Ann: Imugene Licenses Allogeneic CD19 CAR T Cell Therapy, page-356

Well - many good posts here already, by @Taureanbull , @GMT2 , @theoc , @SENARIS , @plumvj and quite a few others. My apologies to those I haven't acknowledged.

It will be very interesting to see what comes up in the promised webinar, but clearly IMU has decided to move into the CAR-T business - as many here have previously speculated might happen. I recall LC saying in a previous interview, or maybe an investor event, that "Imugene is not a CAR-T company" - but it never sounded like a permanent position to me.

Since the OnCARlytics technology arrived, it has been very noticeable that IMU is focused on combining OnCARlytics with new generation CAR-T's - and not with the current commercial products. As has often been discussed here, the first generation autologous CAR-T's come with a high risk of nasty Cytokine Release Syndrome side effects, significant delays (the time it take to develop the drug from the patient's own T cells), and extremely high costs. For a company which prides itself on the low cost, minimal side effects of it's B cell platform, that makes first generation autologous CAR-T's a bad fit.

So the initial steps with OnCARlytics involved partnering with Celularity - for combination with their allogeneic, placenta derived, off the shelf CAR-T (Cycart-19), and also with Eureka for their second generation autologous Artemis CAR-T. Both drugs hold the promise of lower side effects, and off the shelf, cheaper therapy. Both partner companies went ahead with pre-clinical studies, but IMU also ran its own - using an existing (non CAR-T) drug - Blinatumomab (Blincyto).

All three pre-clinical studies produced highly encouraging results, but all three combo drugs required a third party, and both Cycart-19 and Artemis still require IND designation and Phase 1 safety trials .

Now IMU has an allogeneic CAR-T of its own - which already has IND and has already passed Phase 1 safety trials.

The planned Phase 1 "Oasis" trial for OnCARlytics its out a brief initial montherapy stage to assess safety - followed by a combo study with Blinatumomab (see page 32 off the last investor presentation: https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/64bdde10c48ef14d85b12480/1690164768415/Imugene_Corporate_Presentation.01.pdf )

That made perfect sense up until Wednesday's announcement, because neither Cycart-19 nor Artemis are yet at IND stage and ready for a Phase 1 trial in humans.On the other hand Blinatumomab is available, approved for use in humans, and showed good pre-clinical results in combo with OnCARlytics. However, Blinatumomab is not owned by Imugene - (it is produced by Amgen), it's not actually a CAR-T drug (it's a Bi-specific T cell engager), it is massively expensive, and on top of that it comes with a fair chance of nasty side effects.

So.... let's see if IMU can get the FDA to agree to a modification of the Oasis trial, running a combo arm with Azer-cel. Azer-cel is already at IND, with good safety data in humans and very promising efficacy (in Diffuse Large B Cell Lymphoma). Trialling it with OnCARlytics would be a totally new application for the drug, but with the safety data already in, I don't see why the FDA would prevent it.

This could hugely accelerate the development of OnCARlytics and - as many here have pointed out - it puts IMU in a much stronger negotiating position.
They now have their own CAR-T to go with OnCARlytics, and even their own manufacturing facility in the USA. (And yes - that will also add a lot to their spending)

It certainly add to the NASDAQ listing speculation too. I'm personally neutral on NASDAQ (don't know if it would be good or bad) - but I'm extremely positive about IMU having its own CAR-T.

IMU now looks like a very serious emerging Pharma company. I don't know how the market will react today, but if the preliminary data on CF-33 (when it comes out) really does show a good cancer killing effect - that will be huge in its own right, and also further confirmation that the OnCARlytics version is likely to be a success (OnCARlytics can only work if CF33 is sufficiently "infective" of cancer cells). I get the feeling that IMU is a catapult - already heavily wound up and ready to release. Wednesday's announcement just wound it up even tighter.

Cheers

Dave