Pfiz­er biotech spin­out nabs $125M megaround as Bain-backed syn­di­cate bets on its late-stage game plan

Spring­Works Ther­a­peu­tics launched in the fall of 2017 with a whop­ping $103 mil­lion round and some well-de­vel­oped Pfiz­er as­sets that the com­pa­ny had high hopes for. And now Bain, Pfiz­er and the rest of the found­ing in­vestors have joined hands with an even big­ger group of in­vestors led by Per­cep­tive to bankroll a pair of late-stage stud­ies ready to be­gin in a mat­ter of weeks.

The Se­ries B weighs in at a heavy­weight $125 mil­lion, bring­ing their to­tal raise to $228 mil­lion, with ac­cess to more if need­ed.

The fo­cus of this lat­est megaround is cen­tered on two drugs that are be­ing re­pur­posed for rare dis­eases: nirogace­s­tat, a gam­ma sec­re­tase in­hibitor for the treat­ment of desmoid tu­mors (rare soft tis­sue tu­mors), and PD-0325901, a MEK in­hibitor for the treat­ment of neu­rofi­bro­mato­sis type 1-as­so­ci­at­ed plex­i­form neu­rofi­bro­mas. 

Both of these tar­gets are well de­fined, with mul­ti­ple tri­als for re­lat­ed drugs over the past decade or more. The gam­ma sec­re­tase in­hibitor was born in the Alzheimer’s field, where Eli Lil­ly ex­pe­ri­enced a colos­sal dis­as­ter years ago. That MEK in­hibitor, Spring­Works ex­ecs say, al­so has po­ten­tial to make good as a back­bone com­bi­na­tion drug in on­col­o­gy, fol­low­ing oth­er ap­proved ther­a­pies.


Im­age: Saqib Is­lam. CHECK­RARE via YOUTUBE

The big fi­nanc­ing takes the com­pa­ny all the way through the two late-stage stud­ies, says CEO Saqib Is­lam, with a clas­sic cross­roads that could ar­rive in H2 of next year if they do an in­ter­im analy­sis and if it’s pos­i­tive, set­ting up a pos­si­ble FDA ap­pli­ca­tion. The gam­ma sec­re­tase study should read out in ear­ly 2021.

The com­pa­ny, which now has 41 staffers head­ed to about 70 at the end of the year, says the CEO, has the ca­pac­i­ty to go the dis­tance by it­self in rare dis­eases. And as a vet of Alex­ion, Is­lam — who more re­cent­ly did deals for Mod­er­na — says they are ready to do what’s nec­es­sary to launch com­mer­cial op­er­a­tions. Larg­er in­di­ca­tions could be cov­ered with part­ner­ships, and he point­ed to a tie-up they have with BeiGene, com­bin­ing their RAF dimer in­hibitor li­fi­rafenib (BGB-283) with the MEK.

More deals are clear­ly in the works, he adds, which could trig­ger a faster ex­pan­sion of the staff and ca­pa­bil­i­ties at Spring­Works, which has the re­search team in RTP and the cor­po­rate staff now head­quar­tered in Stam­ford, CT.

I asked Is­lam the ob­vi­ous ques­tion: With a syn­di­cate this size with these play­ers, and plans to push through piv­otal tri­als, an IPO would seem to be in the cards as long as the mar­ket holds up. He laughed a lit­tle and lim­it­ed him­self to the stan­dard re­frain: All fi­nanc­ing op­por­tu­ni­ties are un­der re­view.

Pfiz­er has helped craft sev­er­al new com­pa­nies like this re­cent­ly. There’s Bain-backed Cerev­el as well as Al­lo­gene from Arie Bellde­grun and David Chang. In every case, Pfiz­er ex­ecs of­floaded as­sets they no longer want­ed in the pipeline, but which they felt had re­al com­mer­cial prospects in the right hands. Is­lam al­so not­ed that they are in­clud­ed in Pfiz­er’s port­fo­lio re­view process, which could al­so trig­ger more deals down the road as Pfiz­er con­tin­ues to shed projects.

Per­cep­tive Ad­vi­sors led the show for the Se­ries B. New in­vestors par­tic­i­pat­ing in this fi­nanc­ing in­clude Box­er Cap­i­tal of Tavi­s­tock Group, HBM Health­care In­vest­ments, BVF Part­ners, Sur­vey­or Cap­i­tal, Sam­sara Bio­Cap­i­tal, Ar­row­Mark Part­ners, Glax­o­SmithK­line, and Lau­ri­on Cap­i­tal Man­age­ment, as well as “sev­er­al oth­er long-term in­sti­tu­tion­al in­vestors.” All of the com­pa­ny’s ex­ist­ing in­vestors – Or­biMed, Bain Cap­i­tal, Pfiz­er, via Pfiz­er Ven­tures, and LifeArc – al­so par­tic­i­pat­ed.

It’s cu­ri­ous to see GSK in­clud­ed here as a di­rect in­vestor. In re­cent months its cor­po­rate ven­ture arm SR One has been ne­go­ti­at­ing to spin out from un­der the phar­ma gi­ant, which is more in­ter­est­ed in us­ing all of its cash in di­rect line with the R&D game plan set by Hal Bar­ron.

Is­lam said he could of­fer on­ly lim­it­ed in­sight in­to GSK’s cor­po­rate in­volve­ment, but added that “they could be a fab­u­lous part­ner for a cou­ple of things down the road.”

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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