GSK banks on promis­ing da­ta from its PhI­II Gem­i­ni pro­gram to stare down Gilead on HIV — but there are plen­ty of skep­tics

Af­ter more than a decade’s worth of work, Glax­o­SmithK­line $GSK re­searchers to­day are un­veil­ing pooled da­ta from their two late-stage tri­als of a two-drug reg­i­men for keep­ing HIV in check. Fac­ing off against some deep-seat­ed skep­ti­cism and a pow­er­house ri­val at Gilead $GILD, the phar­ma gi­ant’s ma­jor­i­ty owned sub­sidiary Vi­iV says the com­bo per­formed just as well as a triplet in their big face­off in­volv­ing treat­ment-naive pa­tients, mak­ing it a like­ly new en­try in the glob­al fight against the virus that spurs AIDS.

“Ther­a­py has got­ten bet­ter, peo­ple are liv­ing longer,” says Vi­iV CSO John Pot­tage. “Then you have to think about treat­ing peo­ple for their life­time, decades of ther­a­py.”

The sim­pler, the bet­ter.

John Pot­tage

Click on the im­age to see the full-sized ver­sion

The two drugs Vi­iV put to­geth­er in its big Gem­i­ni Phase III pro­gram are do­lute­gravir and lamivu­dine (3TC). The pooled da­ta demon­strat­ed a 91% con­trol rate, with the bulk of the pa­tients un­der the rate of HIV-1 RNA<50 copies/mL com­pared with 93% in a three-drug arm fea­tur­ing do­lute­gravir and two nu­cle­o­side re­verse tran­scrip­tase in­hibitors: teno­fovir diso­prox­il fu­marate/emtric­itabine.

Pot­tage al­so says that the da­ta hold up when you pull out the pa­tients with high vi­ral loads. 

This is one-year da­ta, mean­ing that re­searchers will con­tin­ue to watch on dura­bil­i­ty, a key fea­ture for any new treat­ment in this field, where pa­tients are mon­i­tored to see if their treat­ment reg­i­men is los­ing ef­fect and re­quires a shift to keep the virus at bay.

“It used to be month-to-month,” Pot­tage says to me about the drug changeover rate. “Here they last for years.”

In that sce­nario, the few­er drugs you use, the less like­ly you’ll run in­to prob­lems, in­clud­ing few­er drug-drug in­ter­ac­tions as these pa­tients get old­er and face mul­ti­ple co-mor­bidi­ties. It’s an edge, and an edge can amount to a ma­jor mar­ket niche in HIV.

If the da­ta hold up un­der reg­u­la­to­ry scruti­ny at the FDA, the EMA and in­deed around the world, GSK will quite like­ly have a new prod­uct in this block­buster are­na. Reg­u­la­tors and physi­cians love al­ter­na­tive drug op­tions to put on their list of go-to ther­a­pies for chron­ic dis­eases. But just get­ting an OK like­ly won’t damp­en the skep­ti­cism some an­a­lysts have of­fered about GSK as the UK phar­ma gi­ant bat­tles a dom­i­nant Gilead on what amounts to be their home turf.

Ge­of­frey Porges, Leerink

One of the most skep­ti­cal watch­ing the bat­tle of the HIV gi­ants is Leerink’s Ge­of­frey Porges, who re­cent­ly ticked off a line­up of hur­dles GSK will like­ly find dif­fi­cul­ty clear­ing. GSK al­ready fell be­hind Gilead’s lat­est 3-drug com­bi­na­tion Bik­tarvy with their oth­er two-drug com­bo Ju­lu­ca, us­ing do­lute­gravir and rilpivirine. That, he said, was clear­ly in­fe­ri­or.

Gilead looks to re­main the dom­i­nant play­er, he adds, not­ing:

Though we be­lieve physi­cians will be more will­ing to pre­scribe a two-drug HIV reg­i­men that in­cludes 3TC in­stead of rilpivirine, all of the HIV pre­scrip­tion trends and our pro­pri­etary sur­vey work sug­gest that GSK’s two-drug reg­i­mens will not un­der­mine Gilead’s in­creas­ing HIV mar­ket share trend over the next 3 years, and we do not an­tic­i­pate any val­ue ero­sion in Gilead’s stock from these dis­clo­sures or even the ap­proval of this sec­ond 2 drug com­bi­na­tion from Vi­iV.

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.