Genprex Makes Moves to Bring its Gene Therapy Product Reqorsa to Mesothelioma
Notably, today, September 26, is annually observed as Mesothelioma Awareness Day by the patient and clinician communities.
Genprex has formed a Mesothelioma Clinical Advisory Board with the intent of bringing quaratusugene ozeplasmid (Reqorsa), its investigational immunogene therapy intended to treat various forms of cancer, to mesothelioma.1
Genprex, which has a preclinical program for Reqorsa in mesothelioma, is also currently evaluating the gene therapy product in the phase 1/2 Acclaim-1 clinical trial (NCT04486833) in combination with the marketed epidermal growth factor receptor tyrosine kinase inhibitor osimertinib (Tagrisso; AstraZeneca) for the treatment of non-small cell lung cancer (NSCLC) and in the phase 1/2 Acclaim-3 (NCT05703971) in combination with Genentech's checkpoint inhibitor Tecentriq (atezolizumab) as a maintenance therapy for patients with extensive stage (ES)-SCLC who have not experienced tumor progression following initial standard treatment with Tecentriq and chemotherapy.1,2 The company noted that the new clinical advisory board includes 4 “world-renown researchers” who come from major research institutions specialized in mesothelioma treatment.
Notably, today, September 26, is annually observed as Mesothelioma Awareness Day by the patient and clinician communities. Genprex notes that in the United States 3,000 new patients are diagnosed with mesothelioma every year and 2,500 patients die of mesothelioma-related causes each year. Pleural mesothelioma, which constitutes 80% to 90% of mesothelioma cases affects the tissue around the lungs known as the pleura. Currently, pleural mesothelioma carries a life expectancy of 18 months and a 23% 3-year survival rate with treatment.
“We continue to develop a robust research program around our Reqorsa gene therapy to expand its potential benefit to new patient populations, and we are pleased to assemble a group of highly respected physicians to assist in advancing our preclinical program in mesothelioma,” Ryan Confer, MS, the president and chief executive officer at Genprex, said in a statement.1 “This group of world class researchers will not only provide advice and input to assist the Genprex team in moving forward our potentially promising program in mesothelioma, but the formation of this board underscores our continuous efforts to advance our research programs in some of the most difficult to treat cancers with patients who have limited treatment options or an unmet medical need.”
Reqorsa is delivered intravenously and consists of a plasmid expressing the tumor suppressor gene TUSC2, which has reduced or absent expression in 84% of mesotheliomas, encapsulated in a nonviral lipid-based nanoparticle. In addition to the Acclaim-1 and Acclaim-3 trials, Reqorsa was previously being evaluated in combination with PD1 antibody Keytruda (pembrolizumab, Merck) in a phase 1/2 clinical trial referred to as Acclaim-2 (NCT05062980).2 Notably, however, in August 2024 Genprex made the decision to stop enrolling new patients Acclaim-2, which had been recruiting patients with NSCLC whose disease has progressed after being treated with Keytruda alone. Genprex stated that a number of factors contributed to this decision, highlighting difficulties with enrolling patients related to competition with the many other ongoing clinical trials that are recruiting from the same patient population. The company noted that participants already being treated in Acclaim-2 will continue to receive treatment in the trial until disease progression occurs. All 3 combination therapy clinical programs received fast track designation from the FDA, and the SCLC program received an FDA orphan drug designation.3,4
“The data supports the Acclaim-2 clinical trial that we had initiated,” Confer explained in a September 23, 2024, interview with CEO Magazine.5 “In Acclaim-2, our drug Reqorsagene therapy, was being used in combination with Merck's drug Keytruda, which is one of the largest-selling cancer drugs in the world, and it is used in several different cancer types. The issue we were seeing primarily is that several pharmaceutical companies have clinical trials designed in combination with Keytruda as well, just because it is such a well-known drug, and we were part of that mix. There are hundreds of lung cancer trials that we are essentially competing with to get patients into our trials, and, as a result, we saw slower than expected enrollment. Therefore, it was a business decision to cut that clinical trial. We could certainly come back to that trial in the future if we wanted to. We have an FDA Fast Track Designation associated with that clinical trial patient population, so there is certainly validation of it being an approach that the FDA thought had potential.”
