Au­to­lus en­gi­neers a $100M-plus IPO for it­self as it blue­prints a new gen­er­a­tion of bet­ter, safer cell ther­a­pies

The Lon­don-based T cell en­gi­neers at Au­to­lus are steer­ing the com­pa­ny to a $100 mil­lion-plus IPO, hop­ing to bank on a so far in­sa­tiable ap­petite for a new gen­er­a­tion of cell ther­a­pies built to out­strip the pi­o­neers in the mar­ket.

Chris­t­ian Itin

Helmed by Mi­cromet vet Chris­t­ian Itin, Au­to­lus has been tout­ing its ear­ly-stage ap­proach to CD19 bind­ing with a quick dis­en­gage­ment strat­e­gy that they be­lieve will great­ly re­duce the risk of cy­tokine storms that fre­quent­ly af­flict pa­tients — a tox­i­c­i­ty that has lim­it­ed their ini­tial use.

Be­yond that, though, they al­so have built in mul­ti­ple bind­ing tech­nol­o­gy for BC­MA and TACI, to amp up ef­fec­tive­ness in mul­ti­ple myelo­ma. And there’s a CD22 binder that can latch on­to 5 dif­fer­ent do­mains. Like many in the field, Au­to­lus sees a big fu­ture for it­self in both blood can­cers and sol­id tu­mors, which have elud­ed the first gen drugs.

Mar­tin Pule

Au­to­lus was spun out of the lab of Mar­tin Pule at Uni­ver­si­ty Col­lege Lon­don. Years ago Pule — now CSO at Au­to­lus — got a chance to help with some of the pi­o­neer­ing re­search go­ing in­to reengi­neer­ing T cells in­to can­cer ther­a­pies at Mal­colm Bren­ner’s lab at Bay­lor Col­lege of Med­i­cine.

In the F-1 they filed, Au­to­lus ex­plains that it is look­ing to build its own man­u­fac­tur­ing op­er­a­tions and has some new tech in mind for its next round of safe­ty switch­es to use to defuse their cell ther­a­pies if they pose a threat to their pa­tient.

The next gen­er­a­tion of our safe­ty switch­es, which we plan to in­cor­po­rate in our sol­id tu­mor pro­grams, uti­lizes ra­pamycin ac­ti­vat­ed Cas­pase 9 (ra­paCasp9), a cell ther­a­py safe­ty switch that al­lows for se­lec­tive elim­i­na­tion of pro­grammed T cells us­ing a sin­gle ther­a­peu­tic dose of the com­mer­cial­ly avail­able prod­uct ra­pamycin, such as sirolimus or Ra­pa­mun

Au­to­lus had $129 mil­lion in cash on hand at the end of 2017.

Syn­cona is the big share­hold­er in the mix at Au­to­lus, with 40% of the eq­ui­ty. Neil Wood­ford’s groups are be­hind that, with 27% while Ar­ix has 9% and Itin him­self owns 3.6%.

I se­lect­ed Au­to­lus as one of our E11 biotechs ear­li­er this year.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

Endpoints Premium

Premium subscription required

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

Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

In­tel­lia and Iver­ic sell stocks to raise mon­ey, each net­ting $300M

Wednesday afternoon, Gene editing company Intellia and eye disease company Iveric Bio announced that they had each raised $300 million by selling off some of their stocks. The two biotechs are the latest to raise money via public stock offerings, an increasingly popular tactic used by public companies as the industry falls back from its pandemic boom.

Intellia’s raise comes a few weeks after it posted an update on its hereditary angioedema program that uses CRISPR/Cas9 to directly edit the gene that makes the protein responsible for the attacks that occur with the disease. In that interim cut, Intellia showed that patients dosed with its one-time therapy became attack free (at least thus far) after an observation period of 16 weeks, with the longest patient remaining attack free for 10 months.

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.