Shareholders might be interested to know: ANZCTR - Registration...

Shareholders might be interested to know:

• ANZCTR - Registration shows the full IONIC record as of 10 November 2021
  • It is a Phase I/II trial
  • Four hospitals currently recruiting patients
  • 30 participants
  • Two arms of 15 each
    • Group 1 consists of patients who are already receiving “a” checkpoint inhibitor and have minor disease progression. This means that patients may have failed Keytruda, so both BMS and Merck should be interested in the results
  • Dose escalation for NOX66 @ 1200mg, 1800 mg, 2400 mg (3 patients each dose)
  • Dose expansion for 6 patients each arm at highest tolerable NOX66 dose
  • NOX66 is Idronoxil delivered by a unique suppository formulation that achieves a steady-state level of active drug that cannot be achieved in practice by oral or IV administration.
• Of particular interest:
  • Each treatment cycle is 14 days
    • Opdivo day 1
    • NOX66 days 1-7
  • First patient started 25 October 2021
  • Scans are done every two months
    • First scan should now be done
  • Scan at four months more likely than two-month scan to show tumour response
  • Patent applications include in-vitro examples of synergy between Immuno-Oncology drugs and NOX66; for instance:
    • The work of the inventors leading to the invention includes the unexpected finding that idronoxil promotes immuno-oncology activity in tumor cells. Through SiP inhibition in tumor cells, idronoxil promotes infiltration of T-cells into a tumor by disabling the defences of the tumor. Idronoxil modulates PD1 and PDL1 expression on T-cells and myeloid cells, therefore being immunogenic itself. In addition to promoting infiltration of T-cells in a tumor, the inventors also identified that idronoxil promotes T cell activation, proliferation and cytotoxicity augmenting tumor killing.
• Note that
  • Blood samples are likely to be taken every month, and
  • Blood analysis likely to give first sign of synergy in humans
    • should show whether there are any changes to circulating tumour cells, or PD-L1 expression
  • Two-monthly scans and monthly blood analyses should shorten the time it typically takes to know whether treatment is effective.