Paul Stoffels, J&J CSO (Andrew Harnik/AP Images)

Ebo­la vac­cine built on same tech­nol­o­gy as Covid-19 jab from J&J shows long-last­ing suc­cess

Just weeks af­ter a J&J can­di­date failed its first tri­al in an ef­fort to build a vac­cine against HIV, that same vac­cine tech­nol­o­gy scored the com­pa­ny a vic­to­ry in the fight against a virus that has emerged yet again, and threat­ens to cause hav­oc in Africa if left unchecked along­side Covid-19.

A two-dose vac­cine reg­i­men from J&J to fight Ebo­la was long-last­ing dur­ing tri­als in adults and chil­dren, the com­pa­ny said Mon­day, as the im­mune re­sponse lasts in adults for at least two years.

The reg­i­men — which us­es Zab­de­no (Ad26.ZE­BOV) for one shot, and Mv­abea (MVA-BN-Fi­lo) for the next, 56 days lat­er — spurred no safe­ty con­cerns, and J&J said that a boost­er shot could be ad­min­is­tered two years af­ter the ini­tial vac­ci­na­tion, as it showed a strong im­mune re­sponse sev­en days lat­er.

Vac­ci­na­tion against Ebo­la is wel­comed: The virus has killed about half of the peo­ple it in­fects. The World Health Or­ga­ni­za­tion has put West Africa on no­tice, as new out­breaks have put pres­sure on African health­care sys­tems that are of­ten al­ready work­ing with lim­it­ed re­sources.

“These peer-re­viewed da­ta sup­port the pro­phy­lac­tic use of the John­son & John­son Ebo­la vac­cine reg­i­men to pro­tect peo­ple at risk of Ebo­la, which is es­sen­tial to our vi­sion of pre­vent­ing Ebo­la out­breaks be­fore they can be­gin,” J&J CSO Paul Stof­fels said in a state­ment. “Re­cent and on­go­ing out­breaks in Africa un­der­score that the threat of Ebo­la is not go­ing away, which is why we col­lab­o­rat­ed to de­vel­op a vac­cine reg­i­men ca­pa­ble of in­duc­ing long-term im­mu­ni­ty against Ebo­la and are now work­ing to en­sure that it is ac­ces­si­ble to peo­ple in need.”

Zab­de­no is cre­at­ed on an ade­n­ovirus-based plat­form that ge­net­i­cal­ly mod­i­fies those virus­es to pre­vent them from repli­cat­ing in hu­mans as they fer­ry im­mu­ni­ty-in­duc­ing gly­co­pro­teins in­to the body, while Mv­abea is de­liv­ered on a mod­i­fied Ankara vec­tor.

Be­cause chil­dren ac­count for a large por­tion of Ebo­la cas­es and deaths, a ran­dom­ized, dou­ble-blind­ed tri­al in Sier­ra Leone, a re­gion heav­i­ly af­fect­ed by the 2014-2016 West African Ebo­la out­break that was the worst on record to date, J&J said, was con­duct­ed in healthy chil­dren be­tween the ages of 1 and 17. They were split up in­to three co­horts — ages 1-3, 4-11 and 12-17 — and there were 192 chil­dren in each group.

As far as side ef­fects are con­cerned, the most com­mon was in­jec­tion site pain, the Lancet pa­per said. The com­pa­ny said that there were no treat­ment-re­lat­ed deaths, and the an­ti­body re­sponse 21 days af­ter the sec­ond dose was ob­served in 98% of chil­dren.

The vac­cine reg­i­men was ap­proved in Eu­rope in Ju­ly 2020, and re­ceived pre­qual­i­fi­ca­tion from the WHO in April 2021, which al­lows it to be used in de­vel­op­ing coun­tries.

Ear­li­er this year, out­breaks in Sier­ra Leone and Guinea caused J&J to an­nounce the do­na­tion of 200,000 dos­es of the jab.

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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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.