Genprex Inc (NASDAQ:GNPX) announced Wednesday that it is prioritizing the development of Oncoprex, in combination with osimertinib for the treatment of non-small cell lung cancer.
The company’s announcement comes a few weeks after it received US Food and Drug Administration Fast Track Designation for its Oncoprex immunogene therapy in combination with the EGFR tyrosine kinase inhibitor (TKI) osimertinib -- which is AstraZeneca PLC’s (NYSE:AZN) Tagrisso.
The drug had worldwide sales in 2018 of $1.86 billion, $2.31 billion in the first nine months of 2019 and is currently AstraZeneca’s highest grossing product for the treatment of non-small cell lung cancer (NSCLC) patients with EFGR mutations that progressed after treatment with osimertinib alone.
READ: Genprex wins FDA Fast Track status for its Oncoprex therapy in combination with AstraZeneca's Tagrisso
Oncoprex consists of the TUSC2 (Tumor Suppressor Candidate 2) gene, the active agent in Oncoprex, complexed with a lipid nanovesicle.
Genprex’s current Phase I/II clinical trial utilizes the combination of the EGFR inhibitor erlotinib (marketed by Genentech in the US and elsewhere by Roche as Tarceva) and Oncoprex against NSCLC.
In a statement, the company said the Phase I/II trial is active but is not currently enrolling patients, though it had planned to resume enrollment in mid-2020. It added that tumor shrinkage in patients resistant to erlotinib enrolled in this trial showed that Oncoprex can overcome resistance to TKIs and provided support for the Fast Track Designation.
Osimertinib is now considered a new standard of care for NSCLC patients with an EGFR mutation, the Austin, Texas-based company said.
“Given this and receipt of FDA’s Fast Track Designation for use of Oncoprex combined with osimertinib in patients whose tumors progress on osimertinib, the Company has decided to prioritize this drug combination and patient population,” Genprex said.
Phase I/II clinical combo trial
The company plans to initiate a Phase I/II clinical trial of Oncoprex combined with osimertinib in mid-2020 at multiple cancer centers across the US, and at this time, does not intend to reopen enrollment in the current Phase I/II trial using the combination of Oncoprex and erlotinib.
Additionally, Genprex plans to file an amendment to its Investigational New Drug (IND) application with the FDA for the Oncoprex and osimertinib combination therapy trial within the first quarter of 2020.
Upon FDA acceptance of the amendment, the company expects to be in a position to enroll patients shortly thereafter and believes that enrollment in the new clinical trial may be rapid, as the tumors of almost all patients who are treated with osimertinib progress after treatment, and these patients may be candidates for its clinical trial combining Oncoprex with osimertinib.
“Thus, given the changing landscape in NSCLC and the recent Fast Track Designation, the Company believes prioritizing the combination therapy of Oncoprex with osimertinib represents the most efficient way to advance its lead drug candidate through the clinical process for FDA approval, to have the best commercial success in the $17.9 billion global lung cancer market and to make its treatment available to patients as soon as possible,” the company said.
In related news, Genprex said it will also proceed with its plan to file an IND for the additional combination therapy of Oncoprex combined with the immunotherapy drug pembrolizumab -- marketed as Keytruda by Merck & Co Inc (NYSE:MRK) in the US for NSCLC.
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