Pyxis Oncology’s MICVO Shows Promise in Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma
Pyxis Oncology, a clinical-stage biotech company, recently announced preliminary data from a Phase 1 dose escalation trial of their novel therapy, MICVO (micvotabart pelidotin), for the treatment of recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC). The trial showed a confirmed 50% objective response rate by RECIST 1.1, a widely used measurement system for evaluating response to cancer treatment.
FDA’s Fast Track Designation
The promising results led the U.S. Food and Drug Administration (FDA) to grant MICVO Fast Track Designation for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy. This designation accelerates the development and review process for drugs that demonstrate the potential to address serious conditions and fill an unmet medical need.
Expansion Cohorts and Clinical Trial Collaboration
Pyxis Oncology has initiated monotherapy expansion cohorts for MICVO in 2L and 3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. Preliminary data from these studies is expected in the second half of 2025. Additionally, a collaboration agreement with Merck (known as MSD outside of the US and Canada) was recently announced to evaluate MICVO in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in 1/2L+ R/M HNSCC patients. Preliminary data from this study is expected in the second half of 2025.
Operational Initiatives
Pyxis Oncology has streamlined its organization and implemented operational initiatives to focus resources on the execution of the MICVO clinical program. This includes a workforce reduction of approximately 20%. The company’s CEO, Lara S., stated, “We are committed to the development of a novel therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma who will progress following platinum-based therapies and prior PD-(L)1 therapy, and those that progress after current and emerging EGFRi therapies.”
Impact on Patients and the World
For patients with R/M HNSCC, the current treatment landscape is limited, and there is a significant need for new and effective therapies. The preliminary data from the MICVO trial represents a potential breakthrough for these patients, offering hope for a more effective treatment option. If successful, the collaboration with Merck could expand the reach of MICVO to a larger patient population.
The success of MICVO could also have a broader impact on the world of oncology. The development of new and effective therapies for difficult-to-treat cancers is a critical area of research, and the collaboration between Pyxis Oncology and Merck is an example of the power of partnerships in driving innovation in this field.
Conclusion
Pyxis Oncology’s MICVO is showing promising results in the treatment of recurrent and metastatic head and neck squamous cell carcinoma, with a confirmed 50% objective response rate in a Phase 1 trial. The FDA’s Fast Track Designation and recent clinical collaborations with Merck further support the potential of MICVO as a novel and effective therapy for this patient population. The impact of these developments on individual patients and the wider oncology community could be significant, offering hope for more effective treatment options and driving innovation in the field.
- Pyxis Oncology reports positive preliminary data from Phase 1 trial of MICVO for R/M HNSCC
- FDA grants Fast Track Designation for MICVO for R/M HNSCC treatment
- Expansion cohorts initiated for MICVO in 2L and 3L R/M HNSCC patients
- Collaboration with Merck to evaluate MICVO in combination with KEYTRUDA®
- Operational initiatives to focus resources on MICVO clinical program
