No­vavax shares are rout­ed af­ter its big PhI­II RSV vac­cine tri­al flops


No­vavax $NVAX says that its big Phase III study of its RSV vac­cine failed bad­ly among old­er sub­jects, flop­ping on the pri­ma­ry as well as sec­ondary out­comes and leav­ing the biotech strug­gling to ex­plain how it fell short here.

The com­pa­ny re­cruit­ed 11,856 peo­ple over the age of 60 for this study, look­ing for clear ev­i­dence to sup­port a claim that the vac­cine could sig­nif­i­cant­ly pre­vent RSV-as­so­ci­at­ed low­er res­pi­ra­to­ry tract dis­ease – the pri­ma­ry goal – or at least in­ci­dents of all symp­to­matic res­pi­ra­to­ry dis­ease due to RSV. It didn’t work.

Gre­go­ry Glenn, No­vavax

Shares of No­vavax were crushed by the news, plung­ing 83% and wip­ing out the bulk of its $2.2 bil­lion mar­ket cap.

Com­pa­ny ex­ecs spec­u­lat­ed that the fail­ure may have been re­lat­ed to a par­tic­u­lar­ly mild RSV sea­son. They al­so stressed that they don’t have any plans to drop the RSV vac­cine at this stage.

R&D chief Gre­go­ry Glenn said:

“His­tor­i­cal­ly, an­nu­al sea­son­al RSV ARD at­tack rates be­tween 3% and 7% have been ob­served in old­er adults. In our Phase 2 tri­al, we ob­served an RSV ARD at­tack rate of 4.9% and an RSV msLRTD at­tack rate of 1.8%. In con­trast, we ob­served an RSV ARD at­tack rate of 2.0% and an msLRTD at­tack rate of 0.4% in our Phase 3 tri­al.”

Glenn, though, was singing a com­plete­ly dif­fer­ent tune on May 4, when he said that the RSV sea­son was play­ing out as ex­pect­ed. RSV gen­er­al­ly tracks the flu sea­son, be­gin­ning in the fall and wind­ing up by the time he had this to say on the Q1 call with an­a­lysts:

With re­spect to this year’s at­tack rate, we will con­tin­ue to close­ly mon­i­tor sev­er­al dif­fer­ent RSV sur­veil­lance sys­tems for the 2015-2016 sea­sons. Un­like in­fluen­za, the in­ten­si­ty of the an­nu­al na­tion­al RSV sea­son can be rel­a­tive­ly con­sis­tent year-in and year-out. And to­day, this RSV sea­son has re­mained con­sis­tent with pre­vi­ous years. Based on da­ta pro­vide RSVAlert and CDC’s Na­tion­al Res­pi­ra­to­ry and En­teric Virus Sur­veil­lance Sys­tem, the per­cent of RSV pos­i­tive tests is gen­er­al­ly con­sis­tent with the 2014-2015 sea­son and the pri­or five years. This gives us ad­di­tion­al con­fi­dence that we will have [ph] enough events to eval­u­ate the ef­fi­ca­cy of our vac­cine in this pop­u­la­tion over this sea­son.

Gaithers­burg, MD-based No­vavax was on a roll last year with this pro­gram, pick­ing up an $89 mil­lion grant from the Gates Foun­da­tion and launch­ing a sep­a­rate Phase III at the end of the year to see if the vac­cine would work among in­fants through a ma­ter­nal vac­ci­na­tion. The biotech re­port­ed pos­i­tive Phase II da­ta in that group a year ago, along with the big grant for its nanopar­ti­cle tech.

RSV re­search goes back 60 years, but at­tempts to de­vel­op an ef­fec­tive vac­cine have been in­ef­fec­tive so far, leav­ing a big un­met med­ical need and, as yet, noth­ing to stop it.

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What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Yuval Cohen, Corbus CEO (Corbus via YouTube)

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

Corbus Pharmaceuticals’ plans to position lenabasum as a pipeline-in-a-product aren’t going so well.

After shelving a program in scleroderma, the Norwood, MA-based biotech has revealed that its lead candidate failed both the primary and secondary endpoints in another Phase III trial.

Lenabasum failed to show a statistically significant difference in total improvement compared with placebo in treating dermatomyositis, a rare disease that causes muscle inflammation and skin rash, the company said Thursday. The news sent Corbus’ $CRBP stock spiraling around 30% early Thursday morning.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Elizabeth Warren (Michael Brochstein/Sipa USA)(Sipa via AP Images)

Sen­a­tors call for hear­ing to ex­am­ine how Medicare will han­dle Bio­gen's new Alzheimer's drug

Two top Senate Finance committee senators on Thursday called for a hearing to examine the questions and challenges for Medicare arising from the FDA’s recent approval of Biogen’s Aduhelm, the controversial new drug approved to treat Alzheimer’s disease.

In a letter to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), subcommittee chair Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) hinted at making policy changes to enable Medicare to more directly connect prescription drug pricing to clinical effectiveness. They raised questions about the “dramatic implications for our health care system” from the approval, which they said “stretch well beyond the scope of FDA’s jurisdiction.”

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