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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Raju Mohan, Ventyx Biosciences CEO

Months af­ter a mam­moth raise, Ven­tyx Bio­sciences dips back in­to ven­ture well

Several months after emerging from what CEO Raju Mohan called “quiet mode” with a mammoth $114 million raise, Ventyx Biosciences is now making its plans for the clinic loud and clear.

The California-based immune modulation player kicked the week off with a $51 million Series B, while also naming some key hires ahead of its big clinical push.

The CMO slot is going to Jörn Drappa, former CMO at Viela Bio before it was bought out by Horizon Therapeutics earlier this year. The AstraZeneca vet stayed on at Horizon for a while as executive VP of R&D before making the jump to Ventyx.