Covid-19 manufacturing roundup: 3 companies to collaborate on mRNA vaccine; Omicron-focused vaccine could be on the way

Gen­Script, Suzhou Abo­gen, and Wal­vax Biotech­nol­o­gy have an­nounced the three com­pa­nies will be col­lab­o­rat­ing on a Covid-19 mR­NA vac­cine project dubbed ABO-O28M.

Wal­Vax will sub­mit a BLA for the project, and Gen­Script will pro­vide ex­clu­sive man­u­fac­tur­ing ser­vices, ac­cord­ing to Asia One.

The project stems form an agree­ment be­tween Abo­gen, the  Acad­e­my of Mil­i­tary Med­ical Sci­ences (AMMS) of the PLA Acad­e­my of Mil­i­tary Sci­ence and Wal­vax, which gained clin­i­cal tri­al ap­proval in June 2020. It was one of the first vac­cine projects ap­proved by Chi­na’s gov­ern­ment, and Gen­Script used its plas­mid GMP man­u­fac­tur­ing to ac­cel­er­ate in­to clin­i­cal tri­als.

‘The pan­dem­ic is still rag­ing. Abo­gen Bio­sciences had launched the project since the very be­gin­ning of the out­break of COVID-19. It is one of the first batch of mR­NA vac­cine projects ap­proved by gov­ern­ment of Chi­na,’ Gen­Script CEO Bri­an Min said in a press re­lease.

Omi­cron-fo­cused vac­cine could be on the way

Com­mer­cial man­u­fac­tur­ing for a Covid-19 vac­cine spe­cif­ic to the Omi­cron vari­ant could be­gin as ear­ly as Jan­u­ary, No­vavax said in a state­ment pub­lished Thurs­day.

The com­pa­ny is con­duct­ing stud­ies to eval­u­ate sev­er­al vari­ants or in­ter­est and vari­ants of con­cern, in­clud­ing Omi­cron. Those tests will de­ter­mine whether an­ti­bod­ies from pre­vi­ous­ly vac­ci­nat­ed peo­ple can neu­tral­ize the Omi­cron vari­ant. It will al­so test whether vac­ci­nat­ed in­di­vid­u­als’ an­ti­bod­ies can block Omi­cron-hACE2 re­cep­tor bind­ing, a step re­quired with­in the vi­ral in­va­sion process.

‘Based on this, we will eval­u­ate whether im­mune re­spons­es in­duced by NVX-CoV2373, the com­pa­ny’s re­com­bi­nant nanopar­ti­cle pro­tein-based COVID-19 vac­cine, will of­fer sim­i­lar cross-pro­tec­tion against Omi­cron as seen with oth­er vari­ants,’ the press re­lease said.

GMP man­u­fac­tur­ing is ex­pect­ed to be­gin in Jan­u­ary 2022. Lab-based as­sess­ment of a new strain-matched nanopar­ti­cle vac­cine will be­gin with­in a few weeks, No­vavax said.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Merck’s new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO  — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

‘I think it is super worrisome,’ Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, ‘This is not going to be good.’

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Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the ‘beating heart’ of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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Samsung Biologics has entered an agreement with South Korean biotech GreenLight BioSciences to manufacture its mRNA Covid-19 vaccine at commercial scale, the two companies announced.

Samsung Biologics, one of the fastest growing manufacturers in the world right now, will use its vaccine manufacturing expertise to help patients in lower-income countries, CEO John Rim said in a press release. This will help expand their capabilities from drug substance to aseptic fill-finish and all the way to commercial release from one site.

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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Lisa Deschamps, AviadoBio CEO

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

‘So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,” he told Endpoints News. 

Amgen’s blockbuster Otezla just racked up another Phase III win as it looks to continue expanding on its multibillion-dollar revenue stream.

The drug hit the primary endpoint in a trial researching its use in moderate to severe genital psoriasis, Amgen announced in the topline readout Wednesday afternoon. On top of that, all secondary endpoints were hit, demonstrating ‘meaningful and significant improvements,’ the company said.
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