Genprex is making strides in the development of its Reqorsa immunogene therapy for mesothelioma, a rare and aggressive cancer affecting the lining of the lungs, abdomen, or heart. The company has established a Mesothelioma Clinical Advisory Board to guide the preclinical program of Reqorsa (quaratusugene ozeplasmid) in mesothelioma.
Addressing Unmet Needs in Mesothelioma
Mesothelioma poses a significant challenge, with approximately 3,000 new cases diagnosed annually in the United States and 2,500 deaths each year. Pleural mesothelioma, the most common form, affects the tissue around the lungs and carries a life expectancy of only 18 months, with a 3-year survival rate of 23% despite treatment. Genprex aims to address this unmet medical need with Reqorsa.
Reqorsa Mechanism and Clinical Trials
Reqorsa is an intravenously delivered gene therapy that uses a nonviral lipid-based nanoparticle to deliver a plasmid expressing the TUSC2 tumor suppressor gene. TUSC2 expression is reduced or absent in 84% of mesotheliomas. Besides mesothelioma, Reqorsa is also being evaluated in combination with Tecentriq (atezolizumab) as a maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) in the phase 1/2 Acclaim-3 trial (NCT05703971) and was being evaluated in the phase 1/2 Acclaim-1 clinical trial (NCT04486833) in combination with osimertinib for non-small cell lung cancer (NSCLC).
Clinical Advisory Board
The newly formed clinical advisory board includes four researchers from major research institutions specializing in mesothelioma treatment. According to Ryan Confer, MS, president and chief executive officer at Genprex, this group will provide advice and input to assist the Genprex team in advancing their program in mesothelioma.
Acclaim-2 Trial Update
Genprex has decided to stop enrolling new patients in the Acclaim-2 trial (NCT05062980), which was evaluating Reqorsa in combination with Keytruda (pembrolizumab) for NSCLC patients whose disease had progressed after Keytruda treatment. The company cited difficulties with patient enrollment due to competition with other clinical trials as the primary reason for this decision. Patients already enrolled in Acclaim-2 will continue to receive treatment until disease progression. Despite this adjustment, the FDA has granted Fast Track Designation to all three combination therapy clinical programs, and the SCLC program has received Orphan Drug Designation.
According to Confer, the decision to halt enrollment in Acclaim-2 was a business decision driven by slower than expected enrollment due to the high number of competing lung cancer trials. He also noted the possibility of revisiting this trial in the future, given the FDA's Fast Track Designation.
