Go­ing big: Biotech vets blast off with Ar­rakis on a new jour­ney of RNA ex­plo­ration


Michael Gilman and an ex­pe­ri­enced band of biotech vets are bust­ing out of stealth mode to­day with a start­up that marks the se­r­i­al en­tre­pre­neur’s third launch in 10 years. And he’s com­ing out in style, with a $38 mil­lion A round led by Canaan Part­ners.

Af­ter lit­er­al­ly stum­bling across the com­pa­ny while it was still in the white-board phase of de­vel­op­ment in 2015, Gilman says he was ripe for the chal­lenge and ad­ven­ture. And it’s a big one.

CSO and founder Russ Pet­ter has been hon­ing the bioin­for­mat­ics tools, as­says and chem­i­cal li­braries Ar­rakis Ther­a­peu­tics will need to cre­ate a plat­form tech­nol­o­gy that can be used to de­vel­op small mol­e­cules to in­hib­it dis­ease-caus­ing RNA.

This biotech has a long jour­ney ahead in pre­clin­i­cal work be­fore it can start try­ing this out in hu­mans. But if they’re right, the com­pa­ny will be on their way to work­ing on oral ther­a­pies that would be able to hunt down a host of what had been con­sid­ered un­drug­gable tar­gets — start­ing with an ini­tial aim at neu­rol­o­gy and can­cer.

Most pre­clin­i­cal star­tups like this come out of acad­e­mia. But this is a unique­ly Cam­bridge-based out­fit, bring­ing to­geth­er peo­ple with decades of ex­pe­ri­ence right in the heart of one of the world’s biggest biotech hubs.

“I’ve known Russ for a long time,” says Gilman, whose CV in­ter­sects with the founder’s stint at Bio­gen. “He ran chem­istry when I ran re­search there. He’s been work­ing on this for awhile.”

And Pet­ters isn’t the on­ly oth­er Bio­gen vet on board. Chief Busi­ness Of­fi­cer Daniel Ko­er­w­er and James Bar­soum, SVP of bi­ol­o­gy, al­so trace their ca­reers back to the Cam­bridge, MA gi­ant. Col­lec­tive­ly, they list stints at more than a dozen dif­fer­ent biotech com­pa­nies on their re­sumes.

Gilman crossed paths with Pet­ter in 2015, when the fel­low sci­en­tist was hatch­ing his plans for Ar­rakis — a com­pa­ny named af­ter the plan­et in Frank Her­bert’s Dune — in some shared of­fice space where Gilman had one of his board meet­ings. Pet­ter had had his in­ter­est whet­ted at a con­fer­ence pre­sen­ta­tion on small mol­e­cules and RNA in­ter­ac­tions.

They talked, Bris­tol-My­ers Squibb de­cid­ed it would pay a hand­some price for Gilman’s last com­pa­ny, Pad­lock, and af­ter tak­ing last sum­mer off, they got down to se­ri­ous­ly ex­plor­ing the idea to­geth­er.

The mon­ey fol­lowed the ideas.

Along with Canaan Part­ners, Ad­vent Life Sci­ences, Pfiz­er, Cel­gene, Os­age Uni­ver­si­ty Part­ners, and biotech in­dus­try leader Hen­ri Ter­meer chipped in to the A round. The UK’s Ad­vent and Ter­meer helped seed the ini­tial work. And if Ar­rakis’ team is right, there will be plen­ty of op­por­tu­ni­ties along the way to set up plat­form col­lab­o­ra­tions and part­ner­ships.

Colleen Cuf­faro

“I was very in­trigued from the minute I heard the con­cept,” says Colleen Cuf­faro, a prin­ci­pal at Canaan who’s tak­ing a board spot at Ar­rakis.  “It has enor­mous po­ten­tial, how it opens up a whole new space for un­drug­gable tar­gets on our radar for a long time. I re­al­ly like the ap­proach of us­ing small mol­e­cules that are fun­da­men­tal­ly dif­fer­ent than any oth­er RNA-tar­get­ing ap­proach I’ve seen. The oth­er piece was the team, a re­al­ly proven team, with a track record that is out­stand­ing.”

Gilman isn’t con­cen­trat­ing sole­ly on Ar­rakis. He’s been deeply in­volved with At­las Ven­ture, and they’re plan­ning an­oth­er com­pa­ny launch lat­er in the year. But Gilman isn’t stressed by the idea of helm­ing two ven­tures at once.

At Pad­lock, says Gilman, “I felt like I had ex­tra time on my hands.” Af­ter all, CEOs of star­tups of­ten “spend a lot of time wait­ing around for stuff to hap­pen.” And if you have the kind of team he’s work­ing with at Ar­rakis, it’s not a full-time job.

This is not Gilman’s first biotech rodeo. He knows first hand that a ven­ture-backed start­up of­ten lands in oth­er hands, as hap­pened with Stromedix and Pad­lock. This time around though, he would like to take it all out much fur­ther.

“You can nev­er rule it out,” he says, “but this is a com­pa­ny I would like to see built for the long haul. I tru­ly be­lieve we’ll have the ca­pa­bil­i­ty to crank out new drugs oth­er peo­ple haven’t been able to make.”

Gilman’s a long­time be­liev­er in the adage that in biotech, you should go big or go home.

Once again, he’s go­ing big.

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.

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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.

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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.

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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.

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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.

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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.

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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.

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