Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and Ab­b­Vie go way back. Re­search con­duct­ed in the lab of Scripps sci­en­tist Richard Lern­er led to the dis­cov­ery of Hu­mi­ra. The an­ti­body, ap­proved by the FDA in 2002 and sold by Ab­b­Vie, went on to be­come the world’s best­selling treat­ment. In 2018, the drug­mak­er and the non-prof­it or­ga­ni­za­tion signed a pact fo­cused on de­vel­op­ing can­cer treat­ments — and now, the scope of that part­ner­ship has broad­ened to en­com­pass a range of dis­eases, in­clud­ing im­muno­log­i­cal and neu­ro­log­i­cal con­di­tions.

In the sum­mer of last year, the non­prof­it drug dis­cov­ery di­vi­sion of Scripps Re­search — Cal­i­br — tied up with Ab­b­Vie to col­lab­o­rate on de­vel­op­ing T-cell ther­a­pies aimed pri­mar­i­ly at can­cer, in­clud­ing sol­id tu­mors.

The ef­fort to use CAR-T tech­nol­o­gy to com­bat sol­id tu­mors has been plagued by is­sues of tox­i­c­i­ty — but Scripps-led re­search em­ploy­ing the use of “switch­able” CAR-T cells is de­signed to make the on­co­log­i­cal as­sault more uni­ver­sal, by shep­herd­ing CAR-T cells to hone in on the mol­e­c­u­lar tar­gets of in­ter­est us­ing an an­ti­body-based “switch” — in essence al­low­ing for the use of CAR-T tech across sev­er­al types of hema­to­log­i­cal and sol­id tu­mor in­di­ca­tions. Ab­b­Vie paid an undis­closed up­front li­cense fee for ex­clu­sive ac­cess to Cal­i­br’s CAR-T plat­form for a term of up to four years.

The ex­pand­ed pact — for which fi­nan­cial de­tails have al­so not been dis­closed — in­volves Scripps pre­sent­ing a cer­tain num­ber of pre­clin­i­cal pro­grams of mu­tu­al in­ter­est in the fields of on­col­o­gy, im­munol­o­gy, neu­rol­o­gy, and fi­bro­sis per year for in­clu­sion in­to the part­ner­ship. The agree­ment al­so fea­tures a sharp­er fo­cus on can­cer, with the two part­ners work­ing to­geth­er to ad­vance CD3 bis­pecifics against on­col­o­gy tar­gets nom­i­nat­ed by Ab­b­Vie.

As agreed pre­vi­ous­ly, Scripps is in charge of pre­clin­i­cal R&D — and in some cas­es ear­ly-stage tri­als — while Ab­b­Vie has the op­tion to take the ex­per­i­men­tal drugs fur­ther and com­mer­cial­ize.

Scripps, which has strug­gled fi­nan­cial­ly in re­cent years due to small­er grants from the Na­tion­al In­sti­tutes of Health, swal­lowed Cal­i­br (Cal­i­for­nia In­sti­tute for Bio­med­ical Re­search) in 2016 in a bid to speed the de­vel­op­ment of new med­i­cines with the hope that com­mer­cial suc­cess could go some way in re­plen­ish­ing its cof­fers.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.