The new se­r­i­al en­tre­pre­neur in the biotech are­na launch­es an­oth­er up­start look­ing to drug RNA

Bill Haney

Click on the im­age to see the full-sized ver­sion

Af­ter a life­time of en­tre­pre­neur­ship, Bill Haney has dis­cov­ered how much fun it can be to set up new biotechs.

A year af­ter launch­ing the can­cer start­up Drag­on­fly — al­ly­ing him­self with MIT’s Tyler Jacks and David Raulet out of Berke­ley — he’s now back with his sec­ond up­start called Sky­hawk Ther­a­peu­tics, which is jump­ing in­to the fast-grow­ing new com­pa­ny seg­ment fo­cused on drug­ging RNA with small mol­e­cules.

“Sky­hawk tech­nol­o­gy and in­sight of­fers an en­tire­ly nov­el way to treat a very broad class of dis­eases by en­abling them to tar­get mu­ta­tions in ex­on-splic­ing, (tar­get­ing) loss of func­tion dis­eases,” Haney tells me.

Their first project, which could be in the clin­ic in 2019, ze­roes in on what Haney de­scribes as a pre­vi­ous­ly un­drug­gable onco­gene.

Haney — who is al­so a doc­u­men­tary film­mak­er and chair­man of the green home builder Blu Homes — is tak­ing a leaf from the same play­book he used to launch Drag­on­fly, an­oth­er Boston-area launch that has been work­ing on new tech­nol­o­gy to leapfrog where check­point ther­a­pies are right now, link­ing on­to nat­ur­al killer cells and drag­ging them to a can­cer cell to tack­le a wide range of can­cers.

Like Drag­on­fly, Haney is once again work­ing with a tight-knit group of fam­i­ly of­fice in­vestors like his old friend Tim Dis­ney, who’s come back in on this lat­est ven­ture as well. The Duke of Bed­ford joined the back­ers club, along with Alexan­dria Ven­ture In­vest­ments and oth­er undis­closed pri­vate in­vestors.

They’ve put up $8 mil­lion in seed cash to get things rolling at Sky­hawk, which has a staff of about 25 and is on its way to its first IND and the clin­ic in about a year.

Like his co-in­vestors, Haney works with peo­ple who are rec­og­nized ex­perts in their field, and whom he trusts im­plic­it­ly to do the right thing.

Kath­leen Mc­Carthy

He first met co-founder Kath­leen Mc­Carthy back when she was a col­lege stu­dent work­ing with AIDS pa­tients in a de­vel­op­ing coun­try. And he’s not in the least bit re­luc­tant to praise her as a “strong mind­ed, fe­ro­cious” young sci­en­tist out to do some­thing com­plete­ly new.

Says Haney: “I have a lot of con­fi­dence in Kath­leen. I would help her in any cir­cum­stance.”

That’s the key to back­ing any­one in biotech, he adds: Con­fi­dence and trust. Once you get that out of the way, he adds, every­one can fo­cus on the sci­ence.

This is the fourth biotech to come out of stealth mode with plans to drug RNA. Michael Gilman got the par­ty start­ed last Feb­ru­ary when he ush­ered Ar­rakis out af­ter more than a year of qui­et­ly set­ting up the plat­form. Then at the be­gin­ning of this month Ex­pan­sion Ther­a­peu­tics had its com­ing out par­ty, dis­play­ing a plat­form with R&D roots in the lab of Scripps’ Matthew Dis­ney (not re­lat­ed to Tim), who’s had a long­time in­ter­est ex­plor­ing the field. Ri­bometrix is al­so in­volved.

Sky­hawk’s work is in­spired by an ex­pe­ri­enced group led by Mc­Carthy, who worked at Roche on the SMA drug RG7916 — now in piv­otal tri­als — with a stint at the Spinal Mus­cu­lar At­ro­phy Foun­da­tion, where she had worked on a small mol­e­cule ther­a­peu­tic tar­get­ing mR­NA-pro­tein in­ter­ac­tions for SMA.

When I talked to Haney Wednes­day morn­ing, he was in Cal­i­for­nia af­ter spend­ing time with Jim Al­li­son in Texas, shoot­ing a doc­u­men­tary on the leg­endary sci­en­tist and the I/O rev­o­lu­tion he helped spark.

With two biotechs, ad­di­tion­al ven­tures and a doc­u­men­tary se­ries on can­cer planned, you could say Haney is stay­ing busy. Does he have enough time to squeeze in a third start-up?

He won’t rule it out.

“It’s a maybe,” he says.


Im­age: Bill Haney. Drag­on­fly Ther­a­peu­tics

Elizabeth Nabel speaks at a news conference, Oct. 7, 2019 (Elise Amendola/AP Images)

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Amid recent scrutiny on how Moderna’s top executives have been cashing out their increasingly valuable shares, the biotech is parting ways with a board member who’s also heading a hospital where its Covid-19 vaccine is being tested.

Elizabeth Nabel — the president of Brigham and Women’s Hospital — has followed in Moncef Slaoui’s footsteps in resigning from Moderna’s board of directors. She took the role in 2015, two years before the Operation Warp Speed leader did; and as with Slaoui and MIT professor Robert Langer, her term was due to expire in 2021.

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Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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Roche de­clares a PhI­II fail­ure for Covid-19 as the IL-6 re­pur­pos­ing the­o­ry bites the dust

Another big IL-6 drug has failed to move the needle for Covid-19 patients, leaving that particular field of repurposed drug R&D on the ropes for the pandemic.

This morning it was Roche’s turn to outline a Phase III failure for Actemra, adding compelling data that have now all but extinguished the theory that an IL-6 drug could significantly help the most severely afflicted patients. That comes just weeks after Regeneron and Sanofi hit the red light on their trial for Kevzara after getting back-to-back readouts that made Roche’s trial a long shot at best.

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Robert Nelsen (Illustration by Emma Kumer for Endpoints News)

Af­ter Big Phar­ma aban­doned in­fec­tious dis­eases, 5 biotech con­trar­i­ans de­cid­ed to go all in. Then Covid-19 changed every­thing

Bob Nelsen had been quietly wondering how to eradicate viruses for years, before one day in 2015, he welcomed a pair of immunologists into the ARCH Venture Partners offices on the 34th floor of Seattle’s Wells Fargo Building.

Louis Picker and Klaus Früh, professors at Oregon Health & Science University, had by then spent 5 years running around the country in search of funding for their startup, TomegaVax, and Früh, at least, was nearing wit’s end. The Gates Foundation was interested but told them they needed other investors. Investors told them to come back with more data, pharmaceutical executives said they’re in the wrong game — too little money to be made fighting infectious disease. Still, a well-connected board member named Bob More landed them a meeting with the coveted venture capitalist, and so, in a narrow conference room overlooking the Puget Sound, Picker prepared to again explain the idea he had spent 15 years on: re-engineering a benign microbe into the first vaccines for HIV and better ones for hepatitis and tuberculosis.

“This lightbulb went on his head,” Picker recalled in a recent interview. “Most of them just didn’t get it. And Bob’s hit.”

By that point, Nelsen was more than just a venture capitalist. Scraggly and greying but no less opinionated at 52, he was mobbed at biotech conferences, having earned a reputation for crass wisdom and uncanny foresight, for making big bets on big ideas that changed medicine. Those ideas included DNA sequencing, which he first cut a check for in the 90s, and leveraging the immune system to tackle cancer. He earned millions making billion-dollar companies.

Yet for years he had harbored an almost singular obsession: “I hate viruses,” he told Forbes in 2016. He told me he was “pissed off” at them. The obsession drove him to his first biotech investment in 1993, for an inhalable flu vaccine approved a decade later and still in use. And it drove him to invest in CAR-T as a potential cure for HIV, years before it proved a wildly effective treatment for some cancers.

Now, listening to Picker talk about T cells and antibodies and the curious biology of cytomegalovirus, Nelsen began wondering if it was time for another bet. Picker’s technology was not only promising, he reasoned, it could be the basis of a company that changed how researchers approached viruses. Instead of trying to come up with an antidote for every pathogen, you could do what cancer researchers had learned to do, and harness the immune system to do the work for you.

This wasn’t a popular opinion at the time. “It’s like the least trendy idea in the world,” Nelsen told me. “People would say, ‘Why the hell are you going into infectious disease?’”

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Sanofi and GSK say they're near a vac­cine deal with EU hours af­ter fi­nal­iz­ing Warp Speed con­tract

On the heels of landing the largest Warp Speed contract to date, Sanofi and GlaxoSmithKline continued to make moves Friday afternoon.

The two companies announced they are in advanced discussions with the EU to supply up to 300 million doses of their Covid-19 vaccine candidate, coming just a few hours after securing their $2.1 billion deal with the US. Should the agreement be finalized, all EU member states will have the option to purchase the vaccine.

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President Trump speaks during an event to sign executive orders on lowering drug prices, July 24, 2020 (Alex Brandon/AP Images)

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After years of criticizing high drug prices and threatening legislation that would curb the industry’s pricing freedom, the president warmly encouraged the industry’s commitment to a pell mell race to new vaccines and drugs to fight Covid-19 — often at speeds that would have been considered impossible back in January. And it raised the possibility that biopharma could finally find a way to achieve some kind of popularity after years of public toxicity.

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Paul Hudson, AP Images

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Sanofi and GlaxoSmithKline have become the latest members of Operation Warp Speed, landing a $2.1 billion contract to scale up manufacturing for a vaccine that is on track for completion next year. The deal secures the US 100 million doses, with an option for 500 million more.

It is the largest contract the White House has given yet in its hunt to make 300 million doses of a vaccine available to the US public by January, although Sanofi has not committed to supply vaccines by that time, potentially opening the door for other developers with longer development paths to gain funding. The cash will help Sanofi scale the vaccine, which combines their recombinant DNA technology with GSK’s immune-boosting adjuvant, to a billion doses next year.

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Sandy Macrae, Sangamo CEO

No­var­tis turns to Sang­amo with a $795M-plus deal aimed at us­ing zinc fin­ger tech for the neu­ro pipeline

When Novartis recruited Ricardo Dolmetsch from Stanford to lead its neuroscience group, great emphasis was placed on decoding genomics and the brain circuitry to find new breakthroughs for the beleaguered field. Seven years and a failed Fragile X therapy later, he has a new tool to go after some of these targets his team has unearthed.

In a new collaboration, Novartis is paying Sangamo Therapeutics $75 million upfront to leverage zinc finger protein transcription factors in the regulation of three genes ties to autism — a core focus of Dolmetsch’s academic research days — intellectual disability and other neurodevelopmental disorders. Another $720 million in milestones are on the table, alongside a pledge to reimburse all of Sangamo’s research work.

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Ludwig Hantson, Alexion CEO

UP­DAT­ED: The lead drug in Alex­ion’s $930M buy­out deal last fall just flopped — adding in­jury to an­a­lysts’ M&A in­sults

When Alexion $ALXN put down $930 million in cash last fall to buy Achillion, the biotech’s top execs were particularly proud of 2 clinical-stage assets, with a spotlight on the lead drug danicopan (ACH-4471) in Phase II. That drug, along with a companion therapy in Phase I, fit right in their R&D wheelhouse, noted CEO Ludwig Hantson.

But now the lead drug, redubbed ALXN2040, is being washed out and repositioned after failing 2 Phase II trials for C3 Glomerulopathy.

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