EMA fol­lows FDA to ap­prove Roche's Tecen­triq com­bo for front­line use in triple neg­a­tive breast can­cer

Months af­ter Roche se­cured US ap­proval for its check­point in­hibitor Tecen­triq, in com­bi­na­tion with Cel­gene’s Abrax­ane, for front­line use in an ag­gres­sive, tough-to-treat sub­group of breast can­cer pa­tients — the EU has fol­lowed suit.

On Thurs­day, the Swiss gi­ant said the Tecen­triq com­bo is the first can­cer im­munother­a­py reg­i­men to be cleared by Eu­ro­pean reg­u­la­tors for triple-neg­a­tive breast can­cer (TNBC).

The ap­proval, which cov­ers pa­tients whose tu­mors ex­press PD-L1, is key for the Swiss drug­mak­er that is third-in-line — be­hind Mer­ck $MRK and Bris­tol-My­ers Squibb $BMY — for the check­point in­hibitor Iron throne. Roche must take the lead in cru­cial can­cer ar­eas if it wants to hold on to its po­si­tion, as As­traZeneca carves out a niche for its PD-L1 check­point Imfinzi in a sub­set of non-small cell lung can­cer pa­tients.

Roche’s TNBC ap­proval is based on da­ta from the piv­otal IM­pas­sion130 study, which en­rolled 902 pa­tients. Pa­tients on the Tecen­triq com­bo re­duced the risk of dis­ease wors­en­ing or death by 38% com­pared to Abrax­ane alone (me­di­an PFS 7.5 ver­sus 5 months; p<0.0001) in pa­tients whose tu­mors test­ed pos­i­tive for PD-L1 ex­pres­sion.

The com­bi­na­tion al­so con­ferred a clin­i­cal­ly mean­ing­ful over­all sur­vival (OS) im­prove­ment ver­sus com­para­tor in the PD-L1-pos­i­tive pop­u­la­tion (me­di­an OS=25 vs 18 months), Roche said, cit­ing an in­ter­im analy­sis.

The EU ap­proval al­so comes months af­ter Mer­ck’s flag­ship check­point in­hibitor Keytru­da post­ed pos­i­tive da­ta from an on­go­ing late-stage study called KEYNOTE-522. In Ju­ly, the US drug­mak­er dis­closed that the PD-1 ther­a­py, in com­bi­na­tion with chemother­a­py, in­duced a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in patho­log­i­cal com­plete re­sponse rates — a lack of all signs of can­cer in tis­sue sam­ples an­a­lyzed fol­low­ing com­ple­tion of neoad­ju­vant ther­a­py and de­fin­i­tive surgery — com­pared with chemother­a­py alone, in TNBC pa­tients re­gard­less of PD-L1 sta­tus.

Months pri­or, how­ev­er, Keytru­da failed to im­press in a piv­otal study as a monother­a­py and as a sec­ond or third line of de­fense for TNBC pa­tients.

About 10-20% of all breast can­cers are triple-neg­a­tive breast can­cers (TNBCs), which char­ac­ter­is­ti­cal­ly has a high re­cur­rence rate with­in the first five years af­ter di­ag­no­sis. In TNBC pa­tients, the growth of the can­cer is not fu­eled by the hor­mones es­tro­gen and prog­es­terone, or by the HER2 pro­tein, mak­ing it hard to treat.

About 70% of breast can­cers di­ag­nosed in peo­ple with an in­her­it­ed BR­CA mu­ta­tion, par­tic­u­lar­ly BR­CA1, are di­ag­nosed with TNBC. PARP in­hibitors such as As­traZeneca’s Lyn­parza and Pfiz­er’s Talzen­na are al­ready ap­proved for germline BR­CA-mu­tat­ed breast can­cer and are be­ing in­ves­ti­gat­ed in com­bi­na­tion with check­point in­hibitors for TNBC. Mean­while, an­ti­body-drug con­ju­gates are an­oth­er po­ten­tial treat­ment op­tion for TNBC un­der in­ves­ti­ga­tion.

So­cial im­age: Roche

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.