Genprex, Inc. has successfully completed the 0.09 mg/kg dose group in the Phase 1 portion of the Acclaim-3 clinical trial for Reqorsa® Gene Therapy, targeting patients with extensive stage small cell lung cancer (ES-SCLC).

The Phase 1 trial has demonstrated a favorable safety profile, with no dose-limiting toxicities reported in the completed dose group.

Following this success, the Safety Review Committee has approved the escalation to the highest dose group of 0.12 mg/kg.

Enrollment for the 0.12 mg/kg dose group is expected to begin soon, with completion anticipated in the second half of 2024.

Reqorsa, in combination with Tecentriq® (atezolizumab), has received FDA Fast Track Designation and Orphan Drug Designation for the treatment of SCLC.

Recent data presented at the October 2023 AACR-NCI-EORTC Conference highlighted that the combination therapy significantly controls tumor growth in humanized mouse models.

The studies indicated that the combination of Reqorsa and Tecentriq provided superior tumor growth control compared to either treatment alone.

Initial results from the trial showed that one patient experienced a partial remission, defined by a 30% decrease in tumor size after two cycles of maintenance therapy.

Genprex is dedicated to developing innovative gene therapies for cancer and diabetes, utilizing non-viral delivery systems for its treatment candidates.

In animal models, Reqorsa demonstrated strong antitumor effects in xenografts resistant to sotorasib and showed synergistic effects when combined with sotorasib.

Genprex has filed two provisional patent applications for the use of Reqorsa in treating mesothelioma and glioblastoma, co-owned with collaborating institutions.

Looking ahead, Genprex announced that research collaborators will present further data on Reqorsa® Gene Therapy at the 2024 EORTC-NCI-AACR Symposium in Barcelona, Spain, from October 23-25, 2024.