Joshua Liang, Clover Biopharmaceuticals CEO

Clover Bio­phar­ma­ceu­ti­cals sets up a new R&D cen­ter in a buzzy Chi­nese hub near Shang­hai

Busi­ness in Chi­na is boom­ing, with more than a thou­sand biotech and bio­phar­ma com­pa­nies — in­clud­ing some big multi­na­tion­al play­ers — flock­ing to Zhangjiang Phar­ma Val­ley to take ad­van­tage of a grow­ing tal­ent pool in Shang­hai.

Clover Bio­phar­ma­ceu­ti­cals is the lat­est, an­nounc­ing on Wednes­day that it has be­gun con­struc­tion on a new R&D cen­ter in Zhangjiang Hi-Tech Park. The Chi­nese biotech (which al­so has a cor­po­rate of­fice in Boston) promis­es a state-of-the-art fa­cil­i­ty with new pre­clin­i­cal re­search labs, man­u­fac­tur­ing process de­vel­op­ment labs, and a GMP pi­lot man­u­fac­tur­ing plant.

In to­tal, the com­pa­ny has just un­der 270,000 square feet (about 25,000 square me­ters) to work with. Cur­rent­ly, Clover has an R&D hub about 1,200 miles away in Cheng­du.

“Es­tab­lish­ing a new R&D Cen­ter in Shang­hai will al­low us to ex­pand our R&D ca­pa­bil­i­ties and ac­cel­er­ate our in­no­v­a­tive pipeline,” CEO Joshua Liang said in a state­ment. “In the fu­ture, we plan to es­tab­lish ad­di­tion­al R&D cen­ters around the world as we ad­vance the dis­cov­ery and de­vel­op­ment of new in­no­v­a­tive prod­uct can­di­dates.”

Con­struc­tion of the new R&D fa­cil­i­ties is ex­pect­ed to be com­plet­ed next quar­ter, and the en­tire R&D cen­ter is ex­pect­ed to be done in the sec­ond half of the year. Clover said it plans on re­cruit­ing “hun­dreds of new hires from the area’s deep tal­ent pool.”

Clover was an ear­ly en­trant in the race for a Covid-19 vac­cine, de­vel­oped us­ing its Trimer-Tag tech plat­form. Ear­ly on, it part­nered with Glax­o­SmithK­line to test its pan­dem­ic ad­ju­vant sys­tem. Then back in Feb­ru­ary, it de­cid­ed to go with an ad­ju­vant from Dy­navax in­stead. The com­pa­ny has been award­ed just un­der $400 mil­lion from CEPI to de­vel­op its shot — and back in Sep­tem­ber, it an­nounced a 79% ef­fi­ca­cy rate against the Delta vari­ant and a 67% ef­fi­ca­cy rate against Covid-19 over­all.

On Wednes­day, Clover be­gan dos­ing pa­tients in the on­go­ing Phase II/III Spec­tra tri­al with a ho­mol­o­gous boost­er shot.

Where­as es­tab­lish­ing a pres­ence in Chi­na was once a bold con­cept, a slate of Big Phar­ma com­pa­nies be­gan set­ting up shop over­seas in the last sev­er­al years — in­clud­ing Eli Lil­ly, As­traZeneca, Bay­er, Roche, J&J, Glax­o­SmithK­line, and No­var­tis — of­ten in Zhangjiang Hi-Tech Park in Shang­hai.

“The Zhangjiang Phar­ma Val­ley is one of the top biotech hubs in Chi­na and is home to over 1,000 in­no­v­a­tive biotech­nol­o­gy and bio­phar­ma­ceu­ti­cal com­pa­nies,” Clover said.

Alexander Lefterov/Endpoints News

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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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Roy Baynes, Merck

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

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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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Albert Bourla (Photo by Steven Ferdman/Getty Images)

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

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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.

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

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Steve Worland, eFFECTOR CEO

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When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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