Oncology Virginia, Co-Director of the VCS Research Institute, and Director of the Thoracic and Phase I Program at Johns Hopkins University, is thrilled about the potential of PYX-201. Designed to offer several key safety and efficacy advantages over traditional ADCs, this novel therapeutic is set to be evaluated in a Phase 1 study — an opportunity that Dr. Spira is eager to explore.
PYX-201-101 is an exciting new Phase 1 trial testing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PYX-201. Patients with relapsed or refractory solid tumors, such as non-small cell lung cancer (NSCLC), hormone receptor-positive breast cancer, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma, soft tissue sarcoma, hepatocellular carcinoma or kidney cancer, are invited to take part in this open-label, multicenter study to help identify the best dose for further study. Join us in this ground-breaking investigation and help us find a better treatment for these challenging diseases.
Dr. Jay Feingold, Chief Medical Officer of Pyxis Oncology, believes that Antibody-Drug Conjugates (ADCs) are essential weapons in the fight against cancer, and that further research into ADCs could provide hope to those suffering from solid tumor types with a large unmet medical need.
Dr. Jan Pinkas, Chief Scientific Officer of Pyxis Oncology, has highlighted the unique qualities of PYX-201. Unlike traditional ADCs, PYX-201 has the ability to target tumors regardless of their cell surface marker expression due to its three distinct mechanisms. By binding to EDB fibronectin in the tumor stroma, PYX-201 releases a potent payload that diffuses across tumor cell membranes and surrounding supportive tumor infrastructures. It also has a bystander effect, as the payload is recycled and re-released, directly killing adjacent tumor cells. Furthermore, PYX-201 has been shown to stimulate anti-tumor immunogenic activity by promoting dendritic cell maturation and inducing immunogenic cell death, opening up the possibility of combination-based approaches with immuno-oncology products.
About the Flexible Antibody Conjugation Technology (FACT) Platform
The FACT platform, licensed from Pfizer, Inc. in 2021, is designed to revolutionize the development of next-generation ADCs such as PYX-201. This ground-breaking technology promises to provide improved anti-tumor activity, safety and tolerability compared to traditional ADC approaches. These improvements are made possible through site-specific payload conjugation, linker stability, and payload potency – allowing for a more effective and reliable approach to fighting cancer.
About PYX-201-101
PYX-201-101 (NCT05720117) is a groundbreaking, open-label, multicenter, Phase 1 clinical trial that seeks to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the novel therapy, PYX-201. This trial provides a unique opportunity for those who have been diagnosed with relapsed or refractory solid tumors that have significant expression of EDB of fibronectin, including non-small cell lung cancer, hormone receptor positive breast cancer, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma, soft tissue sarcoma, hepatocellular carcinoma or kidney cancer. Don’t miss out on this opportunity to be part of something revolutionary!
About Pyxis Oncology, Inc.
Pyxis Oncology is on a mission to defeat difficult-to-treat cancers, with a focus on developing next-generation therapeutics that can be used as mono and combination therapies. From antibody-drug conjugates (ADCs) to immuno-oncology (IO) programs, the company is driving innovation in cancer treatments that can directly kill tumor cells and address the underlying issues that cause uncontrollable proliferation and immune evasion. With the potential to revolutionize cancer treatment, Pyxis Oncology is leading the charge in the fight against cancer.