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.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.