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Re: eastcoastguy post# 320593

Tuesday, 12/12/2017 6:54:11 PM

Tuesday, December 12, 2017 6:54:11 PM

Post# of 346050
Eastcoastguy, re your post excerpted in relevant part below:

The rapid wind down of R&D, departure of Shan and the ghosting of SK tells me there is a deal framework in place. What is the trigger, more data, timing issues, or competition from multiple BP's?

. . . . . . . .

What is the IP worth? Some here think it's multiple billions but IMO we don't have enough information to make that assessment. What I do know is SK,ES and many of our legacy team have options averaging over 8/sh. We have investors like Dart and Ronin with substantial investments in this company. The marketplace will decide the value as long as it's open bidding.



As North and Jedd Wolchok have been indicating - a probable "deal framework" is coming together. A human trial design is "ready" - and will start when "the company" says GO !!! But who will be that company? That is the 64 Million Dollar question. Or is it ?

Jedd only referred to "the company" - meaning ONE. He of course did not give a name to "the company." But perhaps a review of a recent post from North might help us discover the most likely "company" to which is may be referring.

1) Dr. Wolchok did discuss more extensively the CAR-T therapy he discussed only briefly during his Wistar presentation a year earlier. He noted the FDA had approved CAR-T therapies for use in humans, specifically that of KITE.

He pointed to the recent acquisition of KITE by GILD, and also the acquisition of the private company discussed in post #s 3202239 and others[e.g.,'264, '256, '273], all in an attempt to improve the safety of such therapies that have been found unpredictably toxic--sometimes fatal as in trials by KITE and JUNO--by reason of cytokine storms. He cautioned that the administration of such therapy to patients must now be accompanied by readiness to quickly administer a mitigating steroid to control those toxicities.

I then renewed that question to ask, in light of the year of further experience, data collection, posters presented at 2017 AACR [e.g. #1651] and 2017 SITC by PPHM and MSKCC, his discussion re CAR-T [my summary in paragraph 1) above], and clinical trials begun by other NCCN members [one by JHU, another by MGH and D-F], if anything had been done by MSKCC to initiate a clinical trial in human patients? He answered by stating that an experimental design had been completed for such a trial...for what indication(s) he did not say, nor did I ask.

Rather, I asked "when will that trial design be implemented"? He said "that depends on the company." as he left the auditorium.



To lend a little more color and credence to the story - see the following excerpts from an article posted on December 10, 2017 by Jonathan Faison:

[quote]Gilead Doubles Down On CAR-T: Updates To Thesis

In my first piece I stated the following:

While many might doubt management's ability to pull off the right kind of acquisition, past deals give me the confidence to give them the benefit of the doubt. The right strategic deal at the right time is simply one of several potential upside drivers- personally, I speculate one in the $5 to $15 billion range, preferably in oncology, could be in the cards.

In August the company announced the $11.9 billion acquisition of Kite Pharma, a move which lit a fire under other CAR-T stocks including a favorite of mine bluebird bio (BLUE) that I recommended as the principal beneficiary of money flowing into the sector. If peak sales of Yescarta come in around estimates of $2 billion or so, the acquisition price would appear in hindsight to be quite acceptable.

Later in mid-October Yescarta crossed the finish line when it became the first CAR-T therapy approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

In the next few years I wouldn´t be surprised to see the CAR-T space continue to heat up. Apparently, Gilead´s management feels the same, as they weren´t content with the first acquisition and announced on December 7th the takeout of Cell Design Labs for $567 million.

Management is not content to be merely a pioneer in the field and wishes to jump ahead of the likes of Novartis and Juno to make its own destiny. While Cell Design Labs is a preclinical company, the company´s proprietary technology platforms synNotch and Throttle should come in handy as useful add ons to Gilead´s existing CAR-T clinical programs, including helping them to eventually expand treatment to additional oncology indications including solid tumors.

Advances in safety would also be very important going forward and a way to distinguish themselves from fierce competition.



And then finally, a short post - again from North - which quite clearly lends support to the ever growing confidence Dr. Wolchok and MSK seems to have for the future of the IP.

Realist, If you have kept up to date, Dr. Wolchok does not appear to think the PPHM mab family is worthless, does he. I will count on his opinion more than I will count on yours or vinmantoo's.



There will of course be at least several "bidders" - but GILD would seem to have the best chance of being "the company" when all the dust settles.

And it appears that the dust may be settling SOON : ) - as the following would seem to strongly suggest:

...Pg.4: “Business Description – We are a company committed to improving the lives of patients by manufacturing pharmaceutical products through our CDMO, Avid Bioservices, Inc. Over the next 60 days, we plan to complete the transition from a R&D company to a dedicated CDMO company focused on dev. & mfg. of biopharmaceutical products derived from mammalian cell culture…”



Enjoy your evening.

James
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