GSK widens the mar­ket for Ze­ju­la as FDA signs off on the PARP in­hibitor for use in ovar­i­an can­cer pa­tients with­out BR­CA mu­ta­tions

GSK has vast­ly ex­pand­ed its mar­ket for can­cer ther­a­py Ze­ju­la — the crown jew­el at the heart of its $5 bil­lion ac­qui­si­tion of Tesaro — by win­ning FDA ap­proval for the drug in a large sub­set of pa­tients with ovar­i­an can­cer.

The ap­proval comes for women with ad­vanced ep­ithe­lial ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer who ex­pe­ri­enced a com­plete or par­tial re­sponse to first-line plat­inum-based chemother­a­py — ac­count­ing for ap­prox­i­mate­ly 80% of all ovar­i­an can­cer pa­tients.

Pre­vi­ous­ly, the drug’s use was lim­it­ed to a sub­set of such can­cer pa­tients who car­ry BR­CA mu­ta­tions — the re­main­ing 20%.

“This ap­proval is high­ly an­tic­i­pat­ed as a po­ten­tial in­flec­tion for Ze­ju­la, which has been lag­ging its main com­peti­tor Lyn­parza,” SVB Leerink’s Ge­of­frey Porges said.

Every oth­er drug in its class — in­clud­ing As­traZeneca and part­ner Mer­ck’s Lyn­parza and Clo­vis On­col­o­gy’s Rubra­ca — are on­ly el­i­gi­ble to treat ovar­i­an can­cer pa­tients with BR­CA mu­ta­tions as a monother­a­py in first-line main­te­nance ther­a­py set­tings.

“Women with ad­vanced ovar­i­an can­cer have a five-year sur­vival rate of less than 50%,” said Hal Bar­ron, GSK’s chief sci­en­tif­ic of­fi­cer in a state­ment. “This ex­pand­ed in­di­ca­tion means that many more women with this dev­as­tat­ing dis­ease can re­ceive ear­li­er treat­ment with Ze­ju­la, which can ex­tend the time it takes for their can­cer to progress.”

Hal Bar­ron at End­points News’ UK­BIO19 event in Lon­don, Oc­to­ber 2019

Click on the im­age to see the full-sized ver­sion

Akin to GSK’s Ze­ju­la, Lyn­parza and Rubra­ca are poly-ADP ri­bose poly­merase (PARP) in­hibitors. PARP is a pro­tein used by dam­aged cells to ini­ti­ate re­pair, and by thwart­ing it, the class of drugs is en­gi­neered to pre­vent can­cer cells from re­pair­ing them­selves, there­by cat­alyz­ing their de­struc­tion.

While drug de­vel­op­ers have pri­mar­i­ly re­lied on BR­CA mu­ta­tions to iden­ti­fy pa­tients who can ben­e­fit from this fam­i­ly of ther­a­pies, sci­en­tists have sug­gest­ed that de­fects in oth­er genes in­volved in DNA re­pair — which ren­der cells can­cer­ous — could be prime tar­gets too.

As the sec­ond-to-mar­ket drug in the class, and viewed as lack­ing dif­fer­en­ti­a­tion, Ze­ju­la on­ly gen­er­at­ed ~25% of the rev­enue Lyn­parza did last year — £229 mil­lion ver­sus £921 mil­lion, not­ed Porges, adding that GSK man­age­ment has in­di­cat­ed Ze­ju­la cur­rent­ly on­ly has a mi­nor­i­ty share (15-20%) in the front-line set­ting, with the ma­jor­i­ty share tak­en by Lyn­parza.

Giv­en the coro­n­avirus pan­dem­ic, the Ze­ju­la launch in the new in­di­ca­tion will like­ly be im­pact­ed. Porges fore­cast £371 mil­lion in sales for Ze­ju­la by the end of 2020, pre­dict­ing it would rise to £851 mil­lion by 2025.

This new ap­proval for Ze­ju­la was based on the re­sults of the 733-pa­tient, place­bo-con­trolled PRI­MA study.

Da­ta on the me­di­an pro­gres­sion-free sur­vival for the tri­al pop­u­la­tion showed the drug in­duced a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment of 13.8 months com­pared with 8.2 months for those re­ceiv­ing place­bo.

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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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.

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.

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.

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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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.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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