From reviewing the Trials submission data the HER 2 vaccine trial is looking at demonstrating, and defining immune responses to two types of EGFR receptors in a range of solid tumours. From the trial data documents this trial is a phase 1 trial which has determined an Otpimum Biological Dose, and is now in an extension phase which is due to conclude in December 2018. The secondary endpoints of the study also include documentation of response however there are only a small number of patients.
The HER 2 overexpression in advanced gastric cancer is a phase 2 study comparing vaccine+ standard chemotherapy vs standard chemotherapy in patients who over express HER 2, this trial continues until December 2020, or earlier if they recruit enough patients early.
The OSU are apparently 2-3 years further developed in their vaccine research than Imugene’s In house program. The B-Vaxx trial had recruited 3 of 12 patients by May 2018, these will be included in a 48 patient phase 2 trial, with interim results due by Dec 2019.So I suspect this would be the earliest preliminary Phase 2 results would be available.
From the scientific data it appears that combination HER-2/PD-1 vaccines have greatest effectiveness in colorectal cancer cell growth inhibition in animal models by a log factor. These haven’t started yet.
The main issue limiting current oncoimmunotherapy (direct drug blocking of PD-1 receptors and others ) is immune side effects from uncontrolled activation of the immune system. The science of the vaccines seems to be that they are more effective at binding these receptors than the drugs. So there will be significant scrutiny of immune side effects of the vaccines.
it is clear from Paul Hoopers you tube interview that Imugene’s strategy will be hoping to be in receipt of a takeover presumably from one of the Big Pharma companies whom they have on the board. He certainly has the pedigree and methodology to execute this.
it is also clear from his interview that this is unlikely to happen until phase 2 data is available. Looking at the timelines from the Gov Trials website and other documents in the public domain this isn’t likely until Dec 2019 at the earliest or could be as late as Dec 2020. Unless the trials are stopped early, the only; circumstance this is likely to occur is if say there is a significant benefit in all treatment arm patients, over and above those treated by conventional means. The trial would also be stopped early if there was evidence of significant harm in the treatment arm of the trial.
I also note the recent speculation regarding selling. I can only assume that this is by a large holder who has a time line much shorter than that outlined above. Given all the recent announcements and information in the public domain as well as social media subject matter the selling of large volumes of stock suggests an element of impatience, or alternatively concern regarding the broader equities market’s fragile state.
I hold
K
IMU Price at posting:
2.3¢ Sentiment: Buy Disclosure: Held
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