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.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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CAR-plus: Irish biotech re­cruits Kite alum Chris Now­ers to prep dual-tar­get­ing NK cell ther­a­py for the clin­ic

Soon after Chris Nowers left Cell Medica — freshly rebranded Kuur Therapeutics — in February, the Kite Pharma alum was introduced to another cell therapy player.

The basic idea of building an off-the-shelf allogeneic platform with a CAR-NK approach was familiar to him, riding on the same wave as Takeda, J&J-backed Fate, Nkarta and others. But then there was something else that stood out: a membrane-bound TNF related apoptosis inducing ligand variant, or TRAIL variant, that’s also engineered onto the NK cell for a dual-targeted attack.

IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.