Ann: Product Development Program Update & Investor Presentation, page-5

After watching Paolo Geurreiro scoring against Australia, I thought let's stay on topic and talk about drug dosing.

Today/now yesterday I was made aware of the differences in dosing between Cynata and MSB, the number 1/4 was mentioned.

When looking into that, I found the following:

MSB (as per February presentation):



Cynata:

Cohort A & B: 2 doses

Meaning:

Day 28:
MSB injected 16 mio (8 x 2 mio*) cells per kg bodyweight
CYP injected between 2 mio (2 x 1 mio - lower dose) and 4 mio (2 x 2 mio) cells per kg bodyweight

Day 100:
MSB injected 24 mio (16 mio + 4 x 2 mio*) cells per kg bodyweight
CYP unchanged between 2-4 mio cells per kg bodyweight

Lets take a 80kg male (below average Japanese, average Aussie/European and way way way below average American):

On day 100 -
MSB injected 1.92 billion cells
Cynata injected between 160 mio cells (lower dose - 1/12 of MSB's) and 320 mio cells (higher dose - 1/6 of MSB's)!

- a lot less cells per treatment/adult
- according to management lower cost of production per cell

Yet, our results (as per previous post):

Cohort A:

Day 28:
OR 100% (8/8)
CR 12.5% (1/8)
Survival rate 87.5% (7/8)

Day 100:
CR 50% (4/8)

Day 180:
Survival rate 87.5% (7/8)

Cohort B:

Day 28:
OR 86% (6/7)
CR 57% (4/7)
Survival rate 100% (7/7)

In comparison to MSB:

• our cells appear to "kick in" a lot faster (day 28: OR 100% compared to 69%),
• our patients seem to life longer (day 100: 87.5% compared to 75%), and all still alive after 6 months (MSB has not yet reported that figure),
• our patients have a greater chance of CR (A 28 days 12.5%/less than MSB using 1/12 of the cells MSB has used & 100 days 50%, B 28 days 57% using 1/6 of the cells MSB has used), compared to... MSB hasn't reported their CR rate? Neither 28 nor 100 days? Unless I missed it. Help? Please note, this is incorrect. MSB reported a CR of 29% at day 28 and a PR of 40% = OR of 69% compared to Cynata A 100%/B 86%).

Also worth while noting that only 89% of their patients (children - less cells needed as based on body weight) are of the worst grade, while ours are 100% (adults). Please note, this is incorrect. As per graph released yesterday, A consisted of 5/8 patients with Grade 3 and B consisted of 4/7 patients with Grade 3. Interesting however, it appears that the worse the disease, the better the chance of a CR (A 100 3/4 patients, B 28 2/4 patients).
Our trial recruited 16 patients (15 dosed), compared to MSB's figures being based on 55 patients.

And all that with a partner lined up, willing to pay the bills from P2 onwards (as opposed to a credit facility).

Yes, maybe the two companies cannot/shouldn't be compared with each other.

Enough to proceed straight to P2 trials not just in GvHD, but also in all other diseases using our cells, as long as pre-clinical data is compelling.

Speaking of multiple shots on goal (if only the same could be applied to the Socceroos vs. Peru...): MSCs, currently ~850 clinical trials world wide in ~70 different disease targets.

#mindblowing

Please correct me if wrong.


*https://globenewswire.com/news-rele...tment-of-Acute-Graft-Versus-Host-Disease.html