As­traZeneca amends li­cense deal with Chi­nese biotech; Chi­nese pro­tein-based vac­cine gets man­u­fac­tur­ing OK

In an ef­fort to boost the sup­ply of its AAV Covid-19 vac­cine abroad, As­traZeneca has amend­ed its li­cense agree­ment with Biokang­tai to com­mer­cial­ize the drug in main­land Chi­na, Pak­istan and In­done­sia, Biokang­tai an­nounced Wednes­day.

Biokang­tai will mar­ket, man­u­fac­ture and dis­trib­ute the drug to ease the short­ened sup­ply and make the vac­cine more ac­ces­si­ble. The vac­cine has been ap­proved in 185 coun­tries so far, the com­pa­ny said in a press re­lease, but short­ened sup­ply, cou­pled with is­sues sur­round­ing rare, but fa­tal, blood clots, have led vac­ci­na­tion num­bers to stall out.

In main­land Chi­na, around 63% of the pop­u­la­tion is ful­ly vac­ci­nat­ed.

Both As­traZeneca and Biokang­tai re­vealed the li­cense agree­ment at the Chi­na In­ter­na­tion­al Im­port Ex­po in No­vem­ber 2020.

As­traZeneca al­so has a li­cense agree­ment with The Serum In­sti­tute in In­dia, mak­ing it eas­i­er to gets dos­es in the arms of res­i­dents of a coun­try that is still see­ing 43,000 cas­es a day. That’s a stark im­prove­ment from May, when the num­ber of dai­ly cas­es hov­ered around the 400,000 mark, but still vul­ner­a­ble, with just 12% of the pop­u­la­tion ful­ly vac­ci­nat­ed. Near­ly 40% have re­ceived at least one dose.

Chi­nese pro­tein-based Covid-19 vac­cine gets man­u­fac­tur­ing OK

Mean­while, Chi­nese biotech Clover Bio­phar­ma­ceu­ti­cals an­nounced that its sub­sidiary Zhe­jiang Clover Bio­phar­ma­ceu­ti­cal re­ceived a man­u­fac­tur­ing per­mit to make their own pro­tein-based Covid-19 vac­cine can­di­date at a Changx­ing fa­cil­i­ty.

Clover’s end-to-end plat­form us­es sin­gle-use tech­nol­o­gy. The fa­cil­i­ty has the ca­pa­bil­i­ty to pro­duce a bil­lion dos­es of anti­gens for the Clover can­di­date SCB-2019, which is cur­rent­ly in Phase II/III tri­als. The com­pa­ny an­tic­i­pates launch­ing the can­di­date by the end of 2021, if grant­ed emer­gency ap­proval. If it is, it will be one of the first pro­tein-based Covid-19 vac­cines.

Us­ing its Trimer-Tag plat­form, Clover has de­vel­oped the vac­cine us­ing an orig­i­nal strain of the SARS-CoV-2 virus. The can­di­date com­bines SCB-2019 with Dy­navax’s CpG 1018 and alu­minum hy­drox­ide.

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.

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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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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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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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.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.