As­traZeneca vet heads to UK biotech as the new CSO; Mallinck­rodt touts pos­i­tive PhI­II da­ta

→ UK-based ear­ly can­cer de­tec­tion com­pa­ny Oncim­mune Hold­ings has wel­comed Tariq Sethi as CSO, Matthew Lut­trell as CMO and Cléa Rosen­feld as head of in­vestor re­la­tions. Sethi is a pro­fes­sor of res­pi­ra­to­ry med­i­cine at King’s Col­lege Lon­don. Be­fore jump­ing on board at Oncim­mune, Sethi was chief physi­cian-sci­en­tist, vice pres­i­dent in the clin­i­cal dis­cov­ery unit at As­traZeneca. He is al­so the founder of Galec­to Biotech. Lut­trell joins the com­pa­ny af­ter a stint as head of hema­tol­ogy, growth and emerg­ing mar­kets at Shire (now Take­da). He’s served in oth­er roles at Eli Lil­ly, No­vo Nordisk, Gilead, and GSK. Rosen­feld brings ex­pe­ri­ence to her new role from her time as head of in­vestor re­la­tions at Shire, where she helped bring the com­pa­ny from a FTSE 250 Com­pa­ny to a top 50 FTSE com­pa­ny.

Mallinck­rodt has re­leased pos­i­tive da­ta from its Phase III clin­i­cal tri­al, test­ing the use of its in­ves­ti­ga­tion­al Strat­a­Graft re­gen­er­a­tive tis­sue in pa­tients with deep par­tial-thick­ness ther­mal burns.

Re­sults showed that with the use of Strat­a­Graft, pa­tients had a sig­nif­i­cant­ly small­er area of burn wounds that re­quired au­to­graft­ing by three months in com­par­i­son to the area of burn wounds treat­ed ex­clu­sive­ly with au­to­graft (p<0.0001). In ad­di­tion, “re­sults showed that the pro­por­tion of Strat­a­Graft-treat­ed wounds that achieved durable wound clo­sure at three months ex­ceed­ed the pre-de­fined thresh­old for sta­tis­ti­cal sig­nif­i­cance.” Based on the da­ta, the com­pa­ny is plan­ning to sub­mit to the FDA a bi­o­log­ics li­cense ap­pli­ca­tion for Strat­a­Graft tis­sue in the first half of 2020.

Back in May, mi­cro­bio­me up­start, Vedan­ta Bio­sciences got an ex­tra $18.5 mil­lion in the bank af­ter wrap­ping up $45.5 in Se­ries C round fi­nanc­ing. The biotech se­cured even more to­day, nab­bing $16.6 mil­lion in a Se­ries C-2 fi­nanc­ing round — bring­ing its to­tal cap­i­tal in its Se­ries C and C-2 round to $62.1 mil­lion. Fund­ing was led by QUAD In­vest­ment Man­age­ment, SV In­vest­ment, Shin­han In­vest­ment-Pri­vate Eq­ui­ty, Shin­han Cap­i­tal-Yeol­lim Part­ners, Part­ners In­vest­ment, FC Cap­i­tal, and Sym­Bio­sis. Oth­ers in­clud­ed pre­vi­ous C-round in­vestors, the Bill & Melin­da Gates Foun­da­tion, Bris­tol-My­ers Squibb, Rock Springs Cap­i­tal, JSR Cor­po­ra­tion, Shumway Cap­i­tal, In­vesco As­set Man­age­ment, Health for Life (Sev­en­ture Part­ners), and founder PureTech Health.

The fund­ing will be used to fur­ther sup­port the ex­pan­sion of the com­pa­ny’s pipeline, in­clud­ing “re­cent­ly launched Phase Ib/II study of VE416 in food al­ler­gy, a planned Phase Ib/II study of VE800 and Op­di­vo (nivolum­ab) in ad­vanced or metasta­t­ic can­cers, and the on­go­ing Phase II study of VE303 in re­cur­rent Clostrid­ioides dif­fi­cile in­fec­tion (rC­DI).”

STAT re­port­ed that RA Cap­i­tal has qui­et­ly launched an in­cu­ba­tor pro­gram, called Carnot. The pro­gram will “serve as a place where the firm’s part­ners can stress-test and de­vel­op ideas that could some­day be­come in­de­pen­dent com­pa­nies.” RA Cap­i­tal has been shift­ing its fo­cus since its found­ing in 2001, now fo­cus­ing more on in­vest­ing in ear­ly-stage biotech com­pa­nies, such as re­cent in­vest­ments in Vor Bio­phar­ma‘s $60 mil­lion Se­ries A round, Freenome’s $160 mil­lion Se­ries B round and Nexus‘ $308 mil­lion VC fund.

 

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

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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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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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.

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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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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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.