CEO Luis Peña (Evommune)

Der­mi­ra vets li­cense back can­di­dates from Eli Lil­ly to launch their own up­start

About a year af­ter Eli Lil­ly ab­sorbed Der­mi­ra in a $1 bil­lion buy­out, the der­ma­tol­ogy com­pa­ny’s co-founders are li­cens­ing back three in­flam­ma­to­ry dis­ease pro­grams they helped de­vel­op for their own up­start, Evom­mune.

Lil­ly had its sights set on le­brik­izum­ab, a cast-off from Roche that Der­mi­ra picked up for $135 mil­lion in near-term cash. But Der­mi­ra was al­so fo­cused on a broad­er an­ti-in­flam­ma­to­ry pipeline, ac­cord­ing to Luis Peña, Evom­mune pres­i­dent and CEO and Der­mi­ra’s co-founder and for­mer chief de­vel­op­ment of­fi­cer. That broad­er pipeline is what Evom­mune is look­ing to mine for its own ef­forts.

“Once Lil­ly ac­quired Der­mi­ra we saw the op­por­tu­ni­ty to con­tin­ue our ef­forts to work on that,” he said. The com­pa­nies are keep­ing the fi­nan­cial terms of the deal un­der wraps.

Peña and Evom­mune’s oth­er co-founders worked at Lil­ly for a short time dur­ing the tran­si­tion, then moved right to the start­up. The jump hap­pened nat­u­ral­ly, Peña said. His last day at Lil­ly was on March 31, and Evom­mune was in­cor­po­rat­ed the fol­low­ing month. In No­vem­ber, they raised $12.5 mil­lion in seed fund­ing.

“We have found­ed com­pa­nies be­fore. We’ve led small com­pa­nies. We’ve led large biotech com­pa­nies … We’ve de­vel­oped small mol­e­cules for both top­i­cal and orals. We’ve de­vel­oped bi­o­log­ics, and seen them all the way through to ap­provals. So it’s pret­ty rare to have a team like that,” Peña said.

Eu­gene Bauer

Evom­mune’s oth­er co-founders in­clude CMO Eu­gene Bauer, Der­mi­ra’s co-founder and for­mer CMO, and se­nior VP of re­search Hans Hofland, who was head of re­search and non­clin­i­cal de­vel­op­ment at Der­mi­ra. Jan­ice Drew, Evom­mune’s se­nior VP of prod­uct de­vel­op­ment, served as se­nior VP of port­fo­lio plan­ning and man­age­ment at Der­mi­ra.

The three com­pounds li­censed from Lil­ly in­clude IRAK4/Tr­kA, a small mol­e­cule that broad­ly in­hibits in­nate in­flam­ma­tion; RORγt, a small mol­e­cule ad­dress­ing Th17 me­di­at­ed in­flam­ma­tion; and MRG­PRX2, a small mol­e­cule to treat chron­ic pru­ri­tus. Evom­mune says IRAK4/Tr­kA has po­ten­tial to treat var­i­ous in­flam­ma­to­ry dis­eases, in­clud­ing atopic der­mati­tis, asth­ma, Be­hçet’s dis­ease, con­junc­tivi­tis, and papu­lo­pus­tu­lar rosacea. RO­Ryt is be­ing de­vel­oped for pso­ri­a­sis, with ad­di­tion­al in­di­ca­tions in­clud­ing graft-ver­sus-host dis­ease, lichen planus, rosacea, and in­flam­ma­to­ry bow­el dis­ease.

The pro­grams were iden­ti­fied us­ing a plat­form built at Der­mi­ra, in which they used donor skin from tum­my tucks to in­duce in­flam­ma­to­ry con­di­tions.

“That serves as an amaz­ing win­dow, not on­ly to in­flam­ma­tion in the skin but in­flam­ma­tion else­where in the body,” Peña said. “It’s al­ways nice to have a dis­ease mod­el that mim­ics what’s hap­pen­ing clin­i­cal­ly, and it’s not al­ways easy to do that,” he added lat­er.

Evom­mune al­so has a fourth can­di­date, PKCθ, in the works for atopic der­mati­tis. Peña hopes to bring the lead pro­gram, IRAK4/Tr­kA to the clin­ic in the sec­ond half of 2021.

“The holy grail for top­i­cal at this point is to find a non steroidal an­ti in­flam­ma­to­ry that works re­al­ly well … we think that the IRAK com­po­nent can give us the abil­i­ty to find that,” he said.

Peña not­ed in­ter­est in in­flam­ma­tion as­so­ci­at­ed with cy­tokine storms that caus­es res­pi­ra­to­ry dis­tress in Covid-19 pa­tients. “That’s like­ly to come back if we have an­oth­er pan­dem­ic and cer­tain­ly hav­ing new and more tar­get­ed po­tent an­ti-in­flam­ma­to­ries is go­ing to help on that side,” he said. “So that’s our goal with our pipeline is to con­tin­ue to de­vel­op new ther­a­pies that cer­tain­ly will pro­vide the type of ther­a­py that we need right now for these in­creas­ing­ly preva­lent chron­ic dis­eases.”

The com­pa­ny is look­ing to raise an­oth­er round of fund­ing this quar­ter, ac­cord­ing to Peña.

A cor­rec­tion has been made to the spelling of PKCθ.

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.

Matt Gline (L) and Vivek Ramaswamy

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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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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.

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

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.