Replies to post #25939 on Biotech Values

[dangerM]

Another rheumatoid arthritis drug, me not impressed

... stumbled over an article today about another ra drug which is described as the next big thing. Well, IMHO, they have an interesting different approach (anti-CD28 mAb), but it's absolutely too early to state anything about efficacy and it's a drug with a horrific history (The article is in German, so not of much use in this forum, anyway: http://www.welt.de/gesundheit/article141436772/Dieses-Rheuma-Mittel-gibt-Millionen-neue-Hoffnung.html).

In case someone here comes across them, to save you work:

It seems a Russian VC fund has bought TGN1412 (see post I am replying to, or http://en.wikipedia.org/wiki/TGN1412), calls it TAB08/theralizumab now and tests it against rheumatoid arthritis*. There is nothing published, nothing peer reviewed yet, only infos from the company itself in an advertorial:

Assessments using the American College of Rheumatology (ACR) response criteria at the 8-week follow-up showed that ACR 20 responses (decrease of disease activity by at least 20%) were observed in 5 of the 9 patients treated with TAB08. In addition, 2 patients had improvements in response criteria of 50% (ACR 50), whereas 1 patient achieved complete remission (markedly over ACR 70)
www.theramab.ru/TheraMAB_NAture.pdf

In short: Me is not impressed. I find the response rather weak at the current dose (c.f. placebo results in Galapagos' Darwin 1: 45% with ACR20, 15% with ACR50). According to the German newspaper article they used about 7% ("1/14") of the original catastrophic dosis of TGN1412, but IMO will need to increase this. Given what happened in the past (near deadly cytokine storm), I'd rather stay away even if they ever progress to a phase III.


*
https://www.clinicaltrials.gov/ct2/show/NCT01885624
https://www.clinicaltrials.gov/ct2/show/NCT01990157