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Genprex Receives Safety Review Committee Approval to Advance to Highest Dose Group in Phase 1 Portion of Acclaim-3 Clinical Trial of Reqorsa® Gene Therapy in Combination with Tecentriq® in Extensive Stage Small Cell Lung Cancer
Genprex (NASDAQ: GNPX) has announced progress in its Acclaim-3 clinical trial for Reqorsa® Gene Therapy combined with Tecentriq® in extensive stage small cell lung cancer (ES-SCLC). The company has completed the 0.09 mg/kg dose group and received approval to advance to the highest dose group of 0.12 mg/kg. Key points include:
- No dose limiting toxicities observed
- A partial remission noted in the first patient treated
- The combination therapy has received FDA Fast Track Designation and Orphan Drug Designation
- Phase 1 dose escalation is expected to complete in the second half of 2024
- Phase 2 expansion will enroll 50 patients at 10-15 U.S. sites
Preclinical data showed the combination therapy provided better tumor control than either agent alone in SCLC mouse models.
- No dose limiting toxicities observed
- A partial remission noted in the first patient treated
- The combination therapy has received FDA Fast Track Designation and Orphan Drug Designation
- Phase 1 dose escalation is expected to complete in the second half of 2024
- Phase 2 expansion will enroll 50 patients at 10-15 U.S. sites
Preclinical data showed the combination therapy provided better tumor control than either agent alone in SCLC mouse models.
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