Dan Hicklin (File photo)

MPM and Long­wood-backed Were­wolf Ther­a­peu­tics grabs $56 mil­lion to take tu­mors by night

Backed with the team from his last com­pa­ny, one of the key de­vel­op­ers be­hind Keytru­da has a new warch­est in the race to bring im­munother­a­py in­to the tu­mor mi­cro-en­vi­ron­ment.

Dan Hick­lin, who over­saw Mer­ck’s I/O port­fo­lio and helped de­vel­op sev­er­al oth­er can­cer drugs, is the founder and pres­i­dent of Were­wolf Ther­a­peu­tics, a com­pa­ny that aims to “shapeshift” its way in­to tu­mors and tear them apart from with­in. With the ex­cep­tion of the COO, its lead­er­ship is en­tire­ly seed­ed from Poten­za Ther­a­peu­tics, the an­ti­body com­pa­ny Hick­lin sold to Astel­las for $165 mil­lion up­front last De­cem­ber. They’ll even use the same lab space.

Were­wolf is backed with $56 mil­lion in Se­ries A fund­ing led by MPM Cap­i­tal and Long­wood and joined by Tai­ho Ven­tures, Arkin Bio Ven­tures, DC In­vest­ment Part­ners and UPMC.

“It was a lit­tle bit of a dif­fer­ent chal­lenge, at least for me,” Hick­lin told End­points News. “It’s quite a bit of a dif­fer­ence from check­point ther­a­py.”

Be­yond the YA nov­el brand­ing, Were­wolf has a seem­ing­ly el­e­gant ap­proach to the prob­lems that have vexed re­searchers try­ing to turn the im­mune sys­tem on tu­mor mi­croen­vi­ron­ments. They use what they call their “PREDA­TOR” plat­form to send com­pounds that on­ly trig­ger an im­mune re­sponse once they en­ter the tu­mor mi­croen­vi­ron­ment.

Past com­pa­ny state­ments have com­pared this process to a were­wolf on­ly trans­form­ing in the light of the full moon, but you can prob­a­bly just think of it as act­ing like those kids toys that change col­or in wa­ter.

Mi­croen­vi­ron­ments are par­tic­u­lar­ly im­por­tant in ad­dress­ing sol­id tu­mors, where Were­wolf is fo­cus­ing its ef­forts. These spaces are of­ten im­muno­sup­pres­sive and have been re­sis­tant to the check­point in­hibitors that have dom­i­nat­ed I/O to date. Oth­er biotechs, such as Ed­i­tas or Gam­maDelta, have worked on us­ing par­tic­u­lar im­mune cells, such as gam­ma delta cells or nat­ur­al killer cells to get in­side.

Were­wolf is less than forth­com­ing about what will be at­tached to the plat­form or ex­act­ly how it’ll work with­in tu­mors, say­ing on­ly they will use pro-in­flam­ma­to­ry cy­tokines and cos­tim­u­la­to­ry re­cep­tor ag­o­nists.

The prob­lem with these agents to date, Hick­lin said, is that they can send the im­mune sys­tem in­to dan­ger­ous over­drive.

The body should have im­mune home­osta­sis. Check­points on tu­mor cells put ar­ti­fi­cial brakes on the sys­tem by bind­ing to T cells, and check­point in­hibitors such as Keytru­da pre­vent the tu­mor cells from bind­ing and putting on those brakes.  Were­wolf and oth­er com­pa­nys’ mi­croen­vi­ron­ment agents such as IL-2 throw the nor­mal im­mune sys­tem in­to over­drive. But if they in­crease the im­mune re­sponse out­side the tu­mor too much, they can cause im­mune cells to dam­age healthy tis­sue.

“These are the ac­cel­er­a­tors rather than the brakes,” Hick­lin said, turn­ing to­wards an in­creas­ing­ly com­mon anal­o­gy.

Hick­lin said Were­wolf will se­lect two lead can­di­dates over the next 6 months and hope­ful­ly aim for the clin­ic. It could be a while, but keep an eye out for a full moon.

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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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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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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