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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”