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Genprex Inc. (NASDAQ: GNPX) Granted Orphan Drug Designation in Small Cell Lung Cancer by FDA, Presented Data at Two October Events Focused on Lung Cancer

  • Genprex was granted orphan drug designation by the FDA earlier this year for development of REQORSA combined with Tecentriq in small cell lung cancer
  • Use of REQORSA combined with Tecentriq is the subject of Genprex’s upcoming Acclaim-3 clinical trial
  • Genprex took part in two events in October – the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; and Genprex’s own hosted event, a Virtual Key Opinion Leaders on Bringing Gene Therapy to the Fight Against Lung Cancers

Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients living with cancer and diabetes, was granted orphan drug designation (“ODD”) by the US Food and Drug Administration (“FDA”) for its REQORSA(R) immunogene therapy for the combination of its immunogene therapy REQORSA(R) and Genentech Inc.’s Tecentriq(R) as maintenance therapy in patients with extensive stage small cell lung cancer (“SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment earlier this year.

The FDA can grant ODD to a drug or biological product being developed to prevent, diagnose, or treat rare diseases or conditions. The designation is intended to spark innovation among biotech companies developing treatments for the more than 30 million people suffering from rare diseases.

Genprex’s therapy is in development for treating both SCLC and non-small cell lung cancer (“NSCLC”). The company’s Acclaim-1 and Acclaim-2 clinical trials are investigating REQORSA in combination with Tagrisso and Keytruda, respectively, in NSCLC. The company’s Acclaim-3 clinical trial is a Phase 1/2 clinical trial using the combination of immunogene therapy REQORSA(R) and Genentech Inc.’s Tecentriq(R) in patients with extensive stage small cell lung cancer. The Acclaim-3 clinical trial will commence enrollment as soon as reasonably practicable and the company expects this will occur between December 2023 and the end of the first quarter of 2024, subject to the availability of a new manufactured batch of REQORSA.  The Acclaim-1 Phase 2 expansion portion of the trial will also commence enrollment within this time frame, based on the availability of the new REQORSA batch.

“This FDA Orphan Drug Designation, in combination with our recently received FDA Fast Track designation, underscores the great need for better treatment options for patients with ES (extensive-stage)-SCLC and non-small cell lung cancer,” said Rodney Varner, Genprex president, chair, and CEO (https://nnw.fm/h9FFi). “We look forward to initiating the Acclaim-3 clinical trial in order to bring hope of an effective new therapy to patients suffering with this life-limiting cancer.”

Genprex recently took part in two events in October – the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; and Genprex’s own hosted Virtual Key Opinion Leader (“KOL”) Event on Bringing Gene Therapy to the Fight Against Lung Cancers. Each event provided Genprex the opportunity to present its findings in the respective areas.

  • 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Genprex presented data on using REQORSA to treat lung cancers (https://nnw.fm/rfcgM). The company presented that the Acclaim-1 Phase 1 study had no dose-limiting toxicity, established a Phase 2 recommended dose, and demonstrated evidence of efficacy of REQORSA in combination with Tagrisso(R). The company’s research collaborators also presented preclinical results showing that REQORSA in combination with a checkpoint inhibitor has anti-tumor activity in a humanized mouse model of SCLC.
  • These data and more were highlighted in the company’s recent KOL event: Bringing Gene Therapy to the Fight Against Lung Cancers. The event discussed REQORSA as a potential treatment for NSCLC and SCLC (https://nnw.fm/HUgum).

The American Cancer Society estimates that almost 127,000 people will die from lung cancer this year, making it one of the most lethal cancers in men and women. SCLC comprises approximately 13% of all lung cancer diagnoses, while NSCLC represents approximately 84% of lung cancer diagnoses (https://nnw.fm/1R1fx). There is currently an unmet need for treatment, which Genprex is on a mission to address.

The company’s oncology pipeline aims to reprogram the course of cancer. The company is evaluating its proprietary, non-viral ONCOPREX(R) Nanoparticle Delivery System, a systemic gene therapy delivery system used in clinical trials for human cancer. It is currently being evaluated in several trials.

For more information, visit the company’s website at www.Genprex.com.

NOTE TO INVESTORS: The latest news and updates relating to GNPX are available in the company’s newsroom at http://nnw.fm/GNPX

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