Situation Report

While we wait for news, I thought it might be worthwhile to comment on some important matters that have occurred in recent times.

• IONIC  This study is open and patients are being screened. I expect patients to be scanned every 2 months, with the 4 month scan being the tell-tale one. NOX is looking for responses where there should be none, so this study should give us signs fairly quickly
  • IONIC is an Investigator-initiated trial led by Professor Paul de Souza, so NOX has had no control over its timing.  Now that all pre-trial procedures have been completed, the addition of trial sites should ensure that patient recruitment is relatively quick.

• DARRT-2  This will be the biggest abscopal response trial of its kind, using for the first time a drug having a mechanism of action confirmed by Weill-Cornell as being critical for the abscopal response. We saw evidence of abscopal responses in the Phase 1 study where we used Veyonda tentatively. In the Phase 2 trial NOX has upped the dose of Veyonda substantially, and doses will be repeated every two weeks. 15 sites in all. First ones now screening, so this study should fill fairly quickly

• CEP-2   CEP-1 was positive. FDA granted an IND on the back of that Phase 1 data. Remarkably, they have allowed use of Veyonda in first line treatment of patients with sarcoma. This will be the first time NOX has used Veyonda in early-stage cancer, so a major step forward

• • CEP-2 is testing NOX66 plus Doxorubicin against Sarcoma, but it will also act as proof-of-principle of using NOX66 in combination with any chemo.

• GBM pipeline drug  Others have tried coming up with drugs that block the way that brain cancers like GBM and DIPG use glutamate to kill brain cells to make room for the cancer to grow. None can be used because glutamate is an essential brain neurotransmitter and those drugs have shut down all brain function. NOX has come up with a drug that blocks the toxic effects of large doses of glutamate, but doesn’t block glutamate brain function generally. The NCI reached out to NOX and the Company is now working with their top GBM researchers

• Pancreas cancer pipeline drug   Early days, but NOX appears to have a drug that blocks the ‘helper’ growth signals coming from the connective tissue cells and which are responsible for the aggressive growth of pancreatic cancer cells

Conclusion.

I haven’t mention Pharmorage, or LuPIN, or COVID but it should be obvious that there is a lot going on in areas of high interest to Big Pharma.  My strong view is that Noxopharm is better placed than it has ever been.