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)

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down a €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.