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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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