Biotech in­vestapalooza con­tin­ues with more ven­ture rounds for star­tups; Ova­Science cuts half of its work­force (again)

Ed­i­tor’s note: We here at End­points News pride our­selves on pro­vid­ing some com­pre­hen­sive ac­counts of all the ven­ture cash flow­ing in­to biotech com­pa­nies, but this week that’s be­come more than a chal­lenge. In just a mat­ter of three days we’ve field­ed news on well over $700 mil­lion in ven­ture in­vest­ments in new and ex­ist­ing life sci com­pa­nies. And we can’t do a sto­ry on each one. So be­low take a snap­shot look at the rest of the com­pa­nies an­nounc­ing new rais­es in the days ahead of JP­Mor­gan. — John Car­roll

Bris­tol-My­ers part­ner En­terome has banked a $38.5 mil­lion round to back work on two key mi­cro bio­me pro­grams for Crohn’s and glioblas­toma. In ad­di­tion to the Se­ries D, there’s al­so a $48 mil­lion loan com­ing from the Eu­ro­pean In­vest­ment Bank. Bris­tol-My­ers sup­port­ed the round along with new ven­ture in­vestor Prin­cip­ia SGR and Sev­en­ture, Health for Life Cap­i­tal, Lund­beck­Fonden Ven­tures, Omnes Cap­i­tal and Nestlé Health Sci­ence.

→ Boston-based Neu­ro­gas­trx has put to­geth­er a $45 mil­lion A round from 5AM Ven­tures, Or­biMed Ad­vi­sors and ven­Bio Part­ners. The biotech is on the look­out for proof-of-con­cept da­ta on a lead as­set — NG-101 — in treat­ing gas­tro­pare­sis. Jim O’Mara has been ap­point­ed CEO and Klaus Veitinger, a part­ner at Or­biMed Ad­vi­sors, will be­come chair­man. The biotech plans to pull up stakes and move to the big Boston hub with this round.

→ Vi­en­na-based Themis has raised a 10 mil­lion eu­ro C round to back their work on new vac­cines. The in­vestor group was led by the Glob­al Health In­vest­ment Fund and in­clud­ed aws Gru­en­der­fonds, Omnes Cap­i­tal, Ven­tech and Welling­ton Part­ners Life Sci­ences.

→ In oth­er mR­NA news this morn­ing, Cure­Vac and Arc­turus $ARCT are team­ing up their tech­nolo­gies on a slate of new de­vel­op­ment pro­grams. They’ll be us­ing Arc­turus’ de­liv­ery tech to de­vel­op 4 en­zyme re­place­ment and an­ti­body gen­er­a­tion projects.

→ An­oth­er round of cor­po­rate re­struc­tur­ing that in­volves slash­ing its staff count by half has come to Ova­Science $OVAS. The Waltham, MA-based fer­til­i­ty com­pa­ny ex­pects to com­plete the lay­offs by March, spend­ing $1-1.5 mil­lion along the way. The ex­act amount of cost sav­ings sup­posed to turn up in Q2 2018 is not dis­cussed in the state­ment. “In its ear­ly years, Ova­Science grew rapid­ly to ac­com­mo­date the glob­al com­mer­cial­iza­tion of the AUG­MENT treat­ment,” said CEO Christo­pher Kroeger (that strat­e­gy is now de­funct). “Fol­low­ing the strate­gic de­ci­sion to fo­cus our re­sources on the ad­vance­ment of OvaPrime and Ova­Ture, how­ev­er, we are now op­er­at­ing with a tighter re­search and de­vel­op­ment fo­cus.” Kroeger start­ed at the helm back in June, 2017 when — if you’re hav­ing de­ja vu, this is why — Ova­Science let go of 50% of its em­ploy­ees. Join­ing him in the C-suite this month will be new CSO James Lil­lie, who will lead pre­clin­i­cal ef­forts.

Pfiz­er has giv­en the boot to EOS200271, the IDO1 in­hibitor it li­censed from Bel­gium-based iTeos Ther­a­peu­tics back in 2014. Pfiz­er paid €24 mil­lion ($29 mil­lion) up­front to se­cure the rights to de­vel­op the drug as a sin­gle agent in pa­tients with brain can­cer. Af­ter fail­ing to find signs of ef­fi­ca­cy in a Phase I brain can­cer tri­al, the phar­ma gi­ant re­turned the rights to de­vel­op the drug back to iTeos. Still, iTeos is op­ti­mistic about the drug: “IDO1 in­hibitors are one of the most promis­ing im­muno-on­col­o­gy drug class­es cur­rent­ly in de­vel­op­ment,” said iTeos CEO Michel De­theux in a state­ment. “This as­set is one of four IDO1 in­hibitors in clin­i­cal de­vel­op­ment world­wide and EOS200271 is the on­ly IDO1 in­hibitor with ex­cel­lent brain pen­e­tra­tion. We be­lieve that the re­turn of this unique as­set gives iTeos the ex­cit­ing op­por­tu­ni­ty to con­tin­ue to eval­u­ate EOS200271’s po­ten­tial in dif­fer­ent in­di­ca­tions and com­bi­na­tions.”

Shire has picked up the FDA’s Break­through Ther­a­py Des­ig­na­tion for marib­avir (SHP620), a Phase III ther­a­py for cy­tomegalovirus in­fec­tion.

With ad­di­tion­al re­port­ing by Brit­tany Meil­ing and Am­ber Tong.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.