Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences cel­e­brates man­u­fac­tur­ing mile­stone for Covid-19 boost­er can­di­date

It was late last year when the biotech Green­Light Bio­sciences inked a deal with CD­MO gi­ant Sam­sung Bi­o­log­ics to man­u­fac­ture its mR­NA Covid-19 vac­cine. Now, as Sam­sung pumps more mon­ey in­to its biotech and CD­MO op­er­a­tions, the South Ko­re­an com­pa­ny has com­plet­ed the first com­mer­cial-scale en­gi­neer­ing run for Green­Light’s Covid-19 vac­cine boost­er can­di­date.

Ac­cord­ing to Sam­sung Bi­o­log­ics, Green­Light’s syn­the­sis re­ac­tion had a titer of 12g/L at a com­mer­cial scale and pro­duced 650g of mR­NA. On the back of this test, Green­Light’s Covid boost­er is ex­pect­ed to have da­ta lat­er this year, with man­u­fac­tur­ing at a com­mer­cial scale start­ing soon af­ter.

In an in­ter­view with End­points News, Green­Light CEO An­drey Zarur said the com­pa­ny can it­er­ate its mR­NA plat­form to pro­duce hun­dreds of mR­NA species. That’s been ben­e­fi­cial in its orig­i­nal agri­cul­tur­al busi­ness and is now be­ing ap­plied to its vac­cine can­di­date. Zarur said the plat­form al­lows the com­pa­ny to ad­just and up­date the vac­cine in­stead of stick­ing with a cer­tain spike pro­tein.

“The beau­ty of our plat­form is that once we have that we have en­sured that what­ev­er the lead­ing can­di­date is that we liked at that mi­cro­scop­ic scale is ful­ly scal­able to pro­duce hun­dreds of mil­lions of dos­es very rapid­ly,” he aid. “So, the val­ue of the man­u­fac­tur­ing plat­form it­self gets am­pli­fied, if you will, by the fact that we have this up­stream dis­cov­ery en­gine.”

As for the first en­gi­neer­ing run, Zarur said it went ex­act­ly as planned, adding that the com­pa­ny now has a high-pro­duc­tiv­i­ty process that can run at a mi­cro­gram scale, a gram scale, a 10-gram scale, and now a mul­ti-100-gram scale.

The over­all tech­nol­o­gy trans­fer and scale-up from the lab to Sam­sung’s com­mer­cial fa­cil­i­ty were com­plet­ed in sev­en months, but ac­cord­ing to Zarur, Green­Light’s man­age­ment team has worked with Sam­sung for years — and that last­ing col­lab­o­ra­tion was key in get­ting the process up and run­ning.

“We are in con­ver­sa­tions with sev­er­al oth­er com­pa­nies in terms of oth­ers us­ing our plat­form to man­u­fac­ture their prod­uct. In terms of our part­ner for large scale clin­i­cal and com­mer­cial, right now we’re on­ly talk­ing to Sam­sung,” he said.

Green­Light al­so struck up oth­er part­ner­ships to cre­ate mR­NA vac­cines for oth­er dis­eases. In March, the Serum In­sti­tute of In­dia inked a deal with the biotech to joint­ly de­sign three mR­NA prod­ucts, in­clud­ing a shin­gles vac­cine, for de­vel­op­ment and even­tu­al man­u­fac­tur­ing and com­mer­cial­iza­tion.

While the de­vel­op­ment of the boost­er con­tin­ues, Zarur hopes to have a clin­i­cal study done by the end of the year and have da­ta by ear­ly next year. Zarur al­so plans to work with reg­u­la­to­ry bod­ies in Africa to start a clin­i­cal study on the con­ti­nent as vac­ci­na­tion rates re­main low.

“We are cur­rent­ly ne­go­ti­at­ing with a num­ber of reg­u­la­to­ry au­thor­i­ties in Africa to ini­ti­ate those clin­i­cal stud­ies in Africa. We have re­leased a GMP batch and so we’re re­al­ly just go­ing through the de­tails of the pro­to­col,” he said.

As far as the fu­ture with Sam­sung, Zarur said they have dis­cussed us­ing the plat­form in dif­fer­ent ca­pac­i­ties, main­ly to pro­vide ac­cess to oth­ers who are de­sign­ing nov­el mR­NA ap­proach­es as well as pro­vide greater scal­a­bil­i­ty.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”