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.

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.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

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Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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