Pyxis Oncology, Inc. engages in the business of developing a multi-modality portfolio of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients. The firm focuses on the development of product candidates to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. The company was founded by David Steinberg, Shaan C. Gandhi, and John L. Flavin on June 11, 2018 and is headquartered in Boston, MA.
Clinical Trials
7
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2019
Active, not recruiting
2
28.6%
Recruiting
5
71.4%
No approval data available
- Pyxis Oncology reported updated Phase 1 data for micvotabart pelidotin (MICVO) in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma. - In 33 efficacy-evaluable patients dosed at 5.4 mg/kg with a dose cap, MICVO achieved a 36% confirmed objective response rate and 94% disease control rate. - Median progression-free survival reached 6.2 months with a 79% 12-month overall survival probability, and no new safety signals were observed in 35 safety-evaluable patients. - The company plans to initiate the pivotal Phase 3 Headliner trial in mid-2027 after FDA and EMA alignment on dose selection and study design.
- Pyxis Oncology has appointed Thomas Civik, a seasoned biotechnology executive with extensive oncology experience, as Interim CEO following the departure of Dr. Lara Sullivan. - The leadership transition aims to maintain continuity for the company's lead program MICVO, a first-in-concept antibody-drug conjugate targeting head and neck squamous cell carcinoma. - MICVO continues advancing through Phase 1 clinical studies as both monotherapy and in combination with pembrolizumab, having received FDA Fast Track Designation. - Civik brings proven experience from leading Five Prime Therapeutics through its $1.9 billion acquisition by Amgen and 17 years at Genentech overseeing major oncology therapies.
- Pyxis Oncology announced positive preliminary Phase 1 data for micvotabart pelidotin (MICVO), showing a 46% objective response rate as monotherapy in heavily pretreated recurrent/metastatic head and neck squamous cell carcinoma patients. - The novel antibody-drug conjugate demonstrated even stronger efficacy when combined with pembrolizumab, achieving a 71% response rate and 100% disease control rate in first and second-line patients. - MICVO targets extradomain-B of fibronectin in the tumor extracellular matrix and has received FDA Fast Track Designation, with pivotal study plans expected in 2026.
- Pyxis Oncology will present translational data for micvotabart pelidotin (MICVO), a first-in-concept extracellular-cleaving ADC targeting extradomain-B of fibronectin, at ESMO 2025 and AACR-NCI-EORTC conferences. - MICVO demonstrates a unique three-pronged mechanism of action including direct tumor cell killing, bystander effect, and immunogenic cell death, distinguishing it from traditional cell surface targeting ADCs. - Clinical data from 37 samples showed reduction in circulating tumor DNA tumor fraction after MICVO treatment, particularly in head and neck squamous cell carcinoma at the 5.4 mg/kg dose. - The drug's non-cellular targeting strategy enables tumor microenvironment remodeling and immune activation, supporting its potential as both monotherapy and in combination with anti-PD1 therapy.
- Crescent Biopharma has appointed Jan Pinkas, Ph.D., as chief scientific officer, bringing over two decades of oncology drug development experience including expertise in antibody-drug conjugates. - The company expects to begin dosing patients in a global Phase 1 trial of CR-001, a PD-1 x VEGF bispecific antibody, in early 2026. - Crescent anticipates submitting an IND application for CR-002, a novel antibody-drug conjugate, in mid-2026. - Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology and contributed to the development of ELAHERE, an approved ADC for platinum-resistant ovarian 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 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.
- 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.
