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This is an excellent comparison. Perspective Tx started their Phase 1 last year and the first results were out in late 2023 or early 2024. The first cohort had a decent safety profile and the SDMC recommended to move on to the 2nd dose cohort in mid-Jan 2024. Since then, the SP has gained ~300%. The platform was partially proven, hence the investment was significantly de-risked so the SP grew. This is the problem with AIM, such rational responses are simply not seen.
The only real difference that I can see is that Perspective Tx does seem to present at nearly every health/oncology conference under the sun. Whereas, Avacta appear to be very conservative on where/when to present.
Spot on. Found this on cancer research uk:
-Incidence rates for soft tissue sarcoma in the UK are highest in people aged 80-84 (1996-2010).
What more data do you think they will release? They give us continued updates on the patients still on trial...but is there something you don't think that they have released yet that they should?
@PL - yeeeehawww!
After the 2QW trial ends, so likely late summer or early fall.
Interesting idea Bella. Definitely possible that the 'important announcement' that it is the sale or spinoff of Dx. However, I don't agree with the rest of the theory. They will never pay off the bond with cash. The cash is always better used to fund the pipeline. Getting new money (either through a sale or a raise), to pay off other debts is simply not something that young biotechs do. They are always cash hungry.
@GoSushi - not sure. But my guess is that we could use the Keytruda Melenoma study as an example...so 150-200 or so?
@GoSushi - that's true, a Phase 1 study with n=173 patients.
@GoSushi - Avacta have mentioned that they are in direct discussions with the FDA currently and that the results of these discussions will be made public 'mid-year', i.e., when the Q2W trials ends. Approval at this stage (it would only be limited approval and further trials would be required) would be a pretty amazing feat, but if the results continue to be stellar it is possible (significantly improved efficacy and reduced side effects). To be fair, it is more likely that these conversations are about trial design in order to obtain approval after the P2 trial. But one can hope.
@AVCT - The disadvantages would be giving a drug to patients (before it is fully proven with long trials and hundreds of patients) that isn't as effective as the standard of care, or has some particularly bad side effect that hasn't been discovered so far in the trial due to low numbers. While the chances are low of this (the data so far are pretty clear about the advantages of ava6k), this is why the FDA (and medical community) go slow and systematically.
Earliest: Sept 2024 (at the end of Q2W)
Latest (most likely): end of P2, so sometime in 2026.
(assuming the stellar results continue)
My guess is August. And like the Q3W trial, the more dose escalations they go through, the larger the potential benefit to patients, but the longer it will take. Hopefully they make it to the C6 dose level.
Exactly my think PL đź‘Ť
Yes, we have been told that Avacta are in active discussions with the FDA and that Avacta will not be able to comment on the discussions until mid-2024. Two things to note: 1) it is not common for a company to be in 'active discussions' during a clinical trial (i.e., normally once approved by the FDA the company just gets on with the trial) which implies that there is something that needs discussion, of which breakthrough status and/or accelerated approval requirements are possibilities. And 2) why mid-2024? That is when the 2QW dosing trial is predicted to end. Hence, it will be after 2QW that the results of the discussions might be released.
What do you mean York? Avacta already have orphan drug designation for av6k.
It will be a subtype of STS.
Great stuff Rambo!
@Taverham and Largo - no, this is standard practice in biotech. New results are often released at conferences and then released to the market afterwards. Sometimes after the conference entirely, but in our case it will just be after the poster presentation on Tuesday. So we will get a copy of the poster along with CC's explainer video Wed morning (the poster could conceivably be released on Tuesday evening UK time, but more likely Wed).
No, poster presentation on Tuesday at the conference. Poster and data will be released to us on Wed.
Agreed LL - it's a tough decision and critically dependent on what the offers (for ava6k or 3996 or other Precision drugs) are for and for how much (upfront and percentages).
A good comparison to ava3996 - BMS paid $100M upfront for a "phase-1 ready ADC" (i.e., end of preclinical) for an ADC from Orum Therapeutics for acute myeloid leukemia which is a relatively rare form of cancer. And ava3996 is meant to be "tumour agnostic". So that's the ballpark we're playing in.
@GoSushi - that has been addressed multiple times. The Phase 2 will be pivotal (assuming that it meets all primary and secondary endpoints), meaning that it can be approved based on the results. Phase 3 will still be required (as in all drugs) but that can take place while the drug is on the market.