In a re­mote Ver­mont ski town, 3 ex­ecs raised $93M for a stem cell re­search cam­pus. Pros­e­cu­tors say it was all just a scam

Jay Peak ski re­sort Jay Peak re­sort

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Pe­ter Shum­lin Twit­ter

The Jay Peak ski re­sort isn’t the most like­ly place you’d find a biotech re­search cam­pus de­vot­ed to stem cell re­search and the de­vel­op­ment of ar­ti­fi­cial or­gans. Set in the rugged moun­tain area in Ver­mont’s North­east King­dom, it’s just a few miles from the Cana­di­an bor­der. And its slopes bring in skiers from the world over.

Just not a lot of biotech ex­ecs, un­less they’re com­ing to hit the black di­a­monds.

Ariel Quiros HCA East Flori­da via Youtube

Nev­er­the­less, a re­sort own­er and two of his al­leged ac­com­plices man­aged to raise $93 mil­lion to back con­struc­tion of a biotech fa­cil­i­ty that was wide­ly her­ald­ed as a big jobs cre­ator. Even for­mer gov­er­nor Pe­ter Shum­lin tout­ed the project, anx­ious to be aligned with an ac­tive de­vel­op­er as re­sort own­er Ariel Quiros and pres­i­dent Bill Stenger pre­sent­ed them­selves as.

But this week, a year af­ter set­tling charges lev­eled by the SEC, Ver­mont U.S. At­tor­ney Christi­na Nolan said it was all just a crim­i­nal con job, wrapped in lies. Quiros, Stenger and Ko­re­an part­ner Jong Weon Choi were in­dict­ed by a Grand Ju­ry on the scam charges, which out­line a scheme to siphon off much of the mon­ey they raised to pay off loans or line their pock­ets.

Christi­na Nolan US De­part­ment of Jus­tice

In late 2013, Quiros, in par­tic­u­lar, was out on a ledge as Ray­mond James de­mand­ed re­pay­ment of a $21 mil­lion loan. Ac­cord­ing to the charges, he got that out of the biotech stash they had cre­at­ed through an EB-5 pro­gram — a fed­er­al plan that pro­vides for­eign­ers with a quick path to per­ma­nent res­i­den­cy if they make an “at-risk” in­vest­ment in the US that cre­ates at least 10 jobs.

To do that, pros­e­cu­tors al­lege, the de­fen­dants came up with a pho­ny es­ti­mate of the num­ber of jobs that would be cre­at­ed. And they pre­sent­ed plans to make mon­ey from stem cell prod­ucts and ar­ti­fi­cial or­gans as part of their busi­ness plan.

The de­fen­dants mis­rep­re­sent­ed their abil­i­ty to mar­ket a heart re­gen­er­a­tion stem cell ther­a­py prod­uct. The prod­uct was not com­mer­cial­ly vi­able and the de­fen­dants had no rights to such a prod­uct.

Bill Stenger Jay Peak Re­sort via Youtube

In fact, there were no stem cell prod­ucts, ac­cord­ing to the in­dict­ment. There was no re­search. And they didn’t try to find a prod­uct. Same goes for the ar­ti­fi­cial or­gans they were go­ing to sell, ac­cord­ing to the plans they laid out in 2012 — a time when the bloom was al­ready off the first rose of stem cell R&D.

Stenger and Quiros plead­ed not guilty to the 14 charges, and their at­tor­ney vowed to pull out all the stops to prove their in­no­cence. Ac­cord­ing to the fed­er­al pros­e­cu­tor, Jong Weon Choi is still at large.

 


Im­age: Shut­ter­stock

So­cial Me­dia Im­age: Ariel Quiros HCA East Flori­da via Youtube and Bill Stenger Jay Peak Re­sort via Youtube

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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