Gilead dou­bles down on HIV pre­ven­tion, treat­ment amid Covid set­backs and await­ing FDA de­ci­sion on long-act­ing can­di­date

Amid pre­dic­tions of HIV ad­vances un­rav­el­ing dur­ing Covid, Gilead Sci­ences is dou­bling down on pre­ven­tion, treat­ment op­tions and on-the-ground com­mu­ni­ty ef­forts, even as it awaits an FDA de­ci­sion on its long-act­ing can­di­date.

Tomáš Cih­lář

At the AIDS 2022 con­fer­ence be­gin­ning next week, Gilead will present new da­ta and stud­ies on HIV treat­ment Bik­tarvy and its long-act­ing PrEP and HIV can­di­date lenaca­pavir, but will al­so host a pan­el lay­ing out the de­tails — and im­por­tance — of com­mu­ni­ty col­lab­o­ra­tions.

“With­out a com­mu­ni­ty, the sci­en­tif­ic dis­cov­er­ies and break­throughs re­main just in pub­li­ca­tions and can­not be tran­si­tioned in­to clin­i­cal prac­tice,” Tomáš Cih­lář, Gilead SVP of re­search and vi­rol­o­gy, said.

Jared Baeten, Gilead’s VP of HIV clin­i­cal de­vel­op­ment, added, “It’s end to end in what we’re de­vel­op­ing in treat­ment, pre­ven­tion and cure and how we’re do­ing the clin­i­cal re­search, and then it al­so has huge com­mu­ni­ty en­gage­ment in try­ing to make sure that the things we de­vel­op ac­tu­al­ly have the im­pact that we all want.”

Jared Baeten

While da­ta on Covid’s ef­fect on HIV/AIDS aren’t ful­ly in yet, an ini­tial CDC re­port in May notes a 17% drop in HIV di­ag­no­sis in 2020 “like­ly due to dis­rup­tions in clin­i­cal care ser­vices, hes­i­tan­cy in ac­cess­ing health care ser­vices and short­ages in ma­te­ri­als for HIV tests” dur­ing the pan­dem­ic.

CDC di­rec­tor of its HIV/AIDS pre­ven­tion di­vi­sion Deme­tre Daskalakis called 2020 “a lost year” in the HIV fight dur­ing an NBC in­ter­view af­ter the CDC re­port was pub­lished.

“We don’t re­al­ly know where HIV trans­mis­sion is go­ing to land, but it’s some­thing that we ob­vi­ous­ly are con­cerned about,” he said.

Deme­tre Daskalakis

Baeten agreed the Covid pan­dem­ic did have neg­a­tive ef­fects on both treat­ment and pre­ven­tion of HIV from ac­cess to meds to eco­nom­ics — which makes new ther­a­pies, dos­ing op­tions and ed­u­ca­tion all the more im­por­tant.

“Covid brings it home re­al­ly strong­ly for us be­cause it em­pha­sizes that HIV treat­ment and pre­ven­tion is just one part of an in­di­vid­ual’s life that can be im­pact­ed by tons of things around them,” he said. “The larg­er so­cial con­text, be it stig­ma and things that im­pact the abil­i­ty to ac­cess ther­a­py ef­fec­tive­ly or take it for the long term, as well as the close in day-to-day is­sues of food in­se­cu­ri­ty, fam­i­ly and oth­er de­mands — Covid flows through all of those.”

Even be­fore the pan­dem­ic, while HIV in­fec­tions had lev­eled off and even de­clined by sin­gle-dig­it per­cent­ages, there were still many peo­ple with HIV who were not ef­fec­tive­ly vi­ral­ly sup­pressed, Baeten said. Along with that, on­ly a “mi­nor­i­ty” of peo­ple who could ben­e­fit from pre-ex­po­sure pro­phy­lax­is (PrEP) were tak­ing it. Pub­lic health es­ti­mates about 25% of el­i­gi­ble HIV-neg­a­tive peo­ple are on PrEP.

Gilead is hop­ing to change that, cur­rent­ly await­ing a de­ci­sion on its FDA ap­pli­ca­tion for its long-act­ing drug lenaca­pavir, re­sub­mit­ted in June af­ter it was hand­ed a CRL in De­cem­ber, cit­ing is­sues with the com­pat­i­bil­i­ty of the drug and borosil­i­cate vials. If ap­proved, lenaca­pavir will be the first HIV-1 cap­sid in­hibitor on the mar­ket and would be the first med with a six-month dos­ing sched­ule for HIV and PrEP.

GSK’s Vi­iV Health­care’s Cabe­nu­va was the first long-act­ing HIV treat­ment reg­i­men ap­proved for month­ly or every-two-month dos­ing for HIV treat­ment in Jan­u­ary 2021, while Vi­iV’s Apre­tude was the first long-act­ing treat­ment ap­proved for PrEP in De­cem­ber.

For Gilead, the longer-act­ing dos­ing of lenaca­pavir adds an­oth­er op­tion that’s great­ly need­ed in the next steps to re­solve the HIV epi­dem­ic.

“We’ve now es­tab­lished well that with a dai­ly pill we’ve cov­ered lots of peo­ple for pre­ven­tion — and lots of peo­ple are still un­cov­ered. So we need to in­no­vate be­yond that,” Baeten said. “It’s re­al­ly about get­ting to the point where we can turn off the epi­dem­ic, right? And the on­ly way to get there is to bump up the num­ber of peo­ple who are cov­ered with treat­ment and pre­ven­tion.”

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.