With all the excitement, anticipation of news and progression of the many clinical trials Imugene is undertaking. I thought I would do an analysis on the timeline PD1-Vaxx followed from '
First Ethics approval' through to '
First Patient dosed' to see if we can identify or anticipate milestones for our Her-vaxx
nextHERIZON (combination) trial given the last announcement was made 10th May, 2022.
There are a number of factors which determine the speed of the trial progression, such as what phase it is, difficulty finding eligible candidates, what country the trial is being conducted in, enrolment size, safety profile etc however there appears to be some similarities between the initiation of the
nextHERIZON Phase 2 trial and the PD1-VAXX Phase 1 trial. As far as the location and estimated enrolment size is concerned.
Recap on recent
nextHERIZON Anns:
US FDA IND APPROVAL FOR THE
nextHERIZON PHASE 2 CLINICAL TRIAL OF HER-VAXX -
13/12/2021 (ANN date) IMU received ethics approval to start HER-Vaxx
NextHERIZON Phase 2 trial (Queen Elizabeth Hospital) -
10/05/2022 (5 months later)
Phase 1 PD1-VAXX TimelineImugene Receives Ethics Approval to Start PD1-VAXX Trial (Chris O’Brien Lifehouse) -
14/07/2020 Imugene Receives Second PD1-VAXX Ethics Trial Approval (Macquarie University hospital) -
17/07/2020 (3 days later)
Imugene Receives Third PD1-VAXX Ethics Trial Approval (Cabrini Hospital) -
21/08/2020 (1 month later)
Imugene Receives PD1-VAXX Ethics Trial Approval in USA - 03/09/2020 (~2 months later)
Imugene Receives FDA IND Approval for PD1-VAXX Trial in USA - 02/11/2020 (~4 months later)
Imugene First Patient Dosed in PD1-VAXX Clinical Trial -
01/12/2020 (~5 months later)
IMUGENE COMPLETES ENROLMENT OF FIRST COHORT IN PHASE I CLINICAL TRIAL OF NEW CHECKPOINT IMMUNOTHERAPY PD1-VAXX -
17/12/2020 (~5 months later)
Imugene Dose Escalates in PD1-VAXX Phase 1 Clinical Trial -
21/01/2021 (~5 months later)
Given
nextHERIZON has already received FDA approval and as of today we're ~2 months since receiving the ethics approval, its likely we could see an announcement in the very near term with a headline reading
'IMU first patient dosed in nextHERIZON clinical trial'. 
It's worth noting that the trial is for patients who have previously received Herceptin and progressed on this treatment, which may or may not hinder the enrolment process.
Obviously there is no complete science to this, the order of the approvals for example suggests that and these are purely my speculations based off past ANNs, but thought I would share for those interested. DYOR GLTAH's!
Cheers, tin-tin
