Mi­cro­bio­me, in­flam­ma­tion and mu­ta­tions: US re­searchers win £60M in Can­cer Re­search UK grants to lead 'grand chal­lenges'

Can­cer Re­search UK is putting lead­ing US re­searchers as the faces of its lat­est Grand Chal­lenge — five-year re­search pro­grams that each draw from £20 mil­lion ($25.9 mil­lion) in fund­ing and an in­ter­na­tion­al group of sci­en­tists to tack­le some of the biggest ques­tions in can­cer.

Se­lect­ed from 134 ap­pli­ca­tions in the sec­ond in­stall­ment of the com­pe­ti­tion, the three projects will at­tempt to ma­nip­u­late the mi­cro­bio­me to fight bow­el can­cer, ex­plore the links be­tween chron­ic in­flam­ma­tion and can­cer, and un­der­stand why cer­tain ge­net­ic mu­ta­tions cause can­cer in some tis­sues but not oth­ers.

Sci­en­tists from Har­vard, UCSF and Brigham and Women’s Hos­pi­tal will lead the charge, co­or­di­nat­ing teams of 10 or 14 scat­tered be­tween the US, UK, Cana­da, The Nether­lands, Spain, and Is­rael.

Matthew Mey­er­son

“In­di­vid­u­al­ly, these re­search teams are among the best in the world in their re­spec­tive fields,” said Iain Foulkes, Can­cer Re­search UK’s ex­ec­u­tive di­rec­tor of re­search and in­no­va­tion, in a state­ment. “By bring­ing them to­geth­er across bor­ders, Grand Chal­lenge is en­abling these teams to think big­ger and es­tab­lish new and ex­cit­ing col­lab­o­ra­tions. The scale of the fund­ing re­flects the op­por­tu­ni­ty we see in har­ness­ing their abil­i­ty to un­der­stand and tack­le can­cer.”

Wendy Gar­rett

Matthew Mey­er­son at the Dana-Far­ber Can­cer In­sti­tute and Har­vard Med­ical School is co-prin­ci­pal in­ves­ti­ga­tor with Wendy Gar­rett at the Har­vard T.H. Chan School of Pub­lic Health on the mi­cro­bio­me project. By com­par­ing in de­tail a healthy mi­cro­bio­me with one as­so­ci­at­ed with can­cer, they hope to iden­ti­fy new in­ter­ven­tions to pre­vent and treat can­cer — whether by im­prov­ing re­sponse to ther­a­pies or be­ing fash­ioned in­to ther­a­pies of their own — that they will take in­to clin­i­cal tri­als.

Thea Tl­sty

In an­oth­er project, UCSF’s Thea Tl­sty wants to tune in­to what she calls “the oth­er side” of the con­ver­sa­tion be­tween can­cer cells and the cells sur­round­ing them, with the ul­ti­mate goal to “de­vise ex­cit­ing new ap­proach­es to treat­ment from re­pur­pos­ing every­day an­ti-in­flam­ma­to­ry drugs, to de­sign­ing cells that tar­get can­cer-pro­mot­ing tis­sues.”

Fi­nal­ly, Stephen Elledge — a pro­fes­sor at Har­vard Med­ical School and an in­ves­ti­ga­tor with the Howard Hugh­es Med­ical In­sti­tute — de­scribes his chal­lenge this way:

Stephen Elledge

We think the rea­son that spe­cif­ic ge­net­ic de­fects cause cer­tain types of can­cer comes down to the way dif­fer­ent cell types are ‘wired’, and whether the tis­sue sees it as a ‘GO’ sig­nal or not. We’re go­ing to de­con­struct what’s go­ing on by switch­ing can­cer genes on and off and track­ing the changes in nor­mal, healthy cells from dif­fer­ent or­gans. This will deep­en our un­der­stand­ing of the very na­ture of can­cer, and by us­ing cut­ting-edge tech­nolo­gies like organoids, we hope to find new tar­gets for can­cer treat­ments in fu­ture.

The Mark Foun­da­tion for Can­cer Re­search in New York is pro­vid­ing half of the grant — £10 mil­lion to this par­tic­u­lar project.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.