Gilead and No­vo Nordisk ex­pand NASH deal with new study; Pfiz­er out-li­cens­es AD­Cs to a biotech start­up

Pfiz­er has out-li­censed a pair of an­ti­body-drug con­ju­gates to Cam­bridge, MA-based Pyx­is On­col­o­gy.

Pyx­is is hand­ing over an un­spec­i­fied up­front pay­ment, mile­stones and a chunk of eq­ui­ty to Pfiz­er, and al­so gains rights to Pfiz­er’s ADC plat­form, “in­clud­ing var­i­ous pay­load class­es, link­er tech­nol­o­gy and site-spe­cif­ic con­ju­ga­tion tech­niques for the fu­ture de­vel­op­ment of ad­di­tion­al AD­Cs.”

Ronald Herb­st, the CSO at Long­wood-fund­ed Pyx­is, said:

The ear­ly gen­er­a­tions of AD­Cs demon­strat­ed sig­nif­i­cant po­ten­cy, but con­sid­er­able room re­mains for in­no­va­tion to gen­er­ate high­ly ef­fec­tive AD­Cs with an im­proved safe­ty pro­file. PYX-201 and PYX-203 rep­re­sent the next gen­er­a­tion of AD­Cs that use in­no­v­a­tive con­ju­ga­tion tech­nolo­gies.

John Car­roll

Gilead, No­vo take NASH com­bo part­ner­ship in­to PhI­Ib

Gilead and No­vo Nordisk are ex­pand­ing a col­lab­o­ra­tion in a field that’s had quite the rough and tum­ble scene late­ly.

The duo is en­gag­ing in fur­ther work in their clin­i­cal NASH deal, launch­ing a new Phase IIb study to eval­u­ate No­vo’s block­buster semaglu­tide and two ex­per­i­men­tal Gilead can­di­dates in the in­di­ca­tion. The tri­al will look at semaglu­tide alone and in com­bi­na­tion with the FXR ag­o­nist cilofex­or and the ACC in­hibitor fir­so­co­stat as part of the four-arm study.

Gilead and No­vo plan to en­roll about 440 pa­tients across all four arms, look­ing at the im­pact on liv­er fi­bro­sis im­prove­ment and NASH res­o­lu­tion. The tri­al will be dou­ble-blind­ed and place­bo-con­trolled.

Re­searchers will look to build off a Phase IIa tri­al, which showed semaglu­tide alone and in com­bi­na­tion with cilofex­or and/or fir­so­co­stat was well tol­er­at­ed in 108 peo­ple over 24 weeks. Ad­di­tion­al­ly, post-hoc analy­ses of ex­plorato­ry ef­fi­ca­cy end­points showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in he­pat­ic steato­sis and liv­er in­jury in the com­bo arm when com­pared to semaglu­tide alone.

Semaglu­tide has been ap­proved by the FDA to treat type 2 di­a­betes, but not in NASH. Nei­ther cilofex­or nor fir­so­co­stat have been ap­proved for any in­di­ca­tion. — Max Gel­man

Mer­ck ex­tends long-run­ning can­cer da­ta col­lab­o­ra­tion with M2GEN

Mer­ck has struck a deal with Tam­pa-based M2GEN which gives the phar­ma gi­ant ac­cess to its anony­mous da­ta bank gleaned from can­cer pa­tients at 18 par­tic­i­pat­ing can­cer clin­ics. Pa­tients agree to do­nate their clin­i­cal and mol­e­c­u­lar da­ta to M2GEN, which then leas­es it out to drug de­vel­op­ers.

This new 5-year deal builds on a col­lab­o­ra­tion that dates back to 2006 and gave Mer­ck some in­sights as it de­vel­oped Keytru­da. And re­searchers ex­pect they can con­tin­ue to use it for the next round of can­cer drugs in the clin­ic. — John Car­roll

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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