GSK, Vi­iV of­fer sneak peek of PhI­II da­ta on in-house two-drug HIV com­bo, tout­ing non-in­fe­ri­or­i­ty

Press­ing on with its am­bi­tious goal to out­shine Gilead in the HIV space, Glax­o­SmithK­line is now armed with pos­i­tive da­ta on its two-drug reg­i­men from a pair of Phase III stud­ies — if we take their word for it.

John Pot­tage

Vi­iV Health­care — GSK’s ded­i­cat­ed HIV arm — re­port­ed overnight that GEM­I­NI-1 and GEM­I­NI-2 met their pri­ma­ry end­point based on plas­ma HIV-1 RNA <50 copies per mil­li­l­itre (c/mL) at week 48, es­sen­tial­ly show­ing non-in­fe­ri­or­i­ty of do­lute­gravir and lamivu­dine com­pared to the stan­dard three-drug reg­i­men. In ad­di­tion to safe­ty in­for­ma­tion, that’s as much as GSK is will­ing to di­vulge at the mo­ment, choos­ing to save the de­tails for an up­com­ing med­ical con­fer­ence.

“Im­por­tant­ly, the stud­ies show that this two-drug reg­i­men could be an op­tion for treat­ment naïve pa­tients and can sup­port a broad range of pa­tients liv­ing with HIV around the world,” said John Pot­tage, chief sci­en­tif­ic and med­ical of­fi­cer of Vi­iV Health­care, in a state­ment.

While dual drug com­bi­na­tions (or “dou­blets”) promise to re­duce tox­i­c­i­ty bur­den — an im­por­tant longterm con­cern giv­en that many now re­ceive HIV treat­ment chron­i­cal­ly — GSK still has its work cut out in lay­ing out a con­vinc­ing case for the par­a­digm shift. As Cred­it Su­isse an­a­lysts note:

HIV clin­i­cians have all grown up with the ethos that hit­ting the virus with mul­ti­ple modes of ac­tion is the best ther­a­peu­tic op­tion. They ac­knowl­edge this brings tol­er­a­bil­i­ty is­sues. Get­ting the com­mu­ni­ty to em­brace dou­blet ther­a­py, es­sen­tial­ly drop­ping one pos­si­ble treat­ment op­tion, is like­ly to take time and ed­u­ca­tion. We ex­pect longer term da­ta on treat­ment emer­gent re­sis­tance will like­ly be need­ed to build the dou­blet cat­e­go­ry sig­nif­i­cant­ly.

Umer Raf­fat of Ever­core has three ques­tions ahead of the full da­ta roll­out: first on the ex­act vi­ro­log­ic fail­ure rates be­tween the arms; sec­ond on how those rates dif­fer be­tween pa­tients with dif­fer­ent lev­els of vi­ral load at base­line; and third on the “ex­act na­ture of re­sis­tance mu­ta­tions.” In their press re­lease, GSK not­ed that “no pa­tient who ex­pe­ri­enced vi­ro­log­ic fail­ure in ei­ther treat­ment arm de­vel­oped treat­ment-emer­gent re­sis­tance.”

If it pans out, the eco­nom­ic up­side is clear, com­pared to both the triplet op­tion and a dou­blet that GSK has de­vel­oped with J&J dubbed Ju­lu­ca (which com­bines do­lute­gravir with J&J’s rilpivirine). Both drugs used in the com­bo are in-house drugs, po­ten­tial­ly set­ting GSK up to snatch mar­ket share from Gilead, which cur­rent­ly pro­vides the two nu­cle­o­side re­verse tran­scrip­tase in­hibitors need­ed to pair with do­lute­gravir in the form of Tru­va­da. That’s what Vi­iV CEO Deb­o­rah Wa­ter­house would like to see over time, she told the Fi­nan­cial Times.

Vi­iV plans to get the ball rolling on reg­u­la­to­ry sub­mis­sions lat­er this year. Pre­dict­ing a launch in the sec­ond half of 2019, Cred­it Su­isse is es­ti­mat­ing a peak sales op­por­tu­ni­ty of $500 mil­lion.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

James Collins, Broad Institute via Youtube

UP­DAT­ED: A space odyssey for new an­tibi­otics: MIT's ma­chine learn­ing ap­proach

Drug development is complex, expensive and comes with lousy odds of success — but in most cases, if you make it across the finish line brandishing a product with an edge (and play your cards right) it can be a lucrative endeavor.

As it stands, the antibiotic market is cursed — it harbors the stink of multiple bankruptcies, a dearth of innovation, and is consequently barely whetting the voracious appetites of big pharma or venture capitalists. Enter artificial intelligence — the biopharma industry’s cure-all for the pesky process of making a therapeutic, including data mining, drug discovery, optimal drug delivery, and addressable patient population.

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Gilead los­es two more patent chal­lenges on HIV pill, set­ting up court­room fight in Delaware

Gilead sustained two more losses in their efforts to rid themselves of an activist-backed patent lawsuit from the US government over a best-selling HIV pill.

Urged on by activists seeking to divert a portion of Gilead’s revenue to clinics and prevention programs, the Department of Health and Human Services made a claim to some of the patents for the best-selling HIV prevention drug, Truvada, also known as PrEP. Gilead responded by arguing in court that HHS’s patents were invalid.

Today, the US Patent and Trademark Office ruled that Gilead was likely to lose the last two of those challenges as well. The USPTO ruled against Gilead on the first two patents earlier this month.

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Jim Scholefield via PR Newswire

Mer­ck los­es its chief dig­i­tal of­fi­cer, spot­light­ing tal­ent hunt for the hottest ti­tle in Big Phar­ma

Over the last few years we’ve seen the chief digital officer title become one of the hottest commodities in Big Pharma as global organizations hunt the best talent to sharpen the cutting edge of their tech platforms.

But Merck just discovered how hard it may be to keep them focused on pharma.

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Kathy High (file photo)

Gene ther­a­py pi­o­neer Kathy High has left Spark af­ter com­plet­ing $4.3B union with Roche

Kathy High dedicated the past seven years of her life shepherding experimental gene therapies she’s developed at Children’s Hospital of Philadelphia toward the market as president and head of R&D at Spark Therapeutics. Now that the biotech startup is fully absorbed into Roche — with an FDA approval, a $4.3 billion buyout and a promising hemophilia program to boast — she’s ready to move on.

Roche confirmed her departure with Endpoints News and noted “she will take some well-deserved time off and then will begin a new chapter in a sabbatical at a university.”

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Tal Zaks (Moderna via YouTube)

For two decades, a new vac­cine tech­nol­o­gy has been slow­ly ap­proach­ing prime time. Now, can it stop a pan­dem­ic?

Two months before the outbreak, Moderna CMO Tal Zaks traveled from Cambridge, MA to Washington DC to meet with Anthony Fauci and the leaders of the National Institutes of Health.

For two years, Moderna had worked closely with NIH researchers to build a new kind of vaccine for MERS, one of the deadliest new viruses to emerge in the 21st century. The program was one test for a new technology designed to be faster, cheaper and more precise than the ways vaccines had been made for over a century. They had gathered evidence the technology could work in principle, and Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases and a longtime advocate for better epidemic preparedness, wanted to see if it, along with a couple of other approaches, could work in a worst-case scenario: A pandemic.

“[We were] trying to find a test case for how to demonstrate if our technology could rapidly prepare,” Zaks told Endpoints News.

Zaks and Fauci, of course, wouldn’t have to wait to develop a new test. By year’s end, an outbreak in China would short circuit the need for one and throw them into 24/7 work on a real-world emergency. They also weren’t the only ones with new technology who saw a chance to help in a crisis.

An ocean away, Lidia Oostvogels was still on vacation and relaxing at her mother’s house in Belgium when her Facebook started changing. It was days after Christmas and on most people’s feeds, the news that China had reported a novel virus to the World Health Organization blurred into the stream of holiday sweaters and fir trees. But on Oostvogels’s feed, full of vaccine researchers and virus experts, speculation boiled: There was a virus in China, something contained to the country, but “exotic,” “weird,” and maybe having to do with animals. Maybe a coronavirus.

Lidia Oostvogels

“I was immediately thinking like, ‘Hey, this is something that if needed, we can play a role,'” Oostvogels told Endpoints.

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Bank­rupt an­tibi­otics mak­er Ar­a­digm turns to old part­ner/in­vestor for fi­nal $3M fire sale

Grifols once paid Aradigm $26 million for a stake in its inhaled antibiotics. But with Aradigm now in bankruptcy, the Spanish drugmaker is dishing out a final $3.2 million to buy it all.

The fire sale — which comes one year after Aradigm filed for Chapter 11 following a regulatory trifecta for disaster — will see Grifols obtain assets and IP to Apulmiq (formerly Pulmaquin and Linhaliq in Europe), Lipoquin and free ciprofloxacin. In addition to waiving its claims in the bankruptcy case, Grifols also agreed to milestone payments up to $3 million more upon any regulatory approvals.

DB­V's peanut pre­ven­tion patch ap­proach­es key stage of ap­proval process

Almost a year and a half after DBV Technologies pulled its peanut allergy immunotherapy patch from FDA review, the biotech will get their day in court. The FDA has scheduled an advisory committee hearing for May 15.

In the two-horse race to develop the first immunotherapy for peanut allergy, DBV had the early lead, filing an NDA for their patch in 2018. But on December 20 of that year, the company withdrew their application after, they said, meeting with regulators and determining they had not submitted “sufficient detail regarding data on manufacturing procedures and quality controls.” Aimmune filed their BLA 3 days later and won approval as the first immunotherapy for peanuts this month.

An­to­nio Gual­ber­to starts post-Ku­ra ca­reer at Ei­sai sub­sidiary H3; eF­FEC­TOR co-founder Siegfried Re­ich jumps to Turn­ing Point

→ Days after Kura Oncology announced the departure of co-founder Antonio Gualberto, we finally know where he wound up. Eisai subsidiary H3 Biomedicine has recruited him as CMO to finding the right patients to its four clinical-stage small molecule assets hitting genomic drivers of cancer.

“Challenges of these and many other precision medicine approaches are on one hand technical — a need for robust and precise diagnostics — and on the other hand derived by the challenge to alter standard clinical practice in settings where patient screening, e.g. by tumor DNA sequencing, is not standard practice,” he wrote to Endpoints News on his way back to Boston from Eisai’s Tokyo offices. “Only compelling clinical activity can drive clinicians and pathologists to modify standard clinical practice.”