GSK, Sanofi en­list in a big ge­nomics project aim­ing to map genes of half a mil­lion Finns

Sev­er­al Eu­ro­pean coun­tries, in­clud­ing Ice­land and the Nether­lands, have an­a­lyzed ge­nom­ic in­for­ma­tion to study their pop­u­lace. Two years ago, Fin­land be­gan its very own large scale pub­lic-pri­vate ge­nomics project – aimed at map­ping the genomes of 500,000 cit­i­zens (or rough­ly 9% of the coun­try’s pop­u­la­tion) to de­code the ori­gins of dis­ease for pre­ven­tion, di­ag­no­sis and treat­ment. GSK and Sanofi have now joined the ef­fort, bring­ing the to­tal num­ber of phar­ma­ceu­ti­cal part­ners to nine.

The project, called FinnGen, uti­lizes blood sam­ples from biobanks to chart ge­nom­ic da­ta and then an­a­lyzes it with in­for­ma­tion from na­tion­al health records. It in­cludes the par­tic­i­pa­tion of both acad­e­mia and in­dus­try, such as the Finnish de­part­ment of health, hos­pi­tals, uni­ver­si­ties as well as 7 oth­er phar­ma com­pa­nies: Ab­b­Vie, As­traZeneca, Bio­gen, Cel­gene, Roche’s Genen­tech, Mer­ck and Pfiz­er. As of De­cem­ber 2018, 108,000 new biobank sam­ples — in­clud­ing more than 15,000 can­cer pa­tients and over 30,000 pa­tients with car­diometa­bol­ic dis­eases — had been col­lect­ed, ac­cord­ing to an an­nounce­ment ear­li­er this week.

The Fin­ish project, led by the Uni­ver­si­ty of Helsin­ki, us­es a ge­nom­ic map­ping ap­proach called genome-wide as­so­ci­a­tion study (GWAS) geno­typ­ing, which is es­sen­tial­ly de­signed to iden­ti­fy com­mon vari­ants that con­tribute to com­mon dis­eases. These com­mon vari­ants are usu­al­ly lo­cat­ed in re­gions of the chro­mo­some that don’t code for spe­cif­ic func­tion­al pro­teins. Mean­while, Eng­land’s genome project us­es a more com­pre­hen­sive, al­beit slow­er, ap­proach called whole genome se­quenc­ing. This strat­e­gy look in­to re­gions of the chro­mo­some that code for func­tion­al pro­teins and pin­point mu­ta­tions that can have a greater im­pact on dis­ease.

Eng­land’s flag­ship genome project was an­nounced in 2013 and five years lat­er the tar­get of se­quenc­ing 100,000 whole genomes from NHS pa­tients with rare dis­eases, and their fam­i­lies, as well as pa­tients with com­mon can­cers was achieved. How­ev­er, last Oc­to­ber the UK gov­ern­ment an­nounced the project would be ex­pand­ed to se­quence 1 mil­lion whole genomes in the com­ing five years.

Ge­nomics Eng­land has al­so been work­ing with com­pa­nies who fo­cus on drug dis­cov­ery, phar­ma­ceu­ti­cal de­vel­op­ment and da­ta analy­sis to put this ge­nom­ic da­ta to use. Their in­dus­try part­ners in­clude Google, Mi­crosoft and Iqvia, in ad­di­tion to the usu­al phar­ma sus­pects, such as As­traZeneca, GSK, Roche and Take­da.

In De­cem­ber As­traZeneca sharp­ened its fo­cus on ge­nomics by pour­ing its R&D heft in­to a new cen­ter in part­ner­ship with Can­cer Re­search UK, to de­vel­op per­son­al­ized can­cer drugs. Fel­low British drug­mak­er GSK $GSK, has tied up with 23andMe to gain ac­cess to the lat­ter’s data­base — to look for dis­ease rel­e­vant genes. Across the At­lantic, Re­gen­eron $REGN has carved out its own ge­net­ics cen­tre, Am­gen $AMGN has sharp­ened its abil­i­ty to iden­ti­fy and val­i­date dis­ease tar­gets with its in­vest­ment in Ox­ford Nanopore Tech­nolo­gies and ac­qui­si­tion of de­CODE ge­net­ics, while Ver­tex $VRTX has part­nered with UK-based Ge­nomics plc on their plat­form for ge­net­ics and ma­chine learn­ing.

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.