As­traZeneca caps its big win in lung can­cer with pos­i­tive sur­vival da­ta for Imfinzi — and what a re­lief it is

As­traZeneca capped its big win on the land­mark PA­CIF­IC study to­day with the news that its PD-L1 check­point Imfinzi de­liv­ered a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival for a key seg­ment of the lung can­cer mar­ket. 

Pas­cal So­ri­ot

The OS score dur­ing an in­ter­im analy­sis is for pa­tients whose stage III non-small cell lung can­cer hasn’t pro­gressed af­ter chemora­di­a­tion and whose tu­mors can’t be sur­gi­cal­ly re­moved. The da­ta here — specifics will fol­low at a con­fer­ence — will help As­traZeneca con­sol­i­date a cru­cial lead spot for it­self, which As­traZeneca CEO Pas­cal So­ri­ot has boast­ed will put the phar­ma gi­ant in the lead for “half the pool in lung can­cer.”

The FDA has al­ready come through with an OK for As­traZeneca here, un­der­scor­ing that reg­u­la­tors aren’t wait­ing for every i to be dot­ted and every t crossed be­fore get­ting new can­cer drugs to pa­tients and doc­tors.

Dave Fredrick­son

The im­por­tance of the very re­al suc­cess here for So­ri­ot is hard to over­state. The CEO has to cap­i­tal­ize on ad­vances for the can­cer drug port­fo­lio to prove to in­vestors that new drugs can fi­nal­ly pro­vide the fi­nan­cial turn­around that As­traZeneca has to have as the Crestor fran­chise melts away. PA­CIF­IC is blaz­ing a path for a would-be block­buster that can let So­ri­ot prove that.

Just a few days ago Dave Fredrick­son, who heads up the on­col­o­gy busi­ness unit for As­traZeneca, told an­a­lysts that PA­CIF­IC had swift­ly opened up a valu­able mar­ket seg­ment demon­strat­ing some pow­er­ful po­ten­tial. He not­ed:

This has re­sult­ed in a true in­flec­tion point for Imfinzi with sales now at $62 mil­lion in the first quar­ter and re­al­ly the over­whelm­ing ma­jor­i­ty of these com­ing from the lung can­cer in­di­ca­tion. As you saw from a slide that Pas­cal showed in Feb­ru­ary when we launched, we had about 3,500 pa­tient in­fu­sions per month and you could see that we’ve now dou­bled in the most re­cent month to 7,000 pa­tient in­fu­sions per month, re­al­ly show­ing that the un­der­ly­ing pa­tient de­mand is the dri­ver of these sales. 

Sean Bo­hen

The suc­cess in this seg­ment gives As­traZeneca’s can­cer team added cred­i­bil­i­ty for un­der­stand­ing how to score a strate­gic ad­vance in an in­tense­ly com­pet­i­tive field, with Mer­ck and Bris­tol-My­ers tus­sling for dom­i­nance in front­line lung can­cer. Com­ing on the heels of the em­bar­rass­ing first-round MYS­TIC fail­ure, it al­so of­fered an en­cour­ag­ing en­dorse­ment for the com­pa­ny’s R&D com­pe­tence.

As­traZeneca CMO Sean Bo­hen said: “The read­out of pos­i­tive over­all sur­vival da­ta at the in­ter­im analy­sis of the PA­CIF­IC tri­al pro­vides ad­di­tion­al com­pelling ev­i­dence of the clin­i­cal ben­e­fit that Imfinzi can of­fer pa­tients in this ear­li­er stage of lung can­cer.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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