MSB's product for aGVHD showed striking efficiacy in a clinical trial and there's clear growth in Temcell. This is enough proof imo that the technology works for this condition.
If the technology works for aGVHD, it's likely to work for other inflammatory conditions. I was interested to learn that Seattle Children's Hospital are planning a trial to examine the similarities of GVHD and IBD:
https://ibdnewstoday.com/2017/05/25...bd-and-graft-versus-host-disease-in-children/
They don't specify whether acute or chronic so I emailed them and got a reply saying they'll be looking at both. With GVHD there are often gastrointestincal symptoms (causing the highest death rate), the feeling of fullness on an empty stomach, diarrhea, nausea and vomiting. There can also be involvement of the liver, skin, eyes. These are also symptoms in IBD. In the case of aGVHD, Infliximab is one of the drugs used for rescue. It's also the most commonly used biologic in IBD.
MSB's phase 3 clinical trial in Crohn's Disease hasn't been mentioned for a while, but their website says it's active. Assuming all is going to plan and considering the similarities between these two conditions, I think it's reasonable to suppose that CD results could be on par with aGVHD.
As of 2012, 0.5% of people in Western society were living with IBD (Molodecky et al. 2012) with the prevalence of IBD potentially increasing exponentially (Kaplan,2015) Visiongain puts the global market for IBD at around 10 billion for 2017.
There's no doubt the biologics have done a good job managing IBD, but a significant number of patients don't respond or build antibodies. The emergence of biosimilars could increase the number of refractory cases if switching occurs. According to Ferrari et al. writing in the World Journal of Gastrointestinal Surgery (May 27, 2016), in spite of the use of biologics, 30-40% of CD patients will still require surgery at some time in their life. Unlike ulcerative colitis, surgery doesn't cure CD and it's not uncommon for a patient to undergo multiple non curative surgeries.
What will follow on from Inflixmab and Humira? I thought the more targeted drugs hadn't materialised but that's incorrect. Vedolozumab (Entyvio) has recently been approved. From what I've read, it doesn't block TNF and is gut-specific. This drug, however, appears to be more effective in Ulcerative Colitis than Crohn's and in patients who haven't previously been exposed to biologics.
Edward V Loftus Jr MD, a gastroenterologist at Mayo clinic in Minnesota, says about Vedoluzumab, "When you look at the data, it raises the question: 'If you have a Crohn's disease patient who is steroid-dependent and has failed anti-TNFs and you're ready to pull the trigger on a biologic, would this be the first choice?
The small number of online reviews for Vedoluzumab in CD are underwhelming. Another important thing from a patient's perspective is side effects. Not talking specifically about Vedoluzumab, but an IBD drug can have 'a good safety profile' but unpleasant side effects. This is not really what patients want but they take these drugs because there's nothing else.
There was hope in the IBD community for Celegene's Mongersen but endoscopic results were disappointing. If there's not mucosal healing, it's not remission. I find it hard to believe Celegene isn't interested in MSB's CD candidate.
According to Wang et al. (Journal of Biomedical Science, November 2016) who provide an overview of clinical trials in MSCs, there are four in phase 3 for CD. I checked myself but could only find three: MSB's and two others. The other two were for fistulising CD. One is autologous and the other localised. It's important to remember is that even if there's a competing product, results may not be the same as some MSC lines are more effective than others.
MSB's aGVHD product showed striking efficacy in a clinical trial and there's impressive growth in Temcell, which speaks to efficacy in clinical practice. While steroid-refractory aGVHD is a very small market, there are implications for other inflammatory conditions. I've looked into the competition and can't really see much.
So what's with the apparant apathy surrounding this company? Any praise seems muted or there's a negative slant like that 'Cash and Burn' article posted on this forum. Someone like me can see the value in MSB technology but big money can't? This doesn't make sense to me and if something doesn't make sense, it's unlikely to be true.
I believe this company is being watched very carefully. I can't say what will happen about partnerships or the share price. Even if a company is really valuable, it doesn't mean things won't get ugly (as we experienced with A2M), which is why I'm prepared for anything. Investing in a biotech at this stage is risky.
All IMO. DYO research and trust your own perception. Good luck to all holders
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