Per Fischer, MinervaX CEO

Dan­ish biotech seek­ing niche vac­cine edge against Pfiz­er snags €72M for piv­otal study

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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

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