Fred Aslan re­turns to biotech as pres­i­dent of Vi­vid­ion; Zai Lab scoops Por­to­la's Tao Fu to spear­head US op­er­a­tions

Fred Aslan

→ Af­ter a stint as CEO of a med­ical de­vice com­pa­ny, Re­cep­tos co-founder and Ven­rock alum Fred Aslan is back in the drug de­vel­op­ment busi­ness. As pres­i­dent and chief busi­ness of­fi­cer of Vi­vid­ion Ther­a­peu­tics, he will play a cru­cial role in en­gi­neer­ing deals to fi­nance the mul­ti­ple ap­pli­ca­tions of Vi­vid­ion’s syn­thet­ic and pro­teom­ic chem­istry plat­forms, which has al­ready scored a big col­lab­o­ra­tion with Cel­gene. Vi­vid­ion has al­so wooed Lar­ry Burgess — long­time ex­ec at Ar­ray Bio­phar­ma — to be­come its head of chem­istry.

→ Re­mem­ber when Tao Fu qui­et­ly re­signed from his post as chief com­mer­cial and busi­ness at Por­to­la? It turns out he was prep­ping a move to Zai Lab $ZLAB, where he’s been ap­point­ed pres­i­dent and COO with re­spon­si­bil­i­ty on every­thing from busi­ness de­vel­op­ment to man­u­fac­tur­ing. The Shang­hai-based biotech likes his US ex­pe­ri­ence — ac­crued over years of work­ing for J&J and Bris­tol-My­ers Squibb — which will come in­to play as they open up their US head­quar­ters around his of­fice in San Fran­cis­co.

→ Wern­er Cautreels, the long­time CEO at Se­lec­ta Bio­sciences $SELB, is re­tir­ing from his post. The biotech re­port­ed this morn­ing that Bay­er vet Carsten Brunn has been named as the new CEO. Cautreels is stay­ing on as an ad­vis­er af­ter he leaves his job at the end of this year. Se­lec­ta is prep­ping a Phase III study for SEL-212, an ex­per­i­men­tal gout drug. Cautreels was named CEO in 2010, a cou­ple of years af­ter the launch of the com­pa­ny fo­cused on syn­thet­ic vac­cine par­ti­cle tech from the lab of MIT’s Bob Langer.

Karim Dab­bagh

→ There’s been a change of lead­er­ship — and strat­e­gy — at one of the Bay Area biotechs look­ing to play a promi­nent role in mi­cro­bio­me R&D. Glenn Ned­win is out as CEO of Sec­ond Genome, leav­ing the top post open for chief sci­en­tif­ic of­fi­cer Karim Dab­bagh to step in­to. Al­so out is the broad-based ap­proach to R&D that Ned­win had, in­clud­ing ag work, as the biotech looks to cre­ate a ra­zor-sharp fo­cus on an up­com­ing Phase II for NASH — a block­buster tar­get which has in­spired a fren­zy of com­pe­ti­tion. Dab­bagh’s next chap­ter as CEO will cen­ter on SGM-1019, a P2X7 in­hibitor that in­hibits NL­RP3, an in­flam­ma­some that has been at­tract­ing a broad group of play­ers.

→ Ali Fat­taey is out as CEO of Curis. The Lex­ing­ton, MA-based biotech says Fat­taey is leav­ing the com­pa­ny, which is about all it has to say about that. The ex-CEO was cred­it­ed with hir­ing his re­place­ment, COO James Dentzer, now pres­i­dent and CEO. “Look­ing for­ward, we be­lieve (Dentzer) is best po­si­tioned to lead Curis as we seek to progress our three high-val­ue pro­grams quick­ly and suc­cess­ful­ly through the clin­ic,” says chair­man Mar­tyn Greenacre.

→ As Ma­rizyme com­pletes the ac­qui­si­tion of its pro­tease plat­form — and some drug can­di­dates de­vel­oped on it — the biotech has ap­point­ed Michael Han­d­ley as its new CEO. Han­d­ley takes over from Nick De­Vi­to and has the big task of re­al­iz­ing Ma­rizyme’s vi­sion for buy­ing late-stage prod­ucts in the acute care space to push them over the reg­u­la­to­ry fin­ish line.

Nau­tic Part­ners has hired biotech vet Michael Kallelis to run Mikart, the con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion it just bought.

Volk­er Her­rmann

→ Weeks af­ter clos­ing a $72 mil­lion round, Ar­mon Sharei, the young founder and CEO at SQZ Biotech has brought in an in­dus­try vet­er­an to shape the biotech’s cor­po­rate strat­e­gy, op­er­a­tions and com­mu­ni­ca­tions as it ap­proach­es the clin­ic. Volk­er Her­rmann’s of­fi­cial ti­tle is pres­i­dent and COO, but he will al­so take over the busi­ness de­vel­op­ment front. A Pfiz­er vet, Her­rmann first made the jump to biotech for Vi­amet Phar­ma­ceu­ti­cals and had since worked as COO of Se­len­i­ty Ther­a­peu­tics.

→ Ramp­ing up for piv­otal stud­ies for an old Sanofi drug, X4 Phar­ma­ceu­ti­cals has ap­point­ed Adam Mostafa as CFO. While Mostafa most re­cent­ly served in the same po­si­tion at Abpro, he spent most of his ca­reer in the in­vest­ment bank­ing world, capped by a stint as man­ag­ing di­rec­tor at Can­tor Fitzger­ald.  

→ Hav­ing steered Gen­fit’s lead drug, elafi­bra­nor, to a Phase III pro­gram, CMO So­phie Még­nien has de­cid­ed to re­sign from the com­pa­ny but em­pha­sizes that the de­ci­sion is “en­tire­ly per­son­al and is to­tal­ly un­re­lat­ed to Gen­fit or its R&D pro­grams” — pre­sum­ably in re­sponse to ru­mors that she has an of­fer to join a com­peti­tor. Pas­cal Bir­man, her for­mer deputy, is step­ping up to lead the clin­i­cal team.

→ Scrap­ping for cash to pro­duce ad­di­tion­al safe­ty da­ta re­quest­ed by the FDA be­fore it could pro­ceed with its lead drug, Gem­phire has cut in­to its C-suite for a round of lay­offs. The re­duc­tion — which claims five staffers, or a third of the tiny biotech’s work­force — caps a tur­bu­lent few months at Gem­phire $GEMP dur­ing which its shares were bat­tered. Among the five laid off are CFO Jef­frey Math­iesen and CMO Lee Gold­en. CEO Steven Gul­lans will now dou­ble as the prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer of the com­pa­ny.

Mer­ck vet Arthur San­to­ra has joined a new­ly pub­lic En­tera $EN­TX as its CMO, re­plac­ing Er­ic Lang. The Jerusalem-based biotech is de­vel­op­ing oral for­mu­la­tions of parathy­roid hor­mone (PTH) for os­teo­poro­sis and hy­poparathy­roidism.

→ With Phase III tri­als for its non-opi­oid, non-steroid pain drug un­der­way, Cen­trex­ion Ther­a­peu­tics is ready to talk com­mer­cial­iza­tion. An­drew Par­tridge, for­mer­ly of Ver­tex and Am­gen, is the new EVP and CCO tasked with build­ing out the team.

→ Emerg­ing from the Nu­plazid scan­dal af­ter an FDA re­view con­clud­ed the Parkin­son’s drug car­ries more ben­e­fit than risks, Aca­dia is now ready to move on with this and oth­er clin­i­cal pro­grams in cen­tral ner­vous sys­tem dis­or­ders, an­nounc­ing two new hires. Organon vet Robert Kaper has joined as SVP, glob­al head of med­ical af­fairs, while Eliseo Sali­nas as­sumes the CSO and SVP post af­ter hop­ping around a slate of biotechs.

Mit­subishi Tan­abe Phar­ma Amer­i­ca has re­cruit­ed Joseph Scalia from Bay­er to head its US op­er­a­tions as VP of com­mer­cial sales and mar­ket­ing.

Ea­gle Phar­ma­ceu­ti­cals $EGRX has el­e­vat­ed chief com­mer­cial of­fi­cer David Per­nock to the COO role, while keep­ing pres­i­dent in his ti­tle, in prepa­ra­tion for the “next phase in com­mer­cial­iza­tion” of their in­jecta­bles.

→ Har­vard pro­fes­sor and Broad re­searcher David Liu — wide­ly rec­og­nized for his work on gene edit­ing and syn­thet­ic bi­ol­o­gy, with a cou­ple of biotech star­tups un­der his belt — has joined the board of WuXi Bi­o­log­ics.

Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.

SJ Lee [File photo]

Go­ing in­side cells, Sung Joo Lee has sketched some big goals for his small — but glob­al — team of drug hunters

For a small biotech based in South Korea with a research arm in Cambridge, MA, Orum Therapeutics has sketched out some big goals aimed at developing antibodies for intracellular targets. And now they have a new $30 million round to push the work forward, aiming at a slate of currently undruggable quests.

Orum has been working on a platform tech out of Ajou University that relies on endocytosis to smuggle antibodies and their cargo inside a cell. They’ve published work in Nature that illustrates its preclinical potential in RAS mutations, and KRAS is on their list of targets. 

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Astel­las buys in­to Fre­quen­cy's re­gen­er­a­tive med strat­e­gy with a $625M al­liance on hear­ing loss

The executive team at Frequency Therapeutics never oversold the results of their maiden Phase I/II study for a new drug to rectify hearing loss. It was, they said back in April, primarily about safety and tolerability, where their drug FX-322 performed as they had hoped. 

That early glimpse of efficacy everyone searches for in their first try on humans? 

(I)mprovements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.

We don’t know exactly what that means. But whatever the details, Astellas found enough in the data to jump in with a sizable collaboration deal.

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