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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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