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.

UP­DAT­ED: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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In­vest­ing in the time of coro­n­avirus: the good, the bad and the hope­ful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.