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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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