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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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