Pyxis Oncology Advances PYX-106 and PYX-201 Clinical Programs

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First subject dosed in Phase 1 trial of PYX-106, a fully human immunotherapy antibody candidate
Second dose level initiated in Phase 1 trial of PYX-201, an antibody-drug conjugate (ADC) candidate
Preliminary data from both trials on track for late-2023/early-2024 timeframe
Company to present and host investor meetings at Jefferies Healthcare Conference in NYC on June 7, 2023
Pyxis Oncology, Inc.(Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today announced dosing of the first subject in the Phase 1 trial of PYX-106. PYX-106 is a fully human immunotherapy antibody candidate that is designed to block the activity of Siglec-15, an immune suppressor expressed across a broad range of tumors. The Company also announced that the second dose level has been initiated in the ongoing Phase 1 trial of PYX-201, a novel antibody-drug conjugate (ADC) product candidate licensed from Pfizer targeting extradomain-B (EDB) of fibronectin, a non-internalizing antigen that is an integral component of the extracellular matrix in tumors.
“We are excited to announce dosing of the first subject in the Phase 1 trial of PYX-106 and we are enthusiastic about the potential PYX-106 may hold for patients, particularly those not well served by currently available immunotherapies,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “We expect to see preliminary data from each of our ongoing Phase 1 trials of PYX-106 and PYX-201, including biomarker results and potential early signs of clinical activity, in the late-2023 to early-2024 timeframe.”
Webcast Presentation at Jefferies Healthcare Conference, June 7, 2023
Pyxis Oncology will present a corporate overview at the Jefferies Healthcare Conference at 4:00 pm ET on June 7, 2023. Lara S. Sullivan, M.D., President and Chief Executive Officer, and Pyxis Oncology management team members will be available during the conference for one-on-one meetings with investors. A live webcast of the presentation can be accessed on the Investors section of the Pyxis Oncology website at ir.pyxisoncology.com. Following the live event, a replay of the webcast will be archived for up to 90 days.
About PYX-106-101
PYX-106-101 (NCT05718557) is an open-label, multicenter, Phase 1 dose escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-106 in patients with advanced solid tumors in order to determine the recommended dose(s) for future study. Patients with relapsed or refractory solid tumors known to have significant infiltration of M2 macrophages and expression of Siglec-15, including non-small cell lung cancer, breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and head and neck squamous cell carcinoma, are eligible to enroll.
About PYX-201-101
PYX-201-101 (NCT05720117) is an open-label, multicenter, Phase 1 dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. Patients with relapsed or refractory solid tumors known to have significant expression of EDB of fibronectin, including with relapsed or refractory solid tumors, 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 are eligible to enroll.
About PYX-106
PYX-106 is a fully human immunotherapy antibody 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.
About PYX-201
PYX-201 is a novel antibody-drug conjugate (ADC) product candidate licensed from Pfizer targeting extradomain-B (EDB) of fibronectin, a non-internalizing antigen, that is an integral component of the extracellular matrix in tumors. EDB fibronectin is overexpressed in many solid tumors and minimally expressed in most normal adult tissues.
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next-generation therapeutics that hold the potential for mono and combination therapies. Pyxis Oncology’s therapeutic candidates are designed to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Pyxis Oncology’s antibody-drug conjugates (ADCs) and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care. To learn more, visit www.pyxisoncology.com or follow us on Twitter and LinkedIn.
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