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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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John Taylor, new Idera Pharmaceuticals CEO

As lead drug flopped and Ab­b­Vie col­lab dis­solved, can­cer biotech re­sorts to buy­ing rare dis­ease com­pa­ny

Ever since disappointing late-stage data on its cancer drug tanked Idera Pharmaceuticals’ stock last year (unhelped by an ill-fated collaboration with AbbVie), execs have been tightening the belt while searching for something — anything — that may dig the company out of its hole.

More than a year later, they finally found it.

In an acquisition that is reminiscent of a reverse merger, Idera is buying private biotech Aceragen in an all-stock deal. Instead of cancer, Idera will now be focused on rare, orphan pulmonary and rheumatic diseases. Specifically, it’s placing its hopes on ACG-701 in cystic fibrosis and melioidosis, and ACG-801 in Farber disease.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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Elisabeth Stampa, Medicines for Europe president

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.