As­traZeneca vet Jen­nifer But­ler takes charge of In­nate Phar­ma's US biz; C4 raids NI­BR

→ France’s In­nate Phar­ma has wooed As­traZeneca vet Jen­nifer But­ler to lead the US op­er­a­tions it has set up af­ter ac­quir­ing Lu­mox­i­ti from the British drug­mak­er in a rich add-on col­lab­o­ra­tion deal. But­ler’s of­fi­cial ti­tle will be EVP and gen­er­al man­ag­er of In­nate Phar­ma US. Most re­cent­ly, she was chief busi­ness of­fi­cer, chief com­mer­cial of­fi­cer and head of US op­er­a­tions at Tes­sa Ther­a­peu­tics.

→ Af­ter cel­e­brat­ing the ap­proval of a Parkin­son’s ther­a­py he helped ac­quired for Acor­da Ther­a­peu­tics, chief busi­ness of­fi­cer An­drew Hind­man has de­cid­ed to step down. Hind­man, who joined Acor­da in 2014, is now “in­ter­est­ed in pur­su­ing op­por­tu­ni­ties in the wider bio­phar­ma in­dus­try,” CEO Ron Co­hen said. Over the next few tran­si­tion­ing months, he will con­tin­ue to help eval­u­ate ex-US com­mer­cial part­ner­ships for In­bri­ja as the com­pa­ny awaits a Eu­ro­pean reg­u­la­to­ry de­ci­sion.

→ C4 Ther­a­peu­tics has raid­ed the No­var­tis In­sti­tutes of Bio­med­ical Re­search for its chief med­ical of­fi­cer. The biotech re­port­ed to­day that it’s hired on Adam Crys­tal for the spot, fol­low­ing a stint as a se­nior di­rec­tor at NI­BR. C4 is one of sev­er­al biotechs work­ing on pro­tein de­graders, which has al­so been a keen in­ter­est of NI­BR chief Jay Brad­ner. “Dr. Crys­tal’s deep un­der­stand­ing of the sci­ence of tar­get­ed pro­tein degra­da­tion, cou­pled to his proven clin­i­cal lead­er­ship and un­der­stand­ing of the pa­tient com­mu­ni­ty, will be in­stru­men­tal to ad­vanc­ing C4T’s pipeline,” said Andy Phillips, the CEO of C4.

John Lea­man is quit­ting his job as CFO and head of cor­po­rate strat­e­gy at Se­lec­ta Bio, a year and a half af­ter join­ing the Wa­ter­town, MA-based biotech. His res­ig­na­tion comes in the wake of a re­vamp that claimed 36% of the staff — most of them work­ing on a now de­funct on­col­o­gy team — and pro­mot­ed a gout drug to the lead po­si­tion.

→ San Diego-based Escient has tapped William Hod­der as its chief busi­ness of­fi­cer, adding a sea­soned BD ex­ec and one-time en­tre­pre­neur to its start­up lead­er­ship team. Less than a year in­to its of­fi­cial ex­is­tence, the biotech is still busy trans­lat­ing in­sights on Mas-re­lat­ed G-pro­tein re­cep­tors to a new class of GCPR-tar­get­ed drugs, and Hod­der will play a hand in the plan­ning and grow­ing process, CEO Alain Baron said. Be­fore a re­cent run as a con­sul­tant, Hod­der has worked for Pro­tag­o­nist Ther­a­peu­tics and Fi­bro­Gen, as well as found­ing and lead­ing Tren­ovus.

In­cyte’s head of clin­i­cal de­vel­op­ment in Eu­rope has jumped ship to shape a nascent pipeline at iOnc­tura, a Mer­ck KGaA spin­out based in Gene­va. As CMO, Michael Lahn will lead first-in-hu­man stud­ies of the biotech’s next-gen PI3Kδ in­hibitor and po­ten­tial first-in-class au­to­tax­in (ATX) in­hibitor. Lahn, an alum­ni of As­traZeneca and Eli Lil­ly, will work close­ly with Zoë John­son, who’s re­cent­ly been pro­mot­ed to CSO.

→ Is­rael’s burn and wound man­age­ment biotech Medi­Wound is part­ing ways with CEO Gal Co­hen af­ter 12 years. Sharon Mal­ka, who helped steer the com­pa­ny to a 2014 Nas­daq de­but along­side Co­hen dur­ing this time as CFO and COO, is step­ping up to the role. Co­hen’s tenure was marked by Eu­rope and Is­rael ap­provals for Nexo­Brid, Medi­Wound’s flag­ship, non-sur­gi­cal prod­uct for burn treat­ment. Now fi­nanced un­der a con­tract with BAR­DA, the ther­a­py has com­plet­ed a sec­ond Phase III that will hope­ful­ly prop up the case for an FDA ap­proval — some­thing that Mal­ka will over­see while sup­port­ing an “on­go­ing strate­gic process.”

→ Or­phan drug de­vel­op­er Mi­no­ryx Ther­a­peu­tics has re­cruit­ed Di­di­er Le Nor­mand to be CFO of its op­er­a­tions across Eu­rope and the gen­er­al man­ag­er of a new­ly es­tab­lished Bel­gian sub­sidiary. The ap­point­ment adds an­oth­er C-suite role to Le Nor­mand’s re­sume, which has been packed with sim­i­lar roles in phar­ma and medtech com­pa­nies.

→ Biotech vet Tony Fior­i­no — per­haps best known as the for­mer CEO of Brain­storm Ther­a­peu­tics — is tak­ing up the CMO post at elec­tro­Core $ECOR as it seeks FDA clear­ance of its non-in­va­sive bio­elec­tron­ic va­gus nerve stim­u­la­tor gam­ma­Core. Com­ing from an in­ter­im CEO role at strug­gling Im­mune Phar­ma, he re­places Pe­ter Staats, who will be­come a se­nior ex­ec­u­tive ad­vis­er. Al­so join­ing the com­pa­ny: Phar­ma­copeia vet Bri­an Pos­ner, elec­tro­Core’s new CFO.

→ While re­searchers at Sang­amo Ther­a­peu­tics $SG­MO con­tin­ue to tweak its gene edit­ing tech for its lead rare dis­ease pro­grams, the biotech is beef­ing up its cell ther­a­py team to grow the CAR-Tregs port­fo­lio. Ja­son Fontenot will now lead that ef­fort, in­clud­ing a part­ner­ship with Sanofi and a pact with Gilead’s Kite for he­mo­glo­binopathies and can­cer re­spec­tive­ly. He comes to his new role of SVP, cell ther­a­py by way of Im­mu­soft, Juno and Bio­gen.

→ Ex­pe­ri­enced medtech ex­ec Kevin Kalish has been re­cruit­ed to lead the R&D ef­fort at En­Clear Ther­a­pies, a neu­rode­gen­er­a­tion-fo­cused start­up that’s just raised $2 mil­lion in seed fund­ing to take a de­vice-based amy­otroph­ic lat­er­al scle­ro­sis ther­a­py to the clin­ic in two years. De­vel­oped by Kevin Eggan of the Broad In­sti­tute, the treat­ment would re­move tox­ic pro­teins be­lieved to dri­ve the dis­ease.

Cold Spring Har­bor Lab’s Mick­ey At­w­al has teased on Twit­ter that he will “soon be join­ing Re­gen­eron to head their ma­chine learn­ing and mol­e­c­u­lar pro­fil­ing ef­forts.” Hav­ing re­searched the in­ter­sec­tion of pop­u­la­tion ge­net­ics, ma­chine learn­ing and can­cer bi­ol­o­gy, de­vel­op­ing math­e­mat­i­cal and com­pu­ta­tion­al tools, he’s mov­ing on­to a new po­si­tion with “di­rect trans­la­tion­al op­por­tu­ni­ties ahead,” At­w­al said.

Tri­umvi­ra Im­muno­log­ics has named Cyn­thia Moli­na as VP of reg­u­la­to­ry af­fairs to dri­ve sub­mis­sions and in­ter­ac­tions with health agen­cies around the world. Moli­na has been im­mersed in the T cell can­cer ther­a­py world while serv­ing in a sim­i­lar role at Hous­ton-based Cell Med­ica for the past six years.

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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