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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of face plants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Paul Hudson, Sanofi CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

In­side look: How a po­ten­tial part­ner­ship turned in­to a $1.9B buy­out for Sanofi

A couple of months before the FDA was set to make a decision on Kadmon’s so-called “knock-your-socks-off kind of results” for its chronic graft-versus-host disease drug, Sanofi put out feelers for a potential collaboration. But an early approval triggered an offer to buy the company outright — and Sanofi didn’t win without a fight, according to an inside look.

Sanofi’s head of business development and licensing Matthieu Merlin reached out to Kadmon on June 26 with a simple request: He wanted to introduce himself and explore potential partnerships, according to an SEC filing. It had been several months since Kadmon’s belumosudil arrived on the FDA’s doorstep, and after delaying their decision once, regulators said they’d have an answer by Aug. 30. But Sanofi wasn’t the only company interested in getting to know the execs over at Kadmon.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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