Danish biotech looking for area of interest vaccine edge towards Pfizer snags €72M for pivotal research – Endfactors News

A biotech 12 years in the mak­ing has se­cured its largest fi­nanc­ing yet, and it has am­bi­tious plans for what the chief ex­ec­u­tive called a “David vs. Go­liath” ven­ture.

Min­er­vaX, based out of Copen­hagen, put out word bright and ear­ly Thurs­day that it se­cured €72 mil­lion in new fund­ing via both eq­ui­ty fi­nanc­ing and a loan. This is the biotech’s biggest fi­nanc­ing since 2020, when Sanofi and No­vo, among oth­ers, in­vest­ed $57 mil­lion (€47.4 mil­lion at the time) in Se­ries B fund­ing. €50 mil­lion of the €72 mil­lion is com­ing through a loan from the Eu­ro­pean In­vest­ment Bank.

With very lit­tle fund­ing since its spin­out in 2010 — on­ly about €20 mil­lion spent in its first ten years — the biotech turned an aca­d­e­m­ic project out of Lund Uni­ver­si­ty in Swe­den in­to a Phase II pro­gram. CEO Per Fis­ch­er tells End­points News that the com­pa­ny spent its first years ma­tur­ing the sci­ence and do­ing more in an­i­mal mod­els.

Thanks to new in­vestors, the com­pa­ny has gone from a se­mi-vir­tu­al com­pa­ny with on­ly five part-time em­ploy­ees to now em­ploy­ing over 20 staffers.

“We weren’t even kind of plan­ning to raise this amount, but then, you know, you have to be op­por­tunis­tic when the mon­ey presents it­self; you have to kind of take it,” Fis­ch­er told End­points.

Fis­ch­er added the €72 mil­lion will last the com­pa­ny in­to the end of 2024 and not­ed the com­pa­ny has some big plans. Min­er­vaX is aim­ing to in­clude prep work for a Phase III tri­al, fin­ish­ing and read­ing out Phase II da­ta some­time next year and work­ing with reg­u­la­tors. Fis­ch­er said the biotech has filed an IND with the FDA and al­ready has PRIME sta­tus with the EMA.

The biotech’s fo­cus is on a vac­cine for GBS, al­so known as group B strep­to­coc­cus. While GBS is gen­er­al­ly harm­less, it can cause still­birth and se­ri­ous in­fec­tions lead­ing to sep­sis and menin­gi­tis for new­borns.

Fis­ch­er al­so said Min­er­vaX is do­ing a lot of fol­low-up pro­tec­tion stud­ies, as med­ical need is high with no vac­cine ap­proved for GBS while in­ci­dence re­mains low. As such, large Phase III tri­als are nec­es­sary for a full ef­fi­ca­cy study.

“Reg­u­la­tors are sort of com­ing around to peo­ple us­ing cor­re­lates of pro­tec­tion, based on nat­ur­al im­mu­ni­ty. So if you ac­tu­al­ly an­a­lyze an­ti­bod­ies, that im­mu­ni­ty in in­fants that be­come sick with this dis­ease, and com­pare it to in­fants that do not be­come sick, you can see that in­fants — sick in­fants  — have much low­er an­ti­body lev­els than those that don’t be­come sick,” Fis­ch­er not­ed.

The next step is to ob­tain a lot of sam­ples for test­ing. Per Fis­ch­er, the tar­get is 20-40,000 moth­er-in­fant pairs to get enough sam­ples for that goal. And while that size is a lot, “ob­vi­ous­ly, it’s go­ing to be a mas­sive lo­gis­ti­cal chal­lenge to run these tri­als,” Fis­ch­er con­ced­ed. How­ev­er, tri­als that have that many sub­jects have al­ready been done in Covid-19.

“The learn­ings from COVID, you know, has re­al­ly paved the way for be­ing able to do such tri­als,” Fis­ch­er added.

Aside from the €50 mil­lion loan, the oth­er €22 mil­lion came from VC back­ers, in­clud­ing lead in­vestors Trill Im­pact Ven­tures and Pure­os Bioven­tures. Pre­vi­ous in­vestors in­clude No­vo Hold­ing’s RE­PAIR Im­pact Fund, Sun­stone Life Sci­ence Ven­tures, LF In­vest­ment, Welling­ton Part­ners, Sanofi Ven­tures, Ad­ju­vant Cap­i­tal and In­dus­tri­fonden.