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# Genprex Gets Orphan Status for Reqorsa
- URL: https://www.fdaweb.com/genprex-gets-orphan-status-for-reqorsa/
- Published: 2023-08-11T12:00:00.000Z
- Updated: 2026-09-14T18:49:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155084

FDA has granted Genprex an orphan drug designation for Reqorsa immunogene therapy (quratusugene ozeplasmid) and its use for treating small cell lung cancer. Genprex says its method is to re-express tumor suppressor genes in cancers, and Reqorsa contains a plasmid that expresses a tumor suppressor gene protein called TUSC2.

“Virtually 100% of small cell lung cancers have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression,” the company says. “Pre-clinical studies in mice suggest that re-expressing the TUSC2 protein may lead to clinical efficacy.”

Genprex says it will begin its Phase 1-2 Acclaim-3 clinical trial in the fourth quarter. The open-label, dose escalation and clinical response study will evaluate Reqorsa in combination with Tecentriq 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.