Malte Peters, departing MorphoSys chief R&D officer (UKBIO19)

Mor­phoSys woos Mer­ck KGaA vet to lead late-stage push for block­buster prospect

Mor­phoSys made it clear when it shut­tered all US-based dis­cov­ery work ear­li­er this year that it wants to keep its re­search fo­cus in its home base of Ger­many. So it may be lit­tle sur­prise that as R&D chief Malte Pe­ters re­tires, his suc­ces­sor will be some­one who’s deeply en­meshed in the Eu­ro­pean bio­phar­ma scene.

Tim De­muth

Tim De­muth, a for­mer head of glob­al clin­i­cal de­vel­op­ment on­col­o­gy at Mer­ck KGaA who most re­cent­ly served as Pieris Phar­ma­ceu­ti­cals’ CMO, will be­come Mor­phoSys’ new chief re­search and de­vel­op­ment of­fi­cer.

You can put a big star next to the de­vel­op­ment part of his ti­tle. He joins as Mor­phoSys nears the fi­nal push for pelabre­sib (CPI-0610), the crown jew­el from its $1.7 bil­lion ac­qui­si­tion of Con­stel­la­tion Phar­ma­ceu­ti­cals, and weeks af­ter the biotech punt­ed two an­ti­bod­ies to a se­cre­tive ARCH-backed start­up in ex­change for $15 mil­lion in cash, plus mile­stones and an eq­ui­ty stake.

Suc­cess here will be crit­i­cal to Mor­phoSys’ goal of reach­ing prof­itabil­i­ty in 2026 — the an­tic­i­pat­ed first full year of pelabre­sib US sales. The com­pa­ny ex­pects the drug to bring in $1 bil­lion at peak.

Over a five-year stint, Pe­ters — whose ca­reer spanned roles at Mer­ck KGaA, Mi­cromet, No­var­tis and San­doz — helped ush­er Mor­phoSys’ first drug to the mar­ket in Mon­ju­vi, or taf­a­sita­m­ab, which was ap­proved by the FDA for use in re­frac­to­ry dif­fuse large B-cell lym­phoma.

The drug, a CD19-tar­get­ing bis­pe­cif­ic, is be­ing test­ed in a Phase III tri­al for first-line use while Mor­phoSys tries to find a niche in the com­pet­i­tive CD19 mar­ket.

Jean-Paul Kress

CEO Jean-Paul Kress praised Pe­ters for push­ing the com­pa­ny “to think dif­fer­ent­ly.” Pe­ters was al­so cred­it­ed for op­ti­miz­ing the pelabre­sib tri­al in first-line myelofi­bro­sis. In a re­cent call with an­a­lysts, Pe­ters not­ed that af­ter a slow start, the tri­al “is now en­rolling re­al­ly at an un­prece­dent­ed speed,” and there’s “in­crease in ex­cite­ment” from physi­cians.

De­muth will now take over all of those. In ad­di­tion to pelabre­sib, which is billed as a po­ten­tial first- and best-in-class BET in­hibitor, among the lega­cy pipeline from Con­stel­la­tion there’s al­so CPI-0209, a sec­ond-gen­er­a­tion EZH2 in­hibitor, that is in mid-to late-stage de­vel­op­ment.

Trained in Ger­many, De­muth pre­vi­ous­ly led hema­tol­ogy de­vel­op­ment for San­doz and held oth­er roles at No­var­tis, Mer­ck and an Ital­ian play­er called Ital­far­ma­co.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Robert Hariri, Celularity CEO (Vivien Killilea/Getty Images for Brain Mapping Foundation)

Celu­lar­i­ty warns of loom­ing lay­offs, spot­lights ear­ly pro­grams as mon­ey runs dry

Celularity has warned “a substantial portion” of its employees that layoffs could be looming in the face of a reprioritization effort. In the same breath, it touted some of its very early next-gen candidates in degenerative diseases and oncology.

“While Celularity is hopeful that there will be no need to substantially reduce its headcount, the notifications were provided in accordance with applicable law and to maintain full transparency with its employees,” the news release reads, in part.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.