Sites Expanded for Acclaim-3 Clinical Study of Reqorsa Therapy in Combination with Tecentriq to Treat Small Cell Lung Cancer

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Through a collaboration agreement with a large network of integrated, community-based oncology practices, Genprex has expanded the site network of the Acclaim-3 clinical study (NCT05703971) 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).¹

Acclaim-3 is a Phase I/II open-label, dose escalation study. It 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 I dose-escalation portion of the study was initially expected to enroll 12 patients at three to five United States clinical sites. That number has now been doubled to approximately 10 sites to determine the maximum tolerated dose.¹

If no dose limiting toxicities occur during the Phase I portion, the highest dose evaluated will be the recommended Phase II dose. The Phase II study is expected to enroll approximately 50 patients at 10-15 US sites. Genprex expects to initiate the Phase II expansion study in the second half of 2024.¹

According to the American Cancer Society, estimates for lung cancer in the US for 2024 are at about 234,580 new cases. In general, about 10%-15% of all cases are SCLC, while 80%-85% are non-small cell lung cancer (NSCLC).²

"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," Rodney Varner, president, chairman, and CEO of Genprex said in a press release. "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."¹

For the Phase II portion, the primary endpoint 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.¹

"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," Mark Berger, MD, chief medical officer of Genprex said in the press release. "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."¹

The Acclaim-1 trial (NCT04486833) is an open-label, multi-center Phase I/II study evaluating Reqorsa in combination with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with Tagrisso. In February 2024, Genprex announced the first patient was dosed in the Phase IIa expansion portion of the study.³

References

1. Genprex Expands Clinical Trial Sites for Acclaim-3 Clinical Study of Reqorsa® Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer. News release. April 3, 2024. Accessed April 4, 2024. https://www.prnewswire.com/news-releases/genprex-expands-clinical-trial-sites-for-acclaim-3-clinical-study-of-reqorsa-therapy-in-combination-with-tecentriq-to-treat-small-cell-lung-cancer-302106790.html

2. Key Statistics for Lung Cancer. American Cancer Society. Updated January 29, 2024. Accessed April 4, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html

3. Genprex Announces First Patient Dosed in Phase 2a Expansion of Acclaim-1 Clinical Study of Reqorsa® Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer. News release. February 5, 2024. Accessed April 4, 2024. https://www.genprex.com/news/genprex-announces-first-patient-dosed-in-phase-2a-expansion-of-acclaim-1-clinical-study-of-reqorsa-therapy-in-combination-with-tagrisso-to-treat-non-small-cell-lung-cancer/