Alpna Seth (Nura Bio)

Three years af­ter leav­ing Bio­gen, Alp­na Seth takes the spot­light with $73M for her neu­ro start­up

When Alp­na Seth re­turned to the US from Eu­rope in 2017 — where she was tasked with set­ting up Bio­gen’s biosim­i­lars busi­ness from the ground up — she knew she was ready to leave her 19-year tenure be­hind and lead her own start­up as CEO. Once she land­ed in the Bay Area, she called George Scan­gos, her just-re­tired boss.

“He said, ‘You know, I’m set­ting up Vir,’” she re­called. “We have a lot of mon­ey, you have ex­pe­ri­ence set­ting up new busi­ness­es — why don’t you come join me as chief op­er­at­ing of­fi­cer?”

By the time she left, Vir had grown to 200 staffers and ac­quired 3 com­pa­nies to con­struct a pipeline months be­fore a pan­dem­ic would strike. De­spite the lit­tle de­tour in in­fec­tious dis­ease, though, neu­ro­log­i­cal dis­eases still oc­cu­pied a spe­cial place in her mind as she be­gan search­ing for a biotech to lead. Hav­ing spear­head­ed the de­vel­op­ment and com­mer­cial­iza­tion of the top-sell­ing mul­ti­ple scle­ro­sis drug Tec­fidera, Seth took the “mas­sive” need for new treat­ments to heart.

Nu­ra Bio, as it turned out, was the one.

Near her 1-year an­niver­sary with the com­pa­ny, Seth is pulling the cur­tain on the sci­ence that at­tract­ed her — plus $73 mil­lion in Se­ries A cash to ad­vance it in pre­clin­i­cal work.

Con­ceived by The Col­umn Group in 2018, Nu­ra Bio was found­ed on break­throughs in ax­on­al de­gen­er­a­tion by Marc Free­man of Ore­gon Health & Sci­ence Uni­ver­si­ty and Steven McK­night of UT South­west­ern.

“Neur­al cells are so in­ter­est­ing,” she said. Ax­ons or nerve fibers, in par­tic­u­lar, can be as long as a me­ter in some cas­es. “Can you imag­ine like one cell that long? It’s like an elec­tric wire, so it has high ac­tion po­ten­tial, and very vul­ner­a­ble to dam­age. Ax­on de­gen­er­a­tion and neu­ronal loss con­nect­ed with that are re­al­ly the ear­ly hall­marks of many pe­riph­er­al, cen­tral, oc­u­lar ner­vous sys­tem dis­eases.”

So how do you halt ax­on­al de­gen­er­a­tion ear­ly? Free­man’s lab found the NAD hy­dro­lase SARM1 was a ax­on-death fac­tor, and knock­ing it out con­fers both struc­tur­al and func­tion­al preser­va­tion.

Drug­gable with small mol­e­cules, the tar­get lends it­self to a “tru­ly di­rect­ly act­ing neu­ro­pro­tec­tive” ther­a­py, Seth said. In a sense it’s al­so a teas­er for the pipeline of new tar­gets that they haven’t dis­closed.

But go­ing ear­ly in a dis­ease — Nu­ra hasn’t elab­o­rat­ed on which ones it’s go­ing af­ter — al­so means find­ing and con­vinc­ing reg­u­la­tors of bio­mark­ers that can mea­sure the ef­fec­tive­ness of its drugs. That would be a key part of the work for the team of around 30 lead­ing in­to the clin­ic, some­thing that still lies in a some­what dis­tant fu­ture.

At the same time, it’s cru­cial ground­work for the com­pa­ny that Seth is look­ing to build: a leader an­swer­ing the call to a field lit­tered with fail­ures and the ghosts of phar­ma com­pa­nies that have pulled out of neu­ro­science. And in ad­di­tion to The Col­umn Group, she has Sam­sara Cap­i­tal and Eu­clid­ean Cap­i­tal by her side to get there.

“Our hope is that tak­ing these nov­el ap­proach­es based on some re­cent break­throughs in our un­der­stand­ing that the time is now,” she said. “We are quite hope­ful, al­though one can nev­er be sure un­til it’s ful­ly test­ed.”

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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