AUSTIN, Texas - Genprex , Inc. (NASDAQ: NASDAQ:GNPX), a clinical-stage gene therapy company, has shared updates on its Acclaim-1 and Acclaim-3 clinical trials, which focus on treatments for different types of lung cancer. The company has reported prolonged progression-free survival in two patients in the Acclaim-1 trial and a partial remission in the first treated patient in the Acclaim-3 trial.
Acclaim-1 is evaluating the combination of Genprex's lead drug candidate, Reqorsa® Gene Therapy, with AstraZeneca (NASDAQ:AZN)'s Tagrisso® for late-stage non-small cell lung cancer (NSCLC) patients with specific mutations. The trial has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). Two patients in the trial have shown prolonged progression-free survival, with one patient maintaining a partial remission for over two years.
In Acclaim-3, which also received Fast Track Designation, Reqorsa is combined with Genentech's Tecentriq® as a maintenance therapy for small cell lung cancer (SCLC). The first patient treated in this trial experienced a partial remission with a 30% decrease in tumor size but was later diagnosed with disease progression.
Genprex has decided to re-focus its enrollment efforts for future Acclaim-1 trial participants, limiting to those who have only received prior Tagrisso treatment. The company expects to complete the enrollment of the first 19 patients in the Phase 2a expansion portion of the study and conduct an interim analysis in the first half of 2025.
The Acclaim-2 trial, which combines Reqorsa with Merck & Co's Keytruda® in late-stage NSCLC patients, will cease new patient enrollment due to challenges in recruiting patients and the high volume of competing trials.
Genprex is also working with an academic research partner to develop biomarkers to enrich clinical trial patient populations and enhance the likelihood of successful treatment responses in its Acclaim studies.
The company's oncology program utilizes a non-viral delivery system to administer gene therapies for cancer treatment. Genprex's diabetes gene therapy program is developing treatments that involve delivering genes directly to the pancreas to transform alpha cells into insulin-producing cells.
This article is based on a press release statement from Genprex, Inc.
In other recent news, Genprex, Inc. has been granted a new patent by the Singapore Patent Office for its lead drug candidate, Reqorsa® Gene Therapy, extending protection through 2037. This comes as a significant development for Genprex's strategic positioning, especially considering the high prevalence of lung cancer in Asia. The Acclaim-3 clinical trial, which combines REQORSA with Genentech's Tecentriq®, is currently in Phase 1/2 as a maintenance therapy for small cell lung cancer patients.
Genprex also reported positive preclinical data for its Reqorsa® Immunogene Therapy and NPRL2 gene therapy. The company has expanded its Acclaim-3 clinical trial sites to accelerate patient enrollment. Analyst firm H.C. Wainwright initiated coverage of Genprex's stock with a Buy rating.
On the corporate front, Genprex has confirmed leadership changes with Ryan M. Confer now serving as President, CEO, and CFO. Brent M. Longnecker was elected as a Class I director and WithumSmith+Brown, PC was ratified as the independent registered public accounting firm. Lastly, Jose A. Moreno Toscano has been named the non-executive Chairman of the Board.
InvestingPro Insights
As Genprex, Inc. (NASDAQ: GNPX) continues to make strides in its clinical trials for lung cancer treatments, investors and stakeholders are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Genprex holds a market capitalization of a modest $2.2 million USD, reflecting the size and speculative nature of the biotech firm. The company's stock has been facing significant challenges, as indicated by a price that is currently at only 3.54% of its 52-week high and a previous close at $0.85 USD.
InvestingPro Tips highlight that Genprex holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability. However, the stock has fared poorly over the last month and is trading near its 52-week low. This could be an indicator of market sentiment and the challenges the company faces in advancing its clinical programs. Additionally, the Relative Strength Index (RSI) suggests that the stock is in oversold territory, which sometimes can signal a potential reversal in the stock's trajectory if other factors align favorably.
While Genprex is progressing in its clinical trials, the financial metrics and market performance reflect the high-risk nature of investing in clinical-stage biotech companies. For investors considering Genprex, the InvestingPro platform offers further insights, including 14 additional InvestingPro Tips that could help in making a more informed investment decision. These tips provide a comprehensive analysis of the company's stock performance and market behavior, which is crucial for understanding the investment potential of Genprex amidst its clinical developments.
For those interested in a deeper dive into Genprex's financials and stock performance, more detailed metrics and tips are available at https://www.investing.com/pro/GNPX.
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