Search­ing for HIV cure, Gilead­'s new 'shock and kil­l' com­bo swats back lethal virus in mon­keys

A promi­nent group of sci­en­tif­ic in­ves­ti­ga­tors has tak­en an­oth­er step to­ward a pos­si­ble even­tu­al cure for HIV — one of the longest and most dif­fi­cult trails in drug R&D — us­ing a com­bo drug from Gilead.

While com­bi­na­tion ther­a­pies have long proven able to keep HIV locked in­to hid­den cel­lu­lar reser­voirs, elim­i­nat­ing those vi­ral pock­ets has proven to be dev­il­ish­ly dif­fi­cult. In a new an­i­mal study in­volv­ing rhe­sus mon­keys, though, re­searchers at Har­vard work­ing at Beth Is­rael Dea­coness Med­ical Cen­ter ad­vanced a lengthy ef­fort in pur­su­ing a “shock and kill” strat­e­gy us­ing a toll-like re­cep­tor com­bined with a killer an­ti­body.

Gilead’s ex­per­i­men­tal TLR7 ag­o­nist GS-9620 did the shock­ing, and the an­ti­body PGT121 did the killing. And while they weren’t able to erad­i­cate the reser­voirs, the re­searchers were able to do a good enough job to al­low close to half the mon­keys in the com­bo arm of the study to go with­out an­ti­retro­vi­ral for a lengthy stretch, rais­ing the promise that the same might be ac­com­plished in a large sub­set of hu­man pa­tients.

Dan Barouch

To test this ap­proach, in­ves­ti­ga­tors took 44 mon­keys in­fect­ed with a simi­an form of the virus and di­vid­ed them in­to 4 groups. They left one group in the place­bo arm, di­vid­ing the rest in­to two groups which were treat­ed with one of the two treat­ments alone and one group tak­ing a com­bi­na­tion. Then they took them off ther­a­py.

While the virus in most of the mon­keys in the place­bo or two monother­a­py arms quick­ly re­bound­ed, ready to kill as ever, 5 of the 11 pri­mates in the com­bo arm were able to go at least 168 days with­out re­bound­ing, with the oth­er 6 re­bound­ing but then able to sup­press the virus with­out an­ti­retro­vi­ral ther­a­py (ART).

Gilead has now ad­vanced the two treat­ments in Phase I stud­ies as they start to test how hu­mans will re­spond. Non­hu­man pri­mates have long been con­sid­ered an ide­al mod­el for an­tivi­ral ther­a­pies.

Why is this im­por­tant?

While pa­tients re­spond to longterm cock­tail ther­a­pies, they al­so ex­pe­ri­ence greater vul­ner­a­bil­i­ty to a va­ri­ety of mal­adies that can short­en their lives. The prospect of go­ing off ART for lengthy pe­ri­ods would hold the promise of sig­nif­i­cant­ly re­duc­ing those risks.

“New HIV ther­a­pies that aim to wake up and tar­get the vi­ral reser­voir have the po­ten­tial to play an im­por­tant role in long-term vi­ral sup­pres­sion with­out ART,” said Har­vard pro­fes­sor Dan Barouch, the di­rec­tor at the Cen­ter for Vi­rol­o­gy and Vac­cine Re­search, Beth Is­rael Dea­coness Med­ical Cen­ter.

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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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.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

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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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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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.