CEO Dan Hicklin (Werewolf)

Were­wolf pre­pares to bare its teeth in 1st tri­al for tar­get­ed cy­tokine tu­mor fight­ers with new round of in­vestor cash

Boston area biotech Were­wolf Ther­a­peu­tics launched in late 2019 with the goal of chas­ing nov­el im­mune sys­tem mod­u­la­tors to erad­i­cate sol­id tu­mors. Just over a year af­ter hit­ting the ground run­ning, Were­wolf has three can­di­dates in de­vel­op­ment and has its eyes set on the clin­ic with a new round of fund­ing.

Were­wolf on Thurs­day un­veiled a $72 mil­lion Se­ries B round to move its im­munother­a­pies, which tar­get the mi­croen­vi­ron­ments of sol­id can­cer tu­mors, to Phase I clin­i­cal proof-of-con­cept stud­ies.

The com­pa­ny, which launched with $56 mil­lion in Se­ries A fi­nanc­ing, is chas­ing pro-in­flam­ma­to­ry im­mune mod­u­la­tor mol­e­cules like IL-2 and IL-12 un­der its In­dukine trade­mark to hunt sol­id tu­mors. Were­wolf’s tar­get­ed cy­tokine can­di­dates aim to on­ly trig­ger an im­mune re­sponse once they en­ter a tu­mor’s mi­croen­vi­ron­ment — there­by spar­ing the sur­round­ing healthy cells from dam­age.

Were­wolf CEO Dan Hick­lin told End­points News that the newest round of fi­nanc­ing sig­ni­fies the lev­el of progress the com­pa­ny has achieved in a rel­a­tive­ly short pe­ri­od of time, but more im­por­tant­ly will al­low fur­ther re­search in­to ad­dress­ing the on­go­ing un­met med­ical needs as­so­ci­at­ed with sol­id can­cer tu­mors that don’t re­spond con­sis­tent­ly to oth­er can­cer ther­a­peu­tics.

“First, we got over the hur­dle of show­ing that you could re­al­ly make im­munother­a­py work and (the sec­ond hur­dle of) not just in one or two can­cers, but mul­ti­ple can­cers. So we have to start tap­ping in­to oth­er ap­proach­es and oth­er mech­a­nisms to stim­u­late the im­mune sys­tem, be­cause right now check­point ther­a­py is re­mark­able in what it can do — but it has its lim­i­ta­tions,” Hick­lin said. “There’s still pa­tients that don’t re­spond. There’s still pa­tients that re­lapse. And so, you know, the ther­a­py is try­ing to go to that next stage where we’re look­ing at ad­di­tion­al mech­a­nisms and dif­fer­ent ways to stim­u­late the im­mune sys­tem.”

Were­wolf Ther­a­peu­tics CEO Dan Hick­lin works along­side a sci­en­tist in the com­pa­ny’s lab­o­ra­to­ry.

Click on the im­age to see the full-sized ver­sion

Were­wolf now has three mol­e­cule pro­grams in its port­fo­lio, Hick­lin said, and is “thrilled” about the progress the com­pa­ny has made in its on­go­ing tech­nol­o­gy de­vel­op­ments. This progress is what led to “a re­al­ly world-class set of life sci­ence in­vestors” fund­ing a new round of in­vest­ments, he added.

Those in­vestors in­clude RA Cap­i­tal Man­age­ment, which led the round and is joined by Deer­field Man­age­ment, HBM Health­care In­vest­ments, Soleus Cap­i­tal, Adage Cap­i­tal, Sphera Health­care and CaaS Cap­i­tal. The com­pa­ny said its Se­ries A in­vestors, in­clud­ing MPM Cap­i­tal, Long­wood, Tai­ho Ven­tures, Arkin Bio Ven­tures, DC In­vest­ment Part­ners and UPMC, al­so con­tributed to the Se­ries B funds.

Were­wolf’s In­dukine us­es a pro­pri­etary en­gi­neer­ing struc­ture dubbed PREDA­TOR, which Hick­lin de­scribes as a mul­ti­fac­eted sys­tem that has phar­ma­ceu­ti­cal prop­er­ties which al­low it to func­tion like a drug. Once ad­min­is­tered in­to the body, the mol­e­cules se­lec­tive­ly ac­ti­vate once they en­counter can­cer­ous dis­ease tis­sue, which could spare reg­u­lar tis­sue from ad­verse ef­fects.

“These are cy­tokines that are a very pow­er­ful way to stim­u­late the im­mune sys­tem to at­tack tu­mors,” he said. “But un­for­tu­nate­ly, these cy­tokines can al­so ac­ti­vate the im­mune sys­tem and ad­verse­ly af­fect nor­mal tis­sues as well, es­pe­cial­ly if they’re not tar­get­ed and con­trolled prop­er­ly once they’re ad­min­is­tered to the host … im­por­tant­ly, we’re do­ing this with­out com­pro­mis­ing their po­ten­cy.”

The new round of fi­nanc­ing comes at an ex­cit­ing time for the com­pa­ny, which in the past six months or so has added two key biotech vets to its C-suite in Ran­di Isaacs, a 20-year vet­er­an who took over as Were­wolf’s chief med­ical of­fi­cer af­ter leav­ing No­var­tis, and Ellen Lub­man, who hopped over as the com­pa­ny’s chief busi­ness of­fi­cer af­ter stints at Im­pel Neu­roPhar­ma and Al­ler­gan.

Ellen Lub­man

Lub­man, who joined Were­wolf in Au­gust, said her first five months have been “noth­ing short of ex­hil­a­rat­ing.”

“Both in terms of where the biotech in­dus­try is to­day, and how we have re­al­ly be­come as an in­dus­try, much more of a uni­corn — giv­en the abil­i­ty to rapid­ly de­vel­op a Covid-19 re­sponse, med­ical­ly speak­ing — and so that’s been an ex­hil­a­rat­ing op­por­tu­ni­ty … to be part of this time in our his­to­ry,” Lub­man said.

Were­wolf has held its pre­clin­i­cal da­ta for its two In­dukine can­di­dates, known as WTX-124 and WTX-330, close to the vest. Hick­lin said the com­pa­ny plans on pub­licly read­ing out da­ta dur­ing the Amer­i­can As­so­ci­a­tion for Can­cer Re­search con­fer­ence, which will be held in April and May.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.