Christina Smolke, Antheia CEO

Say good­bye to plants: Syn­bio play­er An­theia earns new back­ers in quest to re­design flo­ra-de­rived med­i­cine man­u­fac­tur­ing

The age of syn­thet­ic bi­ol­o­gy is of­fi­cial­ly up­on us with su­per-uni­corns like Gink­go Bioworks chang­ing the game in terms of how in­vestors view those cell en­gi­neer­ing plat­forms. Now, a Cal­i­for­nia com­pa­ny look­ing to do away with frag­ile flo­ra sup­ply chains in drug de­vel­op­ment has earned a new round of in­vest­ment to chase its goal.

Syn­bio play­er An­theia raised a $73 mil­lion Se­ries B round it will use to ad­vance its pipeline of com­pounds de­rived from a plant-al­ter­na­tive man­u­fac­tur­ing process us­ing whole yeast cell en­gi­neer­ing, the com­pa­ny said Wednes­day.

The round was led by Viking Glob­al In­vestors and in­clud­ed par­tic­i­pa­tion from Sher­pa­lo Ven­tures and Hill­spire.

An­theia will aim to en­gi­neer and ad­vance its first phar­ma­ceu­ti­cal com­pound de­vel­oped through its yeast cell fer­men­ta­tion process as well as a range of key start­ing ma­te­ri­als (KSM) and API, it said. Many of those pre­cur­sor com­pounds are de­rived from plants with a sup­ply chain An­theia de­scribed as “frag­ile” giv­en en­vi­ron­men­tal threats, in­clud­ing nat­ur­al dis­as­ters and geopo­lit­i­cal con­flict.

The com­pa­ny’s en­gi­neer­ing plat­form would, in the­o­ry, re­place the need for com­plex plant-de­rived com­pounds al­to­geth­er, us­ing en­gi­neered yeast cells act­ing like a “minia­ture fac­to­ry” to churn out mol­e­cules at com­mer­cial scale. The com­pa­ny has some ear­ly da­ta back­ing up its claims, with its first en­gi­neered KSM run­ning at what the biotech calls “com­mer­cial­ly rel­e­vant titers” at the pi­lot scale.

Mean­while, An­theia has achieved biosyn­the­sis in four class­es of plant-de­rived med­i­cines, it said, in­clud­ing tropane al­ka­loids, the process of which was doc­u­ment­ed in a Sep­tem­ber ar­ti­cle from CEO Christi­na Smolke in Na­ture. Those drugs, which are used to treat neu­ro­mus­cu­lar dis­or­ders such as Parkin­son’s and mus­cle spasms, re­ly on the “in­ten­sive cul­ti­va­tion” of night­shades, An­theia said, due to the fact that there is no com­mer­cial-scale chem­i­cal syn­the­sis process avail­able.

The sup­ply chain for tropane al­ka­loids, in­clud­ing the an­timus­carinic agent at­ropine used to re­duce sali­va­tion be­fore surgery and an­ti-nau­sea patch­es made with scopo­lamine, is par­tic­u­lar­ly vul­ner­a­ble to dis­rup­tion, mak­ing it a ripe tar­get for An­theia’s plat­form. To repli­cate the drugs, An­theia’s yeast plat­form had to ex­press 26 genes de­rived from 10 or­gan­isms with eight gene dele­tions, un­der­scor­ing the com­plex­i­ty of those drugs and An­theia’s en­gi­neer­ing pow­er.

“An­theia’s syn­thet­ic bi­ol­o­gy plat­form can pre­vent drug short­ages by en­abling more re­silient and ag­ile pro­duc­tion of es­sen­tial med­i­cines for the US and glob­al mar­kets, solv­ing one of the most chal­leng­ing prob­lems in the in­dus­try and im­prov­ing the over­all health­care sys­tem,” Smolke said in a state­ment.

The three oth­er plant-de­rived med­i­cine class­es where An­theia has achieved biosyn­the­sis in­clude an­ti­tus­sives, chemother­a­peu­tics, and neu­ro­trans­mit­ter in­hibitors. Mean­while, the com­pa­ny has eyes on “un­drug­gable” class­es of ther­a­peu­tics giv­en the po­ten­tial to crack open ar­eas of drug en­gi­neer­ing where chem­i­cal syn­the­sis isn’t pos­si­ble.

Syn­bio plat­forms have come a long way in re­cent years as com­pa­nies that once couldn’t hold in­vestors’ at­ten­tion are now scor­ing mas­sive pub­lic of­fer­ings and fundrais­ing rounds.

The largest, by far, is Gink­go Bioworks, which went pub­lic in May as part of a re­verse merg­er that val­ued the com­pa­ny pre-mon­ey at a whop­ping $15 bil­lion. Gink­go scrapped for years to earn that val­u­a­tion, work­ing on ar­eas as di­verse as per­fume and syn­thet­ic meat be­fore their com­mer­cial-scale drug man­u­fac­tur­ing process went vi­ral.

Mean­while, com­pa­nies like Zymer­gen, us­ing cell fer­men­ta­tion to pro­duce in­dus­tri­al ma­te­ri­als, are al­so see­ing a wave of new in­ter­est. The biotech closed a $500 mil­lion IPO in April with the am­bi­tious goal of us­ing its plat­form to dis­rupt a po­ten­tial $3 bil­lion in­dus­tri­al ma­te­ri­als mar­ket.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.