Genprex Inc. revealed that it has completed the Phase 1 portion of the Acclaim-1 Phase 1/2 clinical trial evaluating REQORSA Immunogene therapy combined with Tagrisso in late-stage non-small cell lung cancer (NSCLC), and the Safety Review Committee (SRC) has approved forging ahead with the Phase 2 expansion part of the trial.
Significantly, the Austin, Texas-based clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, said the REQORSA and Tagrisso (Osimertinib) combo received US Food and Drug Administration's (FDA) Fast Track designation for treatment of the Acclaim-1 patient population.
REQORSA Immunogene therapy (quaratusugene ozeplasmid) for NSCLC uses Genprex's unique ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials.
Genprex shares were up nearly 3% to $0.92 in premarket trade.
Based on full safety data which showed no dose limiting toxicities, the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in Genprex's prior clinical trial combining REQORSA with Tarceva for the treatment of late-stage lung cancer.
The SRC also recommended the trial advance to the Phase 2 expansion portion of the study, which the company expects to begin in 3Q 2023.
"We are proud of the notable progress we made during the Phase 1 portion of the Acclaim-1 clinical trial, and the SRC recommendation to move into the Phase 2 expansion portion of the trial is another validation for our REQORSA development program," said Genprex CEO Rodney Varner.
"We remain steadfast in our efforts to bring new therapies to lung cancer patients with unmet medical need."
Genprex recently shared positive preliminary clinical data from the Phase 1 dose escalation portion of its Acclaim-1 clinical trial in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. The results showed that REQORSA was generally well tolerated, and there were no dose limiting toxicities. The company saw encouraging proof of effectiveness in the Phase 1 portion of the study.
The three physicians who make up the SRC are principal trial investigators. The SRC had the option to recommend that the trial proceeds at the same dose, at a lower dose, or at a higher dose, or that the study be terminated altogether due to safety concerns.
The Phase 2 expansion portion is expected to enroll 66 patients; half will be patients who received only prior Tagrisso treatment, and the other half will be patients who received prior Tagrisso treatment and chemotherapy, in order to determine toxicity profiles of patients with different eligibility criteria. There will be an interim analysis following the treatment of 19 patients in each cohort, said Genprex.
Dawson James maintains Buy rating
Analysts at Dawson James maintained their Buy rating and $3 target price on Genprex stock after the gene-based therapy company announced that the SRC gave its approval to advance REQORSA to the Phase 2 expansion portion of the Acclaim-1 trial.
"We note that as the company established proof of concept as a result of clinical trial data, the risk rate is reduced, and valuation rises," said analysts at Dawson James in an update to clients.
The active agent in REQORSA is a plasmid that expresses the TUSC2 tumor suppressor gene. REQORSA consists of the TUSC2 gene expressing plasmid encapsulated in non-viral lipid nanoparticles made from lipid molecules with a positive electrical charge.
REQORSA is injected intravenously and targets cancer cells. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell. It interrupts cell signaling pathways that cause the proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis in cancer cells, and modulates the immune response against cancer cells.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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