What a cracking announcement to wake up to... well done to the IMU team! Thanks again to some solid contributions from the usual suspects: WMHB, Outlander, Zior, Bluebrando, Fat, Oxxa & Davy + others I have missed.
It doesn't seem that long since I asked Leslie about Breakthrough Therapy during a webinar; even though it is not the same Fast Track, I still didn't expect anything until mid-next year. They really are travelling at a blistering pace.
Fast Track, no matter what anyone tells you is a big deal. Thanks Davy for highlighting some of the data, it's certainly worth diving deep into what it all means. A lot of people switch off when they see Phase I or II trials but in this case they'd be seriously missing a golden opportunity.
In my opinion, one of the biggest implications outside of faster approval is money; IMU will save 10s of millions in trial & staffing costs, data gathering and possibly 100s of millions in the eyes of BPs. Assuming all goes well with the 10 patients, a registrational study Phase II could likely be approved very quickly. I doubt they will do that alone. However, I expect a partner will come very soon. Notably, the CR was in a patient with negative PD-L1, which has a poor prognosis/cold tumour/Keytruda ineffective, and from memory, the other Bile Duct patient who achieved SD was in the Combo arm. It's likely Merck is very well aware both these outcomes...Once a drug is approved, other indications can come fast and frequently. With Vaxinia's safety profile, this will likely occur at lightning speed, especially in unmet need indications like Bile Duct. This will require BP's deep pockets.
For anyone scoffing at the fact this is for the IT arm, these patients have no other option, not even surgery. Unresectable (can't be removed surgically) tumours can still be treated with Vaxinia via intratumoral injections (IT). i.e. CF33 doesn't require IV to be a feasible therapy. 5-year survival for metastatic Bile Duct patients is 2% (See here). Any stage is less than 10 per cent. Approximately 8000 patients in the US are diagnosed with Bile Duct cancer, of which the standard therapy of chemo is hugely inadequate. Therefore, fits 'unmet need'. Recent Phase III trials have achieved an average PFS of around 12 months, according to our CMO. We already have a 1:1 patient on a very low relative dose (compared to the dose in the expansion) who's progression-free beyond that point from our Phase I study. Certainly bodes well for the expansion.
Biotech valuations are very complex but to keep it simple, just suppose for a second Vaxinia ONLY treated Bile Duct patients and became first line treatment. For context the numbers that are relevant 8000 patients annual in the US, if Vaxinia becomes standard of care:
8000 patients x cost of Vaxinia to patient = Yearly Revenue.
The yearly cost of Keytruda is circa $150,000 USD. Coupled with Chemo, it goes well above that.
Even at $100,000 as a sole agent:
8000 x $100,000 USD = $800m USD or $1.2 Billion AUD per annum.
For only one relatively small indication. That also wouldn't be peak sales (as only US), but even at the average multiple for buyouts, you'd be looking at $6 Billion AUD. Again, for one indication. It's still well and truly early days, but Vaxinia and not to mention OnCARLytics could be effective in many indications.
My mind boggles at the potential here, and here is why. Although there have been a lot of positive moves forward with cancer, in my opinion, we (humans) are largely still losing at a hiding to nothing, especially in some of the very nasty ones. Just to name a few there are annually:
~200,000 diagnosed with TNBC ~313,959 diagnosed with Ovarian Cancer ~495,000 diagnosed with Pancreatic Cancer ~30,000 diagnosed with Mesothelioma ~800,000 diagnosed with Liver Cancer
Fast track won't get us approved in these indications in the short term, but if successful in being approved and with a BP partner, it's possible IMU will be able to provide a more effective treatment to a lot of people in desperate need.
In my opinion, it's now become 'when' not 'if' around BPs involvement, let's also keep in mind that although IMU is travelling quickly, BP will be able to travel much much faster, so BP will also be considering that. Will the prefer to wait for more data to come out slowly, or pull the trigger and get the data flowing across multiple indications i.e. multiple potential revenue streams sooner. If they think it's a winner, I have put my money on the latter.
First things first though, at least 10 Bile Duct patients need to be dosed and data read out first for any approval discussions to hold water. It will be very interesting when the data cut takes place for the JP Morgan conference. With rolling data allowed with the FDA, it surely bodes well for swifter confirmation of the data from them. Plus, IMU doesn't need to wait for cohorts to carry on; as soon as the trial starts, they can seek out the 10 patients immediately. Ahhh a lot to look forward to (as always it seems), 2024 looking to be the legit breakout year for IMU, all IMO of course!
Cheers.
IMU Price at posting:
10.0¢ Sentiment: Buy Disclosure: Held
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