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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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David Marek, Myovant

My­ovant beefs up da­ta pack­age in NDA #3, boost­ing its case for longterm dos­ing of Pfiz­er-part­nered re­l­u­golix

When Pfizer handed over $650 million in cash to partner on Myovant’s relugolix, the pharma giant made clear that the deal — valued at $4.2 billion total — was just as much about the approved indication of prostate cancer as the two women’s health conditions the drug could treat.

A month later, the two companies are offering another glimpse of the therapy’s longterm potential in endometriosis.

Look­ing to win over some skep­ti­cal an­a­lysts, Rhythm beats the drum on in­ter­im da­ta in PhII bas­ket study for ad­di­tion­al in­di­ca­tions

Rhythm Pharmaceuticals has been working toward expanding the FDA approval they received just two months ago for three rare genetic disorders that result in obesity. In December, their Phase III cut of data saw mixed reactions from analysts, but new interim results released Tuesday may provide more excitement.

In an ongoing Phase II study for setmelanotide across individuals with one of three distinct rare genetic diseases of obesity, 65 patients had reached the Dec. 17 cutoff date for evaluation. Among patients who met the primary endpoint of at least 5% weight loss over three months, Rhythm saw an average reduction of no less than 7.1% in any of the groups.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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