As­traZeneca throws down the gaunt­let with a PhI­II vic­to­ry in head-to-head PARP war with Tesaro

Sean Bo­hen, As­traZeneca

As­traZeneca has post­ed an­oth­er suc­cess in its cam­paign to ex­pand the use of its PARP in­hibitor Lyn­parza (ola­parib).

In what has be­come a head-to-head show­down with Tesaro, which has a ri­val PARP un­der re­view at the FDA, As­traZeneca to­day her­ald­ed a top-line suc­cess for Lyn­parza in a Phase III study of HER2-neg­a­tive metasta­t­ic breast can­cer har­bor­ing germline BR­CA1 or BR­CA2 mu­ta­tions.

Like Tesaro, As­traZeneca’s piv­otal study fo­cused on a com­par­i­son with physi­cian’s choice of chemother­a­pies, with Lyn­parza com­ing out ahead on pro­gres­sion-free sur­vival.

Lyn­parza got an ear­ly start in the mar­ket, thanks to FDA re­view­ers who were will­ing to look past the rel­a­tive­ly weak da­ta that As­traZeneca $AZN had post­ed for this drug. Richard Paz­dur’s team was anx­ious to get a PARP in­to the mar­ket for ovar­i­an can­cer, where Tesaro is lin­ing up its first shot on their fran­chise drug. A few back­ers on the sell side have pro­ject­ed bil­lions in peak sales for Tesaro’s drug, but they’ll have to get around As­traZeneca to get it.

As we re­port­ed a few days ago, ni­ra­parib sits high on a list of 15 po­ten­tial block­busters ready to hit the mar­ket this year, with 2022 sales rev­enue pro­ject­ed at $1.8 bil­lion for the ovar­i­an can­cer mar­ket. And that has kept the fo­cus on on­go­ing buzz about a po­ten­tial buy­out for Tesaro.

An­a­lysts will have to wait for the ac­tu­al da­ta, though, on an in­di­ca­tion that they say could be worth a block­buster bil­lion dol­lars in an­nu­al rev­enue for Tesaro. Sea­mus Fer­nan­dez called it a clear win for the phar­ma gi­ant:

This is the first Phase 3 read­out for a PARP in­hibitor in breast can­cer and will like­ly have pos­i­tive read-through for sim­i­lar­ly de­signed tri­als of PFE’s (MP) ta­la­zoparib (EM­BRA­CA tri­al; da­ta ex­pect­ed in 1H:17) and TSRO’s (MP) ni­ra­parib (BRA­VO tri­al; da­ta ex­pect­ed in 2H:17). Im­por­tant­ly, this rep­re­sents a win for AZN, which is build­ing its DNA Dam­age Re­sponse (DDR) port­fo­lio around Lyn­parza, as well as pro­vid­ing the first val­i­da­tion for the PARP in­hibitor class out­side of ovar­i­an can­cer. We con­tin­ue to view AZN as our top pick with a num­ber of high-im­pact cat­a­lysts on the hori­zon. Re­it­er­ate OP.

Shares of As­traZeneca jumped 1.7% on the news.

The suc­cess is a key win for As­traZeneca, which has been work­ing hard to fol­low up on Lyn­parza’s ap­proval with sol­id ev­i­dence of its broad­er po­ten­tial. The drug has proven to be one of the few big bright spots for the phar­ma gi­ant as it awaits com­bo da­ta on the check­point in­hibitor dur­val­um­ab and treme­li­mum­ab.

These aren’t the on­ly two PARPs in the pipeline. Pfiz­er ac­quired ta­la­zoparib in its $14 bil­lion buy­out of Medi­va­tion while Clo­vis achieved an ap­proval for Rubra­ca last De­cem­ber.

As­traZeneca CMO Sean Bo­hen said:

These re­sults are pos­i­tive news for pa­tients with BR­CA-mu­tat­ed metasta­t­ic breast can­cer, a dis­ease with a high un­met need, and are the first pos­i­tive Phase III da­ta for a PARP in­hibitor be­yond ovar­i­an can­cer. This is high­ly en­cour­ag­ing for the de­vel­op­ment of our broad port­fo­lio which aims to treat mul­ti­ple can­cers by tar­get­ing DNA dam­age re­sponse path­ways.

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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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.

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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.

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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.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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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.