Christi Shaw, Kite CEO (Jeff Rumans)

Gilead and Kite nab an­oth­er ap­proval for Tecar­tus, as lead­ing CAR-T port­fo­lio con­tin­ues to grow

Gilead and Kite took an­oth­er step Fri­day to­ward ex­pand­ing their fran­chise of CAR-T drugs, nab­bing a new ap­proval for Tecar­tus.

The FDA OK’ed the ther­a­py for adults with re­lapsed or re­frac­to­ry B-cell pre­cur­sor acute lym­phoblas­tic leukemia, Gilead an­nounced Fri­day. It’s the drug’s sec­ond in­di­ca­tion af­ter Gilead ini­tial­ly launched the CAR-T in 2020 for adults with re­lapsed or re­frac­to­ry man­tle cell lym­phoma.

A Kite spokesper­son con­firmed to End­points News that there will be no change in pric­ing for the new in­di­ca­tion. When Tecar­tus was first ap­proved, Gilead priced the drug at $373,000.

As Gilead con­tin­ues build­ing out the on­ly com­mer­cial CAR-T port­fo­lio with Tecar­tus and Yescar­ta, it will be seek­ing to en­sure Tecar­tus has as smooth a roll­out as pos­si­ble in the new in­di­ca­tion, Kite CEO Christi Shaw told End­points in an in­ter­view. The drug is al­ready in use at over 100 treat­ment cen­ters around the coun­try for MCL, but up­take has been slow.

“Look­ing at the first launch in B cell lym­phoma, on­ly 2 out of 10 pa­tients re­ceive the drug, while 4 of 10 are re­ferred,” Shaw said. “Now we’re see­ing with fu­ture launch­es … there’s an in­crease in re­fer­rals to the treat­ment cen­ters, so the share of the mar­ket is much high­er, much quick­er.”

Shaw added that she hopes sim­i­lar pit­falls will be avoid­ed as Tecar­tus and CAR-Ts be­come more com­mon. In ad­di­tion to the ed­u­ca­tion­al and out­reach pro­grams spon­sored by Gilead, clin­i­cians are be­com­ing more adept at rec­og­niz­ing signs of ad­verse events, be­ing able to treat them quick­er than be­fore.

CAR-Ts are in­her­ent­ly risky treat­ments, com­ing with a class-wide black box warn­ing for cy­tokine re­lease syn­drome and neu­ro­log­i­cal events. Fri­day’s new in­di­ca­tion re­ceived one as well. In Gilead’s Tecar­tus tri­al for ALL, re­searchers saw two treat­ment-re­lat­ed deaths: one brain her­ni­a­tion and one case of sep­tic shock. Shaw said she ex­pects the new in­di­ca­tion to come with the same warn­ing.

The FDA, how­ev­er, is clear­ly com­fort­able en­dors­ing the ben­e­fits that out­weigh those risks. Fri­day’s ap­proval came from a study Gilead pre­sent­ed at #AS­CO21 over the sum­mer. Of 54 evalu­able pa­tients who re­ceived Tecar­tus in ALL, 65% saw their signs of can­cer dis­ap­pear. Ad­di­tion­al­ly, 31% saw on­go­ing re­spons­es at the da­ta cut­off, Kite said at the time, and 97% had deep mol­e­c­u­lar re­mis­sion with un­de­tectable min­i­mal resid­ual dis­ease.

Bi­jal Shah, a tri­al in­ves­ti­ga­tor at the Mof­fitt Can­cer Cen­ter in Tam­pa, FL, ac­knowl­edged the risks but said the re­lapsed and re­frac­to­ry pa­tient pop­u­la­tions don’t have much else to try.

“What is the al­ter­na­tive here?” Shah said. “What else are we go­ing to do for them? It’s not like there’s this oth­er tool that we’re go­ing to pull out of our tool­box … we don’t have any oth­er tools. We don’t have any­thing that we can suc­cess­ful­ly say, ‘A-ha! This is our an­swer.’ We’re still stuck.”

Gilead re­mains a step ahead of oth­er big-name CAR-T play­ers, though Bris­tol My­ers Squibb is try­ing to close in. The Big Phar­ma net­ted ap­proval for liso-cel ear­li­er this year, with reg­u­la­tors OK’ing treat­ment for re­lapsed or re­frac­to­ry large B-cell lym­phoma.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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