Saturday, March 26, 2016

Updating A 2011 Item: We Now Know Why A Merck Affiliate Invested In Then-Tiny HTG Molecular (Diagnostics)

It's a calm, sunny (pre-workout) Saturday morning, so let's scratch one off the long neglected "to do" list: back in early 2011, very little was disclosed in Merck's public SEC filings about this privately-held diagnostics company, in which then Whitehouse Station (now Kenilworth) had made an investment through a majority controlled affiliate called Merck Capital Ventures LLC.

I've been meaning to update this for over a year, since HTG went public, and much more was made known about HTG's operations. This was NOT a "throwback" investment (as I wrongly guessed back then) -- in diagnostics, in 2011 -- no, it was a "Back to The Future" one.

It turns out that the HTG technologies may be able to rapidly identify oncology patients with tumors that express high concentrations of PD-1, and are thus very strong candidates for Merck's Keytruda® (or pembrolizumab, if you prefer). Merck's affiliate owns 9 per cent of this company, down from 11.2 per cent pre-IPO.

So here in 2016, it all makes perfect sense -- from the SEC filings of HTG Molecular, then:

. . . .Recently, single-marker IHC tests have been approved as companion or complimentary diagnostics for anti-PD-1 checkpoint-inhibiting therapies. A proliferation of checkpoint inhibitors targeting additional ligands and receptors for CTLA4, OX40, LAG3, Tim-3 and others, coupled with combination approaches, is challenging the one-marker / one-drug diagnostic paradigm that previously advanced IHC-based companion diagnostics (e.g. HER2, ALK, c-KIT, etc). Understanding the complex biological framework of the tumor microenvironment is becoming increasingly important in interpreting the host immune response to tumors and developing the best single or combination therapy approach. The need for multiplexed gene expression assessment is illustrated in the graphic below where two histologically similar DLBCL tumors elicit very different host immune responses. . . . [Editor's note: do click the link here, to see HTG's graphics.]

Now you know -- and so sorry for being so slow to update this item. Enjoy your holiday weekend -- off to the opera tonight, for a son's birthday celebration. [And that makes. . . 3,700 posts, in just under ten years, here.] Onward!

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