AUSTIN, TX / ACCESSWIRE / June 2, 2023 / A clinical-stage gene therapy company is making splashes in the medical world. Genprex, Inc. (NASDAQ:GNPX) is developing potentially life-changing therapies for patients with cancer and diabetes that have limited treatment options. The company is working with world-class institutions in developing new drugs from the company's pipeline of gene therapy candidates in order to provide novel treatment approaches. Its oncology program utilizes its proprietary non-viral ONCOPREX® Nanoparticle Delivery System, which Genprex believes is the first systemic gene therapy delivery platform used for cancer in humans. The company's lead drug candidate is called REQORSA®. The immunogene therapy (also known as quaratusugene ozeplasmid) is for both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and uses the company's unique, proprietary ONCOPREX® Nanoparticle Delivery System. The drug may be helpful for treating patients who have already demonstrated drug resistance to other treatments.
On the heels of the release of recent positive safety and early efficacy data related to the phase 1 portion of its Acclaim-1 phase 1/2 clinical trial for non-small cell lung cancer evaluating REQORSA in combination with Tagrisso, Genprex has released a new patient video featuring an NSCLC patient from the phase 1 portion of its Acclaim-1.
All patients in the trial had disease progression on their previous cancer treatment. In the video, an NSCLC patient who experienced extended Progression Free Survival (PFS) in the trial describes her positive experience taking REQORSA - Genprex's lead drug candidate which she is still taking - while participating in the phase 1 portion of the Acclaim-1 clinical trial.
"While on REQORSA treatment, my doctor noted that the lung cancer lesions have not grown and there is no new growth," said the NSCLC patient in the Phase 1 portion of Acclaim-1. "I believe the REQORSA treatment has benefited my life and has increased my time."
The patient's positive experience is encouraging - she was able to continue working full-time while participating in the clinical trial. She experienced only minor side effects from REQORSA and so far has experienced more than 10 months of progression-free survival.
NSCLC is the most common type of lung cancer, accounting for about 82% of all cases. While there have been some advances in treatment options for NSCLC, such as chemotherapy, radiation therapy and targeted therapies, the overall survival rate for patients with advanced NSCLC remains low. The five-year survival rate for patients with distant spread is 7%.
Genprex has disclosed favorable preliminary clinical data from the Acclaim-1 clinical trial's phase 1 dose-escalation segment in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings show that REQORSA was well tolerated with no dose-limiting toxicities. Furthermore, Genprex reported preliminary evidence of efficacy in the phase 1 portion of the study.
"We are thrilled to have our abstract, which reports positive results from the phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO Annual Meeting," said Mark Berger, MD, Chief Medical Officer at Genprex. "We are encouraged by the favorable safety profile of REQORSA, as well as the preliminary efficacy data we have observed. In fact, the Safety Review Committee has just approved our advancement into the phase 2 expansion portion of the clinical trial."
As noted above, the company also announced that its Safety Review Committee (SRC) has approved the advancement of the Acclaim-1 clinical trial to the phase 2 expansion portion of the trial. The SRC has examined the full safety data and has approved the recommended phase 2 dose of REQORSA, which is 0.12 mg/kg, twice the highest dose level delivered in Genprex's previous clinical trials. This approval is a significant milestone in REQORSA's development program. The SRC's recommendation to advance the trial to the phase 2 expansion portion is a significant milestone for REQORSA.
Genprex's REQORSA drug seems to be a promising innovation in cancer treatment. REQORSA's unique approach of targeting the tumor suppressor gene TUSC2 sets it apart from other cancer treatments and other genetic medicines. Similar to companies like Bluebird Bio or Editas Medicine Inc., who are developing innovative therapies for rare diseases or using different gene editing techniques for cancer, Genprex's REQORSA has the potential to be a game-changer in the field of cancer treatment through gene therapy.