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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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