Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small run­ner-up vac­cine de­vel­op­er says its own Covid-19 jab has in­duced “su­pe­ri­or neu­tral­iz­ing an­ti­body titer lev­els” over As­traZeneca’s AZD1222 when pit­ted head-to-head in a Phase III tri­al.

That and non-in­fe­ri­or­i­ty in se­ro­con­ver­sion rate were the co-pri­ma­ry end­points of the tri­al, which re­cruit­ed 4,012 adult vol­un­teers across the UK.

But on the ex­plorato­ry end­point of Covid-19 case counts, Val­ne­va notes that both treat­ment groups saw a sim­i­lar num­ber of in­fec­tions.

“The com­plete ab­sence of any se­vere COVID-19 cas­es may sug­gest that both vac­cines used in the study pre­vent­ed se­vere COVID-19 caused by the cir­cu­lat­ing vari­ant(s) (pre­dom­i­nant­ly Delta),” reads a re­lease.

In­stead, the com­pa­ny touts that its can­di­date, VLA2001, has a “sig­nif­i­cant­ly more fa­vor­able” tol­er­a­bil­i­ty pro­file. As­traZeneca’s vac­cine, which was de­vel­oped in part­ner­ship with Ox­ford, con­sists of a chim­panzee ade­n­ovirus vac­cine vec­tor de­liv­er­ing a gene for a coro­n­avirus spike pro­tein.

Val­ne­va, a French biotech based out of Saint-Herblain, has been trav­el­ing out­side of the pack tak­ing the in­ac­ti­vat­ed, ad­ju­vant­ed vac­cine ap­proach. Find­ing buy­ers for the shots, though, has proven a chal­lenge. Ne­go­ti­a­tions with the Eu­ro­pean Com­mis­sion haven’t land­ed them any­where; and while the UK had struck a $1.65 bil­lion deal to stock up on the vac­cine ear­li­er, the gov­ern­ment re­port­ed­ly pulled out last month.

Adam Finn, pro­fes­sor of pe­di­atrics at the Uni­ver­si­ty of Bris­tol and the chief in­ves­ti­ga­tor of the tri­al, called the re­sults “im­pres­sive and ex­treme­ly en­cour­ag­ing.”

“This is a much more tra­di­tion­al ap­proach to vac­cine man­u­fac­ture than the vac­cines so far de­ployed in the UK, Eu­rope and North Amer­i­ca and these re­sults sug­gest this vac­cine can­di­date is on track to play an im­por­tant role in over­com­ing the pan­dem­ic,” he said.

Val­ne­va CEO Thomas Lin­gel­bach added that his team will now be pur­su­ing li­cen­sure for this “al­ter­na­tive vac­cine so­lu­tion for peo­ple who have not yet been vac­ci­nat­ed.”

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.