AUSTIN, Texas - Genprex , Inc. (NASDAQ: NASDAQ:GNPX), a clinical-stage gene therapy company, has announced the expansion of its Acclaim-3 clinical trial sites through a collaboration with a network of community-based oncology practices.
This move aims to accelerate patient enrollment and provide broader access to its Reqorsa® Immunogene Therapy in combination with Genentech's Tecentriq® for treating extensive-stage small cell lung cancer (ES-SCLC).
The Acclaim-3 study, which has received FDA Orphan Drug and Fast Track designations, is currently in a Phase 1/2 trial phase. It evaluates Reqorsa® as a maintenance therapy in combination with Tecentriq® in ES-SCLC patients who have not progressed after initial treatment with Tecentriq® and chemotherapy.
The Phase 1 portion of the study will determine the Maximum Tolerated Dose (MTD) across approximately 10 U.S. clinical sites, doubling the initial number. The Phase 2 portion is expected to enroll around 50 patients at 10 to 15 U.S. sites, with initiation projected for the second half of 2024.
Genprex's President and CEO, Rodney Varner, emphasized the significance of the collaboration, stating it may expedite the trial and make the innovative treatment available to more patients, especially those outside major urban areas. The primary endpoint of the Phase 2 trial is to determine the 18-week progression-free survival rate from the start of maintenance therapy with the drug combination.
Reqorsa®, Genprex's lead drug candidate, encapsulates a plasmid expressing the TUSC2 tumor suppressor gene protein, which is often deficient in SCLC. Preclinical studies have supported the hypothesis that re-expressing TUSC2 could improve clinical efficacy when combined with Tecentriq®.
The expansion follows the pattern of the company's Acclaim-1 trial in non-small cell lung cancer (NSCLC), which experienced successful patient enrollment. Genprex is focused on developing therapies for large patient populations with cancer and diabetes with limited treatment options.
This news is based on a press release statement from Genprex, Inc. and has not been independently verified. Investors and those interested in the company's progress in clinical trials can find more details on ClinicalTrials.gov.
InvestingPro Insights
As Genprex, Inc. (NASDAQ: GNPX) continues to make strides in its clinical trials, investors closely monitor the company's financial health and stock performance. According to InvestingPro, Genprex holds more cash than debt on its balance sheet, which could provide some financial stability as it pursues its clinical objectives. The company also maintains liquid assets that exceed short-term obligations, indicating a solid position to manage its liabilities in the near term.
However, the road ahead may present challenges. Genprex's gross profit margins are considered weak, and analysts do not expect the company to turn a profit this year. Moreover, the stock has significantly underperformed in the recent period, with a one-month price total return of -36.61% and a six-month price total return of -79.83%. The stock has also seen a steep decline from its 52-week high, currently priced at around 6.17% of its peak value.
In terms of valuation metrics, Genprex has a negative P/E ratio of -0.16, reflecting the company's current lack of profitability. Despite these challenges, the company's commitment to expanding treatment options for small cell lung cancer patients remains unwavering.
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