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.”)

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.