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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.