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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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