Open wa­ter: NI­BR chief Jay Brad­ner part­ners with UC Berke­ley on pro­tein drug re­search in­sti­tute

Al­most ex­act­ly two years to the day since he was named head of the No­var­tis In­sti­tutes for Bio­Med­ical Re­search, Jay Brad­ner is cel­e­brat­ing the an­niver­sary with a new col­lab­o­ra­tion with top in­ves­ti­ga­tors at UC Berke­ley fo­cus­ing on pro­tein drug re­search.

In­spired by the land­mark al­liance with Penn that re­cent­ly led to the ap­proval of the world’s first CAR-T drug, Brad­ner is div­ing deep in­to a field he was al­ready im­mersed in as a re­searcher at Dana-Far­ber. In do­ing so he plans to take co­va­lent bind­ing to a whole new lev­el in search of new break­throughs that can start hit­ting some cur­rent­ly “un­drug­gable” tar­gets.

The deal cre­ates the new No­var­tis-Berke­ley Cen­ter for Pro­teomics and Chem­istry Tech­nolo­gies, which will be led by Berke­ley’s Daniel No­mu­ra with an eye to get­ting the sci­en­tists at each cam­pus work­ing to­geth­er on some com­mon goals.

“This col­lab­o­ra­tion re­al­ly checks all the box­es,” Brad­ner tells me. It’s im­por­tant chem­istry with a tru­ly out­stand­ing group of in­ves­ti­ga­tors out to ad­dress in­tractable tar­gets. And it helps de­fine the open dis­cov­ery frame­work that No­var­tis is still work­ing on, with more such part­ner­ships planned for the fu­ture.

“More and more,’ says Brad­ner, “this best prac­tice ought to be our stan­dard prac­tice.”

The col­lab­o­ra­tion will seek out ir­re­versibly bind­ing mol­e­cules, he notes, while al­so fol­low­ing a path in search of next-gen ap­proach­es to pro­tein degra­da­tion, some­thing along the lines that his last Dana-Far­ber biotech spin­off — C4 — is en­gaged on. The goal is to “en­gage the ubiq­ui­tin/pro­tea­some sys­tem in a new way.”

Brad­ner spent much of his first year at NI­BR, one of the world’s largest dis­cov­ery or­ga­ni­za­tions with around 6,000 staffers, do­ing some re­struc­tur­ing and re­align­ment. That called for grow­ing chem­i­cal bi­ol­o­gy ex­per­tise while re­lo­cat­ing the trop­i­cal dis­ease group from Sin­ga­pore to a base in Emeryville, CA. NI­BR al­so moved to re­gen­er­ate its res­pi­ra­to­ry dis­ease re­search group. And more re­cent­ly Brad­ner de­light­ed in re­cruit­ing new tal­ent — most no­tably UCSF car­dio ex­pert Shaun Cough­lin — in­to the or­ga­ni­za­tion while pro­mot­ing oth­ers from with­in.

Says Brad­er: “This has ruth­less­ly been the search for the strongest swim­mer.”

Now the fo­cus is on cre­at­ing more of these ex­ter­nal part­ner­ships, while let­ting the sci­en­tists in­volved do some blue sky think­ing about what they can ac­com­plish.

“I have to tell you,” he adds, “I have found that No­var­tis is most com­fort­able in open wa­ter.”

Whether it works or not will be de­ter­mined by the num­ber and qual­i­ty of the new drugs they steer to ap­provals in the world’s big drug ports.


Im­age: Jay Brad­ner (mid­dle) File Pho­to

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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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.

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.