- Pyxis Oncology's lead asset, **Nykbo**, an extracellular targeting ADC, is in clinical trials for both monotherapy and combo therapy with pembro, primarily focused on head and neck cancer.  **[1782223_tx_378150_0]** 
- In Phase 1, Part 1 data read out last November (**November 2024**), Nykbo demonstrated a confirmed ORR of **fifty percent** and a **one hundred percent** disease control rate in **six head and neck patients** at the **3.6 to 5.4 dose range**.  **[1782223_tx_378150_0]** **[1782223_tx_378150_1]**  Responses were observed in patients resistant to prior treatments and in both HPV positive and negative patients.  **[1782223_tx_378150_1]** 
- The company expects to release monotherapy data for PD-1 and platinum resistant patients and preliminary combo data with KEYTRUDA in the **second half of 2025**.  **[1782223_tx_378150_5]**  Monotherapy data for EGFR and PD-1 resistant patients is anticipated in the **first half of 2026**.  **[1782223_tx_378150_5]** 
- Pyxis Oncology aims for a **37%** or higher ORR for the platinum and PD-1 resistant monotherapy cohort, and **20-30%** for the EGFR resistant monotherapy cohort.  **[1782223_tx_378150_6]**  For the combo therapy with pembro, the target ORR is **65%**.  **[1782223_tx_378150_7]** 
- Nykbo's safety profile from Phase 1, Part 1 was comparable to or better than approved ADCs across various adverse events, including neuropathy, neutropenia, and ocular toxicity.  **[1782223_tx_378150_4]**

Pyxis Oncology (PYXS)