On May 29, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has been selected to present at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3 in Chicago, Illinois and online (Press release, Genprex, MAY 29, 2025, View Source [SID1234653485]).
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Genprex’s abstract, which is now available on the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting conference website, was selected for a poster presentation for the Trials in Progress portion of the conference. The Company will present the trial design of the Acclaim-3 Phase 1/2 clinical trial evaluating Genprex’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in combination with Tecentriq as maintenance therapy for the treatment of extensive stage small cell lung cancer (ES-SCLC).
"We are proud of the work that has gone into our Phase 1/2 Acclaim-3 clinical trial evaluating our lead drug candidate, REQORSA, in combination with AstraZeneca’s Tecentriq," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe that by reintroducing the TUSC2 gene, a tumor suppressor gene that is decreased in 100% of SCLCs, we have an opportunity to improve on the median progression free survival rate of only 2.6 months in an effort to help these patients extend their lives and potentially improve their prognosis."
Below are the details for Genprex’s poster presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:
Title: A phase 1/2 clinical trial of quaratusugene ozeplasmid gene therapy and atezolizumab maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC)
Session Type: Poster Session
Presentation Date: Saturday, May 31, 2025
Presentation Time: 1:30 – 4:30 p.m. CT
Presenter: Bo Wang, MD, Oncology Associates of Oregon
The featured Genprex-supported abstract to be presented for poster presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:
The addition of Tecentriq (atezolizumab) to both induction therapy and maintenance therapy for patients with ES-SCLC has improved median progression free survival (PFS) and overall survival. However, the median PFS from starting Tecentriq maintenance is only 2.6 months. Expression of TUSC2, a tumor suppressor gene, is absent in 41% of SCLC patients and is decreased in 100% of SCLC patients. Reoqrsa Gene Therapy (quaratusugene ozeplasmid) consists of a DNA plasmid expressing the TUSC2 gene encapsulated in a positively charged lipoplex which delivers the TUSC2 gene to cancer cells, restoring TUSC2 expression. Xenograft studies using a SCLC cell line in a humanized mouse model treated with a combination of REQORSA and Tecentriq demonstrated significantly increased tumor cell killing compared to that of Tecentriq alone. In addition, infiltration of immune cells was increased in the tumor tissue, whereas myeloid derived suppressor cells were decreased. Thus, in this study REQORSA is added to Tecentriq maintenance therapy with the aim of improving PFS after the start of maintenance therapy.
Eligible patients have ES-SCLC and have completed 3-4 cycles of induction therapy with etoposide, a platinum agent, and Tecentriq without disease progression, and are thus eligible for maintenance therapy. REQORSA is administered via IV every 21 days in escalating dose cohorts in Phase 1 and Tecentriq 1200 mg is also administered via IV every 21 days. Dexamethasone, acetaminophen, and diphenhydramine are given prior to each treatment to prevent delayed infusion-related reactions. Efficacy is evaluated after every even cycle of treatment using RECIST 1.1 criteria. Safety is evaluated using CTCAE v5, with dose limiting toxicities generally defined as ≥Gr 3 adverse events (AEs). TUSC2 protein expression is measured by a validated immunohistochemistry assay in paraffin sections to determine if PFS is related to pretreatment TUSC2 levels. A validated assay measures pharmacokinetics in all patients. In Phase 1, two planned dose levels (0.09, and 0.12 mg/kg) of REQORSA were administered, and a standard dose escalation with 3-6 patients/dose level was used. The Phase 2 portion of the trial will enroll 50 patients which provides 80% power at a one-sided alpha level of 0.05 to detect an 18-week PFS rate of 52% compared to a historical 18-week PFS rate of 34% with Tecentriq alone. This corresponds to a median PFS of approximately 4.3 months compared to a historical median PFS of 2.6 months with Tecentriq alone. A Safety Review Committee (SRC) reviewed safety data at the end of each dose level of Phase 1 to make recommendations about dose escalation. The Phase 2 portion of the trial opened for enrollment in December 2024.
Following the poster presentation, a copy of the poster will be made available on Genprex’s website.