InvestorWire NewsRoom

Article

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
November 22, 2023

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://ibn.fm/n3GXo). “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://ibn.fm/5YzLY). 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://ibn.fm/FnuDk).

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://ibn.fm/R3mLE). 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://ibn.fm/GNPX

About InvestorWire

InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, IW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.

For more information, please visit https://www.InvestorWire.com

Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer

InvestorWire
Los Angeles, CA
www.InvestorWire.com
310.299.1717 Office
[email protected]

Recent Articles

Release Categories

Get Started with InvestorWire

To distribute a release in the next 24 hours. Contact our client services team.

(310) 299-1717

Distribute a press release. Submit your release to get started.

Submit Press Release

Set up a Live demonstration. Schedule a date and time that works for you.

Schedule a LIVE Demo

Press Distribution

Explore Press Distribution Solutions

All releases include an unlimited word count* with full wire-grade syndication, our press release enhancement service, and a follow-up InvestorNewsBreak article distributed to thousands of editorial syndication partners.

Discover Add-on Solutions

Increase the impact of your achievements by adding these exclusive solutions from InvestorWire, delivered in conjunction with the InvestorBrandNetwork (IBN).