Wel­come Imfinzi: As­traZeneca crash­es the check­point par­ty late with a green light for dur­val­um­ab

And then there were 5.

The FDA hand­ed out its lat­est ap­proval for a PD-L1 check­point in­hibitor on Mon­day af­ter­noon, giv­ing a green light to As­traZeneca to start sell­ing dur­val­um­ab as Imfinzi as a sec­ond-line ther­a­py for metasta­t­ic urothe­lial car­ci­no­ma.

Pas­cal So­ri­ot

The reg­u­la­to­ry OK comes in the wake of ap­provals for Mer­ck, Bris­tol-My­ers Squibb, Roche/Genen­tech and Pfiz­er/Mer­ck KGaA. The bi­ol­o­gy of these new check­point drugs is well un­der­stood now, and the FDA is­sued its ap­proval af­ter a rel­a­tive­ly small, sin­gle-arm study.

Reg­u­la­tors waved this one through af­ter giv­ing dur­val­um­ab a break­through drug des­ig­na­tion and pri­or­i­ty re­view, even though its the third ap­proval for a check­point ther­a­py in blad­der can­cer.

Dur­val­um­ab’s longterm suc­cess is cru­cial to the fu­ture of As­traZeneca and CEO Pas­cal So­ri­ot. Billed as a block­buster-to-be, fol­low­ing a com­mer­cial trail al­ready clear­ly laid out, the big show­down for As­traZeneca comes lat­er in the year, when it rolls out late-stage da­ta on a com­bi­na­tion of its check­point com­bo in its MYS­TIC study, which match­es dur­val­um­ab with treme­li­mum­ab, a CT­LA-4 sim­i­lar to Yer­voy, for lung can­cer.

The ju­ry is still out, though, on how well a CT­LA-4 drug — with all its at­ten­dant tox­i­c­i­ty — will do in this field. That’s one rea­son why Bris­tol-My­ers Squibb re­cent­ly inked a deal with Cy­tomX on a next-gen CT­LA-4 that might prove far bet­ter for pa­tients.

Sea­mus Fer­nan­dez at Leerink not­ed some mod­est ex­pec­ta­tions on this first ap­proval. The up­side lies fur­ther down the road.

Al­though this in­di­ca­tion rep­re­sents a rel­a­tive­ly small op­por­tu­ni­ty for AZN (we fore­cast Imfinzi cap­tur­ing 10% of our es­ti­mat­ed ~$2.3B WW blad­der can­cer mar­ket), the ap­proval will al­low the agent to be­come more fa­mil­iar with on­col­o­gists and should help fa­cil­i­tate fu­ture sBLAs for drug. The ma­jor in­di­ca­tion for Imfinzi re­mains first-line (1L) non-small cell lung can­cer (NSCLC) and we await top-line da­ta from the Phase 3 MYS­TIC tri­al in com­bi­na­tion with treme­li­mum­ab (an­ti-CT­LA-4) ex­pect­ed in mid-2017.

As­traZeneca, mean­while, raised a red flag last week when it de­layed its third-line read­out in the ARC­TIC study of the duo, spurring some sus­pi­cions that it was on track to a trou­bling fail­ure that would have raised se­ri­ous doubts about its fu­ture in the field.

The oth­er ques­tion that many of us have is how many of these PD-1/PD-L1 check­points can be ap­proved be­fore they start slic­ing and dic­ing this mar­ket in­to ever small­er bites. A range of sec­ond-wave check­points are in de­vel­op­ment now, with every­one that’s fi­nanced well enough and in­ter­est­ed in it go­ing af­ter one of their own.

That group in­cludes In­cyte, which has been part­ner­ing with the main­stream check­points in nonex­clu­sive arrange­ments. And the main play­ers, like Mer­ck and Bris­tol-My­ers, are al­ready well along with their own com­bi­na­tion tri­als. Hun­dreds of them.

The ap­proval, though, marks a big win for As­traZeneca, which has made sig­nif­i­cant progress on the on­col­o­gy front in the last few years. They had to have this one to re­main a cred­i­ble ri­val. And they got it.

The FDA has been on a drug ap­proval spree over the last few days. This is the fifth OK for a new chem­i­cal en­ti­ty in the last three work­ing days, bring­ing the year-to-date to­tal to 19. Last year, which saw a big dip in ap­provals, the FDA ap­proved a to­tal of 22 new drugs.

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.

Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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