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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.