Arch joins Cel­gene, Chi­na in­vestors bankrolling a pi­o­neer­ing New York biotech start­up fo­cused on a new ap­proach to metas­ta­sis

Julio Aguirre-Ghiso has steered the work in his lab at Mount Sinai down some of the less-trav­eled path­ways of can­cer re­search. And it’s led him to launch a biotech — which is hav­ing its com­ing-out par­ty to­day in New York — that has now set out to de­vel­op new med­i­cines tai­lored for the field he’s been pi­o­neer­ing.

While a mas­sive amount of can­cer re­search has been de­vot­ed to a bet­ter un­der­stand­ing of tu­mors and new and bet­ter ways to kill tu­mor cells, Aguirre-Ghiso’s re­search has cen­tered on “dor­mant” dis­sem­i­nat­ed tu­mor cells, or DTCs, that can re­ac­ti­vate long af­ter drugs have wiped out all ap­pear­ances of can­cer — fu­el­ing a metasta­t­ic re­sponse that comes back to kill the pa­tient with near cer­tain­ty.

Ari Nowacek

That lab work has be­come the foun­da­tion of Hi­ber­Cell, a new com­pa­ny seed­ed by Arch last sum­mer and now de­but­ing with a $60.75 mil­lion launch round. Ari Nowacek, a prin­ci­pal at Arch who has helped cham­pi­on the com­pa­ny, is step­ping in as BD chief for the start­up, which has a small, vir­tu­al team of 5 now run­ning the show.

The syn­di­cate Nowacek helped form is telling about the way mon­ey comes to­geth­er in the bio­phar­ma world these days. Arch al­lied it­self, as it has be­fore, with Hill­house and 6 Di­men­sions out of Chi­na. Cel­gene, still op­er­at­ing as an in­de­pen­dent com­pa­ny in the lead-up to fi­nal­iz­ing the Bris­tol-My­ers buy­out, stepped in here as well. The NYC Life Sci­ences Fund, ea­ger to help fos­ter a Big Ap­ple hub, al­so con­tributed cash, along­side a group of uniden­ti­fied in­sti­tu­tion­al in­vestors and in­di­vid­u­als.

There isn’t any­thing par­tic­u­lar­ly new about the no­tion of dis­sem­i­na­tion in can­cer, says Alan Rig­by, the co-founder and CSO of the com­pa­ny. That dates back decades. But Aguirre-Ghiso’s lab has made some im­por­tant break­throughs in the bi­ol­o­gy of dis­sem­i­na­tion, find­ing that “soli­tary cells or mi­cro-clus­ters break away at ear­ly stages and dis­sem­i­nate ear­ly.” 

On his home page on Mount Sinai’s web­site, the sci­en­tist fur­ther ex­plains:

My lab has al­so de­signed an epi­ge­net­ic re­pro­gram­ming ther­a­py to in­duce dor­man­cy of DTCs, which is be­ing de­vel­oped in­to a clin­i­cal tri­al. We al­so dis­cov­ered that UPR sig­nal­ing can pro­mote the sur­vival of dor­mant tu­mor cells and that macrophages are key play­ers in the reg­u­la­tion of ear­ly dis­sem­i­na­tion and dor­man­cy. With mul­ti­ple col­lab­o­ra­tors we run an NCI-Tu­mor Mi­croen­vi­ron­ment Net­work Cen­ter that stud­ies the mi­croen­vi­ron­men­tal stress and dor­man­cy and de­vel­ops new tech­nolo­gies to im­age and tar­get metas­ta­sis. We al­so col­lab­o­rate to char­ac­ter­ize dor­man­cy in hu­man breast, prostate and head and neck can­cer DTCs and we study the epi­ge­net­ic reg­u­la­tion of DTC dor­man­cy. A ma­jor ef­fort in our lab is al­so to de­vel­op a trans­la­tion­al pro­gram with the phar­ma­ceu­ti­cal in­dus­try to iden­ti­fy po­ten­tial drugs to tar­get dor­mant dis­ease.

The re­search they’re do­ing has di­rect ap­pli­ca­tions that are par­tic­u­lar­ly suit­ed for the Chi­na mar­ket, adds Rig­by, cit­ing esophageal, gas­tric and liv­er can­cers. He adds that the launch round should get them in­to 2022, in­clud­ing a nice stretch af­ter they’re slat­ed to get in­to the clin­ic in 2020 or ear­ly ’21 with their first drug.

Rig­by al­so says that the team, which is like­ly to grow some­what, in-li­censed late pre­clin­i­cal drug can­di­dates that they’re work­ing with now. He de­clined to of­fer de­tails about those drugs, not un­usu­al for a start­up look­ing to get out ahead of any po­ten­tial ri­vals that may ap­pear now.


Im­age: Julio Aguirre-Ghiso and Alan Rig­by. HI­BER­CELL

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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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.

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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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.

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.