Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Green­Light li­cens­es mR­NA shin­gles vac­cine to Serum In­sti­tute fol­low­ing a $10M in­vest­ment

Green­Light Bio­sciences has come a long way from try­ing to shake up the pes­ti­cides mar­ket.

The Med­ford, MA biotech signed a deal Mon­day with the Serum In­sti­tute of In­dia to de­sign three mR­NA prod­ucts, in­clud­ing a shin­gles vac­cine, for de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion in a num­ber of mar­kets around the world.

Green­Light will re­tain the rights to North Amer­i­ca, Eu­rope, Aus­tralia, New Zealand, Chi­na, Japan and South Ko­rea, while SII will get a tech trans­fer to work in Africa, Latin Amer­i­ca, the Mid­dle East and much of Asia. The deal pig­gy­backs off of a $10 mil­lion in­vest­ment made by Serum Life Sci­ences in No­vem­ber 2021.

Green­Light will re­ceive up­front pay­ments and is el­i­gi­ble for ex­clu­siv­i­ty, de­vel­op­ment mile­stones, and man­u­fac­tur­ing tech­nol­o­gy trans­fer pay­ments. Mean­while, SII will pay for the de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion for each emerg­ing mar­ket, as Green­Light will re­tain a per­cent­age of those prof­its.

“Green­Light’s ap­proach res­onates with our mis­sion to make health­care eq­ui­table for all,” SII CEO Adar Poon­awal­la said in a state­ment. “Mes­sen­ger RNA tech­nol­o­gy will play a key role in re­duc­ing the bur­den of hu­man suf­fer­ing caused by vac­cine-pre­ventable dis­eases across LMICs.”

There is an op­tion to ex­pand the li­cense to two ad­di­tion­al vac­cines or ther­a­pies to be named lat­er, Green­Light said in a re­lease, and the shin­gles vac­cine man­u­fac­tur­ing process will be trans­ferred to the SII fa­cil­i­ty in Pune, In­dia.

The com­pa­ny was found­ed in 2008 to use its mR­NA tech­nol­o­gy most­ly on agri­cul­ture, in­clud­ing hon­ey­bees and crops. Since an Au­gust re­verse-merg­er, the com­pa­ny has been work­ing on a vac­cine for sea­son­al flu and a treat­ment for sick­le cell dis­ease.

It al­so land­ed a $1.5 bil­lion val­u­a­tion, and has pro­posed build­ing sev­en new mR­NA man­u­fac­tur­ing fa­cil­i­ties to bring glob­al ca­pa­bil­i­ties up to snuff. Green­Light’s plat­form com­bines two mR­NA ap­proach­es — one that in­volves fer­men­ta­tion-based process­es and an­oth­er uti­lized by high-pro­file com­pa­nies like Mod­er­na and BioN­Tech in­volv­ing tran­scrip­tion, and that helps pro­duce prod­ucts at a high­er scale in a more af­ford­able man­ner.

In De­cem­ber, Green­Light inked a deal with Sam­sung Bi­o­log­ics to man­u­fac­ture its mR­NA Covid-19 vac­cine com­mer­cial­ly. Right around that same time, SII an­nounced that it would waive its pro­tec­tion from le­gal li­a­bil­i­ties for any As­traZeneca-Ox­ford dos­es it pro­vid­ed to CO­V­AX, in an ef­fort to pro­vide mil­lions of mi­grants with ac­cess to the Covid-19 jab.

Many man­u­fac­tur­ers re­quire pro­tec­tion from any side ef­fects. That is not able to be guar­an­teed if there is no gov­ern­ment, as in a sit­u­a­tion with a non­prof­it al­liance such as Gavi. Asy­lum seek­ers, refugees, de­tainees, and peo­ple who are state­less are all el­i­gi­ble.

SII was found­ed in 1966 with the goal of mak­ing life­sav­ing drugs across the world, and ben­e­fit­ing glob­al health as well.

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 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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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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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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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

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.