Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Be­fore Val­ne­va gar­nered the fa­vor of the UK gov­ern­ment as a po­ten­tial sup­pli­er of Covid-19 vac­cines, the French biotech prid­ed it­self on be­ing the first com­pa­ny to bring a chikun­gun­ya vac­cine in­to Phase III.

It now has pos­i­tive piv­otal re­sults to back up the break­through ther­a­py des­ig­na­tion the FDA grant­ed just weeks ago.

There are cur­rent­ly no ap­proved jabs to pre­vent chikun­gun­ya virus in­fec­tion de­spite decades of R&D ef­forts, a fact that un­der­scores just how ar­du­ous tra­di­tion­al vac­cine de­vel­op­ment can be, par­tic­u­lar­ly for ne­glect­ed trop­i­cal dis­ease. In a ab­sence of a ma­jor com­mer­cial mar­ket, the US gov­ern­ment and NGOs such as CEPI have de­ployed var­i­ous grants and in­cen­tives to spur on a small crew of aca­d­e­mics and in­dus­try play­ers, with Mer­ck, via its ac­qui­si­tion of Themis, claim­ing a spot in that race.

It’s not just the hon­or and first-mover ad­van­tage that’s at stake. If Val­ne­va suc­ceeds in bring­ing its vac­cine to mar­ket be­fore any­one else, it would be el­i­gi­ble to re­ceive a pri­or­i­ty re­view vouch­er that, at last count, could sell for $100 mil­lion.

In a tri­al that en­rolled 4,115 adults across the US, the vac­cine — VLA1553 — met the pri­ma­ry end­point by in­duc­ing pro­tec­tive CHIKV neu­tral­iz­ing an­ti­body titers in 98.5% of vol­un­teers 28 days af­ter a sin­gle shot.

“The sero­pro­tec­tion rate re­sult of 98.5% ex­ceed­ed the 70% thresh­old (for non-ac­cep­tance) agreed with the FDA,” the com­pa­ny wrote in a state­ment. “The sero­pro­tec­tive titer was agreed with the FDA to serve as a sur­ro­gate of pro­tec­tion that can be uti­lized in a po­ten­tial FDA sub­mis­sion of VLA1553 un­der the ac­cel­er­at­ed ap­proval path­way.”

The vac­cine of­fered “equal­ly high” sero­pro­tec­tion rates and neu­tral­iz­ing an­ti­body titers among el­der­ly par­tic­i­pants as younger adults, the com­pa­ny not­ed.

A look at 3,082 of the par­tic­i­pants for safe­ty al­so turned up no con­cerns, and most side ef­fects were more or less ex­pect­ed — such as fever and headache, fa­tigue and myal­gia.

What’s next? In­ves­ti­ga­tors are still wait­ing for the six-month safe­ty da­ta to com­plete the fi­nal analy­sis, with re­sults ex­pect­ed with­in the next half-year. There’s a sep­a­rate tri­al on­go­ing to test the lot-to-lot man­u­fac­tur­ing con­sis­ten­cy.

Val­ne­va de­signed VLA1553 as a sin­gle-dose, live at­ten­u­at­ed vac­cine that can of­fer long-term pro­tec­tion.

While Themis had point­ed to a Phase III study for its chikun­gun­ya can­di­date as ear­ly as 2019, the pan­dem­ic ap­pears to have thrown those time­lines out the win­dow. The new own­ers at Mer­ck have since scrapped the Covid-19 shot, but kept the chikun­gun­ya shot — V184 — which was de­vel­oped on the same measles virus vec­tor. It shows up as part of the Phase II pipeline on its web­site.

Mod­er­na is al­so de­vel­op­ing an an­ti­body against chikun­gun­ya, a mos­qui­to-borne virus that can cause fever, joint pain and in rare cas­es, death.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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Biohaven CEO Vlad Coric

Bio­haven turns out a dud in fa­tal neu­rode­gen­er­a­tive dis­ease, cast­ing doubt on drug's chances in ALS

With one migraine drug on the market, Biohaven has gone big with its next phase of growth, targeting major neurodegenerative diseases in Alzheimer’s and ALS. The former effort has already gone up in smoke, and a new failure elsewhere in the pipeline could now bode poorly for the latter.

Biohaven’s verdiperstat failed to outperform placebo in reducing the symptoms of patients with multiple system atrophy (MSA), a rare and fatal neurodegenerative disorder, according to a “focused analysis” of the drug’s Phase III trial in that disease toplined Monday.

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