FDA accepts ApeX Therapeutics’ IND for clinical testing of APX3330 in pancreatic cancer

Apex’s lead drug candidate APX3330 is a small molecule that targets the redox effector factor-1 (Ref-1) protein which regulates the activation of oncogenic transcription factors.

The first part of the phase 1 trial will identify the maximum tolerated dose of APX3330 in several cancer patients with solid tumors refractory to existing treatments.

After the establishment of the maximum tolerated dose, the drug will be assessed in a cohort of patients with pancreatic ductal adenocarcinoma (PDAC), refractory to existing treatments.

The drug has been demonstrated in multiple in vitro and in vivo models of pancreatic cancer to be effective in reducing tumor growth and metastases as a single agent.

In addition, APX3330 in combination with a standard dose of gemcitabine showed significant decreases in tumor volume compared to treatment by the respective drugs as single-agents.

ApeX Therapeutics scientific founder Mark Kelley said: "We are very excited to have reached this very important milestone to evaluate APX3330 in patients with pancreatic cancer. We are now poised to initiate the study in the coming months."

PDAC is the fourth leading cause of cancer-associated death in the US and is one of the few cancers for which survival has not enhanced for about 40 years.