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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Philip Astley-Sparke, Replimune CEO

Replimune looks to rope in $225M on the back of melanoma da­ta

The Massachusetts-based, oncolytic virus biotech Replimune is feeling bullish now that it has lifted the cover on data for its lead product.

Replimune said Thursday it looks to nab about $225 million from a public offering after giving a snapshot of some initial data from its IGNYTE clinical study earlier this week. The trial is investigating RP1 in combination with Opdivo, for patients with melanoma and who did not have a response when being treated with a PD-1.