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

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from Termeer’s widow, Belinda, and other unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Anthony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Gilead-part­nered Goldfinch Bio lands $100M as it piv­ots to clin­i­cal stage biotech

A year after landing $109 million in cash for an early-stage discovery deal with Gilead, Goldfinch Bio has scored a similar bounty from investors, raising $100 million in the biotech’s first financing round since its 2016 launch.

The new round, led by Eventide Asset Management and joined by 8 other firms, confirms that last year’s Gilead deal began a new, busier, more vocal era for the company. After launching out of Third Rock with $55 million and a plan to tackle kidney disease, they focused on preclinical research and made few material announcements. But the latest press release is full of plans, including their first Phase II study and a new therapy scheduled to enter the clinic next year.