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

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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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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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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