Cit­ing sig­nif­i­cant progress on a cure for di­a­betes, No­vo Nordisk beefs up its stem cell pipeline with new col­lab­o­ra­tions

A grow­ing group of biotech star­tups look­ing to ad­vance a line­up of po­ten­tial stem cell cures for Type 1 di­a­betes can look to a big and very ef­fec­tive ri­val mov­ing for­ward in the field.

Mads Krogs­gaard Thom­sen

No­vo Nordisk says it’s been mak­ing ma­jor progress on de­vel­op­ing the em­bry­on­ic stem cell lines it needs for a world-class man­u­fac­tur­ing op­er­a­tion. And No­vo adds that they’ve al­so been mov­ing for­ward in de­vel­op­ing a new en­cap­su­la­tion de­vice to guard their stem cell ther­a­py from a de­struc­tive im­mune re­sponse — all part of the Holy Grail for de­vel­op­ing a cure for the dis­ease.

No­vo is still some years away from de­fin­i­tive hu­man stud­ies, but their pre­clin­i­cal progress will be­come a stan­dard bear­er for one of sev­er­al se­ri­ous ef­forts to find a cure for di­a­betes. Eli Lil­ly re­cent­ly part­nered with Sig­ilon on its pur­suit of a stem cell cure. Then there’s Sem­ma, out of the lab of Har­vard’s Doug Melton, which raised $114 mil­lion for its ap­proach to cre­at­ing in­sulin pro­duc­ing be­ta cells. 

Stem cell ther­a­pies have been up — and they’ve been down. But this new ac­tiv­i­ty among big and lit­tle com­pa­nies in re­gen­er­a­tive med­i­cine un­der­scores the grow­ing be­lief that new tech­nol­o­gy re­lat­ed to man­u­fac­tur­ing and de­liv­ery can over­come some big chal­lenges that sep­a­rat­ed the ear­ly hype from the re­al­i­ty of de­vel­op­ing a cure. As they move for­ward, you can bet that Sanofi and oth­er gi­ants will pay close at­ten­tion.

No­vo, one of the most fo­cused R&D play­ers in the world, says its progress on di­a­betes in­spired the com­pa­ny to broad­en its stem cell pipeline to in­clude pro­grams for Parkin­son’s, work­ing with the Swedish biotech com­pa­ny Bi­o­lam­i­na and Lund Uni­ver­si­ty. And Bi­o­lam­i­na is al­so col­lab­o­rat­ing with Duke (Sin­ga­pore) and No­vo on chron­ic heart fail­ure and age-re­lat­ed mac­u­lar de­gen­er­a­tion. More are on the way.

“Our col­lab­o­ra­tion with UCSF is al­so ex­pect­ed to ac­cel­er­ate cur­rent and fu­ture part­ner­ships to de­vel­op stem cell-based ther­a­pies for treat­ment of oth­er se­ri­ous chron­ic dis­eases,” said Mads Krogs­gaard Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer of No­vo Nordisk.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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