Can­cer spe­cial­ist Hi­ber­Cell snaps up an­a­lyt­ics, com­pu­ta­tion­al tools in all-stock buy­out; Prax­is re­veals new per­i­menopausal de­pres­sion da­ta

In a slight­ly un­con­ven­tion­al deal, New York-based Hi­ber­Cell is lever­ag­ing a chunk of its stock — still pri­vate­ly owned — to buy out Ge­nu­ity Sci­ence and its suite of tools for ge­nomics and mul­ti-om­ic an­a­lyt­ics, as well as an AI and ma­chine learn­ing plat­form.

Alan Rig­by

The goal, ac­cord­ing to CEO Alan Rig­by, is to fur­ther Hi­ber­Cell’s un­der­stand­ing of the adap­tive stress phe­no­type and its role in can­cer pro­gres­sion.

While his co-founder Julio Aguirre-Ghiso has elu­ci­dat­ed how such mech­a­nisms can be ma­nip­u­lat­ed to pre­vent of­ten fa­tal metasta­t­ic re­cur­rence, they are still look­ing for bet­ter ways to an­a­lyze clin­i­cal sam­ples, tease out bio­mark­ers and pre­dict which pa­tients would re­spond. It’s es­pe­cial­ly im­por­tant as Hi­ber­Cell’s drugs en­ter mid-stage clin­i­cal tests.

One thing that Ge­nu­ity’s tech­nol­o­gy will be able to do, for in­stance, is to “ex­haus­tive­ly com­pare pri­ma­ry tu­mor bi­ol­o­gy with paired metasta­t­ic le­sions to bet­ter iden­ti­fy the tar­gets and mech­a­nisms that dri­ve metasta­t­ic dis­ease.”

Hi­ber­Cell is al­so in­her­it­ing $100 mil­lion in cash, as well as part­ner­ships with Io­n­is and Ab­b­Vie from Ge­nu­ity, which will now be­come its sub­sidiary. In ad­di­tion, the top ex­ecs at Ge­nu­ity will take up C-suite posts at Hi­ber­Cell, with Tom Chit­ten­den as chief tech­nol­o­gy of­fi­cer, Jeff Gulcher as chief sci­en­tif­ic of­fi­cer of ge­nomics, and Hákon Guðb­jarts­son as chief in­for­mat­ics of­fi­cer. — Am­ber Tong

Prax­is re­veals new da­ta for per­i­menopausal de­pres­sion drug

Prax­is high­light­ed a small cut of Phase IIa study re­sults Mon­day morn­ing for their up and com­ing per­i­menopausal de­pres­sion pro­gram.

Mar­cio Souza

In the Part B por­tion of the tri­al, Prax­is said that six pa­tients treat­ed with a sin­gle, dai­ly 60 mg dose of PRAX-114 showed im­prove­ments in menopausal and mood symp­toms that were rapid, marked and main­tained through­out the 14-day treat­ment pe­ri­od. Pa­tients were giv­en the ex­per­i­men­tal drug in an out­pa­tient set­ting and Prax­is saw no new safe­ty sig­nals.

“The abil­i­ty to im­pact both menopausal and mood symp­toms in the PRAX-114 proof-of-con­cept study in PMD was our cri­te­ria to con­tin­ue de­vel­op­ment of this pro­gram,” CEO Mar­cio Souza said in a state­ment. “The rapid and con­sis­tent im­prove­ment across dis­tinct ef­fi­ca­cy mea­sures gives us con­fi­dence to ad­vance to a Phase IIb tri­al.”

Prax­is said that pa­tients saw an av­er­age de­crease from base­line at day 15 of 60% in fre­quen­cy of mod­er­ate-to-se­vere hot flash­es, and 68% in the to­tal score of a self-re­port­ed ques­tion­naire. Two weeks fol­low­ing the treat­ment pe­ri­od, scores trend­ed back to­ward the base­line, Prax­is said. — Max Gel­man

Free­line anoints new CEO fol­low­ing gene ther­a­py tri­al pause

There’s been a change at the top of Free­line Ther­a­peu­tics, six months af­ter the biotech halt­ed a gene ther­a­py tri­al.

Michael Pari­ni

Michael Pari­ni is the new CEO of Free­line, suc­ceed­ing There­sa Heg­gie, the com­pa­ny an­nounced Mon­day morn­ing. Pari­ni joined the com­pa­ny from Ver­tex in Feb­ru­ary as the new­ly cre­at­ed pres­i­dent and COO, just a week af­ter the biotech paused a piv­otal tri­al for two years.

“In a short pe­ri­od of time, [Pari­ni] has mo­bi­lized pro­gram ex­e­cu­tion across our pipeline, in­creased fo­cus on our core sci­en­tif­ic and plat­form tech­nol­o­gy ca­pa­bil­i­ties, and dri­ven ef­fi­cien­cies across the or­ga­ni­za­tion that have ex­tend­ed our cash run­way,” Free­line chair­man Chris Hol­lowood said in a state­ment.

Ear­li­er this year, Free­line hit the brakes on a piv­otal tri­al for the he­mo­phil­ia B pro­gram, dubbed FLT180a, af­ter re­ceiv­ing CMC feed­back from the FDA. The com­pa­ny is tar­get­ing a restart in mid-2023 and fil­ing for a BLA be­fore the end of 2024. A Phase I/II study for the pro­gram is still on track to read out da­ta by the end of this year. — Max Gel­man

Ex­elix­is adds op­tion for 20 new tar­gets in In­ven­ra col­lab

Ex­elix­is and In­ven­ra have ex­pand­ed on an old 2018 col­lab­o­ra­tion by up to 20 new tar­gets.

The com­pa­nies an­nounced Mon­day that Ex­elix­is will pay $15 mil­lion up­front in the re­vised deal, with mile­stones and roy­al­ties undis­closed. There is al­so fund­ing for the op­tion to nom­i­nate up to 20 ad­di­tion­al tar­gets in on­col­o­gy, and Ex­elix­is said it will own all an­ti­body se­quences dis­cov­ered from the col­lab­o­ra­tion in all dis­ease ar­eas.

“As Ex­elix­is seeks to build a dif­fer­en­ti­at­ed next-gen­er­a­tion pipeline in on­col­o­gy, we’re lever­ag­ing In­ven­ra’s ex­per­tise in an­ti­body and bis­pe­cif­ic dis­cov­ery to pro­vide key build­ing blocks for po­ten­tial fu­ture Ex­elix­is bi­o­log­ics, in­clud­ing an­ti­body-drug con­ju­gates,” Ex­elix­is CSO Pe­ter Lamb said in a state­ment.

All of the pro­grams un­der this col­lab­o­ra­tion have yet to move past the pre­clin­i­cal stage, and tar­gets re­main undis­closed. — Max Gel­man

Gas­tric can­cer CAR-T ther­a­py li­censed to Gra­cell

Two Chi­nese biotechs have reached a li­cense agree­ment to de­vel­op cell ther­a­py for sol­id tu­mors.

Gra­cell Biotech­nolo­gies and Fu­ture­Gen Bio­pharm will col­lab­o­rate to de­ploy Fu­ture­Gen’s Claudin 18.2 an­ti­bod­ies to make, man­u­fac­ture and com­mer­cial­ize a cell ther­a­py for pa­tients with gas­tric or gas­troe­sophageal junc­tion can­cer, pan­cre­at­ic can­cer and esophageal can­cer.

Gas­tric can­cer is one of the most di­ag­nosed can­cers in the world, the com­pa­nies said in a press re­lease, and there were over 1 mil­lion deaths in 2018 alone.

“Gra­cell has been mak­ing sig­nif­i­cant progress in de­vel­op­ing in­no­v­a­tive CAR-T ther­a­pies for sol­id tu­mors as well as hema­to­log­i­cal ma­lig­nan­cies,” Gra­cell CEO William (Wei) Cao said in a press re­lease. “This part­ner­ship with Fu­ture­Gen marks an­oth­er key mile­stone in our per­sis­tent ef­forts for treat­ing sol­id tu­mors. Mov­ing for­ward, we ex­pect to ex­plore more strate­gic al­liances to iden­ti­fy ad­di­tion­al tar­gets that max­i­mize the val­ue of our high­ly dif­fer­en­ti­at­ed tech­nol­o­gy plat­forms and even­tu­al­ly ben­e­fit can­cer pa­tients world­wide.”

Fu­ture­Gen will re­ceive pay­ment up­front, though that num­ber was not dis­closed. The com­pa­ny will be el­i­gi­ble for mile­stone pay­ments and roy­al­ties. — Josh Sul­li­van

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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