AI-fo­cused No­table Labs score $40M in fund­ing; Seat­tle Ge­net­ics/Astel­las sub­mit mar­ket­ing ap­pli­ca­tion for en­for­tum­ab ve­dotin

→ The AI ex­perts at No­table Labs have gar­nered an­oth­er $40 mil­lion to scale their au­to­mat­ed lab­o­ra­to­ry and an­a­lyt­ics plat­form. De­signed to match pa­tients to clin­i­cal tri­als by pre­dict­ing quick­ly who are most like­ly to re­spond to a can­cer drug, the start­up has pitched it­self as an ad­vo­cate for pa­tients and fa­cil­i­ta­tor to phar­ma com­pa­nies. With the Se­ries B cash, No­table Labs plans to ex­pand their plat­form both in terms of ge­og­ra­phy — build­ing labs out­side of North Amer­i­ca — and can­cer types (it’s cur­rent­ly fo­cused on hema­to­log­i­cal can­cers).

As No­table be­gins iden­ti­fy­ing pat­terns in da­ta, they will al­so be­gin ex­plor­ing drug de­vel­op­ment ef­forts, such as test­ing drugs for new in­di­ca­tions. Even­tu­al­ly, CEO Matthew De Sil­va tells Fierce­Biotech, they could move from re­pur­pos­ing to dis­cov­er­ing its own drugs — though that will be way down the line.
B-Cap­i­tal Group and Life­Force Cap­i­tal co-led the round, with par­tic­i­pa­tion from In­dus­try Ven­tures.

→ Months af­ter Seat­tle Ge­net­ics $SGEN and their part­ners at Astel­las won break­through ther­a­py sta­tus for their an­ti­body drug con­ju­gate, en­for­tum­ab ve­dotin — the com­pa­nies on Tues­day said they had sub­mit­ted an ac­cel­er­at­ed ap­proval ap­pli­ca­tion for the ther­a­py in metasta­t­ic urothe­lial can­cer pa­tients who have been treat­ed with a check­point in­hibitor and plat­inum-con­tain­ing chemother­a­py.

→ In 2014, Cel­gene $CELG inked a part­ner­ship with Van­cou­ver, British Co­lum­bia-based Zymeworks $ZYME to re­search, de­vel­op, and com­mer­cial­ize up to eight bis­pe­cif­ic an­ti­bod­ies. Four years lat­er, the part­ners hiked that num­ber to ten po­ten­tial prod­ucts. For each prod­uct, Zymeworks is el­i­gi­ble to re­ceive up to $164 mil­lion — in­clud­ing li­cens­ing fees and mile­stones pay­ments — in ad­di­tion to roy­al­ties on drug sales. On Tues­day, Cel­gene chose its lead ther­a­peu­tic can­di­date in on­col­o­gy, trig­ger­ing a $7.5 mil­lion pay­ment for Zymeworks.

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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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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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.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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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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Mer­ck­'s wom­en's health spin­out snags mid-stage can­di­date for preterm birth; Keytru­da nails down TNBC ap­proval af­ter March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal.

Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.