Clinical Trials

NAP with Durvalumab

NeoTX is currently conducting a phase 1b clinical trial that is primarily aimed at determining the safety of NAP (naptumomab estafenatox) in combination with checkpoint inhibitors.

Checkpoint inhibitors (CPI) by themselves are not effective for many patients with advanced or metastatic cancers primarily due to a lack of tumor recognition by the immune system. NAP, the lead candidate of our tumor targeted superantigen (TTS) technology, works by binding bacterial components to the tumor surface which enhances the recognition of the tumor by the immune system. The drug elicits a natural antibacterial response directed against the tumor. NAP has demonstrated synergistic effects in combination with durvalumab in pre-clinical settings. For more information on TTS technology, please watch this video.

In this phase 1 b study conducted in collaboration with AstraZeneca (AZ), patients with recurrent solid tumors are treated with a combination of NAP and AZ’s checkpoint inhibitor, IMFINZI® (durvalumab).

The trial is currently enrolling at three locations in Israel: Sheba Medical Center, Tel Aviv Sourasky Medical Center and Rabin Medical Center. For additional study details, please visit https://clinicaltrials.gov/ct2/show/NCT04880863

NAP in Combination with Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

NeoTX is currently conducting a phase 2 clinical trial in patients with progressive NSCLC. The trial is primarily aimed at determining the efficacy of naptumomab estafenatox (NAP) in combination with docetaxel (Taxotere®).

NAP, the lead candidate of our tumor targeted superantigen (TTS) technology, works by binding bacterial components to the tumor surface which enhances the recognition of the tumor by the immune system. The drug elicits a natural antibacterial response directed against the tumor.  For more information on TTS technology, please watch this video. Docetaxel is a widely used cytotoxic chemotherapeutic agent and is a standard of care (SOC) for NSCLC.

The safety of NAP in combination with docetaxel has been previously shown in a small phase 1 trial involving patients with NSCLC. In that trial, one patient had a markedly prolonged survival which would not have been expected with docetaxel alone. In the current phase 2 trial, NeoTX is further exploring the potential of the combination of NAP and docetaxel for the treatment of patients with NSCLC which is not responding or no longer responding to checkpoint inhibitor therapy.

This trial is currently enrolling patients at locations throughout the US. For additional study details, please visit https://clinicaltrials.gov/ct2/show/NCT04880863