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Genprex to Focus on Developing Immunogene Therapy, Start Lung Cancer Trials This Year

NEW YORK − Genprex said Wednesday that after receiving the US Food and Drug Administration's fast track designation last month for its immunogene therapy Oncoprex in combination with the EGFR tyrosine kinase inhibitor (TKI) osimertinib (AstraZeneca’s Tagrisso), the clinical-stage gene therapy company is prioritizing development of this therapy combination for EGFR-mutated non-small cell lung cancer and will start enrollment in Phase I/II clinical trials in mid-2020.

Enrollment will start after the FDA accepts Genprex's amendment to its investigational new drug application.

The company also said last month that it intends to start a new Phase I clinical trial investigating Oncoprex in combination with a checkpoint inhibitor. This is supported by preclinical studies indicating that TUSC2 increases the effectiveness of anti-PD1 checkpoint blockade combined with chemotherapy for lung metastases with KRAS and LKB1 mutations in mice.

Oncoprex is Genprex's lead product candidate and it uses the active agent TUSC2 (Tumor Suppressor Candidate 2) gene combined with a lipid nanovesicle. TUSC2 has been shown to disrupt replication and proliferation of cancer cells, re-establish programmed cell death, as well as modulate the immune response against cancer cells. It's also been observed to block mechanisms that create drug resistance.

Additionally, the company is putting its current Phase I/II trial investigating Oncoprex in combination with EGFR inhibitor erlotinib (Genentech/Roche's Tarceva) ─ which provided support for the fast track designation ─ on hold, citing the reason that osimertinib is now considered the new standard of care of NSCLC patients with an EGFR mutation. Genprex has treated more than 50 lung cancer patients with Oncoprex in Phase I/II trials.