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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.