The End­points 11: A group of dis­rup­tive up­starts on a do-or-die mis­sion to launch new meds

Over the last 15 years I’ve had the chance to help select about 200 private biotechs for up-and-coming awards like this. Looking over the rank and file of this disruptive crowd, I had my standouts, my OK borderline selections, and some truly dreadful, cringe-worthy choices.

Such is the game of judging private biotechs, where you always wind up making hunches based on an incomplete picture. But then that’s also much of the fun, right?

Everyone who does this sort of thing likes to pretend that they can pick which of these fledglings can shoot the rapids of drug development and come out of the white water doing high fives. But the reality is that we all have our good and bad ideas.

And you learn along the way.

With my first selection of the Endpoints 11 (complete with a neat logo conceptualized by our creative assistant editor Amber Tong), I’m getting started on generation 2.0 of my idea of top companies that just may be headed for greatness.

There are several key attributes that characterize each of the E11, and help me hedge my bets. Each represents an important trend in biotech creation.

Most have top teams that are well recognized for earlier successes. Experienced biotech execs these days can generally have their pick of the litter when it comes to new companies angling for a launch. So when you see a prominent biotech exec make the transition out of incubation and onto the stage — often alongside close associates that they have known and worked with for years — it may not guarantee a winner, but it sure is comforting when smart, successful people love the science behind a startup.

That will serve as my segue into technology. Me-too drugs have been discredited for years now. Payers may use them to pick the lock on lower prices, but it’s a woeful development strategy. Every company in this year’s maiden E11 is swinging for the fences, looking to drug the undruggable or race with ambitious rivals to achieve something remarkable.

So scientific ambition is key.

Enough money to get through to the next stage of human data is critical.

There is a healthy debate going on right now whether the 4-year tidal wave of investor cash coursing through the industry is essentially causing risky behavior that will squander cash. Given the inherent risks associated with drug development, and the groundbreaking nature of what they’re trying to achieve, a good chunk of that investment money is going up in flames — under the best of circumstances.

If anyone in the E11 fail, it likely won’t be because they were starved for cash. And this business isn’t cheap. Also, if any of these companies below go belly up, you will hear the explosion from halfway around the world.

The right partner can be everything in this business, helping make all the difference in picking up speed in the clinic and providing the kind of commercial clout needed to move markets. That’s another big factor in the list.

If there’s one overarching theme I’d like to highlight most, it’s that drug development is a global pursuit. The US may be where the money is in terms of windfall profits, and it may still drive the lion’s share of the development work as the industry feels the full flush of cash coursing through labs, but the science is international. So is much of the clinical work. These companies span three continents, from North America to Europe and Asia.

And Asia is coming on strong, with major implications for the industry as a whole.

Finally, just because this is the first E11 doesn’t mean I’m starting over. If you’ve already been highlighted in another annual award I once managed, your chances of a repeat here were reduced to nil. We need to share the spotlight.

I’ll be back in the fall with my picks of 2018. And if you have any recommendations along the way, send them my way as I manage the next short list. — John Carroll 

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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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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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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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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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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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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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