Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

Bioreg­num Opin­ion Col­umn by John Car­roll

You don’t go more than 40 years in biotech with­out ever get­ting a prod­uct to mar­ket un­less you can learn the art of writ­ing a pro­mo­tion­al press re­lease. And In­ovio cap­tures the prize in bait­ing the hook.

Tues­day morn­ing In­ovio, which has been strug­gling to get its Covid-19 vac­cine lined up for mass man­u­fac­tur­ing, put out a re­lease that touched on vir­tu­al­ly every hot but­ton in pan­dem­ic PR.

There was, first and fore­most, an in­ter­im snap­shot of ef­fi­ca­cy from their Phase I pro­gram for INO-4800.

Analy­ses to date have shown that 94% (34 out of 36 to­tal tri­al par­tic­i­pants) demon­strat­ed over­all im­muno­log­i­cal re­sponse rates based on pre­lim­i­nary da­ta as­sess­ing hu­moral (bind­ing and neu­tral­iz­ing) and T cell im­mune re­spons­es.

Mod­er­na was crit­i­cized for its de­ci­sion to sketch ini­tial an­ti­body re­spons­es — which it said were at or above the lev­el need­ed to guard against the pan­dem­ic at 2 dos­es over var­i­ous times. But it pro­vid­ed a trea­sure of in­for­ma­tion com­pared to In­ovio’s bare­bones ex­pla­na­tion. The full da­ta set, In­ovio says, will be pub­lished lat­er in a peer-re­viewed jour­nal. In the mean­time, they’re large­ly leav­ing the da­ta read­out to the read­er to de­ci­pher.

Al­so dan­gling bait to day traders:

A Phase II/III study should be set to go this sum­mer, if reg­u­la­tors sign off. Plus, Op­er­a­tion Warp Speed — the pres­i­dent’s ini­tia­tive at achiev­ing a vac­cine roll­out, around the elec­tion — is in­clud­ing 4800 in a non-hu­man pri­mate study. And then there was the trusty mouse study, in which their vac­cine pre­vent­ed vi­ral repli­ca­tion in ro­dent lungs af­ter the tiny crea­tures were chal­lenged with SARS-CoV-2.

Usu­al­ly, that sort of re­lease de­liv­ers a pow­er­ful — if tem­po­rary — surge in the share price. But this morn­ing, Wall Street proved skep­ti­cal.

In­ovio’s stock price slid 11% as some ex­pe­ri­enced ob­servers called them out.

In­ovio’s at­tempt to break out of the pack seemed to large­ly back­fire this morn­ing. When you’re in a race in­volv­ing As­traZeneca, Pfiz­er, Mod­er­na, a host of Chi­nese com­pa­nies, and many, many more, it seems the usu­al bait doesn’t work so well.

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.

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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.