1. MICVO shows promising 46% ORR and 92% DCR in monotherapy for R/M HNSCC. 2. Combination with KEYTRUDA® yields 71% ORR and 100% DCR in R/M HNSCC. 3. Upcoming data updates expected in mid-2026 could influence treatment landscapes. 4. Non-dilutive funding of $11 million supports ongoing MICVO development. 5. Company has FDA support for pivotal study, highlighting potential market impact.
FAQ
Why Bullish?
The promising preliminary results and FDA alignment on the pivotal study present strong evidence supporting MICVO's potential as a viable therapeutic option, reminiscent of historical instances where similar studies led to significant stock rallies upon positive results.
How important is it?
The combination of strong clinical data and financial backing implies a high probability of positively influencing stock performance as the company progresses towards market approval.
Why Long Term?
The upcoming data in mid-2026 and potential pivotal studies may enhance validation and market position of MICVO, aligning with historical trends where successful trial outcomes led to sustained stock appreciation over longer periods.
Pyxis Oncology Releases Positive Preliminary Phase 1 Data for Micvotabart Pelidotin (MICVO) in Recurrent/Metastatic Head and Neck Cancer
Date: December 18, 2025 | Source: GlobeNewsWire
Overview of Preliminary Data
BOSTON, December 18, 2025 – Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for challenging cancers, today announced encouraging preliminary data from ongoing Phase 1 clinical trials. These trials are assessing the efficacy of micvotabart pelidotin (MICVO), a first-in-class antibody-drug conjugate (ADC) that targets the extradomain-B of fibronectin (EDB+FN), a crucial component of the tumor extracellular matrix (ECM), in patients suffering from recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Notable Findings from the Studies
The recent data showcases results from two sets of studies: the monotherapy group and the combination therapy with pembrolizumab. Key findings include:
- Monotherapy: A confirmed objective response rate (ORR) of 46% and a disease control rate (DCR) of 92% were observed with MICVO administered at a dosage of 5.4 mg/kg.
- Combination Therapy: When MICVO was combined with Merck’s KEYTRUDA® (pembrolizumab), the treatment yielded a confirmed ORR of 71% and a remarkable DCR of 100% at dosages of 3.6 mg/kg and 4.4 mg/kg.
These studies are pivotal as they signify a significant step forward in providing potential treatment options for patients with R/M HNSCC, a group with limited therapeutic choices.
Statements from Key Officials
“The preliminary data for MICVO as both monotherapy and in combination with pembrolizumab bolsters the evidence supporting its potential as a treatment option for R/M HNSCC,” stated Dr. Lara S. Sullivan, President and CEO of Pyxis Oncology. “The promising response rates and disease control rate observed give confidence in MICVO's durability as we progress with our clinical development.”
Dr. Glenn J. Hanna, director at Dana-Farber Cancer Institute, commented on the significance of these findings: “Observing a novel mechanism demonstrating such compelling benefit-risk profiles offers fresh hope in a treatment landscape that has, until now, provided limited options for R/M HNSCC patients.”
Clinical Study Details
Monotherapy Study
The ongoing Phase 1 monotherapy study consists of two parts:
- Part 1: Dose escalation across various doses and tumor types, initially reported in November 2024.
- Part 2: A dose expansion cohort using a fixed dose of 5.4 mg/kg in 2L+ R/M HNSCC.
Key statistics from the monotherapy group (with a cutoff date of November 3, 2025) include:
- 18 patients treated at 5.4 mg/kg via intravenous administration (IV) every three weeks.
- 13 patients were evaluable for response, with an overall confirmed response rate of 46%.
- A high DCR of 92% was achieved with significant tumor regression observed.
Combination Study
Data from the Phase 1/2 study investigating MICVO in combination with KEYTRUDA® includes:
- 7 patients treated, with confirmed responses across varying PD(L)-1 CPS scores.
- A confirmed ORR of 71% and a DCR of 100%, demonstrating significant tumor regression in all patients treated.
Future Steps for Pyxis Oncology
Looking ahead, Pyxis Oncology intends to present updated data from the ongoing Phase 1 monotherapy study in 2L+ R/M HNSCC by mid-2026. Additionally, further insights from the Phase 1/2 combination study, which encompasses data across multiple tumor types, are expected in the second half of 2026.