Pyxis Oncology disclosed preliminary Phase 1 data for its lead antibody‑drug conjugate, MICVO, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The data, released on December 18 2025, show encouraging response rates that could accelerate the drug’s regulatory path and attract strategic partners.
In the monotherapy cohort, 18 patients were treated at a 5.4 mg/kg dose, with 13 evaluable for response. The confirmed objective response rate (ORR) was 46 % and the disease‑control rate (DCR) was 92 %. One patient achieved a complete response and two achieved partial responses, providing the first clinical evidence of efficacy for MICVO.
The combination arm, which paired MICVO with Merck’s KEYTRUDA (pembrolizumab), enrolled seven patients at 3.6 mg/kg and 4.4 mg/kg. The confirmed ORR in this group was 71 % and the DCR was 100 %, indicating a stronger signal when MICVO is combined with checkpoint inhibition.
These results support Pyxis’s strategy to pursue a pivotal study and seek regulatory approval. MICVO has Fast Track designation from the FDA for R/M HNSCC patients who have progressed after platinum‑based chemotherapy and anti‑PD‑(L)1 therapy, a status that can expedite review. The company also recently sold royalty rights for its Enzeshu program, adding $11 million to its cash runway and reducing near‑term financing pressure.
Lara S. Sullivan, President, CEO, and Chief Medical Officer, said the data “are highly encouraging” and that the combination results “add to the growing evidence supporting MICVO’s therapeutic potential.” She emphasized that the findings “highlight MICVO’s agility as a novel treatment option across the R/M HNSCC landscape.”
Analysts at Stephens and Guggenheim have raised their price targets for Pyxis, citing the robust clinical data and the company’s extended cash runway. The upgrades reflect confidence that MICVO’s early efficacy signals will translate into a viable product and that the company can secure additional funding or a partnership to advance the program.
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