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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Pearl Huang, former Cygnal Therapeutics president and CEO

UP­DAT­ED: Flag­ship builds a new start­up out of pieces from 2 of its biotechs. And a Roche vet leaves to do some­thing new

Flagship has crafted a new startup out of pieces from a pair of fledglings in the VC’s nest. And a prominent Roche veteran who ran one of the biotechs won’t be making the next leg of the journey.

The new company is called Sonata Therapeutics, which is picking up the work that Inzen was doing related to the cellular microenvironment and combining with Flagship’s Cygnal Therapeutics, which came out of stealth more than 3 years ago and put Pearl Huang — the BeiGene founder and former Roche SVP — at the helm.

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Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.