Sean Mackay, IsoPlexis

Iso­Plex­is scores big backer for per­son­al­ized pro­tein 'bar­codes' as Per­cep­tive jumps on board new fund­ing round

A lit­tle less than two years af­ter bag­ging an ex­tend­ed $50 mil­lion Se­ries C, Iso­Plex­is and its “pro­teom­ic bar­codes” for per­son­al­ized can­cer care are back set­ting hooks to bring even more in­vestors on board. And this time, they’ve caught a big fish.

Per­cep­tive Ad­vi­sors is lead­ing a $135 mil­lion Se­ries D round for the com­pa­ny, the firms an­nounced Thurs­day, com­pris­ing $85 mil­lion in eq­ui­ty and a $50 mil­lion line of cred­it. Iso­Plex­is plans to use the pro­ceeds to ex­pand com­mer­cial and R&D staff, in­crease op­er­a­tional ca­pac­i­ty and ac­cel­er­ate prod­uct de­vel­op­ment.

The Bran­ford, CT-based com­pa­ny works with can­cer cen­ters and bio­phar­ma com­pa­nies in the US, Eu­rope and Chi­na, us­ing its bio­mark­er-dri­ven sys­tem de­signed to pre­dict re­spons­es to such treat­ments and per­son­al­ize treat­ment for pa­tients. Iso­Plex­is em­ploys a pro­pri­etary sin­gle-cell analy­sis tool to re­fine its im­munother­a­pies.

Sam Chawla

“We be­lieve the fu­ture of ad­vanced med­i­cines will re­ly up­on deep­er ac­cess to in vi­vo bi­ol­o­gy for the de­vel­op­ment of new ther­a­pies and are ex­cit­ed to back the team at Iso­Plex­is,” Per­cep­tive port­fo­lio man­ag­er Sam Chawla said in a state­ment.

Re­searchers have de­vel­oped what they call pro­teom­ic bar­code chips, which al­low them to look at the en­tire com­ple­ment of pro­teins with­in a pa­tient’s cells. It’s a process they say pro­vides the map­ping of new and ac­ces­si­ble lay­ers of bi­o­log­i­cal da­ta for every sin­gle cell, ul­ti­mate­ly al­low­ing for a bet­ter un­der­stand­ing of how in­di­vid­u­als may re­spond to ther­a­pies.

Es­sen­tial­ly, pa­tients re­ceive sam­ples of these chips, which CEO Sean Mack­ay says is bar­cod­ed with an­ti­bod­ies. Af­ter the com­pa­ny re­ceives the sam­ple back, they place it in­to their sys­tem to see just how a per­son’s im­mune sys­tem would re­spond to dif­fer­ent treat­ments.

“We call that the sin­gle-cell im­mune land­scap­ing,” Mack­ay told End­points News. “What we’re able to do with that is find sub­sets of pow­er­ful im­mune cells that you typ­i­cal­ly miss in bulk pro­fil­ing, sort of sta­tus quo, and that is a prod­uct that works on our in­stru­ment, ba­si­cal­ly a soft­ware-en­abled sys­tem that reads out what the chips look like and what the pro­teins are per cell.”

That soft­ware then lets Iso­Plex­is com­pare what’s typ­i­cal­ly missed in that bulk pro­fil­ing to long-term re­spon­der pa­tients in sev­er­al dif­fer­ent fields like can­cer im­munother­a­py, cell and gene ther­a­py, Covid-19 and au­toim­mune dis­ease, among oth­er ar­eas. Iso­Plex­is can then pick and choose the ap­pro­pri­ate pre­clin­i­cal treat­ments and bio­mark­ers in the clin­ic, pack­ag­ing that in­fo to phar­ma com­pa­nies and aca­d­e­m­ic labs.

Per­cep­tive, his­tor­i­cal­ly a pas­sive in­vestor that en­joys clin­i­cal-stage in­vest­ments and crossover rounds, has been fair­ly busy over the last year or so. It made its first for­ay in­to the com­pa­ny for­ma­tion and Se­ries A spaces in late 2019, set­ting up a $210 mil­lion ear­ly-stage VC fund with Xon­toge­ny. Then last Au­gust, they launched their first in-house start-up in Chi­na, fol­lowed by a $310 mil­lion raise a few months lat­er. Per­cep­tive’s third SPAC al­so filed for an IPO in late Ju­ly.

Oth­er new in­vestors in­clud­ed Al­ly Bridge Group and funds and ac­counts man­aged by Black­Rock. Un­named ex­ist­ing in­vestors al­so par­tic­i­pat­ed in the round.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.