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)

Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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