A mon­ster dis­cov­ery deal be­tween Ab­b­Vie and Google’s Cal­i­co gets a new lease on the lab, with $1B more to back ag­ing re­search

Near­ly 4 years af­ter Ab­b­Vie and Google’s fledg­ling Cal­i­co stepped up to the al­tar of drug sci­ence and com­mit­ted them­selves to a $1.5 bil­lion part­ner­ship on de­vel­op­ing a pipeline of an­ti-ag­ing drugs, they’ve de­cid­ed to re­new their vows.

Bob Co­hen

And this time they’re back­ing it up with a joint $1 bil­lion pledge — $500 mil­lion each — to keep the al­liance go­ing for some years to come, with an eye to slow­ly step­ping up the re­la­tion­ship in a move to­ward the clin­ic. In a rare pub­lic dis­play of af­fec­tion, the two com­pa­nies are tout­ing the ad­vance of more than two dozen late dis­cov­ery projects, with a spe­cial fo­cus on cel­lu­lar stress that they be­lieve has some pro­found long term im­pli­ca­tions for hu­man health. 

An­oth­er piece of in­fo: The fa­mous­ly qui­et Cal­i­co has built a big team of 150-plus around an HQ base in South San Fran­cis­co, with plans to add more.

But that’s about it. If they are work­ing on a rev­o­lu­tion in drug de­vel­op­ment aimed at putting more life in­to lengthy spans of liv­ing, don’t ex­pect any claims along the way about cur­ing can­cer, or di­a­betes or arthri­tis in mice. This new deal ex­tends their first pact by three years, with Cal­i­co re­spon­si­ble for re­search and ear­ly de­vel­op­ment un­til 2022. The Google-backed biotech will take projects through Phase IIa over the next nine years, with an op­tion on man­ag­ing late-stage ef­forts and com­mer­cial­iza­tion.

Prof­its — if they come — will be split.

Press ex­ecs on what they’ve been work­ing on, though, and you get point­ed to a long line­up of pa­pers Cal­i­co has pub­lished on their work, but no specifics on the most promis­ing tar­gets in their cho­sen field. How about the bud­get? Did they spend the $1.5 bil­lion?

Noth­ing.

Jim Sul­li­van

“We’re not go­ing to be spe­cif­ic about mol­e­c­u­lar tar­gets,” says Cal­i­co’s Bob Co­hen, a Genen­tech vet and can­cer spe­cial­ist. “It hasn’t been in our na­ture to hype about what we have.”

That’s ex­act­ly how Cal­i­co got things start­ed in 2014, tak­ing more of a tech ap­proach to bunker­ing in their labs as they work on drugs that can bend and stretch the span and qual­i­ty of an av­er­age life. At that time they had 10 staffers. That’s changed a lot, but you still won’t find ex­ecs talk­ing loose­ly about their spe­cif­ic fo­cus­es.

“What I can tell you is that we are very pleased with the progress of the col­lab­o­ra­tion,” says Jim Sul­li­van, the head of dis­cov­ery at Ab­b­Vie. “We have a num­ber of po­ten­tial vi­able clin­i­cal pro­grams.” There are un­spec­i­fied tar­gets for aug­ment­ing check­point in­hibitors, neu­ro­sciences is a big fo­cus. And tar­get­ing cel­lu­lar stress sys­tems is key.

Jonathan Lewis

“Our in­ter­est in ag­ing goes to the ba­sic roots of ag­ing,” says Co­hen. And that in­cludes us­ing a va­ri­ety of an­i­mal mod­els, from mice to naked mole rats and worms — on to yeast.

This next bil­lion should pave the way to the clin­ic, he adds, where hu­mans can get in­volved in one of the biggest, longest run­ning dis­cov­ery col­lab­o­ra­tions in the in­dus­try. Ab­b­Vie and Cal­i­co be­lieve they are defin­ing a new field of R&D. And they’re think­ing in decade-long time spans to reach some im­por­tant goals — af­ter spend­ing a con­sid­er­able amount of mon­ey.

“It’s al­so im­por­tant to bear in mind that it takes many years to get things for­ward,” says Jonathan Lewis, the vice pres­i­dent of BD at Cal­i­co. “We are con­fi­dent we won’t need to raise more fund­ing.”

(Or not. A rep­re­sen­ta­tive for Cal­i­co  fol­lowed up to say that “fu­ture fund­ing needs will be dri­ven by the suc­cess of these pro­grams.”)

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.