- Imugene Limited (ASX:IMU) has received the approval from CRC to progress to second dose cohort in PD-1 Vaxx’s Phase I clinical trial.
- The CRC has unanimously agreed on PD1-Vaxx to be safe following a review of the first low dose cohort of patient’s data.
- Imugene is also progressing with the Phase 1 trial of PD1-Vaxx in the USA.
Marking a major breakthrough, Imugene Limited (ASX:IMU) has obtained the Cohort Review Committee’s (CRC) approval for the ongoing PD-1 Vaxx’s Phase I clinical trial. The Cohort Review Committee has validated that the Phase 1 trial of PD1-Vaxx will progress to the second dose cohort.
In mid-December 2020, Imugene completed the enrolment of the first cohort of patients with low-dose PD1-Vaxx at the Cabrini Hospital in Melbourne and Macquarie Hospital in Sydney. Three patients with non-small cell lung cancer were successfully dosed as part of the first cohort.
Medical investigators are testing three separate doses of PD1-Vaxx in patients with non-small cell lung cancer under Phase 1, multi-centre, dose-escalation study. The key objective of the trial is to ascertain an optimal biological dose as a monotherapy (mOBD) and determine safety.
The Cohort Review Committee will determine the optimal biological dose that requires successive dosing of PD1-Vaxx within cohorts of minimum three patients each.
CRC’s Approval for 2nd PD1-Vaxx Phase 1 Cohort
The Cohort Review Committee evaluated all tolerability and safety data for the first three patients dosed with the minimum dose of PD1-Vaxx (i.e., 10mcg) as monotherapy. The committee observed no serious adverse reactions & no dose-limiting toxicities (DLTs), and unanimously agreed on PD1-Vaxx to be safe.
After reviewing the first low dose cohort of patient’s data, the CRC has recommended continuing to the subsequent dose escalation due to tolerability and safety. Principal Investigator Professor Gary Richardson from the Cabrini Hospital has confirmed the same.
Imugene informed that the Cohort Review Committee has advised the Company to proceed with initiating the second PD1-Vaxx Phase 1 cohort at the mid-dose level of 50mcg.
Phase 1 Trial Underway in the USA
Besides Australia, Imugene is also progressing with the Phase 1 trial of PD1-Vaxx in the USA following the receipt of US FDA Investigational New Drug (IND) approval. The FDA IND approval is a huge milestone for the Company, which has been granted after a gold-standard scientific and regulatory review.
The Company also holds Independent Review Boards’ (IRBs) approval to proceed with the Phase 1 trial of PD1-Vaxx in the USA. The approval reflects that it is scientifically and ethically appropriate to progress with the PD1-Vaxx clinical trial.
Imugene has recently notified that clinicians at study sites in the USA and Australia will determine whether the administration of the Company’s PD1-Vaxx as monotherapy in lung cancer patients who have progressed on SOC (standard of care) immune checkpoint inhibitors will:
- delay tumour progression,
- reduce the tumour burden, or
- prolong survival.
Imugene shares traded at $0.115 on 22 January 2021.