Four years af­ter near-death ex­pe­ri­ence, PhI­II da­ta bring good news for No­vavax

No­vavax is cel­e­brat­ing tri­al re­sults again four years af­ter a Phase III fail­ure in RSV sent their stock price off a cliff.

The com­pa­ny an­nounced that their re­com­bi­nant flu vac­cine NanoFlu met all pri­ma­ry and sec­ondary end­points in a Phase III study of 2,652 adults old­er than 65. The num­bers, No­vavax sug­gest­ed, should al­low them to clear reg­u­la­to­ry hur­dles and snag the biotech’s first ap­proval since its found­ing in 1987.

“With these da­ta, we now have a clear path for­ward to li­cen­sure with our dif­fer­en­ti­at­ed re­com­bi­nant in­fluen­za vac­cine,” CEO Stan­ley Er­ck said in a state­ment. “We ex­pect that both Fast Track des­ig­na­tion and the ac­cel­er­at­ed ap­proval path­way from the FDA will help No­vavax bring NanoFlu to mar­ket as quick­ly as pos­si­ble to ad­dress the se­ri­ous pub­lic health threat of in­fluen­za.”

Stan­ley Er­ck

The study was a non-in­fe­ri­or­i­ty tri­al test­ing NanoFlu head-to-head with Sanofi’s best-sell­ing Flu­zone. The com­pa­ny, though, did not re­lease the sta­tis­tics for the pri­ma­ry end­points. In­stead, they re­leased the sec­ondary end­points, which tests in part how the vac­cine per­forms against a wild-type virus that has drift­ed from the pre­vi­ous year, ar­gu­ing that those num­bers bet­ter re­flect the re­al world. They showed NanoFlu in­duced pa­tients to build more an­ti­bod­ies against the wild-type virus than Flu­zone.

The com­pa­ny said the safe­ty pro­files were sim­i­lar but ac­knowl­edged NanoFlu brought “a mod­est in­crease in lo­cal ad­verse events.”

The read­out comes near­ly four years af­ter an RSV read­out popped the in­dus­try’s ex­pec­ta­tions for No­vavax and its nanopar­ti­cle vac­cine plat­form.  The biotech had re­ceived an $89 mil­lion grant from the Bill and Melin­da Gates Foun­da­tion to de­vel­op the vac­cine for res­pi­ra­to­ry syn­cy­tial virus, which re­mains a lead­ing hos­pi­tal­iz­er for ba­bies in Eu­rope and oth­er parts of the globe and is a fre­quent tar­get for vac­cine mak­ers. Mod­er­na, Cure­Vac and Sanofi each have pro­grams.

That tri­al didn’t meet any pri­ma­ry or sec­ondary end­points and trig­gered an 84% one-day drop in the stock price, from $155 per share to $24. The stock fell again af­ter an­oth­er RSV fail­ure last Feb­ru­ary. Once at $2 bil­lion, its mar­ket cap hov­ers around $550 mil­lion.

The flu is the main pro­gram out­side of RSV, al­though the com­pa­ny has re­cent­ly re­ceived out­side back­ing for an emer­gency coro­n­avirus vac­cine ef­fort.

So­cial im­age: Stan­ley Er­ck (Cindy Bertaut, Glo­gau Pho­tog­ra­phy)

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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Covid-19 roundup: No­var­tis, In­cyte pitch Jakafi PhI­II to tack­le se­vere cas­es; Is coro­n­avirus spread­ing like measles?

Novartis, which has so far taken a supporting role in the global R&D campaign against Covid-19, is stepping up to launch its own clinical trial. Together with Incyte, the Swiss pharma giant will test their partnered Jakafi in patients who experience cytokine storm as a result of the coronavirus infection.

Marketed as Jakavi outside of the US, the JAK1/2 inhibitor is a blockbuster product that’s already approved for a number of cancers and graft versus host disease. Incyte noted that many Covid-19 patients with severe respiratory disease appear to have “increased activation of the JAK-STAT pathway.” Novartis added that preclinical evidence and preliminary reports form independent studies support their decision to go ahead with a Phase III.

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J&J gives pi­o­neer­ing stem cell biotech its first Big Phar­ma deal, part­ner­ing on iP­SC CAR-T and CAR-NK

Late last summer, one of the earliest stem cell therapy companies got two government decisions in the span of three weeks: The USPTO granted them a patent for iPSC-derived CAR-T cells, and then the FDA cleared them for their first-in-human CAR-NK trial.

Yesterday, the two technologies landed them an up-to $3.1 billion deal.

Fate Therapeutics and J&J announced a global collaboration that will pay Fate $100 million upfront and a trove of potential milestones to develop multiple CAR-T and CAR-NK therapies. It’s the first Big Pharma partnership Fate has announced in their 13-year existence and the largest, although at least one longtime follower thought they could have landed more.

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Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Noubar Afeyan, Flagship

Step­ping out along­side ARCH's record raise, Flag­ship adds a $1.1B mon­ster fund of its own

ARCH’s unveiling this morning of 2 new funds bulging with $1.5 billion in cash for biotech startups was just the first round of today’s venture news.

Right on its heels we have another monster fund debuting at Flagship Pioneering, another big venture group known for making huge bets on cutting-edge tech — the kind it brews up in its labs.

And this one weighs in at $1.1 billion, which will operate in tandem with the $1.1 billion in funds Flagship rolled out last year.

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