Just in case you haven't read this yet, sent this morning.Dear...

Just in case you haven't read this yet, sent this morning.

Dear all, Hello from Leslie Chong. I am very pleased to announce the Cohort Review Committee (CRC) has confirmed the Phase I clinical trial of our checkpoint immunotherapy candidate, PD1-Vaxx, will proceed to the third and final highest dose cohort. Click here to read the ASX announcement. Phase 1 trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development. I am encouraged that we are seeing positive signals at such an early stage of our PD1-Vaxx Phase I trial. The clinical results indicate that PD1-Vaxx is showing early signs of an immune response in patients, with antibodies to the target biomarker PD1 evident in validated assays. The CRC unanimously agreed PD1-Vaxx to be safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after CRC review of all safety and tolerability data for the second mid-dose patients dosed with PD1-Vaxx (50µg) as monotherapy. At completion of the review meeting, the CRC advised Imugene to proceed with opening the third PD1-Vaxx Phase 1 cohort at the 100µg highest-dose level. Principal Investigator Professor Gary Richardson from the Cabrini Hospital in Melbourne said, " I am excited to hear the Cohort Review Committee recommended opening the third and final dose cohort based on the outstanding safety and tolerability of PD1-Vaxx reviewed to date.". After 6 weeks (day 43) treatment with PD1-Vaxx, one patient’s tumor was non-measurable indicating a complete response (CR), with three patients showing stabilization of disease (SD) and a single patient progressing (PD). The status of two patients from cohort 1 (1 x SD, 1 x CR) were unchanged at day 85. In other news, we are pleased to announce that the prestigious Mayo Clinic in Phoenix Arizona has received Institutional Review Board (IRB) approval to commence and join the Phase I clinical trial of PD1-Vaxx in USA. I am personally very excited about the transformational opportunities we are developing. I encourage you to continue to follow our progress. As always, many thanks for your enduring support. Warmest, Leslie Facebook Website Twitter LinkedIn