As­traZeneca, Can­cer Re­search UK set up ge­nomics hub to fight up­hill bat­tle against can­cer

In the wake of two big fail­ures for their check­point in­hibitor/CT­LA-4 com­bo, As­traZeneca $AZN is brush­ing its Brex­it fear aside and pour­ing its R&D heft in­to a new cen­ter in part­ner­ship with Can­cer Re­search UK, de­signed to har­ness the pow­er of ge­nomics to de­vel­op per­son­al­ized can­cer drugs.

The fa­cil­i­ty, which will be housed at the Uni­ver­si­ty of Cam­bridge, is hop­ing to tap in­to the po­ten­tial of func­tion­al ge­nomics, in par­tic­u­lar the gene edit­ing tool CRISPR, to bet­ter un­der­stand can­cer bi­ol­o­gy and ge­net­ic dri­vers of drug re­sis­tance, in a bid to bring treat­ments to pa­tients faster.

Greg Han­non

“As we de­vel­op high-qual­i­ty stan­dard­ised tech­niques through the cen­tre, we can cre­ate more so­phis­ti­cat­ed and pow­er­ful bi­o­log­i­cal mod­els of dis­ease, han­dle larg­er and more com­plex da­ta sets, and iden­ti­fy suc­cess­ful can­cer drug tar­gets with bet­ter ac­cu­ra­cy,” pro­fes­sor Greg Han­non, di­rec­tor of the Can­cer Re­search UK Cam­bridge In­sti­tute, said in a state­ment on Mon­day.

As­traZeneca is hard­ly the first drug­mak­er to set its sights on ge­nomics to tack­le hard-to-treat dis­eases, such as can­cer. It joins fel­low British drug­mak­er GSK $GSK, who ear­li­er this year 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.

Pre­lim­i­nary re­search at the As­traZeneca/Can­cer Re­search UK Cen­tre is ex­pect­ed to be­gin Jan­u­ary next year, with lab­o­ra­to­ry work ex­pect­ed to com­mence in the sec­ond half of 2019.

Can­cer Re­search UK is a char­i­ty that has long cat­alyzed re­search in­to can­cer ther­a­peu­tics, vac­cines as well as di­ag­nos­tics, and has pre­vi­ous­ly forged part­ner­ships with oth­er drug­mak­ers such as Te­va $TE­VA and Mer­ck $MRK.

The bat­tle against can­cer has long tak­en up a large chunk of the Na­tion­al Health Ser­vice bud­get, with an ag­ing pop­u­la­tion and fla­grant lifestyles cul­mi­nat­ing in high rates of can­cer — every two min­utes some­one in the UK is di­ag­nosed with the dis­ease, ac­cord­ing to the char­i­ty.

 

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

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

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 fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

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When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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