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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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