Thorsten Graef

An Ab­b­Vie clin­i­cal vet head­ing ear­ly on­col­o­gy jumps ship to build his own team at NK cell-fo­cused biotech

Mak­ing the leap from a mid-sized biotech in­to the ranks of phar­ma can be a chaf­ing ex­pe­ri­ence for ex­ec­u­tives used to a more flex­i­ble work en­vi­ron­ment — and that jump gets even hard­er dur­ing an ac­qui­si­tion. For Thorsten Graef, a clin­i­cal vet­er­an who tran­si­tioned from Phar­ma­cyclics in­to Ab­b­Vie, the move was a learn­ing ex­pe­ri­ence in terms of what sort of team he want­ed to run.

Now, he’s get­ting his chance.

Graef, for­mer­ly Ab­b­Vie’s head of ear­ly on­col­o­gy de­vel­op­ment, has leapt over to NK cell play­er Ace­po­dia to helm the small team’s clin­i­cal pro­gram as it walks its lead drug through ear­ly hu­man tests, Ace­po­dia said Tues­day.

Graef comes aboard af­ter two years at Ab­b­Vie prop­er pre­ced­ed by near­ly sev­en years at Phar­ma­cyclics, the mak­er of blood can­cer med Im­bru­vi­ca, which the Illi­nois drug gi­ant ac­quired for $21 bil­lion back in 2015. Graef had just as­sumed the head of clin­i­cal de­vel­op­ment role in De­cem­ber 2014 when Ab­b­Vie pounced and watched the Phar­ma­cyclics team grow from about 80 em­ploy­ees in­to a com­mer­cial out­fit that op­er­at­ed in­de­pen­dent­ly from the Ab­b­Vie borg but has since been ful­ly con­sumed.

Mak­ing that tran­si­tion in­to a role at a glob­al drug­mak­er was a tough one for Graef, who longed for the op­por­tu­ni­ty to build and lead his own clin­i­cal team. In Ace­po­dia, Graef, who sports more than 20 years of ex­pe­ri­ence in the clin­ic, saw an op­por­tu­ni­ty to get in ear­ly on ex­cit­ing sci­ence and shape a con­stant­ly grow­ing clin­i­cal team in his own im­age.

“As a drug de­vel­op­er, hav­ing the chance to be one of the first and hav­ing the chance to take this com­pa­ny through mid- to long-term mile­stones was very ap­peal­ing,” Graef said.

Ace­po­dia comes with an ex­cit­ing — if com­plex — tech plat­form, con­ju­gat­ing an­ti­bod­ies with off-the-shelf nat­ur­al killer cells to of­fer a new path to crack­ing tu­mor cells. The biotech’s lead pro­gram, dubbed ACE1702, is cur­rent­ly in a Phase I study tar­get­ing HER2-ex­press­ing sol­id tu­mors. The first pa­tient was dosed last Au­gust, and topline da­ta are ex­pect­ed at this year’s ES­MO.

Mean­while, the drug­mak­er has three oth­er can­di­dates at the pre­clin­i­cal stage with hopes to take those over the thresh­old in­to hu­mans in the com­ing years. Next week, Ace­po­dia will of­fi­cial­ly un­veil its next two lead can­di­dates, an­oth­er NK-line can­di­date and a donor-de­rived, gam­ma delta T cell prod­uct, at an up­com­ing cell ther­a­py meet­ing, adding even more stakes to the com­pa­ny’s grow­ing port­fo­lio. For Graef, that means rapid­ly scal­ing up a clin­i­cal team to han­dle those projects as well as be­ing pre­pared for what else comes through the pipeline.

“Build­ing a team is more work, but it’s al­so more in­ter­est­ing work,” Graef said. “Par­tic­u­lar­ly in this field, there’s a lot of in­ter­est. There’s al­ready some good clin­i­cal set up and a good foun­da­tion. Ide­al­ly, you want to have some peo­ple with some pas­sion and cre­ate a mix of new­com­ers to the in­dus­try who are re­al­ly ex­cit­ed and fill that out with peo­ple who have some in­dus­try skills.”

Mean­while, Ace­po­dia, which has of­fices in both San Ma­teo, CA, and Tai­wan, has been flesh­ing out the rest of its C-suite in an­tic­i­pa­tion of more tri­als. In con­junc­tion with Graef’s hire, the team added Michael Brock as chief strat­e­gy of­fi­cer. Brock comes with 20 years of strate­gic health­care in­vest­ment bank­ing ex­pe­ri­ence, in­clud­ing a 10-year stint as a man­ag­ing di­rec­tor in Wells Far­go Se­cu­ri­ties’ Health­care In­vest­ment Bank­ing group.

The com­pa­ny re­cent­ly an­nounced the hires of Jim­my Lai as chief fi­nan­cial of­fi­cer and Ani­ta Kawa­tra as an ad­vi­sor on cor­po­rate af­fairs.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Ver­tex and CRISPR Ther­a­peu­tics un­veil more pos­i­tive gene ther­a­py da­ta, but busul­fan again casts a shad­ow over the field

Less than 12 hours after revealing a flop on its second shot for alpha-1 antitrypsin deficiency, Vertex plowed ahead with another data drop from its partnership with CRISPR Therapeutics. And though the topline proved positive, concerns over conditioning agents continue to linger over the collaboration, as well as the entire gene therapy space.

Presenting data from two trials at the European Hematology Association annual meeting, the pair announced that follow-up data of at least three months for 22 patients with genetic blood disorders indicated a “consistent and sustained” response to the experimental drug CTX001. All 15 patients with transfusion-dependent beta thalassemia did not need further blood transfusions and all seven with severe sickle cell disease were pain free, the biotechs announced.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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