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.”)

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Boston skyline (Shutterstock)

Boston, the Bay Area and San Diego dom­i­nate the life sci­ences re­al es­tate mar­ket. Where to next?

With strong competition for life sciences real estate in key clusters — greater Boston, San Francisco and San Diego — where will the industry look to expand next? That’s the question that real estate company JLL sought to answer in its latest report, released on Wednesday.

JLL scored US biotech hubs on a variety of criteria to come up with this year’s ranking, including talent, industry depth, innovation and lab real estate dynamics. Unsurprisingly, they found that last year’s top three clusters remain unchanged. JLL predicts that these core clusters will be “immovable” for the foreseeable future, comparing them to the Silicon Valley of biotech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.