Robert Clarke (Kinaset)

Ki­naset launch­es with $40M and a JAK in­hibitor from Vec­tura's old pipeline

Ki­naset Ther­a­peu­tics is join­ing the search for a bet­ter se­vere asth­ma treat­ment, pick­ing up where Vec­tura left off when it de­cid­ed to clear house last year.

UK-based Vec­tura — which took a big hit when its most ad­vanced can­di­date flopped in a Phase III asth­ma tri­al back in 2018 — re­cent­ly shift­ed to a CD­MO mod­el, of­fload­ing all of its R&D pro­grams. Robert Clarke, who’s worked on in­hal­able ther­a­peu­tics for 21-plus years, had close con­tacts at the com­pa­ny and took a look at what they were of­fer­ing. Af­ter do­ing some re­search, he was at­tract­ed by VR588, a pan-JAK in­hibitor.

“I thought there was a re­al­ly in­ter­est­ing op­por­tu­ni­ty here,” said Clarke, who hailed from Pul­ma­trix. So he jumped, build­ing a com­pa­ny of his own around the can­di­date. On Mon­day, Ki­naset launched with a $40 mil­lion Se­ries A and its sights set on the clin­ic.

The small mol­e­cule can­di­date, re­named KN-002, is an an­ti-in­flam­ma­to­ry — or as Clarke calls it, “a bet­ter mouse­trap.” It tar­gets “all of the JAKs,” he said, as op­posed to just JAK1 or JAK2, for in­stance. “We’re hit­ting every­thing with­in that in­flam­ma­to­ry cas­cade,” he con­tin­ued.

The biotech is poised to launch a Phase I/Ib clin­i­cal tri­al for eosinophilic and non-eosinophilic se­vere asth­ma in the first half of 2021. Just north of 100 pa­tients will be en­rolled. First will be a sin­gle as­cend­ing dose study with healthy vol­un­teers to es­tab­lish safe­ty and tol­er­a­bil­i­ty. Then the biotech will move in­to a mild to mod­er­ate asth­ma phe­no­type look­ing at safe­ty, tol­er­a­bil­i­ty, as well as phar­ma­co­dy­nam­ic and phar­ma­co­ki­net­ic mark­ers. The third part of the study will test the drug in more se­vere pa­tients.

Clarke says the Se­ries A should see KN-002 through a Phase I/Ib read­out, as well as a Phase II proof-of-con­cept. The round was co-led by 5AM Ven­tures and At­las Ven­ture, with a hand from Eu­ro­pean in­vestor Gimv.

Ki­naset and Vec­tura are keep­ing mum about the terms of their li­cens­ing deal. But they did say that Vec­tura will be re­spon­si­ble for man­u­fac­tur­ing clin­i­cal tri­al sup­plies, and stands to earn reg­u­la­to­ry and com­mer­cial mile­stones, as well as po­ten­tial roy­al­ties on glob­al net sales should the drug get ap­proved.

JAK in­hibitors have faced ques­tions about their safe­ty. Ab­b­Vie’s rheuma­toid arthri­tis drug Rin­voq, for ex­am­ple, was slapped with a black­box warn­ing last year af­ter stud­ies showed 1% of pa­tients came down with a se­ri­ous in­fec­tion, op­por­tunis­tic in­fec­tion, or her­pes zoster.

“We ex­pect that should not be an is­sue for us be­cause we’ll be de­liv­er­ing a rel­a­tive­ly low dose to the lung and keep­ing it out of the sys­temic cir­cu­la­tion,” Clarke said of the safe­ty con­cerns. “It’s go­ing to be a… much pre­ferred de­liv­ery pro­file.”

Ki­naset isn’t too far be­hind Genen­tech and As­traZeneca, which both have in­haled JAK in­hibitors for asth­ma in Phase I. Ther­a­vance Bio­phar­ma is ahead of the pack with two can­di­dates in Phase II.

“If you have asth­ma and you take your typ­i­cal asth­ma reg­i­men of steroids and bron­chodila­tors, over time the pa­tients will find that those wane in ef­fec­tive­ness and they need some­thing else in or­der to sup­port that stan­dard of care,” Clarke said, adding that Ki­naset’s can­di­date could pro­vide “par­tic­u­lar­ly the non-eosinophilic pa­tients with re­lief that they cur­rent­ly can’t get.”

A cor­rec­tion has been made to note that the Ki­naset can­di­date was for­mer­ly known as VR588, not VR475.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Several months after striking an alliance with Novartis, TCR therapy-focused TScan Therapeutics has reeled in a crossover round that should hold it over for the next two years as it eyes a public debut.

The Christoph Westphal portfolio company had been arranging the crossover for the last few months, CEO David Southwell said. Just before Christmas, they nailed down what he called a “really blue-chip” syndicate of four new investors, including BlackRock, RA Capital Management and two undisclosed funds. They closed on the $100 million Series C just over a week ago, and waited until Monday morning to announce it.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.