Genprex has dosed the first subject in Phase I/II clinical trial of its drug candidate, Reqorsa Immunogene Therapy (quaratusugene ozeplasmid), plus Tagrisso (osimertinib) to treat late-stage non-small cell lung cancer (NSCLC).

Reqorsa leverages ONCOPREX Nanoparticle Delivery System of Genprex and has the tumour suppressor TUSC2 gene as its vital ingredient. 

Administered intravenously, Reqorsa comprises TUSC2 gene encapsulated in a nanoparticle developed from lipid molecules possessing a net positive electrical charge. 

It can precisely act on target cancer cells that usually have a negative electrical charge. 

Named Acclaim-1, the open-label, multicentre trial will enrol late-stage NSCLC patients with activating epidermal growth factor receptor (EGFR) mutations who have progressed on receiving Tagrisso, a registered trademark of AstraZeneca

The company anticipates enrolling up to 18 patients in the Phase I part of the trial, a dose-escalation study, to determine the maximum tolerated dose of the Reqorsa plus Tagrisso combination therapy. 

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The Phase II segment will have nearly 74 subjects who will be randomised into a 1:1 ratio to receive either Reqorsa plus Tagrisso or Tagrisso alone. 

Progression-free survival, assessed as time from randomisation to progression or mortality, is the primary endpoint of this segment of the trial.

Furthermore, an interim assessment will be carried out at 25 events. 

To expedite subject enrolment in the Acclaim-1 trial, Genprex had included four more study centres taking the total number of sites to five. 

The company also intends to include more sites for the trial’s Phase II segment. 

Genprex chief medical officer Mark Berger said: “Based on both the preclinical data and previous clinical data, Reqorsa has the potential to improve the response to current targeted therapies, such as Tagrisso, for this study patient population.”

“Reqorsa is a pan-kinase inhibitor shown to inhibit both the EGFR and AKT oncogenic kinase pathways. 

“We believe that Reqorsa’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.”