Competitive landscape, page-193

How does IMU's OV pipeline rate against 'the rest'?

Recently, @Hunter bunch posted a link to Delvelsight’s overview of the biotech ‘players’ in the oncolytic virus (OV) space. Of course, Imugene is just one of the ‘major’ companies pursuing OV treatments for cancer.

“DelveInsight’s Oncolytic Virus Cancer Therapy Pipeline report depicts a robust space with 70+ active players working to develop100+ pipeline therapies for Oncolytic Viruses Cancer treatment”. It sounds like a crowded space, doesn’t it?

My time is limited, but I thought I should have a closer (but quick) look at the leading OV candidates (ie those in, or entering Phase 3). Or, in other words, know thy enemy.

There seems to be two ‘front-runners’. Very happy to be corrected here.

1.CG Oncology -USA based (via the work of Kissei in Japan). They are using CG0070, which is an adenovirus, so a medium sized virus. Adenovirus is a common virus that can cause a range of cold or flu-like infections. It appears there are about 50 types of adenoviruses that can infect humans. By most counts it is not a ‘severe’ virus, compared to many. During its Phase 2 trials it has proved safe and effective. CG Oncology are targeting NMIBC – a specific bladder cancer. Thedosing levels they are using are 1 X 10 to 12^th. It has even had success in combo with, yes, you guessed it .... Keytruda (pembrolizumab). So, you would have to say ... very promising.

2. Oncolytics Biotech (ONCY) – a Canadian based bio, are using palareorep, which is a reovirus. Reovirus is a large complex virus, and like the adenovirus, is generally not considered severe (outside some nasty diarrhea sometimes seen in children). Pelareorep in combination with anti-PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), and chemo, has received fast track designation from the FDA for the treatment of patients with advanced/metastatic pancreatic cancer. Pelareorep causes tumour cell lysis (result = death of cell) and generates innate and adaptive anti-tumour immune responses, so to me, it’s also a good candidate.

Should IMU worry about these ‘front-runners’?

Well, in my opinion ... not really, and for several reasons. You of course, may weigh this up differently to me ... but here our (IMU’s) strengths, when compared to the candidates mentioned above.

First: These other potential treatments seem to be targeting very specific cancers. This is not a bad thing at all, because in the ‘history of trials’, narrowing your target may increase your chances of success. This I believe, was a lesson learned in the early HER-Vaxx trials.

BUT ... Yuman, in his CF33 trials, appears keen to challenge just about ANY cancer. The ‘standard’ 60 lines + 20 more. There doesn’t appear to be a need to just tackle a single type of cancer. If indeed the CF33 suite can successfully treat any cancer, then it is already way ahead of the‘front-runners’ mentioned above.

Second: We are also in combo with Keytruda (pembrolizumab) with both CF33 and HER-Vaxx, so we are ‘well in the game’.

Third: With the recent chances made by the FDA under the Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics guidance, IMU has the opportunity to catch up, if indeed we are granted an accelerated approval (AA) under the ‘new’ guidelines. Remember, we can see what our CF33 suite is doing to tumours (via tracking) ... sometimes within a week. That’s ridiculously fast.

Fourth: Did you notice the virus dosing level required by the adenovirus above? We are on track to hit the ‘sweet spot’, at a much lower dosing level. Think ... safety.

Fifth, sixth, seventh ... well, its over to you. This was just my ‘quick look’, in an effort to start a discussion around the science. I know there is at least one oncologist out there, on these threads (I won’t name you), probably more ... so I would like to hear your thoughts (and anyone else who is prepared to write more than a ‘one-liner’).

So, this is my opinion. What are your thoughts?

And please provide some ‘evidence’ to support your comments. We have many here that are more than capable.