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.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.