Rahul Singhvi, Resilience CEO

Months af­ter land­ing Cana­di­an site from gov­ern­ment, Re­silience an­nounces a big mR­NA part­ner

Bob Nelsen

Bob Nelsen’s lat­est project, dreamed up out of anger, has been fo­cused on be­com­ing the Ama­zon Web Ser­vices of drug man­u­fac­tur­ing, with the abil­i­ty to scale in the most ef­fi­cient way pos­si­ble. It has now part­nered with one of the most in­flu­en­tial play­ers in the pan­dem­ic re­sponse.

Re­silience will start mak­ing mR­NA for Mod­er­na’s Covid-19 vac­cine at its new site in Cana­da, the com­pa­ny an­nounced Wednes­day.

The com­pa­ny had al­ready struck a deal with the Cana­di­an gov­ern­ment to cap­i­tal­ize off of $163 mil­lion in spend­ing from Prime Min­is­ter Justin Trudeau’s ad­min­is­tra­tion to ex­pand mR­NA pro­duc­tion ca­pac­i­ty. The mon­ey will go to­ward a new man­u­fac­tur­ing site in Mis­sis­sauga, east of Toron­to, which will have the ca­pac­i­ty to make be­tween 112 mil­lion and 640 mil­lion mR­NA vac­cine dos­es a year.

“Mod­er­na’s Covid-19 vac­cine has saved count­less lives, and we’re ex­cit­ed to man­u­fac­ture mR­NA for this im­por­tant vac­cine,” CEO Rahul Singhvi said in a press re­lease. “This col­lab­o­ra­tion has the po­ten­tial to en­sure more peo­ple are pro­tect­ed around the world from the dead­ly Covid-19 virus.”

Re­silience was found­ed in 2020, and fo­cus­es on end-to-end man­u­fac­tur­ing that can free up time for its part­ners to work on per­fect­ing the drugs. The com­pa­ny emerged from stealth in No­vem­ber with $800 mil­lion in fund­ing from Nelsen’s Arch Ven­ture Part­ners. Nelsen start­ed the com­pa­ny be­cause he was frus­trat­ed with how long it was tak­ing to get things off the ground in the re­sponse to the pan­dem­ic.

The com­pa­ny hasn’t been sit­ting on the side­lines. Since its in­cep­tion, it has kicked up a flur­ry of ac­qui­si­tions, shelling out $110 mil­lion for blue­bird bio’s North Car­oli­na lentivi­ral vec­tor man­u­fac­tur­ing fa­cil­i­ty just two years af­ter the com­pa­ny bought the site and spent an­oth­er $80 mil­lion on it in up­grades. It took on a 310,000 square-foot plant in Boston from Sanofi and an­oth­er 136,000 square-foot site in On­tario to add up its net­work in March, just three months af­ter the com­pa­ny emerged.

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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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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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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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.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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Kim Smith, ViiV CEO, at GlaxoSmithKline's Investor Day

Bank­ing on in­te­grase in­hibitors as HIV cor­ner­stone, Vi­iV bags 3rd-gen­er­a­tion com­pound from Sh­iono­gi

As a 12% shareholder of ViiV Healthcare, Japan’s Shionogi has commanded a much lower profile than its fellow owners, GlaxoSmithKline and Pfizer. But behind the scenes, it’s played an outsized role in the development of ViiV’s HIV drugs, coming up with the two top programs — the integrase inhibitors dolutegravir and cabotegravir — currently in ViiV’s portfolio.

And it’s time for round three.

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.