With $500M-plus, a buy­out and two new bil­lion-dol­lar pacts, up­start Vir is ready to roll on in­fec­tious dis­eases

George Scan­gos has been busy since leav­ing Bio­gen’s helm and jump­ing to the start­up Vir Biotech­nol­o­gy in San Fran­cis­co. Now it’s time for the com­ing out par­ty, which in­volves de­vel­op­ment al­liances with two of the biotechs back at his for­mer base in Cam­bridge, MA. And ac­cord­ing to Scan­gos, Vir is still just get­ting start­ed in build­ing a whole new com­pa­ny.

To­day Scan­gos un­veiled a biotech buy­out, two bil­lion-dol­lar drug de­vel­op­ment deals to build the pipeline, more than $500 mil­lion in fi­nanc­ing from some high-rolling tech gam­blers and four aca­d­e­m­ic part­ner­ships at Vir, which has set out to cre­ate a new pipeline for in­fec­tious dis­ease drug de­vel­op­ment.

Let’s kick this off with the part­ner­ships.

Robert Nelsen, Arch Ven­tures

Al­nyam gets it start­ed with a pact cov­er­ing RNAi drugs for in­fec­tious dis­eases, with Vir bag­ging de­vel­op­ment rights for a next-gen he­pati­tis B drug along with rights to four oth­er pro­grams that go in­to the pack­age. Sig­nif­i­cant­ly, Al­ny­lam si­mul­ta­ne­ous­ly said it’s ax­ing its orig­i­nal ear­ly-stage hep B pro­gram for ALN-HBV and re­plac­ing it with an amped up suc­ces­sor dubbed ALN-HBV02.

In the Al­ny­lam pact, Vir will pick up the pro­gram for the first hu­man proof-of-con­cept study, with the part­ners co-fund­ing the work. Vir takes con­trol in Phase II and Al­ny­lam has an op­tion to jump in­to a prof­it-shar­ing pact ahead of Phase III.

Al­ny­lam gets an un­spec­i­fied up­front in cash and stock in Vir, with $1 bil­lion-plus in mile­stones.

Then there’s Vis­ter­ra. This biotech has built a plat­form us­ing an epi­tope-tar­get­ing tech that can be used for pre­ci­sion an­ti­body de­vel­op­ment.

Vir has bagged an op­tion on mi­nor­i­ty rights to VIS410 for in­fluen­za A hos­pi­tal cas­es with a shot at a re­gion­al co-pro­mo­tion li­cense, plus pro­grams for RSV, fun­gal in­fec­tions and two oth­er pro­grams to be de­cid­ed on. Vis­ter­ra al­so gets more than a bil­lion dol­lars in po­ten­tial mile­stones.

Build­ing its own plat­form, Vir has ac­quired Switzer­land’s Hum­abs Bio­Med SA for an un­spec­i­fied amount, adding its op­er­a­tions and staff, who will re­main in Eu­rope.

The four new aca­d­e­m­ic deals cov­er an AI col­lab­o­ra­tion for drug dis­cov­ery with Stan­ford; a part­ner­ship with Har­vard that will give Vir an in-li­cens­ing edge for fu­ture pro­grams; an ex­pand­ed pact with OHSU and an al­liance with the Fred Hutchin­son Can­cer Re­search Cen­ter for cell ther­a­pies.

Pay­ing for all this is a syn­di­cate that was led by Arch Ven­tures’ Robert Nelsen, who seed­ed the com­pa­ny, along with the Bill & Melin­da Gates Foun­da­tion, Al­ti­tude Life Sci­ence Ven­tures and Al­ta Part­ners. They’re joined by Soft­Bank Vi­sion Fund, Temasek, Bail­lie Gif­ford, the Alas­ka Per­ma­nent Fund, and se­lect sov­er­eign wealth funds, pri­vate in­di­vid­u­als, fam­i­ly of­fices and in­sti­tu­tion­al in­vestors.

Scan­gos calls Vir a sci­ence-dri­ven com­pa­ny, but it’s very much fo­cused on clin­i­cal stage de­vel­op­ment. In a state­ment, he not­ed:

“We ex­pect to move sev­er­al com­pounds in­to clin­i­cal de­vel­op­ment in the next 18 months and we have an op­tion to ac­quire a por­tion of a Phase II com­pound tar­get­ing flu. We al­so con­tin­ue to eval­u­ate sev­er­al near-term op­por­tu­ni­ties to ac­quire ad­di­tion­al mid- and late-stage clin­i­cal com­pounds, as well as ex­pand our tech­nol­o­gy base even fur­ther. We have hired an ex­pe­ri­enced man­age­ment team and built in­ter­nal tech­nol­o­gy de­vel­op­ment ca­pa­bil­i­ties re­quired for the pro­duc­tion of bi­o­log­i­cal prod­ucts. I am pleased that in our first year we have been able to align lead­ing ideas, tech­nol­o­gy, and ex­per­tise fo­cused on trans­form­ing the care of peo­ple with se­ri­ous in­fec­tious dis­eases and pro­vid­ing a re­turn to our in­vestors.”

George Scan­gos pic­tured dur­ing a TV in­ter­view on Jan­u­ary 12, 2016. David Paul Mor­ris/Bloomberg via Get­ty Im­ages

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.