Gates Foun­da­tion sets up biotech-like in­sti­tute in hands-on ef­fort to spur drug de­vel­op­ment for ne­glect­ed dis­eases

BOSTON — Af­ter years of care­ful­ly dol­ing out mon­ey to spur drug de­vel­op­ment, the Bill and Melin­da Gates Foun­da­tion is of­fi­cial­ly get­ting its hands dirty with the busi­ness, clin­i­cal and reg­u­la­to­ry work nec­es­sary to bring drugs to mar­ket.

Pen­ny Heaton

The new ef­fort takes the shape of what has been named the Bill and Melin­da Gates Med­ical Re­search In­sti­tute, which will func­tion in much the same way as its biotech neigh­bors in Cam­bridge, MA ex­cept in one re­gard: It will not seek to make mon­ey.

Hav­ing set­tled in­to a small of­fice and qui­et­ly built up a team since Jan­u­ary, the Gates MRI shared more de­tails about its scale and fo­cus for the first time to­day. The en­ti­ty will op­er­ate on an an­nu­al bud­get of around $100 mil­lion and fo­cus on malar­ia, tu­ber­cu­lo­sis and en­teric dis­eases — ail­ments that are of­ten fa­tal in low-in­come coun­tries but have not seen much progress in R&D. Their goal? To break down si­los and “ac­cel­er­ate find­ing so­lu­tions” for these dis­eases, STAT notes.

Sue Desmond-Hell­mann

Gates Foun­da­tion CEO (and famed for­mer Genen­tech ex­ec) Su­san Desmond-Hell­mann and Trevor Mundel, its head of glob­al health, cham­pi­oned the ini­tia­tive and see it as cen­tral to the foun­da­tion in the fu­ture. Mundel — who used to run de­vel­op­ment for No­var­tis, con­vinced an old col­league and vac­cine de­vel­op­er, Pen­ny Heaton — to move from the foun­da­tion’s vac­cine team to the helm of this new en­ti­ty.

Heaton, in turn, filled her team with sea­soned bio­phar­ma ex­ecs: CMO David Kauf­man led trans­la­tion­al on­col­o­gy at Mer­ck Re­search Labs; chief of staff Mary This­tle Di­men­sion Ther­a­peu­tics; Di­na Berdie­va, head of -project man­age­ment & clin­i­cal op­er­a­tions, spent time at No­var­tis vac­cines be­fore join­ing Boston Phar­ma; and Jared Sil­ver­man, head of trans­la­tion­al dis­cov­ery, was an 18-year Cu­bist Phar­ma vet­er­an.

Trevor Mundel

That’s a pat­tern you can ex­pect to see at the Gates MRI. Mundel told Forbes “the new ef­fort will be staffed al­most en­tire­ly with in­dus­try vets, not aca­d­e­mics.”

To­geth­er, they will first turn their at­ten­tion to a tu­ber­cu­lo­sis pro­gram, in­ves­ti­gat­ing whether giv­ing a boost­er shot of the Bacil­lus Cal­mette–Guérin (BCG) vac­cine to ado­les­cents who’ve re­ceived it as an in­fant could re­duce in­fec­tion rates.

That’s the kind of study that the Gates MRI is in the best po­si­tion to do, Heaton told Forbes: “These stud­ies need to be done, but this is a very in­ex­pen­sive vac­cine, and there’s not a big mar­ket—there would be no in­cen­tive for a pri­vate part­ner to take on a study of this na­ture.”

Way down the road, the group might al­so file for reg­u­la­to­ry ap­provals, com­mu­ni­cate with the FDA, and even hold own­er­ship of a drug if nec­es­sary.

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).

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.

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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Takeda's trans­la­tion­al cell ther­a­py group revs up for a race to the clin­ic with off-the-shelf CAR-T

Four years after Takeda launched a wide-ranging induced pluripotent stem cell project with the researchers at Nobel prize-winning Shinya Yamanaka’s lab at the University of Kyoto, the pharma company is taking delivery of the first of what it hopes will be a whole pipeline of iPS cell-derived therapies that can deliver on the promise of off-the-shelf CAR-T therapies.

From here, Stefan Wildt — the head of pharma sciences and translational cell therapy at Takeda — and his group of 100-plus scientists will be charged with steering their way to the clinic as they build out the manufacturing and support work for this pipeline-in-the-making. 

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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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