UP­DAT­ED: Hav­ing shipped its first bench­top gene edit­ing de­vices, In­scrip­ta draws an­oth­er $150M from deep in­vestor well

In­scrip­ta is one big step clos­er to reach­ing its am­bi­tious vi­sion of vast­ly scal­ing and de­moc­ra­tiz­ing ac­cess to gene edit­ing. And in­vestors have thrown in $150 mil­lion more to join the ride.

Sri Kosara­ju

The first batch of Onyx, its bench­top sys­tem for genome en­gi­neer­ing, has been shipped to cus­tomers, the com­pa­ny said, en­abling sci­en­tists to con­duct au­to­mat­ed high-through­put gene edit­ing on a ma­chine about the size of a mi­crowave.

Rather than serv­ing one par­tic­u­lar pur­pose, CEO Sri Kosara­ju said the Se­ries E “(val­i­dates) our con­fi­dence in the ad­di­tion­al ar­eas where we think our tech­nol­o­gy can cre­ate op­por­tu­ni­ties” and will sup­port In­scrip­ta for the long term. Fi­deli­ty and T. Rowe Price led the round, joined by D1 Cap­i­tal Part­ners and Durable Cap­i­tal Part­ners as well as ex­ist­ing in­vestors Fore­site Cap­i­tal, Coun­ter­point Glob­al and JS Cap­i­tal.

Kosara­ju points to two key ap­pli­ca­tion ar­eas that are al­ready emerg­ing for the tech­nol­o­gy: The first is genome dis­cov­ery, where sci­en­tists can un­der­stand the un­char­ac­ter­ized re­gions of genomes by cre­at­ing more vari­a­tions and study­ing them; the oth­er is for­ward en­gi­neer­ing — de­sign­ing cer­tain func­tions for agri­cul­ture, cos­met­ic or ther­a­peu­tic pur­pos­es.

An ear­ly play­er in the boom­ing syn­thet­ic bi­ol­o­gy field, In­scrip­ta’s grand rhetoric echoes peers like Gink­go and Zymer­gen: “We do for genome edit­ing what Il­lu­mi­na did for genome read­ing,” for­mer chief Kevin Ness told End­points News be­fore hand­ing over to Kosara­ju.

Both are fa­mil­iar with the se­quenc­ing world: Ness had co-found­ed test­ing equip­ment mak­er 10x Ge­nomics, where Kosara­ju served on the board of di­rec­tors.

In Onyx, they be­lieve they have a tool in hand that would al­low sci­en­tists to gain ready ac­cess to what they call the “bioe­con­o­my,” edit­ing genomes eas­i­ly rather than re­ly­ing on com­pa­nies with large fa­cil­i­ties.

A bi­ol­o­gist with the plat­form can se­lect the genes they want to knock out from In­scrip­ta’s com­put­er in­ter­face. In­scrip­ta then cre­ates the agents to knock out those genes at their man­u­fac­tur­ing fa­cil­i­ty and sends them to the bi­ol­o­gist’s lab. The bi­ol­o­gist ap­plies those agents to the cell lines, cre­at­ing thou­sands of dif­fer­ent lines that are “bar-cod­ed.” The bi­ol­o­gist can run what­ev­er ex­per­i­ment — ex­pos­ing them to a drug, say, or an agent — and the In­scrip­ta tech can see which cell lines sur­vived.

Since clos­ing its Se­ries D in 2019, Kosara­ju not­ed, In­scrip­ta has run a num­ber of in­ter­nal tests as well as col­lect­ing feed­back from a be­ta cus­tomer.

“So we have over 100 runs now with this in­stru­ment which has giv­en us a lot more con­fi­dence as we ship our first unit,” he said.

Key to that whole work­flow is MAD7, a syn­thet­ic en­zyme In­scrip­ta has billed as an al­ter­na­tive to Cas9 that’s free for sci­en­tif­ic re­search, with­out the li­cens­ing fee tied to the orig­i­nal CRISPR mol­e­cule.

For now the de­vice, which sells for $347,000, is lim­it­ed to edit­ing E. coli and S. cere­visi­ae, but In­scrip­ta is eye­ing mam­malian cells for fu­ture ma­chines down the road.

It’s still ear­ly in the process of fig­ur­ing out where their first sys­tem is the most valu­able, Kosara­ju said. So while they ac­knowl­edge the “ro­bust” IPO mar­ket — Zymer­gen has al­ready jumped in, and Gink­go is re­port­ed plot­ting a list­ing — he’s in no rush.

“The thing we’ve learned is there are a lot of ad­van­tages to build­ing the com­pa­ny and hav­ing ma­tu­ri­ty and vis­i­bil­i­ty be­fore you go pub­lic,” he said.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

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

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.