AUSTIN, Texas - Genprex , Inc. (NASDAQ: NASDAQ:GNPX), a clinical-stage gene therapy company, announced today the completion of a key phase in its Acclaim-3 clinical trial for REQORSA Gene Therapy, which is being evaluated in combination with Tecentriq as a treatment for small cell lung cancer (SCLC). The Safety Review Committee (SRC) has endorsed the progression to the highest dose group in the trial following favorable safety results.
The Acclaim-3 trial is assessing the safety and efficacy of REQORSA in conjunction with Tecentriq as a maintenance therapy for patients with extensive stage SCLC who have not experienced tumor progression after initial treatment. The trial has completed the 0.09 mg/kg dose group without any dose-limiting toxicities and is now escalating to the 0.12 mg/kg dose group.
Ryan Confer, President and CEO of Genprex, expressed confidence in the SRC's recommendation to move forward, highlighting the favorable safety profile demonstrated in the trial as well as partial remission observed in a patient. The company believes the results suggest a potential clinical benefit of REQORSA, especially since the patient had previously been treated with Tecentriq.
The Phase 1 dose escalation portion aims to determine the maximum tolerated dose or recommended Phase 2 dose. Following this phase, a Phase 2 expansion will enroll 50 patients across 10 to 15 U.S. sites to further assess the 18-week progression-free survival rate. The company anticipates starting the Phase 2 portion in the second half of 2024, contingent on the enrollment in the 0.12 mg/kg dose group.
Genprex's REQORSA has received Fast Track Designation and Orphan Drug Designation from the FDA for the treatment of SCLC. The company's approach involves a non-viral delivery system to administer gene therapy for patients with cancer and diabetes.
Data from studies presented at the October 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics showed that REQORSA combined with atezolizumab controlled tumor growth more effectively than either agent alone and increased immune cell infiltration in tumors.
This report is based on a press release statement from Genprex, Inc. detailing the recent developments in the Acclaim-3 clinical trial.
In other recent news, Genprex Inc. is facing potential delisting from Nasdaq due to a failure to meet the minimum bid price requirement. The company has until March 25, 2025, to regain compliance. In a bid to expand its oncology program, Genprex has formed a Mesothelioma Clinical Advisory Board and reported progress in its Acclaim-1 and Acclaim-3 lung cancer gene therapy trials. The company has also secured a new patent for its Reqorsa® Gene Therapy from the Singapore Patent Office. Analyst firm H.C. Wainwright has initiated coverage of Genprex's stock with a Buy rating. Genprex has also announced plans to spin off its diabetes gene therapy program into a new subsidiary, named NewCo, to further focus on the development of GPX-002, a gene therapy drug candidate for Type 1 and Type 2 diabetes. This spin-off is expected to be completed by the end of 2024. These recent developments reflect Genprex's ongoing efforts to advance its pharmaceutical preparations in the biotechnology sector.
InvestingPro Insights
As Genprex (NASDAQ: GNPX) advances its Acclaim-3 clinical trial for REQORSA Gene Therapy, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, Genprex's market capitalization stands at a modest $1.37 million, reflecting its status as a clinical-stage biotech company. The company's financial position aligns with its developmental phase, as evidenced by an operating income of -$26.29 million for the last twelve months as of Q2 2024.
An InvestingPro Tip highlights that Genprex holds more cash than debt on its balance sheet, which is crucial for a company in the resource-intensive process of drug development and clinical trials. This financial cushion could provide some runway as the company progresses through its clinical stages.
Another relevant InvestingPro Tip indicates that analysts do not anticipate the company to be profitable this year. This is not uncommon for biotech companies in the clinical trial phase, as they often prioritize research and development over immediate profitability.
The stock's recent performance has been challenging, with InvestingPro data showing a one-month price total return of -18.62% and a more substantial three-month return of -82.74%. These figures underscore the volatility often associated with clinical-stage biotech stocks, especially as they approach critical milestones in their drug development process.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for Genprex, providing a deeper understanding of the company's financial health and market position.
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