Imugene Limited (ASX:IMU) Doses First Patient in Cohort 2 under PD1-Vaxx Phase 1 Trial

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Imugene Limited (ASX:IMU) Doses First Patient in Cohort 2 under PD1-Vaxx Phase 1 Trial

 Imugene Limited (ASX:IMU) Doses First Patient in Cohort 2 under PD1-Vaxx Phase 1 Trial


  • Imugene Limited (ASX:IMU) has dosed its first patient under the PD1-Vaxx Phase 1 trial in the mid-dose (50µg) cohort 2 in the USA.
  • Three different doses of PD1-Vaxx will be examined by medical investigators as a part of the PD1-Vaxx Phase 1 trial.
  • The recent dosing marks the official commencement of Imugene’s FDA IND approved clinical trial in the USA.

Imugene Limited (ASX:IMU) has recently announced the dosing of first patient in cohort 2 in the Phase I clinical trial of PD1-Vaxx. The Company dosed its first patient in the mid-dose (50µg) cohort 2 at the New Jersey-based Hackensack University Medical Center, USA.

Following the key update, Imugene shares marked an uptick of ~10 per cent to $0.110 as at 12:04 PM AEDT.

The Company is progressing with the Phase 1, multi-center, first-in-human, dose escalation study of PD1-Vaxx, which is recruiting patients with non-small cell lung cancer. The Phase 1 trial includes testing of three different doses of PD1-Vaxx - 10µg, 50µg and 100µg.

The key objective of the Phase 1 study is to determine safety as well as an optimal biological dose as a monotherapy (mOBD). Moreover, the trial will also measure efficacy, tolerability & immune response in patients dosed with PD1-Vaxx.

Necessary Approvals in Hand

Imugene holds FDA Investigational New Drug (IND) and Independent Review Boards’ (IRBs) approvals to proceed with the Phase 1 trial of PD1-Vaxx in the USA.

Furthermore, the Company recently received the Cohort Review Committee’s (CRC) approval for the Phase 1 clinical trial. The committee validated that the Phase 1 study of PD1-Vaxx would proceed to the second dose cohort.

Related Read: Imugene Limited (ASX:IMU) Proceeds to Next Dose Escalation in PD1-Vaxx’s Phase 1 Trial

The CRC granted an approval after assessing all safety and tolerability data for the first three patients dosed with 10µg of PD1-Vaxx (the minimum dose) as monotherapy. Additionally, the committee noted no dose-limiting toxicities (DLTs) & no serious adverse reactions, and unanimously agreed on the B-cell immunotherapy PD1-Vaxx to be safe.

Following the review, the CRC advised Imugene to progress with kick-starting the 2nd PD1-Vaxx Phase 1 cohort at the middle dose level of 50µg.

Know About PD1-Vaxx

The PD1-Vaxx is Imugene’s B-cell immunotherapy, peptide cancer vaccine which has been designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction. Besides, the PD1-Vaxx has been devised to produce an anti-cancer effect akin to Keytruda, Opdivo & other immune checkpoint inhibitor monoclonal antibodies, which are transforming the treatment of an array of cancers.

The Company is proposing to develop anti PD-1 immunotherapy to treat patients with lung tumours that overexpress the ligand of PD1, PD-L1/2. The hypothesis is that a polyclonal-induced B-cell antibody response will be as effective or more effective with improved safety over existing monoclonal antibody therapy.

Notably, therapies with monoclonal antibodies targeting PD-1 and its ligands are associated with impressive response rates in various cancers and have revolutionised cancer treatment.

Interesting Read: Imugene’s (ASX:IMU) Q4 2020 is All About HER-Vaxx and PD1-Vaxx Developments


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