Noxopharm presses ahead with Veyonda® clinical activity over June quarter

Noxopharm Ltd has made study progress across its drug development portfolio during the June quarter, setting the stage for a busy September quarter. The clinical-stage drug development company worked across its four development programs over FY21’s final quarter, with activity across its clinical oncology, cancer research, septic shock and chronic inflammatory and autoimmune diseases portfolios. Moving into the September quarter, Noxopharm anticipates its NOXCOVID data release and will decide on the next stage of this candidate’s clinical development, while patient treatment is set to commence in the company’s IONIC and DARRt-2 clinical cancer studies. The ASX-lister capped off the financial year with $26.8 million in the bank to fund its future operations. Veyonda clinical — cancer Over the June quarter, Noxopharm worked across four clinical cancer programs that utilise its Veyonda® anti-cancer treatment candidate. As part of its DARRT program, the ASX-lister secured Investigational New Drug approval, paving the way for a clinical phase two trial in the US. Since then, Noxopharm has confirmed the international sites for a phase two trial, while start-up activities continue. In the current quarter, the drug development company hopes to refine the trial’s clinical protocol with investigator feedback. Meanwhile, Noxopharm’s IONIC program underwent two major modifications in the June quarter. First, the study’s recruitment base was expanded to include patients whose cancers have progressed on several different immune checkpoint inhibitor. Then, a number of additional Australian sites, including major teaching hospitals, requested to join the study. Both the IONIC and DARRT-2 studies expect to commence patient treatment in the September quarter. In addition to its work across these two programs, Noxopharm also evolved its clinical CEP and LuPIN and pre-clinical cancer studies over the June quarter. Generally, each of these programs are designed to evaluate Veyonda’s efficacy in tandem with existing anti-cancer drugs or therapies. Veyonda clinical — septic shock Noxopharm is also trialling Veyonda in a NOXCOVID trial, which is designed to test whether the treatment candidate can block cytokine release syndrome (CRS), colloquially known as the ‘cytokine storm’, and improve the outcomes in patients hospitalised with COVID-19. A major trigger for CRS is thought to be the Stimulator of Interferon Genes (STING) signalling pathway, an inflammation trigger mechanism that responds to lung tissue damaged by viruses like the coronavirus and influenza.  In some individuals, the STING response is inappropriately excessive, inflicting even more damage on the body and predisposing to septic shock.  So far, independent pre-clinical studies have confirmed that idronoxil (the active ingredient in Veyonda) blocks this excessive STING response in what appears to be a comprehensive way, raising the prospect of successfully dampening down CRS in at-risk patients. The results of the NOXCOVID and pre-clinical studies, along with the in-vitro studies demonstrating the exact STING signalling blockade mechanism, are intended to provide the scientific rationale needed to further examine Veyonda’s efficacy against COVID-19 and sepsis. Phamorage In November last year, Noxopharm teamed up with the Hudson Institue and Australian National University to form Phamorage, a drug development company focused on a treatment for septic shock. However, because STING signalling has been identified as a legitimate drug target for a wide range of chronic inflammatory and autoimmune diseases, Phamorage will also focus on pre-clinical studies in this space. Combining expertise on the STING signalling pathway from the Hudson Institute and Noxopharm’s proprietary drug discovery and delivery platforms, Phamorage is currently screening molecules designed in-house to selectively interact with two molecular targets. The company plans to file its first provisional patents on these compounds during the September quarter. Overall, Pharmorage believes it has established a key proprietary position in this new area of drug development and proposes to focus on particular autoimmune disease indications along with septic shock. Oncology research and development Over the June quarter, Noxopharm also made a series of major advances across drug pipeline designed to complement Veyonda and increase the company’s profile as a drug discovery company. The pipeline is focused on drugs designed to block growth signals from neighbouring healthy support cells, as well as killing cancer cells directly. These signals, known as ‘helper’ growth signals, are now seen as major contributors to cancer growth, particularly in highly aggressive cancers, such as brain and pancreatic cancers. Noxopharm has identified a novel family of molecules from the same proprietary technology platform that produced idronoxil that block these so-called ‘helper’ growth signals and is working with a number of Australian universities to help identify lead candidate compounds.