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

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.