Christina Smolke, Antheia CEO

UP­DAT­ED: Out to re­vamp plant-based drug man­u­fac­tur­ing, An­theia locks in part­ner­ship with syn­thet­ic bi­ol­o­gy gi­ant Gink­go

With sup­ply chain short­ages at the fore­front of near­ly every busi­ness in the world right now, whether it be chick­en wings or CAR-T cell ther­a­py, syn­thet­ic bi­ol­o­gy up­start An­theia is look­ing to aid in the fight. It just an­nounced a deal with a gi­ant in the field to help it along.

An­theia will join forces with Gink­go Bioworks to beef up its pipeline of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents and key start­ing ma­te­ri­als, lever­ag­ing Gink­go’s high-through­put en­zyme de­sign and screen­ing in­fra­struc­ture to scale up at high­er speed.

Cur­rent­ly, the sup­ply chain for plant-based med­i­cines de­pends on the long process of sourc­ing spe­cial­ty plants. An­theia is fo­cused on a plant-al­ter­na­tive man­u­fac­tur­ing process that us­es yeast through what it calls whole-cell en­gi­neer­ing. The en­gi­neer­ing plat­form would in the­o­ry re­place the need for com­plex plant-de­rived com­pounds, and use the en­gi­neered yeast cells as a mi­ni-fac­to­ry that would churn out mol­e­cules at a com­mer­cial scale.

For drugs that re­ly on plant-based ac­tive in­gre­di­ents, such as the chemother­a­py vin­blas­tine, there are fragili­ties that come with such a re­liance. Geopo­lit­i­cal con­flict, nat­ur­al dis­as­ters and cli­mate change can of­ten play a role in avail­able sup­ply. A re­cent ex­am­ple of that, An­theia co-founder and CEO Christi­na Smolke said, is the wild­fires in Aus­tralia in 2019 and 2020 that wiped out an en­tire pro­duc­tion source. As cli­mate change con­tin­ues and weath­er pat­terns change, events like these can on­ly hap­pen more of­ten.

“When you look at the con­ven­tion­al ap­proach­es we use for man­u­fac­tur­ing drugs as well as drug dis­cov­ery, those ap­proach­es in gen­er­al lim­it what mol­e­cules we’re able to syn­the­size as well as how ef­fi­cient­ly, at what scale, and where we can do that in man­u­fac­tur­ing,” Smolke said in an in­ter­view with End­points News Wednes­day. “In­no­va­tion in phar­ma has suf­fered, and that has led to the lim­i­ta­tions in both the de­vel­op­ment of new drugs, as well as the pro­duc­tion of many es­sen­tial med­i­cines which as of to­day re­ly on a frag­ile sup­ply chain. And what we’ve seen over the last year and a half, two years with the Covid pan­dem­ic is that it’s shown us that when the med­ical sup­ply chains break down, there are very re­al hu­man costs.”

Gink­go, whose am­bi­tion is to be the “Mi­crosoft of syn­thet­ic bi­ol­o­gy,” has caught the at­ten­tion of in­vestors, val­ued at $15 bil­lion as it went pub­lic in May via a SPAC merg­er. The com­pa­ny show­cased its man­u­fac­tur­ing prowess through per­fume and syn­thet­ic meat be­fore plung­ing deep in­to oth­er sec­tors, all while build­ing up a com­pre­hen­sive set of tools to re­pro­gram cells with in­dus­tri­al ef­fi­cien­cy.

That hefty plat­form, An­theia says, will be of great help as it brings its en­gi­neered mi­crobes to com­mer­cial scale. Gink­go’s tech­nol­o­gy and bi­o­log­i­cal code­base can help in the cru­cial step of strain op­ti­miza­tion, en­sur­ing that the pro­duc­tion of any giv­en com­pound is as ef­fi­cient as pos­si­ble.

In June, An­theia raised a $73 mil­lion Se­ries B round to ad­vance its pipeline. And ef­fi­cient­ly scal­ing has been top of mind as a big chal­lenge.

So far, the fo­cus has been on the R&D side of things, de­vel­op­ing the yeast strains, fer­men­ta­tion process and the down­stream pu­rifi­ca­tion process.

“One im­por­tant fact is to just re­al­ly un­der­stand what your lim­i­ta­tions are go­ing to be at scale, and build a ro­bust scaled-down mod­el so that you’re eval­u­at­ing your strains and you’re de­vel­op­ing that un­der re­al­is­tic con­di­tions that are go­ing to be able to scale that to hun­dreds of thou­sands of liters,” CSO Christy Hawkins said. “And al­so look­ing at the ro­bust­ness of the strain in your process, and how de­vi­a­tions can cause you to have is­sues at scale.”

Ear­li­er this week, Gink­go al­so an­nounced an mR­NA break­through with part­ner Alde­vron. The com­pa­ny says it has found a way to boost the man­u­fac­tur­ing yield of the vac­cinia cap­ping en­zyme, al­so known as VCE, which Alde­veron’s pres­i­dent Tom Foti said is a dif­fi­cult en­zyme to pro­duce.

“We be­lieve this yield break­through will ac­cel­er­ate mR­NA ther­a­peu­tic and vac­cine de­vel­op­ment for man­u­fac­tur­ing teams around the world,” he said in a press re­lease.

VCE, Gink­go CEO Ja­son Kel­ly said, is seen as a key in­gre­di­ent for scal­ing mR­NA pro­duc­tion. Alde­vron has ex­clu­sive rights to the man­u­fac­tur­ing process, which it says is 10-times more ef­fi­cient that its pre­vi­ous process.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.

invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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