Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) welcomes Cohort Review Committee (CRC) confirmation that the Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx, will proceed to the third and final highest dose cohort.
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.
Imugene has been advised that it can proceed with opening the third PD1-Vaxx Phase 1 cohort at the 100μg highest dose level.
Shares have been as much as 16% higher to A$0.15, a new high of more than 10 years.
“Safety and tolerability”
The ongoing Phase 1 data represents a clinical proof-of-concept signal for PD1-Vaxx monotherapy with early efficacy signals and indicate that B-cell activating immunotherapies can induce clinically active antibody responses against an important immune regulation receptor target.
Imugene managing director and CEO Leslie Chong said: “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.”
Clinical results to date
After six weeks (day 43) treatment with PD1-Vaxx, one patient’s tumour 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.
These are encouraging results in patients who have progressed after previous treatment with checkpoint inhibitors including Keytruda®, Opdivo® or Tecentriq®.
Further results and scans are scheduled over the coming weeks.
Mayo Clinic receives IRB approval
The company has also announced 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.
The first-in-human, Phase 1, multi-centre, dose-escalation study of PD1-Vaxx is recruiting patients with non-small cell lung cancer.
Imugene’s PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction, and produce an anti-cancer effect similar to Keytrudaâ, Opdivoâ and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.
The primary goal of the Phase 1 trial is to determine safety and an optimal biological dose as a monotherapy (mOBD) with efficacy, tolerability and immune response also being measured.
Determination of mOBD will be made by the Cohort Review Committee (CRC) and requires successive dosing within cohorts of at least three patients each.
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