Com­pu­ta­tion­al sci­en­tists de­sign a new IL-2 can­cer drug and spin it out in­to a biotech start­up

One of the Holy Grails in the boom­ing im­muno-on­col­o­gy re­search field right now in­volves find­ing an IL-2 drug that can be used safe­ly and ef­fec­tive­ly to com­bat can­cer, with­out the im­mense tox­i­c­i­ty that has large­ly side­lined the orig­i­nal IL-2 Pro­leukin. Bris­tol-My­ers Squibb paid Nek­tar $1.85 bil­lion in up­front cash to part­ner on NK­TR-214 — which has since come un­der a cloud of un­cer­tain­ty over flail­ing re­sponse rates in their key demon­stra­tion study com­bin­ing it with Op­di­vo.

Now a group of sci­en­tists at the Uni­ver­si­ty of Wash­ing­ton says they built an IL-2 pro­tein ther­a­py all their own, and they’ve launched a new biotech — Ne­oleukin — to take it for­ward from mouse stud­ies to­ward the clin­ic.

Umut Ulge

De­scrib­ing their work to a writer at UW Med­i­cine, the group says they de­signed their pro­tein to bind specif­i­cal­ly to IL-2  be­ta and gam­ma re­cep­tors to whip up a more po­tent T cell re­sponse to can­cer while steer­ing clear of CD25 to cir­cum­vent the tox­ic re­ac­tion. By do­ing that they cre­at­ed a lab mod­el of the drug that the sci­en­tists were able to ratch­et up the dose on with­out the lethal re­ac­tion.

They al­so added a com­ple­men­tary com­po­nent for IL-15 to in­crease the ef­fi­ca­cy and dubbed the drug Neo-2/15, de­scrib­ing it as par­tic­u­lar­ly small and sta­ble. And the game plan is to con­tin­ue to use their com­pu­ta­tion­al skills to im­prove the drug.

“Neo-2/15 has ther­a­peu­tic prop­er­ties that are at least as good as or bet­ter than nat­u­ral­ly oc­cur­ring IL-2, but it was com­pu­ta­tion­al­ly de­signed to be much less tox­ic,” said Umut Ulge, one of the lead au­thors of a pa­per pub­lished in Na­ture.

An il­lus­tra­tion de­pict­ing how the new pro­tein, in red, binds on­ly to the be­ta and gam­ma re­cep­tors, and not to cells with a third kind of re­cep­tor. (UW MED­I­CINE)

Click on the im­age to see the full-sized ver­sion

Ne­oleukin, though, is hard­ly the on­ly ri­val to the throne that Nek­tar and Bris­tol-My­ers Squibb have been striv­ing for. Lau­ra Shawver’s Syn­thorx has al­so been an­gling for the clin­ic — in H1 of this year — with their drug can­di­date Syn­thorin IL-2, backed by Or­bimed and Medicxi. The biotech $THOR went pub­lic just a few weeks ago, rais­ing $150 mil­lion.

Last No­vem­ber Nek­tar Ther­a­peu­tics $NK­TR man­aged to add 1 more pa­tient out of its 38 evalu­able stage 4 melanoma pa­tients to the win col­umn with its close­ly-watched 3-month up­date on Op­di­vo/NK­TR-214’s ob­jec­tive re­sponse rate. That man­aged to nudge up the ORR from 50% — a fig­ure that rout­ed Nek­tar’s stock at AS­CO — to 53%. But the sci­en­tists al­so pushed up the com­plete re­sponse rate to 24%, main­tain­ing they were sat­is­fied with the im­proved re­sponse they were see­ing.

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.

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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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.

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