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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.