Ideas & Technologies

Genprex’s 21st Century Gene Therapies for Cancer

Genprex is a clinical-stage biopharmaceutical company developing targeted molecular therapies for cancer.

The company is developing molecular therapies that control universal cancer pathways to unlock the unrealized potential of targeted cancer therapies, such as tyrosine kinase inhibitory drugs (TKIs).

Genprex’s tumor suppression technologies are pan-kinase inhibitors that work to induce apoptosis (programmed cell death) in cancer cells and to control cell signaling and inflammatory pathways to treat cancer at the molecular level. Their discoveries and R&D programs have been the subject of more than 30 peer-reviewed publications and have been supported by corporate investment and grants from the NIH, SBIR, U.S. Department of Treasury, and State of Texas. The company now controls a portfolio of 30 issued and 6 pending patents covering tumor suppressors, therapeutics, diagnostics, nanovesicle delivery systems, and manufacturing processes.

Oncoprex, the company’s lead, is a biologic therapy targeting key oncogenic pathways to treat tumors and cancer metastases at the molecular level. The active anti-cancer agent in Oncoprex is TUSC2, also known as FUS1, which is incorporated into nanovesicles and formulated for intravenous administration. TUSC2 was originally discovered as a tumor suppressor and was subsequently confirmed as a powerful pan-kinase inhibitor.

Oncoprex has been evaluated as a single agent in a phase I clinical trial in Stage IV lung cancer patients at the University of Texas MD Anderson Cancer Center (UTMDACC). This study established the phase II dosage and demonstrated that Oncoprex was well tolerated. Tumor regressions were observed in primary lung tumors and metastatic cancers in liver, pancreas, and lymph nodes. Analyses of pre and post-treatment patient biopsies demonstrated that intravenous Oncoprex monotherapy selectively and preferentially targeted patients’ cancer cells resulting in TUSC2-mediated clinical anti-cancer activity.

Pre-clinical data showed that when Oncoprex is combined with EGFR TKI therapy in EGFR mutated and TKI resistant cancers, the Oncoprex combination overcomes drug-induced and intrinsic therapeutic resistance by simultaneously inactivating the EGFR and the AKT signaling pathways in the cancers that have become resistant to EGFR TKI therapy, thus inducing apoptosis. Importantly, synergistic anticancer results were also obtained from studies combining Oncoprex with EGFR TKIs in K-ras associated cancers, which are significant in that patients with K-ras mutation cancers are, in general, unresponsive to EGFR TKIs.

An FDA approved phase I/II clinical trial protocol will be used to evaluate Oncoprex + erlotinib in Stage IIIb/IV NSCLC patients without an activating EGFR mutation(prior chemo)and patients with an activating EGFR mutation, progressing on erlotinib. Pre and post-treatment biopsies from each patient will be analyzed for prognostic biomarkers.

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