IMU (ASX) Ann: Quarterly Activities/Appendix 4C Cash Flow Report

Originally posted by Watmighthavben ↑

My take on the quarterly activities report is that Imugene appear to be devoting much time to recruiting sites for their clinical trials when perhaps the focus needs to change toward educating oncologists and in turn recruiting patients to them. Historically speaking there appears to be a very slow take up in many of their clinical trials with participants always on the minimal side, despite the large number of sites in play. The FDA allows Imugene to recruit between 3 - 6 patients per cohort in some of their trials, only to find its always closer to 3 enrolled. We only now hear as at May 2023 of one patient enrolled in the much lauded OASIS Trial for solid tumours when close to 90 percent of all cancer patients suffer with solid tumour diagnosis. With the right information surely oncologists in the US let alone Australia would be jumping all over this for their patients. Likewise PD1 Vaxx, the Imprinter Trial and the supposed supply agreement with Roche. What there aren't enough lung cancer patients out there worthy of Professor Kauamaya's already successful B cell vaccine, and a subsequent update in this Quarterly Activities Report?

Imugene promises much at the commencement of these trials, but attaining an FDA IND and dosing the first patients is but a small part of the job done. Their Her-Vaxx Keytruda Combination Trial being but one example. Big Pharma is often seen spending large sums recruiting hundreds if not thousands of patients to their clinical trials (i.e, competitors Enhertu and Jemperli). I realise for whatever reason Imugene does not wish to hop on board with them in the early stage of drug development, but from where I sit with low participation numbers its beginning to hurt them. A slow boat to China may have been ok a decade ago, but now the world of cancer research is moving at a rapid clip. With quantum computing and AI on the uptick vaccines are being tried and tested in years, not decades. Within a few years these timelines may be reduced to months. I would like to see Imugene rapidly expand their existing clinical trials to amass much more meaningful data through larger sample sizes across the broad spectrum of cancer indications. After close to two years in the clinic the company's flagship candidate Vaxinia now has only 20 patients on ongoing therapy. Whilst that may be suitable for some, I see the sample size as being far too small given the drugs exciting potential pre clinically. Particularly now the CF33 TNBC Trial appears dead in the water.

A rethink of trial expansion, commercial direction and supply/partnership agreements is required from the top down if Imugene is to deliver on investor expectations. The shareholders I'm confident would support the necessary company expansion to create more of the aforementioned data, be it via the NASDAQ, partnership or out licensing route. But clearly decisions need to be made sooner rather than later. PD1 Vaxx and in particular their extensive oncolytic viral arm and ancillary products need a real "pick me up" when one assesses these activities from an objective viewpoint, as opposed to the subjective view of a rusted on shareholder.

DYOR Seek investment advice as and when required Opinions only

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"The FDA allows Imugene to recruit between 3 - 6 patients per cohort in some of their trials, only to find its always closer to 3 enrolled"

The 3+3 cohort design is a widely used approach in early-phase clinical trials.
It is considered to be a practical and straightforward method for determining the maximum tolerated dose (MTD) of investigational drugs or treatments.

The 3+3 design involves enrolling patients in cohorts (batches) with increasing doses.
Each cohort consists of three patients initially.
The goal is to identify the highest dose level that does not cause unacceptable toxicity.
The trial starts with the lowest planned dose, If no significant toxicity (dose-limiting toxicity, or DLT) is observed in the first cohort, the trial proceeds to the next higher dose.

Only if a DLT occurs, additional patients are enrolled at the same dose level.

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Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-94

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Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-94

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