Genprex, Inc. (NASDAQ: GNPX) Receives Third Fast Track Designation for REQORSA(R), Setting Stage for Commencement of Acclaim-3 Clinical Trial in Q3

  • Genprex recently received a Fast Track Designation (“FTD”) from the FDA for its REQORSA(R) Immunogene Therapy in combination with Genentech, Inc.’s Tecentriq(R) in patients with extensive-stage small cell lung cancer
  • This is Genprex’s third FTD and sets the stage for the initiation of its third lung cancer clinical trial, Acclaim-3
  • Acclaim-3 clinical trial is a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq
  • The company expects to enroll the first patient in its Acclaim-3 clinical trial in the third quarter of 2023
  • Genprex is combining its lead product candidate, REQORSA, with existing lung cancer medications – Tagrisso, Keytruda, and Tecentriq – in an effort to help patients benefit for longer periods of time and allow some patients to benefit who may not have benefited at all

Genprex (NASDAQ: GNPX), a gene therapy company, recently received U.S. Food and Drug Administration (“FDA”) Fast Track Designation (“FTD”) for its lead product candidate, REQORSA(R) immunogene therapy, in combination with Tecentriq(R), a cancer immunotherapy treatment developed and sold by Genentech, Inc., in patients with extensive-stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment (https://ibn.fm/jIv3I).

The FTD is for the company’s Acclaim-3 patient population, and Genprex expects to initiate its Acclaim-3 clinical trial by enrolling the first patient in the third quarter of 2023. The Acclaim-3 clinical trial is a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq. Patients in this study will be enrolled after receiving treatment with 3-4 cycles of carboplatin, etoposide, and Tecentriq and achieving a complete response, partial response, or stable disease. They will then receive treatment with REQORSA and Tecentriq as maintenance therapy every 21 days until disease progression.

The company has previously received two other FTDs. In 2020, Genprex announced that the FDA had granted FTD for its REQORSA therapy in combination with AstraZeneca’s (NASDAQ: AZN) Tagrisso(R) in patients with late-stage non-small cell lung cancer (“NSCLC”) whose disease has progressed after treatment with Tagrisso (https://ibn.fm/p5bPW). Later, in 2022, the company received its second FTD for REQORSA in combination with Merck & Co Inc.’s (NYSE: MRK) Keytruda(R) in patients whose disease progressed after treatment with Keytruda(R) (https://ibn.fm/Asm5m).

To get a Fast Track Designation, a drug company must file an application with the FDA and provide all non-clinical and clinical data demonstrating the potential for a drug to benefit patients with a serious or life-threatening disease where there is an unmet need. “Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one,” explains the FDA (https://ibn.fm/nFpR4).

“This is another exciting achievement in our REQORSA drug development program, which further validates REQORSA’s potential not only in NSCLC but also in SCLC. We look forward to accelerating the clinical development of REQORSA, and potentially providing a new treatment option for patients with SCLC,” commented Rodney Varner, Chairman, President, and CEO of Genprex.

As the leading cause of cancer-related deaths globally, accounting for 1.8 million deaths in 2020 or about 18% of total cancer deaths (https://ibn.fm/TCEDH), lung cancer is an obvious example of a serious condition. (Lung cancer was also the second most common type of cancer in 2020, after female breast cancer, accounting for 2.2 million new cases.) With these numbers in mind, Genprex hopes to leverage its lead product candidate to help patients benefit from Tagrisso, Keytruda, or Tecentriq for a longer period of time and allow some patients to benefit who may not have benefited at all.

REQORSA consists of the TUSC2 tumor suppressor gene encapsulated in a nanoparticle made from lipid molecules with a positive electrical charge. “REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell,” explains Genprex’s website (https://ibn.fm/oWpT5).

According to Varner, data generated so far validates the company’s theory that using REQORSA in combination with these lung cancer therapies can extend the benefits of the drugs (https://ibn.fm/0QD5X). These findings are allowing the company to participate in the burgeoning lung cancer drugs market despite its relatively small size compared to AstraZeneca, Genentech, and Merck & Co, for example. Valued at $18.328 billion in 2018, the global lung cancer therapeutics market is expected to grow at a 13% CAGR reaching a value of $48.726 billion by 2026 (https://ibn.fm/R1u7R).

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

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