Avid Bioservices Inc (CDMO)

[Protector]

EndoTarget, from this fragment:

Disclosed are methods of identifying tumor-derived exosomes as an early cancer diagnostic, as well as for staging, assessing progression and assessing therapy of cancer.

...

Also provided is a kit comprising (a) a phosphatidylserine (PS) binding agent; and (b) an exosome detection agent.

I cannot with certainty derive that the PPHM exosome test can identify the cancer. It suggest that they inject something (a binding agent that binds PS and (geuss) exosomes at another arm) and then use a blood test after (and possibly one just before the injection) to detect the presence of exosomes bound to PS and compare it between the either two blood tests or with a scale. It says DETECT exosomes (incl. amounts), not IDENTIFY exosome type and extrapolate the cancer type. However, I seem to remember something as been said about detecting metastases and they might either be based on amounts or because of the ability to see a MIX of exosomes being bound to PS in sufficiently high critical masses in staid of always the same ones

The RED part in the above quote can be seen in several ways:
- to assess therapy of cancer you'd have to know what cancer you are dealing with.

- but maybe that statement is based on the value of the test of assessing the cancer therapy AFTER an initial EXOSOME test and one does OTHER tests to find what the cancer type is (helped by standard diagnostics).

IMO the above or the rest of the quote that I didn't re-post does not clearly tell us IDENTIFY the TYPE of CANCER.

We know it works for ALL SOLID CANCERS but it isn't clear WHAT it does for ALL SOLID CANCERS. Maybe just tell us we have a cancer, that it is benign or not and in what stage it is. That on its own, certainly if a BASE-LINE test would be required, would immediately generate HUGE business when ready as a production test, but that is not my point.

My point is that, FOR NOW, I have no HARD FACTUAL EVIDENCE that this PPHM EXOSOME BLOOD TEST can tell us also WHAT CANCER it detected.

In other words, we know PS is PS, no matter what cell it comes from because PS stands for phosphatidylserine and that is a well defined molecule.

We know that for this test something is BOUND to PS and that PPHM is looking at a combination of PS and EXOSOMES. We also know that the tumour environments of liver, lung, etc cancers are different because the cell types in which the tumours grow are different to begin with, hence there debris and microvesicle composition.

If this tests knows how to extract the PS from the bloodstream and filter it (PS with exosomes attached and without) and if the exosomes can then be identified and mapped based on an list, then the cancer could be indentified. Question is, does this test do that and/or can any future test do it based on the patents even if they didn't start with that now?

SO I would like to have the answer from PPHM or UTSW and skip the guessing part. It is not so difficult for PPHM that knows it has share-holder to write a non-research biologist grade sentence in a PR, is it.

Actually, I am not asking for more than that, just tell us what it exactly does AND NOT DOES.

As for the patent. Very possibly we will indeed be able to extract such information from it, BUT that doesn't tell us if that has ALSO be implemented in this exosome test (or the one that will be commercial grade). From a COST perspective we'dd like to know if we are talking about ONE TEST or if a specific test PER CANCER would be needed. That last case would, IMO, take the binary use away because you would have to know UP-FRONT what cancer you suspect to be there and then test for it.

That may still have value in different from of what we THINK this test can do so far.

So PPHM must fill us in here and with us the MARKET with clear statements on what they have so we can evaluate the potential impact it will have on our investment.

I don't know how FDA regulation works for this. You don't treat a patient, this is ex-vivo diagnotics. So blood tests are allowed, doing test on the blood with patients consent too. So that leave the question if proof-of-concept suffices or if a clinical trial is needed. Possibly if you produce a few 100% proof-of-concepts the FDA will grant some speed-up path to approval (if approval is applicable).

Next we can then SPECULATE if all this has something to do with CEO King's statement to become profitable within 21 months (the re-confirmed as 18 months, that would be about 15 months from now). Or was that purely based on Avid or something else?

With the ANALYST short-cut in last Q/CC useful information on these topics might not have come our way.