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.

 

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Marshall Fordyce, Vera CEO

Gene ther­a­py play­er turned kid­ney spe­cial­ist Ve­ra drops a dud in lead­up to Nas­daq, pric­ing well be­low range

Vera Therapeutics took a big risk at the start of the year, pivoting away from its gene editing mission statement to chase a lead kidney drug instead — and they doubled down with an IPO just months later. But investors don’t seem impressed with Vera’s promise, and now the biotech is looking at a far more scaled-back offering.

On Friday, Vera priced its 4.35-million-share IPO at $11 per share, well below its targeted range of $14 to $16 and good for $47.58 million in proceeds. The biotech will start trading Monday under the ticker $VERA.

Darren Ji, Elpiscience CEO (Lilly Asia Ventures)

Kept an ocean away from its sci­en­tif­ic ad­vi­sors, Shang­hai's Elpi­science keeps up the clin­i­cal progress, re­fu­els for its I/O pipeline

When Elpiscience pooled $100 million for its Series B in late 2019, CEO Darren Ji promised to move what he described as one of the broadest immuno-oncology pipelines swiftly through the clinic in both the US and China.

Then a pandemic got in the way — but not by much. The Shanghai-based biotech managed to keep testing its 4-1BB/PD-L1 drug, get an OX40 agonist cleared for clinical trials (nabbing a collaboration with Junshi in the process), while in-licensing a Phase I bispecific from California’s TRIGR Therapeutics.

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