Pfiz­er's CD22-tar­get­ed can­cer drug in­o­tuzum­ab wins an ac­cel­er­at­ed OK at FDA

Pfiz­er’s armed an­ti­body in­o­tuzum­ab ozogam­icin — held up as a top on­col­o­gy con­tender at the phar­ma gi­ant — has just won an ac­cel­er­at­ed ap­proval at the FDA for re­lapsed or re­frac­to­ry B-cell pre­cur­sor acute lym­phoblas­tic leukemia.

Liz Bar­rett

The drug is the first to reach the mar­ket which is de­signed to bind to the CD22 anti­gen on B-cells, where it then goes in­to the can­cer cell to de­liv­er a cy­to­tox­ic pay­load of calicheam­icin, de­stroy­ing the cell. Pfiz­er has made a strong push on the can­cer front in re­cent years, as wit­nessed by its rapid-fire ap­proval for its check­point in­hibitor avelum­ab, part­nered with Mer­ck KGaA, and a $14 bil­lion buy­out deal for Medi­va­tion.

In­ves­ti­ga­tors tracked a com­plete re­sponse rate of 81% for this drug — which will now be sold as Be­spon­sa — com­pared to 29% in a chemo arm. And that has some an­a­lysts pro­ject­ing peak sales of around $2 bil­lion, a sol­id hit for the phar­ma gi­ant’s on­col­o­gy di­vi­sion.

The ap­proval — com­ing af­ter the FDA of­fered a 6-month pri­or­i­ty re­view sched­ule — marks a big come­back for Pfiz­er on this drug, which flopped in a Phase III tri­al for non-Hodgkin’s lym­phoma four years ago,

Said Liz Bar­rett, glob­al pres­i­dent, Pfiz­er On­col­o­gy:

“Be­spon­sa will help ad­dress a sig­nif­i­cant need for new treat­ment op­tions in B-cell acute lym­phoblas­tic leukemia, and may help more pa­tients reach stem cell trans­plant, which pro­vides the best chance for long term re­mis­sion. We’re proud to build on our con­tin­ued com­mit­ment to pa­tients with hema­to­log­ic ma­lig­nan­cies, and will con­tin­ue our work to find new treat­ments in acute lym­phoblas­tic leukemia and oth­er blood can­cers.”

Im­age: Shut­ter­stock

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Christophe Weber, Takeda CEO (Kyodo via AP Images)

Take­da flesh­es out CNS pact with pep­tide drug­mak­er, set­ting aside $3.5B in fu­ture mile­stones

One of a suite of drugmakers looking to reinvest in the neuroscience space, Takeda has been aggressive in signing on new partners to help build up its pipeline in that space. But sometimes the best partner is the one you already have.

Takeda will set aside $3.5 billion in future milestones and an undisclosed upfront payment to build out its drug discovery deal with Japanese peptide conjugate maker PeptiDream, adding neurodegeneration to the partnership’s list of CNS targets, the companies said Tuesday.

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George Yancopoulos, Regeneron

Re­gen­eron's lat­est ge­net­ics dis­cov­ery hooks As­traZeneca — now all-in on de­vel­op­ing small mol­e­cules for obe­si­ty

Just weeks after its widely lauded genetics research arm tagged a promising new target for obesity, Regeneron has signed up an industry heavyweight to collaborate with on developing new drugs that can potentially act as a game-changer in what has proven to be a tough field for developers.

The Regeneron Genetics Center published a paper in Science at the beginning of this month highlighting how their work sequencing the genomes of 650,000 people highlighted how people with at least 1 inactive copy of the GPR75 gene weighed on average 12 pounds less than the rest of the population with a 54% reduction in risk of obesity.

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Al Sandrock (Biogen via YouTube)

Wav­ing off re­cent PhII flop, Bio­gen trum­pets ear­ly pos­i­tive Alzheimer's da­ta for an­ti-tau an­ti­sense

Even as Biogen execs scrambled to defend Aduhelm and paint a rosy future the drug promises to unleash, R&D chief Al Sandrock reassured analysts during a recent earnings call that his team had more Alzheimer’s tricks.

In particular, he emphasized his belief in tau as a potential target — even though gosuranemab, the lead anti-tau antibody, had just failed a Phase II study.

“Whereas we have discontinued the BIIB092 program, we are continuing the development of BIIB080, our antisense oligonucleotide, which aims to reduce the production of all forms of tau both intra and extracellular,” he said.