Fresh? No, sorry. However, we will finally see all these different puzzle pieces put together by Thursday morning the latest. 90+3 days - probably on purpose as you don't want to break with tradition (for Cynata shareholders, good news generally happen on Thursdays)
Even if FujiFilm was to "only" take up the GvHD licence for now, it is still a third party commercial validation by an industry major, with manufacturing plants all around the globe now.
Reality check: just over 5 years ago Cynata (EcoQuest back then) still provided updates on "green nappy technology", now it is seen to be disappointing if FujiFilm "only" exercises a licence (our first btw) for CYP-001 in GvHD?!
It took us less than 5 years to get a university experiment from the lab in Madison, Wisconsin to a completed world-first clinical trial, using an iPS derived MSC therapeutic product.
There are now peer-reviewed articles emerging (not ours), citing our preclinical studies and clinical trial (a), in addition to general peer-reviewed articles discussing the potential of iPS-derived MSCs (b), not to mention science journals, especially in Japan (c) and the UK (d):
(a) "Besides this pioneering trial, only one more interventional trial using allogeneic iPSC‐derived mesenchymal stem cells (MSCs) is currently being conducted by the Australian Company Cynata Therapeutics. In this trial, the investigator aims to use mesenchymoangioblast‐derived MSCs for the treatment of steroid‐resistant acute graft‐versus‐host disease (Clinical Trials.gov: NCT02923375). Currently, all eight patients treated so far have demonstrated at least a partial response, while no treatment‐related serious adverse events or safety concerns have been observed 70. The outcomes of these two trials will certainly be helpful for further clinical translation of iPSC‐based therapies."
https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm.18-0134(b) "The key finding from our study is the identification of a rejuvenation gene signature in iMSCs (irrespective of donor age) which also is present in pluripotent stem cells but not in the parental MSCs. Most important for regenerative medicine, iMSCs irrespective of initial age re-acquire a more similar secretome to that of fetal MSCs than aged MSCs. In conclusion, our findings show that the acquisition of a rejuvenated phenotype in iMSCs re-enforces the utility of the “iMSC concept” in regenerative medicine and cell replacement therapy in an ever increasing aging population."
https://stemcellres.biomedcentral.com/articles/10.1186/s13287-019-1209-x(c) "Australia's Cynata started the world's first clinical trial using iPS cell-derived cells for graft vs. host disease (GVHD, a complication causing multiple organ failure after hematopoietic stem cell transplantation) in the UK, with good data released at the end of the year."
https://weekly-economist.mainichi.jp/articles/20190312/se1/00m/020/020000c(d) "[...] The company produced these cells by starting from iPSCs, reprogramming them in to an intermediary cell called a mesenchymoangioblast, and then directing them to become mesenchymal cells. [...]"
https://www.the-scientist.com/news-opinion/increasing-number-of-ips-cell-therapies-in-clinical-trials--65150Whatever FujiFilm decided to do, this is only the beginning, with many more announcements to follow within the next few days/weeks: option exercise, manufacturing, trial in Japan and US.
The meetings we had with the Japanese Regulatory Agency we had in September 2018 (1), sounds a lot like the meeting we had with the FDA back in July 2017 (2), resulting in an Orphan Drug Designation in March 2018 (3).
(1)
https://www.asx.com.au/asxpdf/20180903/pdf/43xzmqzpwy45dd.pdf(2)
https://www.asx.com.au/asxpdf/20170705/pdf/43kfk6m271xqs1.pdf(3)
https://www.asx.com.au/asxpdf/20180328/pdf/43ssdw575gh5vm.pdfRegulatory discussions therefore further advanced in the US you would think, perhaps an IND announcement to follow shortly after FujiFilm exercising (given that they will fund development going forward).
With an industry major with collaborations a la Takeda as partner, we could also see Wotton's connections (finally) coming in handy. In case you don't know, Dr Paul Wotton is our Chairman, who apparently orchestrated the sale of Ocata Therapeutics to Astellas Pharmaceuticals while he was CEO of Ocata. Perhaps a collaboration on the cards there as well, given their interest in iPSCs?
https://sw4503.swcms.net/en/ir-library/ir-meetings/inframe/main/00/teaserItems1/03/linkList/0/link/FINAL_2_181212_RD%20Day_eg.pdfI bet former "nappy shareholders" didn't see ANY of that coming. Even so-called "experts' such as Chris Behrenbruch thought Cynata was nothing but a "hollow chocolate bunny" with a "flip-flop" strategy
Anyways, enough from me for now. Time to sit back and enjoy the show!
- and then went on to invest and head Factor...FTT......one of the biggest duds in biotech ever
(20min delay)