FDA vet — and Wood­cock neme­sis — John Jenk­ins is step­ping over to a new role as a board mem­ber at Cor­bus Phar­ma

Af­ter mak­ing head­lines for his part in the FDA’s painful rup­ture over Sarep­ta’s Duchenne ap­proval, news of John Jenk­ins has been rather slow. But now, the for­mer head of the agency’s Of­fice of New Drugs is step­ping out to join the board of a small com­pa­ny just out­side Boston.

Jenk­ins — who spent about 15 years work­ing as the di­rec­tor of OND, over­see­ing the re­view of thou­sands of drug ap­pli­ca­tions — is quite the catch for Cor­bus Phar­ma­ceu­ti­cals. With his ex­ten­sive reg­u­la­to­ry back­ground, it makes sense for com­pa­nies to be seek­ing his in­sight on their boards. But Cor­bus is the first com­pa­ny board Jenk­ins agreed to sit on since leav­ing the FDA in 2017.

The last time we wrote about Jenk­ins was dur­ing the Sarep­ta de­bate that di­vid­ed the FDA a cou­ple years back. Jenk­ins came out swing­ing against the ap­proval of Sarep­ta’s Duchenne mus­cu­lar dy­s­tro­phy drug eteplirsen, which now goes by the brand name Ex­ondys 51. The for­mer agency leader sided with top of­fi­cials at the FDA who said Sarep­ta nev­er came close to pro­vid­ing clear ev­i­dence of ef­fi­ca­cy and safe­ty for eteplirsen. He went as far as to go head-to-head with CDER chief Janet Wood­cock, es­sen­tial­ly ac­cus­ing her of ap­pear­ing bi­ased and brow­beat­ing re­view­ers to ap­prove Sarep­ta’s drug. He even­tu­al­ly lost that bat­tle, and Jenk­ins re­tired from the agency months af­ter the de­bate.

Since de­part­ing from the agency, Jenk­ins has been work­ing at Green­leaf Health, an FDA-fo­cused strate­gic con­sult­ing firm. But this is his first board seat post-OND.

What’s in­ter­est­ing about Cor­bus?

The com­pa­ny, found­ed in 2009, is in a Phase III tri­al test­ing its drug lenaba­sum in sys­temic scle­ro­sis and a Phase IIb tri­al in cys­tic fi­bro­sis, among oth­er pro­grams. Its CF tri­al was the first that used pul­monary ex­ac­er­ba­tions as its sole pri­ma­ry end­point, rather than along­side the co-pri­ma­ry end­point of FEV1, or forced ex­pi­ra­to­ry vol­ume. Un­like oth­er cys­tic fi­bro­sis meds, lenaba­sum doesn’t aim to hy­drate pa­tients’ mu­cus or tar­get the ge­net­ic mu­ta­tion be­hind the dis­ease, which are cap­tured with FEV1. The com­pa­ny is tack­ling the un­der­ly­ing in­flam­ma­tion in­stead.

To Jenk­ins, Cor­bus checked all the box­es on his list: the drug has an in­ter­est­ing mech­a­nism of ac­tion and pos­i­tive da­ta, it’s go­ing af­ter dis­eases with un­met need (CF, scle­ro­der­ma, der­mato­myosi­tis, lu­pus), and there’s po­ten­tial to treat in­flam­ma­tion in oth­er dis­eases. In a state­ment, Jenk­ins had this to say:

I look for­ward to work­ing with the board and the com­pa­ny’s se­nior lead­er­ship team to ad­vance the de­vel­op­ment of new in­no­v­a­tive ther­a­pies for pa­tients suf­fer­ing from se­ri­ous, chron­ic in­flam­ma­to­ry and fi­brot­ic dis­eases.

Im­age: John Jenk­ins. GREEN­LEAF HEALTH

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.