Kevin Judice

DiCE gets its 'li­brary' card ready as it speeds de­vel­op­ment of DNA data­base-de­rived mol­e­cules with more in­vestor cash

In­vestors like to see big plans, and Kevin Ju­dice has plen­ty. The DiCE Mol­e­cules CEO is plot­ting a clin­i­cal tri­al launch for the biotech’s lead small mol­e­cule for pso­ri­a­sis and wants to dou­ble the staff in the next year and a half.

On Fri­day, those big plans land­ed him an $80 mil­lion Se­ries C round.

“We’re very ex­cit­ed about it,” he said of the raise led by RA Cap­i­tal Man­age­ment.

The round comes around two years af­ter a $50 mil­lion Se­ries B. While the B round was used for op­ti­miz­ing tech­nol­o­gy and build­ing a pipeline, Ju­dice says the Se­ries C will pro­pel the biotech’s IL-17 an­tag­o­nist to the clin­ic and fund the de­vel­op­ment of two oth­er undis­closed pro­grams.

“This new cap­i­tal al­lows us to ex­pand our reach and get at more tar­gets and have more op­por­tu­ni­ties to make high im­pact,” Ju­dice said.

DiCE’s de­vel­op­ment process re­volves around its DNA-en­cod­ed li­brary. Such li­braries al­low re­searchers to screen mil­lions — even bil­lions — of com­pounds in par­al­lel, us­ing DNA tags that Ju­dice com­pared to bar­codes, which tell you what the con­stituent pieces of a mol­e­cule are.

“Usu­al­ly you do some kind of screen, like a high-through­put screen, or a DNA-en­cod­ed li­brary screen, some­thing like that, and you get a few hits. And then there’s a long phase of just lab chem­istry, where you’re mak­ing in­di­vid­ual com­pounds and try­ing to progress those hits, those ini­tial binders, to some­thing that’s clos­er to a drug,” Ju­dice said.

That hit-to-lead phase is typ­i­cal­ly la­bor-in­ten­sive and slow, the CEO said. But DiCE’s ap­proach ac­cel­er­ates that work by us­ing a small­er DNA-en­cod­ed li­brary — much small­er but rich­er in in­for­ma­tion, Ju­dice said — to screen in dif­fer­ent ways af­ter get­ting a hit.

“What we’re ac­tu­al­ly look­ing for is the dif­fer­ence be­tween just bind­ing and some­thing that is func­tion­al,” Ju­dice said.

DiCE’s lead pro­gram is an ag­o­nist for cy­tokine re­cep­tor IL-17, which is im­pli­cat­ed in dis­eases like pso­ri­a­sis and pso­ri­at­ic arthri­tis. Cur­rent an­ti­body treat­ments tar­get­ing IL-17 are quite ef­fec­tive at treat­ing pso­ri­a­sis, but they are in­jectable and lack in con­ve­nience. DiCE’s can­di­date would be oral, and the biotech is hop­ing to top the ef­fi­ca­cy of Am­gen’s al­ready ap­proved oral PDE4 in­hibitor Ote­zla.

“What we’re work­ing on is an oral that will work as well as the an­ti-IL-17 an­ti­bod­ies. So it com­bines the con­ve­nience and safe­ty of some­thing like Ote­zla with the ef­fi­ca­cy of an an­ti­body like Cosen­tyx,” Ju­dice said. “The an­ti­bod­ies tell us that IL-17 is ex­act­ly the right tar­get.”

Since 2017, DiCE has grown from a sev­en-per­son, “peanut-sized” com­pa­ny to a 29-per­son staff. And in the next 18 months, Ju­dice is look­ing to bring that num­ber to 58. The biotech inked a $2.3 bil­lion dis­cov­ery pact with Sanofi years ago, and is cur­rent­ly part­ner­ing with them on an I/O small mol­e­cule pro­gram that Ju­dice says isn’t far be­hind the IL-17 can­di­date.

“We should be ready to go pub­lic with more da­ta on ear­li­er pro­grams over the course of the next 12 months. And then I’m re­al­ly ex­cit­ed about the op­por­tu­ni­ty to grow the pipeline by adding new pro­grams to it,” he said. “That’s one of the things that is par­tic­u­lar­ly great, from my per­spec­tive, about hav­ing RA Cap­i­tal lead this round.”

In ad­di­tion to RA, Even­tide As­set Man­age­ment, New Leaf Ven­ture Part­ners, Soleus Cap­i­tal, Driehaus Cap­i­tal Man­age­ment, Os­age Uni­ver­si­ty Part­ners and Asym­me­try Cap­i­tal Man­age­ment, North­pond Ven­tures, Sands Cap­i­tal, Sanofi Ven­tures, Alexan­dria Ven­ture In­vest­ments, Al­ti­tude Ven­tures and Agent Cap­i­tal al­so chipped in­to the Se­ries C.

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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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.

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.