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)

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

David Coman, Science 37

Amid vir­tu­al tri­al craze, Sci­ence 37 earns uni­corn sta­tus and a trip to Nas­daq on the back of SPAC deal

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

As the Covid-19 pandemic made conventional trials impossible for some drugmakers, more and more companies moved to decentralize their clinical studies, accelerating business for tech developers like Science 37. Leveraging that boost, the company is on the verge of a SPAC merger, landing unicorn status and its very own stock ticker.