No­vo Nordisk to re­search oral obe­si­ty treat­ment; Dana-Far­ber taps in­to Har­bour Bio­Med's mice plat­form in mul­ti­year deal

No­vo Nordisk and Lu­men Bio­science have en­tered a re­search col­lab­o­ra­tion to ex­plore R&D and man­u­fac­tur­ing with­in obe­si­ty and oth­er meta­bol­ic dis­or­ders, the com­pa­nies an­nounced Wednes­day.

The col­lab­o­ra­tion builds off of re­search sur­round­ing an oral­ly de­liv­ered drug for the GI tract that can be man­u­fac­tured with more scal­a­bil­i­ty and af­ford­abil­i­ty than a typ­i­cal small-mol­e­cule drug. The ini­tial stages of re­search will last about a year, and the 2 com­pa­nies will de­vel­op mol­e­cules us­ing spir­uli­na, a type of cyanobac­te­ria.

“No­vo Nordisk is a world lead­ing meta­bol­ic dis­ease com­pa­ny, and we are thrilled that they share our en­thu­si­asm for new strate­gies for de­liv­er­ing oral bi­o­log­ics,” Lu­men’s CEO Bri­an Fin­row, said in a state­ment. “This col­lab­o­ra­tion brings the best of two worlds to­geth­er: Lu­men’s ex­per­tise in large-scale, af­ford­able man­u­fac­tur­ing of oral­ly de­liv­ered bi­o­log­ic drugs and No­vo Nordisk’s ex­per­tise in the clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion of treat­ments for car­diometa­bol­ic dis­ease.”

Fi­nan­cial terms of the deal were not dis­closed. — Josh Sul­li­van

Dana-Far­ber taps in­to Har­bour Bio­Med’s mice plat­form in mul­ti­year deal

Har­bour Bio­Med has reached a mul­ti­year agree­ment with the Dana-Far­ber Can­cer In­sti­tute for the de­vel­op­ment of new CAR-T cell ther­a­pies and bis­pe­cif­ic an­ti­bod­ies in can­cer treat­ment, the com­pa­ny an­nounced Wednes­day.

The col­lab­o­ra­tion will com­bine Har­bour’s trans­genic mice plat­form with the ex­per­tise of Dana-Far­ber’s sci­en­tists in CAR-T cell de­vel­op­ment.

Har­bour used its mice plat­form and dis­cov­ered the an­ti­body 47D11 in 2019, which has since been li­censed out by Ab­b­Vie. In De­cem­ber, the com­pa­ny’s sci­en­tists said that the an­ti­body showed promise fight­ing Covid-19 and vari­ants of the virus.

The Har­bour mice pro­gram is based on two pro­pri­etary trans­genic mouse plat­forms that have the po­ten­tial for gen­er­at­ing bi and mul­ti-specifics, CAR-Ts or VH do­main de­liv­ered prod­ucts.

Er­ic Smith of the Dana-Far­ber Can­cer In­sti­tute said this in the press re­lease:

“We are de­light­ed to ini­ti­ate this col­lab­o­ra­tion with Har­bour Bio­Med. The com­ple­men­tary tech­nol­o­gy and ex­per­tise be­tween Har­bour and DF­CI will dra­mat­i­cal­ly short­en the in­ter­val from nov­el dis­cov­ery to de­vel­op­ing op­ti­mized an­ti­body and cel­lu­lar ther­a­pies for clin­i­cal trans­la­tion.” — Josh Sul­li­van

As it looks to boost ex­pan­sion in­to pet health, Elan­co ac­quires San Fran­cis­co-based pet ther­a­peu­tic com­pa­ny

Elan­co An­i­mal Health has an­nounced the ac­qui­si­tion of San Fran­cis­co-based Kin­dred Bio­sciences and with it, three “po­ten­tial block­busters in the de­vel­op­ment phase.”

All of Kin­dred­Bio’s out­stand­ing stock will be ac­quired at $9.25 a share, mak­ing the deal worth a to­tal of about $440 mil­lion. The com­pa­ny was found­ed in 2012, and brings three pro­grams that Elan­co calls po­ten­tial der­ma­tol­ogy block­busters that are ex­pect­ed to launch through 2025. Kin­dred­Bio al­so has a hand­ful of R&D pro­grams for chron­ic dis­or­ders and un­met needs, in­clud­ing ca­nine par­vovirus, a high­ly con­ta­gious virus that af­fects dogs’ gas­troin­testi­nal tract and spreads through con­t­a­m­i­nat­ed stool.

Elan­co be­lieves that the ac­qui­si­tion will add an­oth­er $100 mil­lion in rev­enue to its op­er­a­tions by 2025.

“This high­ly com­ple­men­tary com­bi­na­tion is fo­cused in one of the most ex­cit­ing spaces in pet health, and one where we see a strate­gic im­per­a­tive to build a dif­fer­en­ti­at­ed com­pet­i­tive of­fer­ing,” Jeff Sim­mons, pres­i­dent and CEO of Elan­co, said in a press re­lease. “It fur­ther ac­cel­er­ates our mix shift in­to pet health and ad­vances our IPP strat­e­gy.”

Elan­co and Kin­dred­Bio’s ex­ist­ing re­la­tion­ship be­gan when Kin­dred li­censed out the rights of its late-stage ca­nine par­vovirus treat­ment. — Josh Sul­li­van

Ab­Sci ac­quires an­ti­body play­er To­tient

A for­mer­ly un­known play­er that burst on­to the scene with a Gink­go Bioworks deal last Sep­tem­ber has found a new home. The an­ti­body-fo­cused start­up To­tient out of the Vi­va Biotech in­cu­ba­tor was ac­quired by Ab­Sci, the com­pa­nies an­nounced late Tues­day.

Fi­nan­cial terms of the deal were not dis­closed.

To­tient emerged from stealth in Sep­tem­ber with the Gink­go part­ner­ship, in which they are try­ing to turn their al­ter­nate means of gen­er­at­ing virus-neu­tral­iz­ing an­ti­bod­ies in­to a treat­ment that could po­ten­tial­ly treat or tem­porar­i­ly pre­vent Covid-19 in­fec­tion. The biotech de­rives its an­ti­bod­ies from what is known as ter­tiary lym­phoid struc­tures, or ac­cu­mu­la­tions of im­mune cells that can form in places of height­ened in­flam­ma­tion.

In a state­ment Tues­day, To­tient said it had re­con­struct­ed more than 4,500 an­ti­bod­ies from over 50,000 pa­tients. By com­bin­ing these with Ab­Sci’s plat­form, the pair are go­ing af­ter a new set of undis­closed dis­eases.

“We look for­ward to scal­ing our tar­get dis­cov­ery ca­pa­bil­i­ties to com­pre­hen­sive­ly de-or­phan an­ti­bod­ies and val­i­date new op­por­tu­ni­ties for drug de­vel­op­ment,” To­tient CEO Deniz Kur­al said in a state­ment.

The buy­out comes less than three months af­ter Ab­Sci com­plet­ed a $125 mil­lion crossover round and fol­lows a sim­i­lar ac­qui­si­tion of the AI com­pa­ny De­n­ovi­um back in Jan­u­ary. — Max Gel­man

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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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.