An in­tro­duc­tion to the End­points 100

John Car­roll, Ed­i­tor

I’m well in­to a new project at End­points that I’d like to tell you about. It’s called the End­points 100. (Up­date: List of ex­ec­u­tives is at the bot­tom of this ar­ti­cle.)

For the 14 or so years that I’ve cov­ered biotech on a dai­ly ba­sis, I’ve seen some dra­mat­ic shifts in biotechs’ ac­cess to cap­i­tal, at­ti­tudes about reg­u­la­to­ry con­di­tions for new drug ap­provals (on both sides of the At­lantic), views on gen­der di­ver­si­ty, along with a whole new fo­cus on drug pric­ing and the fu­ture of the in­dus­try. Usu­al­ly, these trends and at­ti­tudes are all tracked in ret­ro­spec­tive analy­ses.

The End­points 100 is aim­ing at keep­ing a fin­ger on the pulse of the in­dus­try, to de­tect changes — pos­i­tive or neg­a­tive — as they oc­cur.

Over the last 10 days I’ve reached out to about 50 biotech CEOs who have agreed to par­tic­i­pate. By the end of the month, I’ll have the rest of the group in place; an in­vi­ta­tion-on­ly af­fair that will bring to­geth­er a broad cross sec­tion of top in­dus­try ex­ec­u­tives from small and large com­pa­nies. They’ll be ge­o­graph­i­cal­ly di­verse, though you can ex­pect a lot of East Coast/West Coast, UK and con­ti­nen­tal ex­ecs in the mix. The vast ma­jor­i­ty, though not all, will be CEOs.

From this group I plan to gath­er re­spons­es for a quar­ter­ly con­fi­dence sur­vey on biotech, of­fer­ing a col­lec­tive ex­pres­sion on the mood of the in­dus­try as we jour­ney through one of the most crit­i­cal pas­sages faced in drug de­vel­op­ment. It’s al­so a re­source for me to get some di­rect feed­back on End­points as my part­ner Ar­salan Arif and I craft this niche biotech news com­pa­ny over the com­ing year. And I’ll be ask­ing a month­ly poll ques­tion for the group.

There is one re­quire­ment: End­points 100 mem­bers need to be reg­u­lar End­points read­ers. That doesn’t mean read­ing every­thing from top to bot­tom (who does that with any pub­li­ca­tion?). But in or­der to par­tic­i­pate, you’ll need to be con­ver­sant with our cov­er­age. (Here’s our ded­i­cat­ed sub­scrip­tion page. There’s nev­er any cost to re­ceive End­points. We’re look­ing for in­volve­ment, not cash.)

If you’d like to nom­i­nate some­one, drop me a line. Just re­mem­ber, though, that many are called, few are cho­sen. It’s go­ing to take some bal­anc­ing to get the right group to­geth­er.

Look for the first sur­vey in Sep­tem­ber. And if you have any ques­tions, you can find me at: john@end­pointsnews.com.

– John Car­roll


Up­date: Here is the list of cur­rent End­points 100 ex­ec­u­tives.

An­drea Pfeifer AC Im­mune
Ron Co­hen Acor­da
Rick Orr Ad­ynxx
Mary Szela Aege­ri­on Phar­ma­ceu­ti­cals
David Schenkein Agios
Richard Pops Alk­er­mes
Alex­ey Mar­golin Al­lena Phar­ma­ceu­ti­cals
John Maraganore Al­ny­lam
John Crow­ley Am­i­cus
Mike Grey Am­plyx
Hamza Suria Anap­tys­Bio
Nor­bert Riedel Aptinyx
Joe Payne Arc­turus Ther­a­peu­tics
Tim Van Hauw­er­meiren Ar­genx
Bruce Booth At­las Ven­ture
Tito Ser­afi­ni Atre­ca
Na­tal­ie Holles Au­dentes Ther­a­peu­tics, Inc.
Jay Lichter Aval­on Ven­tures
Carmine N. Sten­gone Ave­las Bio­sciences, Inc.
Robert Con­nel­ly Ax­cel­la (Pronu­tria)
Howard Liang BeiGene
Jean-Jacques Bi­en­aimé Bio­Marin Phar­ma­ceu­ti­cal
Jef­frey Al­bers Blue­print Med­i­cines
An­drew J. Phillips C4 Ther­a­peu­tics
Gregg San­do Cell Med­ica
Prab­ha­vathi Fer­nan­des Cem­pra
Art Krieg Check­mate Phar­ma­ceu­ti­cals
Jeff Stein Cidara
Lau­ra Shawver Cleave Bio
Doug Williams Co­di­ak
Kei­th Dionne Con­stel­la­tion Phar­ma
Yu­val Co­hen Cor­bus Phar­ma
ROBERT I. BLUM Cy­to­ki­net­ics, Inc.
Sean Mc­Carthy Cy­tomX Ther­a­peu­tics
Steve Holtz­man Deci­bel Ther­a­peu­tics
Ryan Watts De­nali
Kevin Ju­dice DiCE Mol­e­cules
An­nal­isa Jenk­ins Di­men­sion Ther­a­peu­tics
Geral­dine Hamil­ton Em­u­late
Tim Mayleben Es­pe­ri­on
David Giljo­hann Ex­i­cure
Alexan­der Pas­teur F-Prime Cap­i­tal Part­ners
John Hau­rum F-star
Greg Ver­dine Fog Phar­ma
Sander Slootweg For­bion Cap­i­tal Part­ners
Steve Tre­gay For­ma Ther­a­peu­tics
Michael Pelli­ni Foun­da­tion Med­i­cine
Robert Gould Ful­crum Ther­a­peu­tics
Mark Vel­le­ca G1 Ther­a­peu­tics
Pier­lui­gi Parac­chi GENEN­TA Sci­ence
Chip Clark Geno­cea Bio­sciences
He­len Tor­ley Halozyme
Mal­colm Weir Hep­tares
Rich Hey­man Hey­man Biotech
Rus­sell Hern­don Hy­dra Bio­sciences
Eliot Forster Im­muno­core
Hervé Hop­penot In­cyte
Nes­san Berming­ham In­tel­lia Ther­a­puet­ics
Pe­ter Hecht Iron­wood
Kim Cobleigh Drap­kin Jounce Ther­a­peu­tics
Cameron Dur­rant Kalo­Bios
Arie Bellde­grun Kite Phar­ma
Troy Wil­son Ku­ra On­col­o­gy
Paul Sekhri Lyc­era Corp.
Kees Been Lyso­so­mal Ther­a­peu­tics
Denise Scots-Knight Mereo Bio­phar­ma
An­na Pro­topa­pas Mer­sana Ther­a­peu­tics
Ju­lia Owens Mil­len­do
Chuck Baum Mi­rati Ther­a­peu­tics
Stephane Ban­cel Mod­er­na
Praveen Tipir­neni Mor­phic Ther­a­peu­tic
Tas­sos Gi­anakakos MyoKar­dia
George P. Vla­suk Nav­i­tor Phar­ma­ceu­ti­cals, Inc.
David Mott NEA
Jeff Jonker NGM Bio
Don Nichol­son Nim­bus Ther­a­peu­tics
Jon Con­gle­ton Ni­valis Ther­a­peu­tics
Clif­ford J. Stocks On­coRe­sponse
Je­re­my Levin Ovid Ther­a­peu­tics
Bernard Coulie Pli­ant Ther­a­peu­tics
Kevin Bit­ter­man Po­laris Part­ners
Dale Schenk Prothena
John Bea­dle PsiOxus
Alan Auer­bach Puma
Dou­glas Tre­co Ra Phar­ma­ceu­ti­cals
Robert Ward Ra­dius
Olav Helle­bø ReNeu­ron Group plc
Robert Cof­fin Replimune
Clay Sie­gall Seat­tle Ge­net­ics
Glenn Ned­win Sec­ond Genome
Wern­er Cautreels Se­lec­ta
An­toine Pa­piernik Sofinno­va
Ar­mon Sharei SQZ Ther­a­peu­tics
Glyn Ed­wards Sum­mit Ther­a­peu­tics plc
Detlev Bin­iszkiewicz Sur­face On­col­o­gy
Kate Bing­ham SV Life Sci­ences
Nan­cy Si­mon­ian Sy­ros Phar­ma­ceu­ti­cals
Lon­nie Moul­der Tesaro
Mary Lynne Hed­ley Tesaro
Ed­uar­do Bra­vo Tigenix, SAU
Max­ine Gowen Treve­na
Niclas Stiern­holm Tril­li­um Ther­a­peu­tics
Bernat Olle Vedan­ta
Lau­rence Reid Warp Dri­ve Bio
Steve Yang WuXi AppTec
Rachel King Gly­coMimet­ics

The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMedO

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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