Christina Smolke, Antheia CEO

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.

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.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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Lars Fruergaard Jørgensen, Novo Nordisk CEO (Photographer: Christopher Goodney/Bloomberg via Getty Images)

Most dos­es of No­vo Nordisk's Ozem­pic are re­moved from FDA drug short­age list af­ter sup­ply is­sues

Novo Nordisk’s type 2 diabetes treatment Ozempic, which is also used off-label for weight loss, is back in stock following a months-long shortage, according to the FDA’s drug shortages list.

The FDA updated its website on Friday to show that Ozempic’s 0.25 mg, 0.5 mg and 1 mg doses are now available across the US. The 0.25 mg and 0.5 mg doses suffered limited supply for the last few months, according to a Novo Nordisk spokesperson. However, the 2 mg dose has “limited availability and may not fully meet demand until the end of this month,” the company told Endpoints News on Monday.

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