Hey Sector,
Look - I actually think Cynata have a great product and I think it's very fair to see them as a strong competitive product next to Mesoblast's cell lines. I think they will have really potent efficacy in a range of indications and have a great platform for scaling their technology.
A couple of problems:
1) Osteoarthritis is a very difficult first disease area to target. It's got a very complicated pathophysiology. We're pretty sure that OA sees a benefit from MSC therapies due to their anti-inflammatory nature and are likely to lead to cartilage regeneration and hopefully bone spur reduction. However, it is a noisey first target. A hyaluronic vehicle would probably be beneficial, but then you will need to include an HA only condition (which you're not) and the standard of care for OA is already HA gels. I am sure Cynata's cells will out perform HA gels when they are combined with HA gel, but you will likely need a big sample size to show that. However, you're not even testing against HA - you're testing against placebo - which is hardly a clinically relevant study. It is also being performed in Aus - the FDA really don't like that. Regardless, collectively your looking at requiring another phase III before you go commercial and that's AFTER this one completes and potentially yields sufficiently positive data. A long way from market.
2) You don't have freedom to operate even when you get to market. Cynata only has these patents for disease treatment:
- Asthma: US20200276243A1
- Side effect to immunotherapy: TW201920659A
Meanwhile, Mesoblast holds these bad boys:- Joint repair using mesenchymal stem cells: US9814580B2
1. A method of repairing damaged meniscal tissue in a joint of an animal with osteoarthritis, rheumatoid arthritis, gout, reactive arthritis, psoriatic arthritis, or juvenile arthritis, comprising:administering directly to the joint via intra-articular injection a suspension comprising isolated allogeneic mesenchymal stem cells in an amount effective to repair damaged meniscal tissue in the joint of the animal, wherein the mesenchymal stem cells differentiate into and/or stimulate production of meniscal tissue, andwherein the suspension is administered in the absence of a scaffold.
- Methods of generating, repairing and/or maintaining connective tissue in vivo: US20200101118A1
1. A method of treating or preventing a disease in a subject arising from degradation or inflammation of connective tissue, the method comprising administering to the subject a population of cells enriched for STRO-1+ MPCs or progeny cells thereof.
- Enhanced msc preparations: US20200231936A1
1. A method of making an MSC preparation which inhibits IL2Ra expression by CD3/CD28 activated PBMCs
- Multipotential Expanded Mesenchymal Precursor Cell Progeny (MEMP) and Uses Thereof: US20210355447A1
56. A composition comprising a cultured or expanded cell population wherein at least 10% of the total cell population are expanded multipotential MPCs that have the phenotype STRO-1bright, ALP− and are also positive for one or more of the markers Ki67, CD44, CD49c/CD29, VLA-3 or α3β1, and wherein the composition further comprises STRO-1dim cells wherein the STRO-1dim cells are committed to a lineage of tissue or cell type selected from the group consisting of neural tissue, fat, cartilage, skeletal muscle, cardiac muscle, epithelial tissue, tendon, ligament, odnotoblast, pericyte, smooth muscle, glial tissue, vascular tissue, endothelial tissue, haematopoietic tissue, hepatic tissue and renal tissue.
To name a few...
Cynata does not have freedom to operate in these markets as their cells are not sufficiently different from MSB's to hold up in litigation. I believe this is one of the reasons Ross is so salty towards MSB because he has such a great product, but MSB don't want to buy it, and if MSB doesn't want to buy it, everyone else is put off by their IP position. Maybe that's why that take over bid didn't come to pass, they had a look under the hood and saw that Cynata would have to pay license fees to MSB for any revenues.
Don't believe me? Why does Cynata have 5 ish patents and none of them are patents that cover composition of matter or even methods to treat for their main pipeline item? Kinda fundamental don't you think? Wouldn't these have been prioritised if they were able to get past the US examiner?
Who knows, maybe MSB will finally acquire you guys once we have a bit of spare cash from their 4 commercial products. To be fair Cynata is far enough away from having their OA indication go commercial that MSBs patents may have expired by then, so maybe Cynata will wait it out and hope that MSB doesn't file an extension.
Happy to provide a more indepth analysis on Cynata's IP position on the Cynata forums if you would like...
Gang Gang
(20min delay)