Austin-based Genprex Inc., a biopharmaceutical company working to expand the cancer pharmaceuticals sector, enrolled the first patient in its Phase 1/2 clinical trial evaluating its own Oncoprex® in combination with Genetech’s Tarceva® (erlotinib) to treat patients with late-stage lung cancer.
The trial is being conducted at University of Texas MD Anderson Cancer Center and is intended to evaluate safety and efficacy of treatment.
Oncoprex, otherwise known as TUSC2 or FUS-1 nanoparticles, has shown synergistic anti-cancer activity when it is combined with kinase inhibitor drugs such as Tarceva, which acts on the epidermal growth factor receptor (EGFR) tyrosine kinase. It is itself a kinase inhibitor, but since TUSC2 is a pan-kinase inhibitor, its effects are more broad.
Research at MD Anderson showed that the combination of Oncoprex and erlotinib inactivates the EGFR signaling pathway, regardless of any resistance-granting mutations, to allow apoptosis of cancer cells.
These features become relevant when considering one goal of the trial, that is to determine the drug’s benefit for both patients without the EGFR activating mutation and patients with the EGFR activating mutation who failed to see a response to erlotinib treatment. Although erlotinib has helped many cancer patients, most patients will eventually become resistant to therapy and require another treatment for their aggressive cancer.
It is expected 57 patients will enroll in the trial. Phase 1 is evaluating the maximum tolerated dose of Oncoprex, which is defined as the dose at which fewer than two patients experience dose-limiting toxicity. Forty patients in the highest dose cohort will progress to phase 2.
Phase 2 is evaluating the ability of the drug combination to benefit patients with stage IV lung cancer, and its outcome measure will use Response Evaluation Criteria in Solid Tumors (RECIST).
Full results of the trials are expected in 2018.
According to a news release from Genprex, the outlook for Oncoprex’s safety profile is positive. Previously, when 32 late-stage lung cancer patients were treated with intravenous Oncoprex alone, no immunological response was seen. The nanoparticles traveled throughout patients’ bodies undetected and specifically targeted cancer cells in both primary and metastatic tumors. What’s more, a positive tumor response was seen, which boosts the efficacy profile of Oncoprex, as well.