Julio Aguirre-Ghiso (L) and Alan Rigby (HiberCell)

Look­ing to re­shape the metasta­t­ic can­cer land­scape, Hi­ber­Cell fills the tank with a slate of mid-stage tests queued up

A lit­tle over two years since its last raise, New York-based biotech Hi­ber­Cell is re­turn­ing to the ven­ture well for some more cap­i­tal.

The com­pa­ny has pulled in a new $67.4 mil­lion Se­ries B, Hi­ber­Cell an­nounced Wednes­day morn­ing, as it con­tin­ues its trek to de­vel­op drugs pre­vent­ing can­cer re­lapse and metas­ta­sis. Wednes­day’s funds will be used to ad­vance its pro­grams re­search­ing how stress bi­ol­o­gy and in­nate im­mu­ni­ty can play a role in can­cer re­cur­rence.

In ad­di­tion to the Se­ries B, Hi­ber­Cell con­cur­rent­ly se­cured a $30 mil­lion debt fa­cil­i­ty with Her­cules Cap­i­tal.

Hi­ber­Cell’s foun­da­tion comes from the lab work of Julio Aguirre-Ghiso at Mount Sinai, cen­tered around the no­tion that “dor­mant” dis­sem­i­nat­ed tu­mor cells — or DTCs — can re­ac­ti­vate long af­ter drugs have flushed all ap­pear­ances of can­cer. The the­o­ry goes that this re­sponse can lead to a metasta­t­ic can­cer with a near-cer­tain fa­tal­i­ty rate.

Though this no­tion isn’t par­tic­u­lar­ly new, Aguirre-Ghiso’s lab made some im­por­tant break­throughs re­gard­ing the bi­ol­o­gy of dis­sem­i­na­tion, co-founder and CEO Alan Rig­by said in an in­ter­view af­ter Hi­ber­Cell’s Se­ries A back in Feb­ru­ary 2019.

It may al­so ring a bell to some ob­servers in the field, as oth­er biotechs re­search­ing senes­cent cells have sim­i­lar ob­jec­tives, Rig­by told End­points News on Wednes­day. Dor­mant DTCs and senes­cent cells are es­sen­tial­ly the same thing, Rig­by said, and Hi­ber­Cell’s ul­ti­mate goal is to con­nect the un­der­ly­ing bi­ol­o­gy of these cells with clin­i­cal out­comes for pa­tients.

“These are the cells that cre­ate and ex­tend the win­dow of clin­i­cal dor­man­cy,” Rig­by told End­points. “It’s how some pa­tients with breast can­cer have the abil­i­ty to be fine for 20 years and then it comes back … we be­lieve they’re in­stru­men­tal in metasta­t­ic re­cur­rence.”

Two years af­ter the Se­ries A, Hi­ber­Cell’s pipeline now sits at three can­di­dates: one tu­mor mi­croen­vi­ron­ment mod­u­la­tor and two adap­tive stress mod­u­la­tors. The pro­gram far­thest along falls in that for­mer cat­e­go­ry, one that Hi­ber­Cell ac­quired last June. Known as Im­prime PGG, the can­di­date is be­ing stud­ied in com­bi­na­tion with Keytru­da for re­sectable melanoma and metasta­t­ic breast can­cer.

A Phase II study look­ing at treat­ment-naïve, re­sectable stage III melanoma is ex­pect­ed to launch right around when Q2 ends, Rig­by said. There’s al­so a Phase II tri­al for metasta­t­ic breast can­cer fol­low­ing HR fail­ure planned for some­time in the third quar­ter, he added.

Even though this can­di­date has on­ly re­cent­ly joined the Hi­ber­Cell pipeline, Rig­by be­lieves it can be in­stru­men­tal in mov­ing its oth­er in­ter­nal pro­grams along thanks to its “1-2 punch” in im­prov­ing sur­vival ad­van­tages and pro­mot­ing im­muno­sup­pres­sion. Those two can­di­dates, adap­tive stress mod­u­la­tors, are still in the ear­ly stages.

First up is their PERK in­hibitor for re­nal cell car­ci­no­ma and gas­tric can­cer, which re­cent­ly launched a Phase Ia safe­ty study. Then there’s an ISR mod­u­la­tor geared up for the gen­er­al “sol­id and liq­uid tu­mor” cat­e­go­ry, which is on track for a third quar­ter IND ap­pli­ca­tion.

As the whole field moves for­ward, there may be a time where non-metasta­t­ic can­cer pa­tients end up need­ing drugs like Hi­ber­Cell’s as a main­te­nance ther­a­py to pre­vent re­cur­rence af­ter their first bout with the dis­ease ends up in re­mis­sion, Rig­by said. But right now it’s still too ear­ly for any­one to say how long that might take.

“It’s up to us and oth­ers to ul­ti­mate­ly con­nect this unique bi­ol­o­gy to can­cer es­cape,” Rig­by said.

Wednes­day’s round in­clud­ed new in­vestors Huizen­ga, Monashee, Tekla, Her­cules Cap­i­tal, Mount Sinai In­no­va­tion Part­ners and oth­er undis­closed in­vestors. Re­turn­ing in­vestors, in­clud­ing ARCH, Mag­net­ic Ven­tures, Bris­tol My­ers Squibb, Trini­tas Cap­i­tal and oth­ers from the Se­ries A syn­di­cate al­so par­tic­i­pat­ed.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A flurry of biotechs are expected to hit Nasdaq this week, with two companies, Ambrx Biopharma and Century Therapeutics, setting the terms for their public debuts, with expected raises at $126 million and $200 million, respectively. Alzamend Neuro is also joining in with a $12.5 million raise and two preclinical Alzheimer’s treatments in tow.