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smart spider

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03/03/24

20:13

Post #: 72721357
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Originally posted by Jov88: ↑

As Rolly suggested, impossible for us to know. But I have provided some thoughts below on how I see it.

The speed of approval revolves around safety and efficacy.

Vaxinia is currently in Phase I. Phase I’s are conducted to mainly determine safety (it’s the first time a therapy has been tested in a human) with the added intention of determining the recommended Phase II dose (RP2D). Or human dose that’s most effective with acceptable safety. With that being said IMU has been efficient with their design of the MAST trial to have a focus ALSO on efficacy. Which means they are gathering clinical data to confirm effectiveness.

Currently Vaxinia has proved to be safe and efficacious. However, the RP2D hasn’t been confirmed yet. Although, it’s likely they are currently at this dosage or close to it.

Once this dosage is confirmed, there will be multiple expansion trials, the first one being in Bile Duct Cancer which has already been announced and has received Fast Track designation.

Once that starts the data produced from it will really be the confirmation needed to achieve approval. It’s a smaller trial however in a rare cancer type, so who knows how long it will take to gather the 10-20 patients they are aiming for. If Vaxinia performs relatively well in this trial you could make a case for 12-18 months from commencement until an approval in granted.

That’s not to say there wouldn’t be significant SP inflection points in between with any positive announcements across the rest of the trials though. Even positive data from current higher dose cohorts in MAST could boost the SP in a big way. Not to mention OnCARlytics…

So in summary:

1. Vaxinia RP2D still needs to be confirmed (3-6 months)
2. Expansion Trial to commence and enrol (12-18 months)

With these loose estimates conservatively 1.5 to 2 years from now until approval.

Now, of course if 10 Bile Tract patients are enrolled fast, are treated and it’s looking stella (Objective response rates in most and little toxicity) it could happen faster. This is mainly due to Bile Duct cancer qualifying as a rare disease, so IMU could apply for Vaxinia to be approved as an orphan drug. Which means approval can be granted within 60 days from confirmed Real World Data from a small sample size (hence why expansion trial n=10-20) and also no requirement for a randomised trial (Phase II or Phase III). Even on this basis I’d give it 12 months minimum from now.

It could be a stroke of genius attacking Bile Tract cancer first and seeking fast approval in this space. If approved and data continues to be positive other indications will be approved ‘tout de suite’.

Cheers.

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Thanks @Jov88 this answers my questions. I posed the question fully knowing there are many ifs and buts.

All i wanted to know was any prior scenario that any one aware of the process and logical end of a drug being assigned a fast track FDA.

Thanks for your response, much appreciated.
SS

IMU Price at posting: 12.0¢ Sentiment: Hold Disclosure: Held
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