Jørgen Søberg Petersen, Hemab chairman (Novo Holdings)

No­vo Hold­ings in­vests in Hemab, a com­pa­ny go­ing against the he­mo­phil­ia gene ther­a­py grain with a plan for bis­pecifics

No­vo Hold­ings, the hold­ing com­pa­ny com­pris­ing No­vo Nordisk and man­ag­ing the No­vo Nordisk Foun­da­tion’s as­sets, has made a new in­vest­ment through its seed cap­i­tal arm.

The in­cu­ba­tor No­vo Seeds is fund­ing a com­pa­ny called Hemab ApS, which is fo­cused on de­vel­op­ing bis­pe­cif­ic an­ti­bod­ies for rare bleed­ing dis­or­ders. Co-found­ed by two for­mer No­vo Nordisk ex­ecs in their he­mo­phil­ia R&D de­part­ment, Hemab is aim­ing for he­mo­phil­ia to be its first tar­get with re­lat­ed blood dis­eases to fol­low af­ter­ward.

Fi­nan­cial terms of the deal were not dis­closed, but Hemab chair­man and No­vo Hold­ings part­ner Jør­gen Søberg Pe­tersen told End­points News that No­vo Hold­ings is the sole in­vestor in the com­pa­ny. Hemab not­ed that it will be li­cens­ing IP from No­vo in or­der to de­vel­op its pro­grams, as well as a plat­form from the Dan­ish biotech Gen­mab to help the com­pa­ny pro­duce its bis­pecifics.

“It’s a broad area to­day, I think there’s maybe 40 or 50 dif­fer­ent for­mats out there and they all claim to be bet­ter than the oth­er. I’m not to say which one will be the win­ner ul­ti­mate­ly, but I will say is that Gen­mab’s tech­nol­o­gy is among the best val­i­dat­ed in this space,” Pe­ter­son said.

Hemab en­ters a packed he­mo­phil­ia space, stuffed with an­ti­bod­ies and sur­round­ed by en­croach­ing gene ther­a­pies. No­vo Nordisk, sep­a­rate from the hold­ing com­pa­ny that made Mon­day’s in­vest­ment, has its own he­mo­phil­ia pro­gram in con­cizum­ab, which restart­ed Phase III stud­ies back in Au­gust af­ter be­ing shut down in March over three pa­tients de­vel­op­ing non-fa­tal blood clots.

The Dan­ish phar­ma had been hop­ing the can­di­date could ri­val Roche’s Hem­li­bra, but that drug has al­ready proven some­what of a block­buster, tal­ly­ing more than $1.5 bil­lion in glob­al sales through the first three quar­ters of 2020. Not every­thing was ros­es for Roche, how­ev­er, as the drug ran in­to some speed bumps back in 2017 for he­mo­phil­ia A, and now ex­pects to start a Phase III some­time in 2021.

Bio­Marin is the ma­jor name in he­mo­phil­ia gene ther­a­py, but was sur­pris­ing­ly turned away by the FDA in Au­gust af­ter ques­tions arose about the dura­bil­i­ty of its safe­ty da­ta for val­rox. The EMA al­so gave it the thumbs down in No­vem­ber, but not­ed they were look­ing for less fol­low-up da­ta than their US coun­ter­parts.

Hemab, though, is fol­low­ing the Hem­li­bra path with bis­pecifics. For the ul­tra-rare dis­eases Hemab is tar­get­ing, Pe­ter­son said he doesn’t see the choice of gene ther­a­py or bis­pe­cif­ic as an ei­ther/or.

“When we speak with peo­ple in the gene ther­a­py space, I think there’s al­so hope that some pa­tients will get a com­plete re­mis­sion and I cer­tain­ly hope that will be the case,” Pe­ter­son said. “But re­al­is­ti­cal­ly speak­ing, with the ap­proach­es that are used right now, I think most in­ves­ti­ga­tors in this space will ex­pect that there will be a lot of oth­er pa­tients who ei­ther re­spond poor­ly, or on­ly par­tial­ly, and where there will be a need for ad­di­tion­al phar­ma­co­log­i­cal ther­a­py to re­al­ly op­ti­mize the treat­ment.

“We think there will be a place for both prin­ci­ples for many years ahead,” he added.

Hemab was co-found­ed by Jo­han Faber and Søren Bjørn back in 2018 af­ter the two wrapped up their tenures at No­vo Nordisk. Faber had worked at the phar­ma since 2006, start­ing as a post­doc­tor­al fel­low and work­ing his way up to be­com­ing the head of their glob­al re­search tech­nolo­gies de­part­ment for pro­tein in­ter­ac­tion char­ac­ter­i­za­tion.

Pe­ter­son said Hemab will like­ly see to close a Se­ries A round some­time with­in the next 12 months, and hope to see a prod­uct hit the clin­ic be­fore the end of 2023 at the lat­est.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.