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

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

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

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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