Con­fo Ther­a­peu­tics rais­es €30 mil­lion; Waylivra re­ceives ap­proval from EU; end­point met for Mer­ck­'s Bel­som­ra in PhI­II tri­al

Cedric Ververken

→ In an in­vest­ment led by Bio­Gen­er­a­tion Ven­tures and co-led by Welling­ton Part­ners, with Fund+ and Per­cep­tive Ad­vi­sors step­ping in, Con­fo Ther­a­peu­tics an­nounced to­day that it has raised €30 mil­lion ($33.4 mil­lion) in Se­ries A fi­nanc­ing. The com­pa­ny said that the funds will be al­lo­cat­ed to use to­wards ac­cel­er­at­ing its Con­fo­Body-en­abled drug dis­cov­ery ac­tiv­i­ties and to de­vel­op its pipeline of GPCR mod­u­lat­ing com­pounds to pro­duce drug can­di­dates for clin­i­cal tri­als.

“We ap­pre­ci­ate the strong and con­tin­ued sup­port from our ex­ist­ing in­vestors, who have en­abled the Com­pa­ny to progress to this point. We are proud to wel­come BGV, Welling­ton Part­ners, Fund+ and Per­cep­tive Ad­vi­sors as new in­vestors, com­plet­ing a high-qual­i­ty in­ter­na­tion­al syn­di­cate. We look for­ward to boost­ing the com­pa­ny’s drug dis­cov­ery en­gine and ad­vanc­ing our port­fo­lio of GPCR-mod­u­lat­ing com­pounds,” com­ment­ed CEO Cedric Ververken.

Mer­ck $MRK an­nounced to­day that its drug Bel­som­ra (su­vorex­ant) C-IV met the pri­ma­ry ef­fi­ca­cy end­point in its Phase III tri­al for the treat­ment of in­som­nia in peo­ple with mild-to-mod­er­ate Alzheimer’s dis­ease de­men­tia. 

The com­pa­ny said that “this is the first ded­i­cat­ed Phase III polysomnog­ra­phy study of an in­som­nia med­ica­tion in peo­ple with mild-to-mod­er­ate Alzheimer’s dis­ease de­men­tia, and in the tri­al, Bel­som­ra met its pri­ma­ry and sec­ondary ef­fi­ca­cy end­points. For the pri­ma­ry end­point, 4-weeks of treat­ment with Bel­som­ra im­proved mean to­tal sleep time (TST) by 28.2 min­utes ver­sus place­bo (n=135 vs. n=139, re­spec­tive­ly; [95% CI:11.1,45.2], p<0.005). This cor­re­spond­ed to a mean in­crease from base­line of 73.4 min­utes with Bel­som­ra [95% CI: 61.3, 85.5] and a mean in­crease from base­line of 45.2 min­utes with place­bo [95% CI: 33.3, 57.2]. Ad­verse events were re­port­ed in 22.5% of pa­tients re­ceiv­ing Bel­som­ra com­pared to 16.1% of those re­ceiv­ing place­bo.”

MIT Solve an­nounced to­day the launch of Solve In­no­va­tion Fund — a phil­an­thropic ven­ture fund that will raise $30 mil­lion over time from donors con­tribut­ing through tax-de­ductible gifts to MIT, to cre­ate debt and eq­ui­ty in­vest­ments for ear­ly-stage en­tre­pre­neurs look­ing to solve glob­al chal­lenges. The com­pa­ny said that the fund will be set up as a donor-ad­vised fund (DAF), in­de­pen­dent to and ex­ter­nal to MIT, with MIT Solve act­ing as a donor-ad­vi­sor.

Noubar Afeyan

MIT grad­u­ate, founder and CEO of Flag­ship Pi­o­neer­ing Noubar Afeyan is com­mit­ting up to $3 mil­lion to the fund.

“Solve’s mis­sion is to tack­le glob­al chal­lenges by help­ing ear­ly-stage in­no­va­tors from all around the world con­nect with each oth­er, tap the strength of MIT’s in­no­va­tion ecosys­tem and, cru­cial­ly, gain the re­sources to trans­form their ideas in­to im­pact­ful so­lu­tions. The Solve In­no­va­tion Fund is an in­spir­ing step to pro­vid­ing Solver teams with the cap­i­tal to de­liv­er their so­lu­tions at scale,” said MIT pres­i­dent L. Rafael Reif.

→ The Eu­ro­pean Union has ap­proved Akcea and Io­n­is’ drug, Waylivra (volane­sors­en) — a ther­a­py used to­wards Fa­mil­ial Chy­lomi­crone­mia Syn­drome (FCS). The com­pa­ny said that the ther­a­py will be used as an ad­junct di­et in adult pa­tients with ge­net­i­cal­ly con­firmed FCS and at high risk for pan­cre­ati­tis, who’ve had an in­ad­e­quate re­sponse to di­et and triglyc­eride-low­er­ing ther­a­py.

Paula Soteropou­los

“Waylivra is the on­ly ap­proved treat­ment for peo­ple with FCS and is a ma­jor mile­stone for the glob­al FCS com­mu­ni­ty. This al­so marks Akcea’s sec­ond drug ap­proval in the last year,” said Paula Soteropou­los, CEO of Akcea Ther­a­peu­tics. “We plan to launch Waylivra in Ger­many this year fol­lowed by ad­di­tion­al Eu­ro­pean coun­tries in 2020. Our team is ready to de­liv­er this treat­ment op­tion to pa­tients with FCS.”

→ On Tues­day, Den­ver vot­ers will de­cide whether to de­crim­i­nal­ize pos­ses­sion of psilo­cy­bin, a hal­lu­cino­genic drug used in “mag­ic mush­rooms,” re­port­ed Reuters. Den­ver will be the first US city to stop such pros­e­cu­tions and if passed, in­di­vid­u­als at least 21 years old who use or pos­sess the drug will not re­ceive crim­i­nal penal­ties. 

The drug will re­main il­le­gal un­der both Col­orado and fed­er­al law and has been deemed by the US Drug En­force­ment Ad­min­is­tra­tion (DEA) to have a high po­ten­tial for abuse and cur­rent­ly has no ac­cept­ed med­ical use.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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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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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.