CYP (ASX) Ann: Quarterly Activity Report &amp; Appendix 4C

Originally posted by benelong: ↑

Well, @JB1975, @Barman76 is looking pretty good, even though I doubted his claim also. This should interest you too, @pfeifer1982. Here's the source material he relies on and that you asked for. Convinces me. You are entitled to disbelieve Dr Itescu if you like. A totally unjustified opinion in the case of this particular person. Your assertions vs his professionalism? Anyway, we won't have long to know for certain.

Below is an extract of the relevant part of @vinn's post Post #:43755148 from 29 March. A very penetrating article from TWST. The whole article is worth a read. I have added some emphases.

The whole advantage of our cells is that they work in terms of the effect that they produce. They are able to simultaneously affect multiple pathways. So by definition, the underlying mechanism itself positions us to target the most refractory, sickest subsegments of major diseases. That is how we would look at each of these disease states. If we succeed, we make a major impact. Obviously, manufacturing, regulatory and clinical trial design all come into it, and I think that Mesoblast has successfully navigated through all of those factors.

In terms of manufacturing, which I was touching on earlier, we have an industrialized, scalable manufacturing process. From individual donor source material, we are able to substantially scale and make thousands of therapeutic doses that all look the same, that have the same release criteria, potency assays,characteristics to ensure that each product that is cryopreserved and frozen and shipped to supply chain from the manufacturing side to the end user meets the same rigorous release criteria and reproducibility that you would expect from any drug.

That is important because it provides the confidence that clinical trials will be meaningful. It will give us data that we can be confident around because of the consistency of the product. But equally as important, it provides the comfort to regulators such as the FDA that we have a process that we can control well and that each product looks the same and is safe. At the end of the day, as a commercial company, we need to be able to verify that to the patients, to the stakeholders and to the regulators.

TWST: And I understand too that your company’s off-the-shelf products are allogeneic, so cells from a single donor can be used in different recipients without the need for matching. Could you talk about that?

Dr.Itescu: Yes, that is unique to this type of cell. This cell is lacking co-stimulatory molecules, which are normally necessary for the immune system to recognize and respond, so they do not activate the immune system and, therefore, can be used across genetic boundaries. Using our media, they can be quickly grown up and expanded in very large numbers. They are ideal to use from a single donor to treat literally thousands of unrelated recipients.

So unlike CAR-T therapies, which are patient-specific autologous, our therapies are all off-the-shelf allogeneic. That is unique to their cell type and allows us to scale and manufacture large batches of reproducible products from individual donors. Now, each of our Phase III programs has products made from different donors to ensure that there is no donor-to-donor variability, and this has already been verified.

At the end of the day,the final batch of products that goes out the door is the same no matter which donor it came from, but very few donors are needed for us to make very large numbers of therapeutic doses for our commercial needs. This is a very scalable and efficient manufacturing process. Moreover, we have proprietary technologies developed using serum-free media and the use of bioreactors as it allows to scale up to much higher levels — as and when the commercial requirement arises— so that we are not in any way constrained by manufacturing.

Expand

Sorry benelong I dropped the reply box - looking back at your reference in vinns post in what seems to be a sort of transcript I see he has Dr Itescu above the statement " From individual donor source material, we are able to substantially scale and make thousands of therapeutic doses that all look the same, that have the same release criteria, potency assays,characteristics to ensure that each product that is cryopreserved and frozen and shipped to supply chain from the manufacturing side to the end user meets the same rigorous release criteria and reproducibility that you would expect from any drug."

If Dr Itescu said that in writing or on a record its a pretty provocative statement of prowess and I won't deny that. He is claiming that are able to do that now (at the time of the statement) as I read it. He is saying nothing about cost (which is likely to matter at some point).

I'm not sure what he means by "that all look the same" - it could be just a trivial reference that all the cells look similar in form or it could be a reference to deeper looking like checking for karyotype. If the cells didn't look the same (even trivially to a trained eye) that would be a fair indication that something wasn't right with them.

To be fair I've got to admit that looks provocative.

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