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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Kelly Ganjei, AmplifyBio CEO

Am­pli­fy­Bio scoops up lab space and oth­er as­sets from PACT Phar­ma as cell ther­a­py biotech read­justs

The West Coast cell therapy biotech PACT Pharma was facing some challenges after several employees got the axe from the company and execs put the kibosh on its only clinical trial. Now, the company has sold some of its assets to an Ohio-based contract research organization.

AmplifyBio has acquired a 46,280 square-foot lab in South San Francisco, CA, with around 40 employees specializing in cell and gene therapy development and access to technology platforms that can be applied to “product characterization.”

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Hervé Hoppenot, Incyte CEO

In­cyte pays out $70M to get hands on Medicxi-backed vi­tili­go biotech

The M&A wheels keep on turning in biotech — and this time it’s Incyte that gets to do the dealmaking.

The Delaware biotech put out word on Monday morning that it will be shelling out $70 million in cash to acquire Villaris Therapeutics. Incyte will not only acquire Villaris, but also exclusive global rights for Villaris’s lead candidate auremolimab.

Auremolimab, currently in IND-enabling studies, is an anti-IL-15Rβ monoclonal antibody being investigated in vitiligo, with a possibility of other autoimmune and inflammatory indications. Villaris says it is targeting that pathway after a mouse study showed that doing so could be effective at reversing the disease.