Pyxis Oncology reported third-quarter 2026 results and outlined the next steps for micvotabart pelidotin, or MICVO, its experimental cancer drug. The company is preparing a pivotal Phase 3 trial in previously treated recurrent or metastatic head and neck cancer, while planning further updates on MICVO alone and in combination with pembrolizumab.
The company said its cash at the end of September, together with net proceeds from an October public offering, is expected to fund operations into the first half of 2028.
MICVO development plans
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Pyxis plans to start a global Phase 3 trial in mid-2027, after aligning with the FDA and European Medicines Agency on the study’s design. FDA feedback on dose selection is expected in the first quarter of 2027, following an End-of-Phase 2 meeting.
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The planned trial will test MICVO alone in about 500 patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after both platinum-based chemotherapy and anti-PD-1 treatment. Patients will be assigned equally to MICVO or to a physician’s choice of cetuximab, docetaxel or methotrexate.
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The study’s two primary measures will be overall response rate and overall survival. Updated overall-survival data from the ongoing MICVO monotherapy study are expected in the first half of 2027.
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Pyxis plans a corporate update in December 2026 covering its MICVO strategy in recurrent or metastatic head and neck cancer, including updated efficacy and safety results from the first-line study combining MICVO with pembrolizumab, sold as Keytruda.
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Further results from that combination study, including initial data on how long responses last to help guide selection of a Phase 3 dose, are expected in the second half of 2027.
Monotherapy results and presentations
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The company reiterated updated results from its Phase 1 monotherapy study, based on data through August 18, 2026. Among 33 efficacy-evaluable patients receiving MICVO at 5.4 mg/kg every three weeks, 12 had a confirmed response, for an objective response rate of 36%. Disease control was reported in 31 of 33 patients.
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Responses were often evident early: 75% of responders had responded by the first scan at six weeks, and 83% of responders had tumor reductions greater than 50%.
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Median progression-free survival was 6.2 months. The estimated probability of being alive at 12 months was 79%; median overall survival had not yet been reached. The company said activity was seen across HPV-status and prior-treatment groups.
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Among 35 patients assessed for safety, Pyxis reported no new safety signals. It said dose capping reduced the frequency and severity of adverse events among patients with higher body weight.
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Pyxis plans to present MICVO monotherapy results in a late-breaking oral presentation at the EORTC-NCI-AACR Symposium in November 2026, alongside two posters on preclinical findings.
What changes for investors
The announcement sets out a development timetable rather than reporting a new pivotal-trial start: the Phase 3 study remains planned for mid-2027, with FDA dose feedback still pending. The proposed trial would compare MICVO directly with three established treatment options in patients who have already received chemotherapy and anti-PD-1 therapy. Pyxis also says its cash position, including October offering proceeds, is expected to support operations into the first half of 2028.