Andrey Zarur, GreenLight Biosciences CEO

Q&A: De­ter­mined to not re­peat mis­takes from the last pan­dem­ic, An­drey Zarur talks about lat­est deal with Serum In­sti­tute

The Mass­a­chu­setts biotech Green­Light made waves Mon­day with the an­nounce­ment of its li­cens­ing deal with the Serum In­sti­tute of In­dia. Three of its mR­NA prod­ucts, start­ing with its shin­gles vac­cine, will be pro­duced by Serum in a deal that pig­gy­backs off of its $10 mil­lion in­vest­ment from No­vem­ber.

Green­Light is rid­ing high off of its re­verse merg­er that net­ted it­self a $1.5 bil­lion val­u­a­tion, af­ter it merged with the SPAC En­vi­ron­men­tal Im­pact Ac­qui­si­tion Corp. It’s still work­ing on ex­per­i­men­tal vac­cines and ther­a­pies us­ing mR­NA tech­nol­o­gy for the sea­son­al flu and sick­le cell dis­ease, a long way from where it orig­i­nal­ly got its start: shak­ing up the pes­ti­cides mar­ket for agri­cul­ture.

An­drey Zarur, the founder and CEO of Green­Light, took some time to sit down and talk with me about the deal with Serum on Tues­day. Here’s our con­ver­sa­tion.

Con­grat­u­la­tions on this deal. What does the part­ner­ship mean for Green­Light?

We’re su­per ex­cit­ed, right? I mean, Serum is not on­ly the largest vac­cine man­u­fac­ture in the world, by the num­ber of dos­es sold, but they al­so have an in­cred­i­ble foot­print and reach across the low­er- and mid­dle-in­come coun­tries, which are a fun­da­men­tal piece of pre­vent­ing pan­demics. If we’ve learned any­thing about Covid it’s that if we just ig­nore the rest of the world and do what we al­ways do, here in the US and Eu­rope, we’re go­ing to get screwed time and again. We are one hu­man race, and we need to treat it as such. The on­ly way to get out of this is to have a co­or­di­nat­ed glob­al vac­cine strat­e­gy, which Serum is go­ing to help us with …Their abil­i­ty to dis­trib­ute glob­al is I think what is miss­ing from this equa­tion.

Talk to me about the treat­ments and vac­cines to be named lat­er. Are those some­thing you’ve had con­ver­sa­tions about that you’re wait­ing to an­nounce pub­licly?

We haven’t made a de­ci­sion yet … We have a close re­la­tion­ship, and they’re very aligned with our mis­sion. And a lit­tle of it is where are the needs that are preva­lent that are not be­ing ad­dressed, and an­oth­er one is where are these dis­eases go­ing.

Can you talk to me about how you’ve iden­ti­fied the shin­gles vac­cine as a key area of fo­cus?

The shin­gles virus is the same virus as (the chick­en pox). In the US, we vac­ci­nate kids against the chick­en pox. And so the chances that they grow up to be adults and get shin­gles is rel­a­tive­ly low. But the rest of the world, that’s not the case. The rest of the world, you get chick­en pox when you’re a kid, pret­ty much every­body con­tin­ues to get chick­en pox as they get old­er. It can be dan­ger­ous and it is ex­tra­or­di­nary painful. It’s a huge un­met need, there are bil­lions of peo­ple who are at risk of shin­gles who don’t have a so­lu­tion, and of course there is no es­tab­lished busi­ness mod­el. So we’re fo­cused on a ma­jor need that’s like­ly to af­fect every­body over the age of 60.

I had shin­gles when I was a fresh­man in high school, which I know is a weird time to get it, but I can vouch for how painful it can be.

I had it in my thir­ties, and you can still see the big scar it left. But it nev­er re­al­ly goes away.

It’s been such a crazy jour­ney for you all, can you walk me through the last year or so on your end?

It hasn’t re­al­ly been crazy. It was a long and very, very chal­leng­ing jour­ney by de­sign.

We set out in 2008 to come up with a new way of pro­duc­ing bi­o­log­i­cal en­er­gy, which the vast ma­jor­i­ty of the top bi­ol­o­gy pro­grams in all the top re­search in­sti­tu­tions had tried and failed. So we knew that we were em­bark­ing on a near-im­pos­si­ble jour­ney … This is re­al­ly hard. We’re try­ing to rewire na­ture, so we knew it was go­ing to be in­cred­i­bly dif­fi­cult when we start­ed. It took 7 or 8 years to fig­ure out a sys­tem that would en­able us to con­trol bi­ol­o­gy.

Once we got there five or six years ago, we start­ed with agri­cul­ture be­cause we be­lieved we need­ed to make a dra­mat­ic im­pact in the way the world grows their own food. It is, I be­lieve, the biggest threat to life on the plan­et, more so than glob­al warm­ing. Be­cause while glob­al warm­ing is re­al­ly re­al­ly se­ri­ous, at the end of the day, with enough mon­ey and enough sci­en­tists, you can mit­i­gate those ef­fects, and the world is al­ready mak­ing a tran­si­tion to clean en­er­gy. You look at our fields, and we haven’t done any­thing for the last 50 years. In fact, every­thing we’ve done has made the agri­cul­tur­al sys­tem less sus­tain­able.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Genen­tech to halt com­mer­cial man­u­fac­tur­ing in Cal­i­for­nia HQ, with lay­offs at­tached

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate its commercial manufacturing operations from its South San Francisco headquarters said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech will produce medicines at its new clinical supply center, which opened in South San Francisco last year while many of its commercial products will be made at other production sites or by contract manufacturers.

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Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

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