Swiss biotech rais­es $16M to test 'un­de­liv­ery mech­a­nis­m' for rare liv­er dis­ease

The process is grind­ing and of­ten ter­mi­nal, like a fine car with a trans­mis­sion patched up a dozen times but still jam­ming and in dire need of re­place­ment. Pa­tients with late-stage chron­ic liv­er dis­ease will de­com­pen­sate (lose or­gan func­tion) and though that in­stance can be treat­ed, each time is like an­oth­er jolt on the gears. Even­tu­al­ly, the car won’t dri­ve. There are trans­plants, but over half of the pa­tients die wait­ing for those.

Meri­am Kab­baj

A new method from Swiss biotech Ver­san­tis wouldn’t cure chron­ic liv­er dis­ease but it promis­es to give far bet­ter im­me­di­ate care and of­fer a treat­ment for a cou­ple rare forms of liv­er dis­ease that cur­rent­ly leave pa­tients with­out good op­tions short of a trans­plant. The com­pa­ny just took in $16 mil­lion in Se­ries B fund­ing to put its plat­form through first-in-hu­man and ef­fi­ca­cy tri­als in small sub­sets of a dis­ease that kills around 2 mil­lion world­wide very year.

“This is a very dis­rup­tive tech­nol­o­gy,” Ver­san­tis co-founder and COO Meri­am Kab­baj told End­points News. “Liv­er dis­ease is on­ly grow­ing and cause many deaths year af­ter year and so far there haven’t been any ef­fi­cient treat­ments.”

Vince Forster

Ver­san­tis’s plat­form works by tak­ing a pop­u­lar and well-re­searched drug de­liv­ery method called li­po­somes and turn­ing it on its head, to cre­ate what CEO Vince Forster called an “un­de­liv­ery mech­a­nism”: Rather than de­liv­er­ing drugs, it takes out tox­ins. Two liters of liq­uid filled with “mi­croscav­engers” — their VS-01 drug — would be ad­min­is­tered in­to a pa­tient’s bel­ly. The scav­engers would swoop up am­mo­nia and oth­er tox­ins the liv­er can no longer me­tab­o­lize, and then the so­lu­tion is sim­ply tak­en out.

“What we can pro­vide is the same ef­fi­cien­cy as dial­y­sis,” Kab­baj said, “but the main dif­fer­ence is that it’s much safer and it can be im­ple­ment­ed very ear­ly on.”

Al­though liv­er dis­ease is one of the most com­mon in the de­vel­oped world, Ver­san­tis cur­rent­ly fo­cus­es on niche ar­eas with­in it: de­com­pen­sat­ed liv­er cir­rho­sis that has caused a form of di­min­ished brain func­tion called he­pat­ic en­cephalopa­thy and acute-on-chron­ic liv­er fail­ure, the more se­vere dis­ease for which they’ve re­ceived FDA or­phan drug sta­tus in 2017. A Phase I tri­al they say promis­es some ef­fi­ca­cy da­ta is just un­der­way and the Se­ries B mon­ey will fund a Phase IIa tri­al.

Ver­san­tis is not the on­ly com­pa­ny get­ting in­to the rapid­ly grow­ing liv­er game. An­oth­er young Swiss biotech, Alen­tis, got near­ly as much in March for their Se­ries A fund­ing while Bel­gium’s Promethera Bio­sciences col­lect­ed $44 mil­lion in May for end-stage liv­er dis­ease, among oth­ers. The area can be a mine­field, though. Last year, Vi­tal Ther­a­pies saw its stock fall 88% to $0.70 af­ter its plat­form to treat acute liv­er dis­ease bombed a Phase III tri­al.

But Kab­baj ar­gued that Ver­san­tis had an edge be­cause un­like oth­er treat­ments, its mi­croscav­engers re­move not just am­mo­nia but oth­er tox­ic metabo­lites. And it’s not on­ly the liv­er. Oth­er parts of the body, in­clud­ing the brain and kid­neys, which al­so see tox­ic buildup from liv­er dis­ease, ben­e­fit as well.

Ver­san­tis is al­so look­ing at broad­er ap­pli­ca­tions for the drug, in­clud­ing for broad­er forms of liv­er dis­ease, for a con­di­tion in in­fants that caus­es po­ten­tial­ly fa­tal buildups in am­mo­nia and, fur­ther down, for treat­ing opi­od over­dos­es.

Swiss­canto In­vest by Zürcher Kan­ton­al­bank led the fi­nanc­ing , Es­per­ante Ven­tures and new pri­vate in­vestors. Redalpine HealthE­quity and Zürcher Kan­ton­al­bank Start-up Fi­nance, both ex­ist­ing in­vestors,  al­so par­tic­i­pat­ed in this round.

So­cial im­age left to right: Vince Forster, So­phie Biguenet, Rekha John­son, Meri­am Kab­baj (Ver­san­tis)

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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