Genprex advances to phase 2 in lung cancer trial

Published 16/12/2024, 15:22
Genprex advances to phase 2 in lung cancer trial
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AUSTIN, Texas - Genprex , Inc. (NASDAQ: NASDAQ:GNPX), a clinical-stage biotechnology company with a market capitalization of approximately $10 million, has completed the Phase 1 dose escalation part of its Acclaim-3 clinical trial for Reqorsa® Gene Therapy in combination with Tecentriq® as a maintenance therapy for extensive stage small cell lung cancer (ES-SCLC), the company announced today. Following a favorable safety profile and no dose limiting toxicities, the trial will now proceed to Phase 2, with enrollment already underway. According to InvestingPro data, the company maintains a favorable cash position relative to its debt, though its overall financial health score indicates some challenges ahead.

The Safety Review Committee (SRC) has determined the Recommended Phase 2 Dose (RP2D) of REQORSA to be 0.12 mg/kg, the highest dose level tested in Phase 1. The Phase 2 expansion will evaluate the 18-week progression-free survival rate among approximately 50 patients at 10 to 15 U.S sites. While the stock has shown significant volatility, with a beta of -1.38, analysts maintain a bullish outlook with a price target of $7.50.

Genprex's President and CEO, Ryan Confer, expressed satisfaction with the trial's progress and the partnership with community-based oncology practices that has facilitated successful enrollment rates. The company anticipates presenting Phase 1 results at a clinical meeting in 2025, with early efficacy data in ES-SCLC patients providing encouragement.

The Acclaim-3 trial is part of Genprex's broader focus on gene therapy treatments for cancer and diabetes. Their lead candidate, Reqorsa® Gene Therapy, has received Fast Track and Orphan Drug Designations from the FDA for SCLC treatment. The company also highlighted previous positive results from humanized mouse model studies, which indicated that the combination of REQORSA and Tecentriq could control tumor burden more effectively than either agent alone.

This announcement is based on a press release statement from Genprex. The company has not disclosed any additional information regarding the trial's future outcomes or the potential commercialization of the treatment. For deeper insights into Genprex's financial health and growth prospects, InvestingPro subscribers can access 13 additional key metrics and analysis tools. Investors and stakeholders are advised to consider this development as part of the company's ongoing research efforts.

In other recent news, Genprex, Inc. has secured an exclusive license from the University of Michigan for a patented gene therapy technology to potentially treat ALK-positive lung cancer. The company has also reported promising preclinical data for its lead drug candidate, Reqorsa® Gene Therapy, showing potential in modulating immune responses in cancer. Despite facing a potential delisting from the Nasdaq Capital Market due to an equity shortfall, Genprex has regained compliance with Nasdaq's minimum bid price requirement. Analyst firm H.C. Wainwright has initiated coverage of Genprex's stock with a Buy rating. Furthermore, Genprex has announced plans to spin off its diabetes gene therapy program into a new subsidiary, NewCo, to focus on the development of GPX-002, a gene therapy drug candidate for Type 1 and Type 2 diabetes. These are among the recent developments at Genprex, Inc. in its ongoing commitment to advancing gene therapies for large patient populations with limited treatment options.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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