PYX-201
- Generic Name
- PYX-201
- Drug Type
- Biotech
- Background
PYX-201 is an antibody-drug conjugate directed against the extra domain-B splice variant of fibronectin.
FDA Grants Fast Track Status to Pyxis Oncology's PYX-201 for Advanced Head and Neck Cancer
• Pyxis Oncology's novel antibody-drug conjugate PYX-201, targeting Extradomain-B Fibronectin, receives FDA Fast Track Designation for treating recurrent or metastatic head and neck squamous cell carcinoma.
• The designation addresses a critical unmet need in head and neck cancer treatment, particularly for patients who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy.
• Two clinical trials are currently recruiting patients: a monotherapy study and a combination trial with Merck's KEYTRUDA, highlighting the drug's potential in multiple treatment approaches.
Pyxis Oncology Expands PYX-201 Clinical Program with New Combination Trial and Monotherapy Cohorts
• Pyxis Oncology launches Phase 1/2 trial evaluating PYX-201 in combination with pembrolizumab across multiple advanced solid tumors, including HNSCC, TNBC, and gastric cancer.
• The company initiates expansion cohorts in its ongoing Phase 1 PYX-201 monotherapy trial, focusing on second and third-line HNSCC patients with prior platinum and PD-1 inhibitor treatment.
• PYX-201, an antibody-drug conjugate targeting EDB+FN in the tumor microenvironment, represents a novel approach to treating difficult-to-treat cancers.
Akeso's Gumokimab (IL-17 mAb) Application Accepted for Psoriasis Treatment in China
• Akeso's gumokimab, an IL-17 targeting monoclonal antibody, has its NDA accepted by China's NMPA for treating moderate to severe plaque psoriasis.
• Clinical trials showed gumokimab's rapid efficacy, with PASI 75 response rates approaching 96% at week 12 and sustained improvement over 52 weeks.
• Safety profiles of gumokimab were comparable to placebo, indicating good tolerability, which addresses the need for safer psoriasis treatments.
• Akeso aims to meet diverse patient needs by combining gumokimab with other drugs like ebronucimab, enhancing their autoimmune disease product synergy.
Cytokinetics and Pyxis Oncology Announce Key Milestones for 2025; CytomX Prioritizes Pipeline
• Cytokinetics anticipates a pivotal year in 2025, focusing on the potential FDA approval and commercial launch of aficamten for obstructive hypertrophic cardiomyopathy (HCM) in the U.S.
• Pyxis Oncology is prioritizing the advancement of PYX-201, a novel antibody-drug conjugate (ADC), with data readouts expected in the second half of 2025 and the first half of 2026.
• CytomX Therapeutics is focusing on its lead program, CX-2051, an EpCAM-targeting PROBODY ADC for advanced metastatic colorectal cancer, with initial Phase 1a data expected in 1H 2025.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
Drug Development Updates
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