No­vo takes on gut-brain ax­is dis­cov­ery with Kally­ope, fo­cus­ing on obe­si­ty and di­a­betes

As the phar­ma gi­ant push­es to keep its pipeline rel­e­vant, No­vo Nordisk has inked yet an­oth­er part­ner­ship — this time, with gut-brain ax­is com­pa­ny Kally­ope.

The duo hopes to dis­cov­er nov­el pep­tides in the obe­si­ty and di­a­betes space, giv­ing No­vo the op­tion to li­cense ex­clu­sive glob­al rights to de­vel­op and com­mer­cial­ize up to six prod­ucts dis­cov­ered in the col­lab­o­ra­tion. Fi­nan­cial de­tails weren’t shared, but we hear Kally­ope will get an up­front pay­ment, along with li­cense fees, R&D/sales mile­stones, and roy­al­ties down the line.

The col­lab­o­ra­tion is lever­ag­ing Kally­ope’s plat­form to in­ter­ro­gate the gut-brain ax­is. The com­pa­ny’s tech in­te­grates sin­gle-cell se­quenc­ing, bioin­for­mat­ics, func­tion­al and anatom­i­cal cir­cuit map­ping, and organoids. Kally­ope says its led to the dis­cov­ery of new bi­o­log­i­cal mech­a­nisms, in­clud­ing mul­ti­ple po­ten­tial se­cret­ed prod­ucts from the gut-brain ax­is that may play a role in me­tab­o­lism.

Mar­cus Schindler

“(Kally­ope) has de­vel­oped a unique and in­no­v­a­tive plat­form and is led by an out­stand­ing lead­er­ship team,” said Mar­cus Schindler, No­vo’s SVP of glob­al drug dis­cov­ery, in a state­ment.  “In com­bi­na­tion with the ex­pe­ri­ence that No­vo Nordisk has in the dis­ease bi­ol­o­gy un­der­stand­ing, pep­tidomics and pep­tide pro­duc­tion, the projects that we will col­lab­o­rate on hold po­ten­tial to make a re­al dif­fer­ence for peo­ple liv­ing with di­a­betes and obe­si­ty.”

Un­der the deal, Kally­ope and No­vo will col­lab­o­rate stud­ies to val­i­date a num­ber of prod­uct can­di­dates. Fol­low­ing val­i­da­tion and op­tion ex­er­cise, No­vo takeover for fur­ther pre­clin­i­cal and clin­i­cal de­vel­op­ment work, along with man­u­fac­tur­ing and com­mer­cial­iza­tion — should it come to that.

No­vo has been pump­ing out bull­ish news for the past few months, in­clud­ing new col­lab­o­ra­tions on the stem cell ther­a­py front, a li­cens­ing deal in hema­tol­ogy, and en­cour­ag­ing da­ta paving a piv­otal path to obe­si­ty for its new­ly ap­proved GLP-1 di­a­betes drug semaglu­tide. Of course, there’s al­so ru­mors that No­vo might be cut­ting as many as 3,000 jobs as part of a sav­ings plan.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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