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.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

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

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.