With a 'monopoly' on gly­co­pro­teomics, In­ter­Venn rais­es $34M to push can­cer di­ag­nos­tic in­to the clin­ic, woos Il­lu­mi­na BD ex­ec

For a few years now, ear­ly de­tec­tion of can­cer has been the sex­i­est top­ic in all of di­ag­nos­tics. With bil­lions of VC dol­lars poured in­to the pur­suit of tests to sniff out tu­mors ear­ly, the field is full of new ap­proach­es that promise to ac­cu­rate­ly pick up traces of can­cer, when pa­tients are more like­ly to be cured. But amid all the -omics — rang­ing from next-gen­er­a­tion ge­net­ic se­quenc­ing to high-through­put pro­tein screen­ing — one par­tic­u­lar type of mol­e­cule is al­ways ab­sent.

Al­do Car­ras­coso

What’s miss­ing is an analy­sis of pro­tein gly­co­sy­la­tion, ac­cord­ing to In­ter­Venn Bio­sciences, which has just raised $34 mil­lion to com­mer­cial­ize its first di­ag­nos­tics.

While In­ter­Venn may lack the glam­our of big-mon­ey out­fits such as Grail (now ac­quired by Il­lu­mi­na), Thrive, Kar­ius, Seer and Freenome, the South San Fran­cis­co-based com­pa­ny boasts of two star founders who’ve spent years to un­earth the in­tri­ca­cies of gly­co­bi­ol­o­gy: Car­olyn Bertozzi of Stan­ford and Car­l­i­to Le­bril­la of UC Davis.

It’s al­so re­cruit­ed a new chief busi­ness of­fi­cer, John Leite, from di­ag­nos­tics gi­ant Il­lu­mi­na to scout deals for some of the 24 dif­fer­ent tests in the port­fo­lio.

In­ter­Venn CEO Al­do Car­ras­coso, whose en­tre­pre­neur­ial ef­forts have pre­vi­ous­ly re­volved around busi­ness man­age­ment, dig­i­tal me­dia and blockchain, crossed paths with the sci­en­tists af­ter his cousin, fol­low­ing his moth­er and a close rel­a­tive, suc­cumbed to breast can­cer in 2016. The fam­i­ly tried every type of se­quenc­ing to no avail. The in­tense frus­tra­tion in un­der­stand­ing what’s go­ing on even­tu­al­ly led him to Le­bril­la’s lab, where he took a blood test.

He wait­ed a few hours for the blood to be processed by the mass spec­trom­e­ter. Then he was asked to come back in 12 months.

Car­l­i­to Le­bril­la

“I said, what do you mean come back in 12 months?” Car­ras­coso re­called to End­points News. The stu­dents and post­docs need­ed the time to run through the da­ta, re­peat­ing the process a few hun­dred thou­sand times to iden­ti­fy spec­tral sig­na­tures.

He had an idea of how you can su­per­charge what they were do­ing and trans­form the “in­sane process” with ar­ti­fi­cial in­tel­li­gence — a re­cur­rent neur­al net­work to be spe­cif­ic — and Le­bril­la took in­ter­est. The next year was spent build­ing a hand-cu­rat­ed dataset of gly­co­pro­teomics and us­ing it to train their first neur­al net­work.

The re­sult­ing al­go­rithm could spit out re­sults in 12 min­utes, some­times even 12 sec­onds.

John Leite

“That was the biggest bot­tle­neck for Car­l­i­to Le­bril­la and Car­olyn Bertozzi,” Car­ras­coso said. “The abil­i­ty to man­age the im­mense in­for­ma­tion that gly­co­pro­teomics gen­er­ate. It’s just over­whelm­ing for sci­en­tists.”

Through run­ning sam­ples for bio­phar­ma, hos­pi­tal and aca­d­e­m­ic clients, In­ter­Venn has dis­cov­ered bio­mark­ers that formed the ba­sis of 24 di­ag­nos­tics. In ear­ly 2021 they hope to com­plete en­roll­ment of a tri­al to com­pare its pan­el, VO­CAL, against the wide­ly used CA 125.

Af­ter that comes a slew of tests for re­nal, lung, liv­er, prostate, pan­cre­at­ic, na­sopha­ryn­geal, col­orec­tal can­cer and oth­ers, all con­sist­ing of dis­tinct sets of gly­copep­tides. In­ter­Venn al­so sees po­ten­tial ap­pli­ca­tion of its tech in im­muno-on­col­o­gy, where it may help drug de­vel­op­ers iden­ti­fy the pa­tients who would ben­e­fit from ther­a­pies that to­day on­ly helps 20% to 30% of pa­tients.

Er­win Es­ti­gar­rib­ia

“That’s some­thing that to­day doesn’t ex­ist,” COO Er­win Es­ti­gar­rib­ia, a vet­er­an of the di­ag­nos­tics space, said.

The re­al test lies ahead. With­out for­mal FDA ap­proval, In­ter­Venn’s pan­els must be processed cen­tral­ly at its San Fran­cis­co fa­cil­i­ty. But there’s a plan to ex­pand the over­sub­scribed ser­vice, not just by ex­pand­ing ca­pac­i­ty but ob­tain­ing reg­u­la­to­ry clear­ance to al­low oth­ers to run their di­ag­nos­tics, com­plete with a “plat­form ag­nos­tic” soft­ware that can han­dle da­ta from any mass spec­trom­e­ter. With the new cash com­ing in from Anzu Part­ners, Genoa Ven­tures, Am­pli­fy Part­ners, True Ven­tures, Xer­aya Cap­i­tal and the Oj­jeh Fam­i­ly, Car­ras­coso ex­pects the head­count to grow dra­mat­i­cal­ly from the cur­rent 50.

But for now, In­ter­Venn is con­tent oc­cu­py­ing what the CEO de­scribes as a mo­nop­oly.

“I wait for the day that there is an­oth­er In­ter­Venn,” he said. “But we’ve been search­ing for years. There hasn’t.”

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.

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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CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

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

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

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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In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice

Like many who work in biopharma, Richard Paulson got started in the field because of a love of science.

Paulson had just finished business school and was looking to start a career that married his two passions. While looking for jobs, he thought of his grandmother who had struggled with Alzheimer’s disease, recalling how he saw first-hand what innovative medicines can do for patients. Ultimately, he started his first job in the space as a sales rep at Glaxo Wellcome, one of GlaxoSmithKline’s predecessors before its merger with SmithKline Beecham in 2000.