On April 3, 2024 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 through its collaboration agreement with a large network of integrated, community-based oncology practices, the Company has added multiple clinical trial sites for its Acclaim-3 clinical study of Reqorsa Immunogene Therapy (quaratusugene ozeplasmid) in combination with Genentech’s Tecentriq (atezolizumab) to treat patients with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Genprex, APR 3, 2024, View Source [SID1234641739]).
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"With the majority of oncology patients treated by community-based oncology practices, this collaboration to expand our Acclaim-3 clinical study to additional trial sites is important as it may accelerate patient enrollment, provide access to our innovative clinical trial treatment for patients outside of major urban or academic settings, broaden the geographic reach of our study to more ES-SCLC patients in need and potentially benefit ES-SCLC patients who currently have limited benefit from existing treatment options," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. "This collaboration leverages the broad network of oncologists and enables patients to access our promising treatment at the office of their primary oncologist, while allowing Genprex to more efficiently and expeditiously accelerate our Acclaim-3 clinical trial."
ES-SCLC is an aggressive form of lung cancer that is presently incurable. ES-SCLC has a median progression free survival (PFS) of 5.4 months from the start of initial therapy. However, once patients start receiving maintenance therapy with Tecentriq they have a median PFS of only 2.6 months. The combination of REQORSA and Tecentriq as maintenance therapy may provide a new therapeutic option for the treatment of small cell lung cancer (SCLC).
Genprex has a novel cancer treatment platform that re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. REQORSA, the Company’s lead drug candidate, contains a plasmid that expresses TUSC2, a tumor suppressor gene protein. Nearly 100% of SCLCs have reduced or no TUSC2 protein expression, and 41% of SCLCs completely lack TUSC2 protein expression. Preclinical studies in mice support the hypothesis that re-expressing the TUSC2 protein may lead to improved clinical efficacy in combination with Tecentriq.
"We look forward to continuing our relationship with this large, nationwide network of oncology practices for our Acclaim-3 clinical trial in SCLC, which is the same partner we used for our Acclaim-1 clinical trial in NSCLC," said Mark Berger, M.D., Chief Medical Officer at Genprex. "Based on the success we experienced in patient enrollment from our other lung cancer clinical trial, we believe this collaboration will enhance our patient enrollment for Acclaim-3 and help us to expeditiously begin treating patients in need."
About the Acclaim-3 Clinical Trial
The Acclaim-3 clinical trial is a Phase 1/2 open-label, dose escalation and clinical response study of maintenance therapy evaluating Reqorsa in combination with Tecentriq in patients with ES-SCLC. The Acclaim-3 clinical trial will enroll patients who did not develop tumor progression after receiving Tecentriq and chemotherapy as standard initial treatment, and who are therefore eligible for maintenance therapy.
The Phase 1 dose escalation portion of the Acclaim-3 clinical study was initially expected to enroll up to 12 patients at three to five U.S. clinical sites, which has now doubled to approximately 10 U.S. clinical sites, to determine the Maximum Tolerated Dose (MTD). If no dose limiting toxicities occur during the Phase 1 study, the highest dose evaluated will be the Recommended Phase 2 Dose. The Phase 2 portion of the study is expected to enroll approximately 50 patients at ten to fifteen U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Genprex expects to initiate the Phase 2 expansion study in the second half of 2024.
The primary endpoint of the Phase 2 portion of the trial is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq treatment in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up.
Genprex has received U.S. Food and Drug Administration (FDA) Ophran Drug and Fast Track designations for the Acclaim-3 patient population. Additional information about the Acclaim-3 clinical trial can be found by visiting ClinicalTrials.gov.