Por­to­la may not have had much suc­cess prov­ing the com­mer­cial val­ue of an an­ti-an­ti­co­ag­u­lant, but that’s not stop­ping Eu­ro­pean in­vestors from pour­ing $36.2 mil­lion (€32 mil­lion) in­to what they see as a su­pe­ri­or ap­proach put forth by a Dutch biotech.

Var­mX’s blood thin­ner re­ver­sal agent stems from re­search done by founder and CSO Pieter Re­its­ma at Lei­den Uni­ver­si­ty Med­ical Cen­ter. A mod­i­fied re­com­bi­nant form of fac­tor X, VMX-C001 “has an in­ser­tion of 16 amino acids that re­places a stretch of 7 amino acids in the so-called ser­ine pro­tease do­main” com­pared to the na­tive co­ag­u­la­tion fac­tor, CEO Alexan­der Vos told End­points News.

“This in­ser­tion leaves suf­fi­cient clot­ting ac­tiv­i­ty, whilst in­tro­duc­ing vir­tu­al­ly com­plete in­sen­si­tiv­i­ty to fac­tor Xa DOACS,” he added, re­fer­ring to oral fac­tor Xa in­hibitors.

Un­like Por­to­la’s An­dexxa — which is on­ly ap­proved to quick­ly dis­arm Eliquis and Xarel­to — Var­mX’s drug promis­es to counter the ef­fect of any DOAC. The biotech said it’s al­so eas­i­er to ad­min­is­ter and doesn’t lead to pro-throm­bot­ic risk.

Re­ports sug­gest that 2% to 3% of the 10 mil­lion pa­tients tak­ing FXa DOACs ex­pe­ri­ence spon­ta­neous se­vere bleed­ing, Vos said, which could be life-threat­en­ing. And there are al­ways pa­tients on an­ti­co­ag­u­lants who need to re­store some blood clot­ting func­tions for an emer­gency surgery.

The Se­ries B is de­signed to put the drug through clin­i­cal proof-of-con­cept, all the way up to the thresh­old of reg­is­tra­tional stud­ies for both se­vere bleed­ing and emer­gency surgery.

At that point — and there’s no guar­an­tee they will get there — Var­mX will find it­self fac­ing off with Alex­ion, which bagged Por­to­la and An­dexxa in a $1.4 bil­lion buy­out in May. The ac­qui­si­tion val­ued Por­to­la at $18 per share, a frac­tion of where it was at peak.

“The da­ta gen­er­at­ed so far sug­gests that VMX-C001 can be­come a dif­fer­en­ti­at­ed treat­ment so­lu­tion in an ever grow­ing mar­ket,” Guillem La­por­ta, whose Ys­ios Cap­i­tal co-led the fi­nanc­ing with INKEF Cap­i­tal, said in a state­ment.

Lund­beck­fonden Ven­tures joined the round, to­geth­er with ex­ist­ing in­vestors Bio­Gen­er­a­tion Ven­tures and In­no­va­tion­Quar­ter.

In ad­di­tion to the lead pro­gram, the lean team of 5 at Var­mX is de­vel­op­ing re­ver­sal agents for fu­ture class­es of an­ti­co­ag­u­lants, such as those tar­get­ing fac­tor XI(a).

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Before the advent of CAR-T, the term cell therapy conjured up very different images. Sure, there were cancer immunotherapies like Dendreon’s Provenge, but more common were the various flavors of stem cell therapies and cell transplantation.

None of that has gone away, even if they’ve been nudged out of the spotlight — and a little biotech has garnered $54 million (£40 million) to show that both the old and new ideas of cell (and gene) therapy can mesh together to form a special breed of platform company.