Hemab, still play­ing coy, gets its first ma­jor fundraise for he­mo­phil­ia bis­pecifics

A com­pa­ny seed­ed by No­vo’s in­cu­ba­tor at the end of 2020 is tak­ing its next step Thurs­day, emerg­ing in­to the he­mo­phil­ia space with a hefty Se­ries A.

The Dan­ish biotech Hemab is putting the bow on a $55 mil­lion round ear­ly Thurs­day, raised with mon­ey from No­vo Seeds as well as promi­nent in­vestor RA Cap­i­tal. See­ing RA in­vest as ear­ly as a Se­ries A rais­es the nat­ur­al sus­pi­cion of a po­ten­tial IPO, and new­ly-ap­point­ed CEO Ben­ny Sorensen told End­points News he’d hoped to be asked about it.

But that doesn’t mean he’s giv­ing away any free an­swers, de­mur­ring with “it de­pends.”

Ben­ny Sorensen

“We have tons of cap­i­tal to ad­vance pro­grams right now, but the very clear mis­sion for Hemab is to ad­vance the com­pa­ny and gen­er­ate fur­ther da­ta,” Sorensen said. “Our clear­ly stat­ed mis­sion is to be­come a ful­ly in­de­pen­dent biotech com­pa­ny that dis­cov­ers and launch­es phar­ma­ceu­ti­cals for blood clot­ting dis­or­ders. We have to raise more cap­i­tal in the fu­ture, but right now we’re ex­cit­ed to have plen­ty of cap­i­tal.”

So what’s gen­er­at­ing all the ex­cite­ment be­hind Thurs­day’s raise? Hemab has been fo­cus­ing on its lead can­di­date, a bis­pe­cif­ic an­ti­body the com­pa­ny is look­ing to eval­u­ate in a “va­ri­ety” of bleed­ing dis­or­ders, Sorensen said. The biotech re­vealed lit­tle back in De­cem­ber, and Sorensen again kept things close to the vest.

The on­ly clue Sorensen dropped in­volves the “tremen­dous” amount of progress Hemab has made since that seed round sev­en months ago.

Re­gard­less of what in­di­ca­tion Hemab specif­i­cal­ly goes af­ter, Sorensen will be lead­ing the com­pa­ny in­to an ex­treme­ly crowd­ed he­mo­phil­ia mar­ket. The Dan­ish bio­phar­ma No­vo Nordisk, sep­a­rate from the in­cu­ba­tor that has fund­ed Hemab thus far, has its own pro­gram in con­cizum­ab it hopes can com­pete against Roche gi­ant Hem­li­bra.

Even though No­vo Nordisk got a Phase III tri­al back on track last sum­mer fol­low­ing safe­ty is­sues back in March 2020, Hem­li­bra is a tough cook­ie to catch. The drug quick­ly reached block­buster sta­tus af­ter ap­proval in Oc­to­ber 2018 for rou­tine pro­phy­lax­is to lessen bleed­ing episodes, tal­ly­ing al­most $2.4 bil­lion in 2020 sales and an­oth­er $720 mil­lion in the first quar­ter of 2021.

Roche is al­so look­ing to ex­pand the drug in­to mild to mod­er­ate he­mo­phil­ia A and re­leased fi­nal pos­i­tive analy­ses for a Phase II­Ib study in­to he­mo­phil­ia A pa­tients with in­hibitors to fac­tor VI­II last Mon­day. But No­vo Seeds is chas­ing small­er pa­tient pop­u­la­tion where there aren’t any ap­proved treat­ments, man­ag­ing part­ner Søren Møller told End­points.

“The pro­gram fits, it’s well po­si­tioned with rare bleed­ing dis­or­ders,” Møller said. “We take sort of that or­phan niche ap­proach. We do feel that this is a prod­uct that can eas­i­ly work in the con­text of gene ther­a­py and oth­er ap­proach­es that are com­ing out.”

In ad­di­tion to No­vo Seeds and RA Cap­i­tal, Health­Cap co-lead Thurs­day’s round.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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 part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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