Kimberly Smith, ViiV R&D chief

GSK sub’s in­jectable out­per­forms Gilead in late-stage PrEP tri­al

Since 2012, when Tru­va­da was first ap­proved as a pre­ven­ta­tive treat­ment for HIV, Gilead has had a mo­nop­oly on PrEP, or pre-ex­po­sure pro­phy­lax­is. Now, in a large NIH-backed tri­al, a new drug from a pair of Big Phar­ma ri­vals looked just as ef­fec­tive, if not more.

In­ves­ti­ga­tors test­ed a long act­ing in­jectable from Vi­iV Health­care — the joint HIV ini­tia­tive be­tween Pfiz­er and Glax­o­SmithK­line — against Tru­va­da across 4,600 peo­ple at risk for HIV in­fec­tion. The tri­al, al­though on­ly pow­ered for non-in­fe­ri­or­i­ty, showed those on the long-act­ing in­jectable were 69% less like­ly to con­tract HIV than those on Tru­va­da, a once-dai­ly pill.

The drug, called cabote­gravir, en­ters in­to a shift­ing land­scape for PrEP. Tru­va­da is set to come off patent pro­tec­tion next year, set­ting the stage for the first gener­ic com­pe­ti­tion. Gilead hopes their new for­mu­la­tion for treat­ment and pre­ven­tion, De­scovy, will prove a sim­i­lar block­buster, no­tably of­fer­ing a bet­ter safe­ty pro­file, but they are al­so fac­ing law­suits from ac­tivists ac­cus­ing them of ma­nip­u­lat­ing de­vel­op­ment times to ex­tend their mo­nop­oly and from the US gov­ern­ment, who in a rare move has ac­cused the drug­mak­er of fail­ing to li­cense their in­tel­lec­tu­al prop­er­ty on the use of Tru­va­da as HIV pre­ven­tion.

Vi­iV and the NIH had un­til re­cent­ly been run­ning the tri­al as a su­pe­ri­or­i­ty tri­al, study pro­to­col chair Raphael Lan­dovitz told Sci­ence. But ear­li­er this year Covid-19 be­gan dis­rupt­ing the study, clos­ing 11 of 43 tri­al sites and pre­vent­ing par­tic­i­pants at oth­er sites from com­ing in. In April, in­ves­ti­ga­tors asked the da­ta and safe­ty mon­i­tor­ing board to change the study’s end­points to non-in­fe­ri­or­i­ty, to en­sure the study could be com­plet­ed with an un­com­pro­mised da­ta set.

On May 14, the DSMB did a sched­uled re­view and found it had al­ready met that thresh­old. The da­ta showed 12 in­fec­tions oc­curred in the cabote­gravir group ver­sus 38 in the Tru­va­da group, or a 0.38% chance of in­fec­tion ver­sus 1.21%.

”We are thrilled with the re­sults not on­ly be­cause of the high ef­fi­ca­cy of cabote­gravir but al­so be­cause we have demon­strat­ed high ef­fi­ca­cy in a study that ad­e­quate­ly rep­re­sents some of the pop­u­la­tions most dis­pro­por­tion­ate­ly im­pact­ed by HIV — black MSM in the US, young MSM glob­al­ly and trans­gen­der women,” Vi­iV R&D chief Kim­ber­ly Smith said in a state­ment, us­ing an aca­d­e­m­ic short­hand for men who have sex with men.

Tru­va­da is high­ly ef­fec­tive at pre­vent­ing HIV, and oth­er stud­ies have shown those who are in­fect­ed while on the reg­i­men had missed dos­es of the once dai­ly pill. One of the goals of cabote­gravir was to im­prove com­pli­ance, as it on­ly has to be giv­en once every two months.

In­ves­ti­ga­tors are still un­sure, though, why there were 12 in­fec­tions in the cabote­gravir arm, telling Sci­ence it could be be­cause of weight dif­fer­ences or be­cause in­fec­tion oc­curred ear­ly in the tri­al, when pa­tients in both arms had been re­quired to take Tru­va­da.

The com­pa­ny could face an up­hill bat­tle for ap­proval, though. In De­cem­ber, the FDA hit Vi­iV with a CRL on its ap­pli­ca­tion to get a com­bi­na­tion of cabote­gravir and the an­tivi­ral rilpivirine ap­proved as a month­ly in­jectable treat­ment for HIV. Vi­iV said the is­sue was around chem­istry man­u­fac­tur­ing and con­trols — con­cerns that say lit­tle about the drug’s ef­fec­tive­ness but have held up com­pa­nies for long pe­ri­ods in the past.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.