GSK/Tesaro PARP in­hibitor Ze­ju­la wins an­oth­er speedy re­view

Months af­ter part­ner Zai Lab $ZLAB scored an ac­cel­er­at­ed re­view for PARP ther­a­py Ze­ju­la in Chi­na, GSK has se­cured pri­or­i­ty US re­view for the drug, known chem­i­cal­ly as ni­ra­parib, to ex­pand the use of the drug in pa­tients with ad­vanced ovar­i­an can­cer.

GSK $GSK, which shelled out just over $5 bil­lion to swal­low Ze­ju­la-de­vel­op­er Tesaro, said the FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24.

The drug was sub­mit­ted for re­view in pa­tients with ad­vanced ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer pa­tients with or with­out BR­CA mu­ta­tions who have been treat­ed with three or more pri­or chemother­a­py reg­i­mens based on da­ta from the QUADRA tri­al, which showed 13 (28%) of 47 pa­tients in the pri­ma­ry ef­fi­ca­cy pop­u­la­tion achieved an over­all re­sponse — the best re­sponse record­ed from the start of the treat­ment un­til the dis­ease pro­gress­es — as per RE­CIST (Re­sponse Eval­u­a­tion Cri­te­ria in Sol­id Tu­mors) method­ol­o­gy.

Mary Lynne Hed­ley

“The re­sults of the QUADRA study demon­strate that ZE­JU­LA is ac­tive as a late-line treat­ment for pa­tients be­yond those with BR­CA mu­ta­tions,” said Tesaro’s COO Mary Lynne Hed­ley in a state­ment.

Ovar­i­an can­cer is the most com­mon cause of gy­nae­co­log­i­cal can­cer death in the Unit­ed States. Al­though most pa­tients with ad­vanced ovar­i­an can­cer re­spond to ini­tial ther­a­py, 70% will re­lapse and ul­ti­mate­ly suc­cumb to their dis­ease. Late-line treat­ment op­tions for pa­tients with ovar­i­an can­cer are few, with the pro­por­tion of pa­tients achiev­ing an over­all re­sponse typ­i­cal­ly less than 10%, and me­di­an over­all sur­vival af­ter third-line ther­a­py of 5–9 months, re­searchers not­ed in Lancet On­col­o­gy.

The drug, which com­petes against As­traZeneca’s $AZN Lyn­parza as well as Clo­vis’ $CLVS Rubra­ca, is al­ready ap­proved as a first­line main­te­nance treat­ment of women with re­cur­rent ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer when their can­cer comes back.

The once-dai­ly Ze­ju­la is cur­rent­ly be­ing eval­u­at­ed in three piv­otal tri­als, in­clud­ing a late-stage tri­al in pa­tients with first-line ovar­i­an can­cer (the PRI­MA tri­al), a Phase III tri­al for the treat­ment of pa­tients with germline BR­CA-mu­tat­ed, metasta­t­ic breast can­cer (the BRA­VO tri­al), and a reg­is­tra­tional Phase II treat­ment tri­al in pa­tients with ovar­i­an can­cer (the QUADRA tri­al). Part­ner J&J $JNJ is test­ing the use of the drug in prostate can­cer. Mean­while, a num­ber of com­bi­na­tion tri­als are al­so un­der­way, in­clud­ing test­ing the use of Ze­ju­la and Mer­ck’s $MRK key­stone check­point in­hibitor Keytru­da in breast and ovar­i­an can­cer.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Fau­ci fires back at White House cam­paign to un­der­mine him

Anthony Fauci has called the White House campaign to discredit him “a bit bizarre” and said he stands by his previous statements, even if he has since changed his views.

The NIAID chief — who has received an outpouring of support following reports that the Trump administration has sent a document akin to opposition research to multiple news outlets — spoke with his usual candor in interviews with The Atlantic.

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Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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De­spite safe­ty, ef­fi­ca­cy con­cerns, FDA Ad­Com nar­row­ly rec­om­mends Mallinck­rodt drug

A day after the FDA detailed significant concerns about just how effective or safe an experimental Mallinckrodt liver drug was, an advisory committee decided by a single vote to recommend it for approval.

“I voted yes to approve, but I also wrote in, ‘but barely,’” Paul Ridker, a cardiologist at Brigham and Women’s Hospital and one of the panelists, said at the meeting, according to FierceBiotech. The vote was 8-7.