An­oth­er PhI­II RSV fail­ure thumps be­lea­guered No­vavax, but ex­ecs claim there's a way for­ward

Back in No­vem­ber 2016, when No­vavax was pick­ing up the scraps from a Phase III crash of its RSV vac­cine in old­er adults, the com­pa­ny point­ed to the Gates Foun­da­tion-backed pro­gram to test the vac­cine in in­fants as a “sig­nif­i­cant com­mer­cial op­por­tu­ni­ty.” It went on to be­come the lead pro­gram as No­vavax mount­ed an ar­du­ous come­back cam­paign for RSV-F vac­cine.

But to­day, ex­ecs con­ced­ed that the in­fant tri­al has suf­fered the same late-stage fate.

Stan­ley Er­ck

In­vestors showed lit­tle pa­tience for a com­pa­ny that’s been quick with ex­pla­na­tions but slow to de­liv­er. The stock $NVAX tanked more than 65% in pre-mar­ket trad­ing to $2.13.

As it turned out, im­mu­niz­ing moth­ers with ResVax while they are preg­nant did not pre­vent med­ical­ly sig­nif­i­cant low­er res­pi­ra­to­ry tract in­fec­tions caused by RSV in in­fants for the first three months of their lives — the pri­ma­ry end­point.

To be sure, No­vavax is op­er­at­ing in a tough field lit­tered with set­backs, in­clud­ing a flop from Re­gen­eron (which has since dropped its RSV an­ti­body). In a rare win, As­traZeneca re­cent­ly se­cured ex­pe­dit­ed re­views in the US and EU for a dif­fer­ent ap­proach — a sin­gle dose long-act­ing drug for a broad swath of new­borns.

What the treat­ment did achieve — and this is the sil­ver lin­ing that ex­ecs are hold­ing on­to as they try to beat down a path to ap­proval — was pro­tect­ing in­fants from “some of the most se­ri­ous con­se­quences of RSV, in­clud­ing RSV LR­TI hos­pi­tal­iza­tions and RSV LR­TI with se­vere hy­pox­emia,” CEO Stan­ley Er­ck said in a state­ment.

In oth­er words, ex­ecs elab­o­rat­ed on a con­fer­ence call, while the vac­cine was not deemed ef­fec­tive for com­mon — but less se­vere — man­i­fes­ta­tions of the res­pi­ra­to­ry syn­cy­tial virus, it ap­pears to pro­tect the small group of in­fants who get the worst at­tacks.

They al­so sug­gest­ed that vac­ci­nat­ing moth­ers at an ear­li­er stage of ges­ta­tion (from 28 to 33 weeks) might in­crease ef­fi­ca­cy — po­ten­tial­ly a key point in their pitch to reg­u­la­tors.

No­vavax of­fered a peek on the da­ta, which it plans to un­veil at a med­ical meet­ing. Re­spec­tive­ly, the ef­fi­ca­cy rates of ResVax in per-pro­to­col in­fants were as fol­lows::

  • 39% against med­ical­ly sig­nif­i­cant RSV LR­TI (97.5%CI, -1% to 64%)
  • 44% against RSV LR­TI hos­pi­tal­iza­tions (95%CI, 20% to 62%)
  • 48% against RSV LR­TI with se­vere hy­pox­emia (95%CI, -8% to 75%)

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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Af­ter three years of courtship (and turn­downs), Mer­ck pounced on the first glance of clin­i­cal da­ta in $1.85B Pan­dion takeover

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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