Frank Neumann

'Can't say no': Kite Phar­ma taps Frank Neu­mann as new head of clin­i­cal de­vel­op­ment

Kite Phar­ma hit a ma­jor land­mark in Ju­ly when it got a sec­ond FDA OK, cre­at­ing the first com­mer­cial CAR-T port­fo­lio. But a biotech’s work is nev­er done. Now it’s time to ex­pand — and the Gilead sub­sidiary has tapped a new glob­al head of clin­i­cal de­vel­op­ment to lead the charge.

“Kite was al­ways kind of on the hori­zon as the… dream job come true,” Frank Neu­mann told End­points News. “This is a po­si­tion (where) if you’re in­ter­est­ed in cell ther­a­py, if you’re in­ter­est­ed in mak­ing a big im­pact on pa­tients’ lives, you just can’t say no.”

The Rheinis­che-Friedrich-Wil­helm Uni­ver­si­ty grad cut his teeth in cell ther­a­py at Take­da, where he served as glob­al head of clin­i­cal de­vel­op­ment for projects from proof-of-con­cept to Phase I eval­u­a­tion. Af­ter that, he spent about two years at blue­bird bio, then just two weeks as CMO of Ve­rastem On­col­o­gy be­fore jump­ing to Kite.

Ken Takeshi­ta

“The peo­ple at Ve­rastem, the da­ta, the sci­ence — bril­liant,” he said. But if “some­one of­fers you to fly to the moon, you’re go­ing to be­come an as­tro­naut,” he said of the de­ci­sion to leave.

Neu­mann is tak­ing over for Ken Takeshi­ta, who is leav­ing the com­pa­ny at the end of this month to pur­sue an­oth­er op­por­tu­ni­ty, Kite vague­ly an­nounced on Mon­day morn­ing.

Takeshi­ta is pass­ing the torch just be­fore the FDA is set to make a de­ci­sion on Kite’s sup­ple­men­tal BLA for three-year-old Yescar­ta in fol­lic­u­lar lym­phoma (FL) and mar­gin­al zone lym­phoma (MZL), two types of in­do­lent non-Hodgkin’s lym­phoma (iNHL). The com­pa­ny read out pos­i­tive da­ta from the Phase II ZU­MA-5 tri­al at vir­tu­al ASH 2020 to back the new in­di­ca­tion, and reg­u­la­tors have set a PDU­FA date for March 5.

“Lym­phoma — Yescar­ta, Tecar­tus — will re­main a key fo­cus,” Neu­mann said, while de­clin­ing to go in­to much de­tail on what’s com­ing down the pipeline. He pegged sol­id tu­mors (which he called the “Holy Grail”) and ad­di­tion­al hema­to­log­i­cal ma­lig­nan­cies as long-term goals.

“The fun­da­men­tal theme is, I think, bring­ing cell ther­a­py to a point where we an­swer the ques­tion: Where can we use it?” he added lat­er.

Gilead be­came an overnight CAR-T leader when it bought Kite for $12 bil­lion back in 2017, snatch­ing up Yescar­ta in the process. It nabbed a quick OK in re­lapsed or re­frac­to­ry large B-cell lym­phoma two weeks lat­er — not long af­ter No­var­tis’ Kym­ri­ah be­came the world’s first ap­proved CAR-T ther­a­py. This past Ju­ly, Kite nabbed its sec­ond ap­proval with Tecar­tus for treat­ment for re­lapsed or re­frac­to­ry man­tle cell lym­phoma.

But Kym­ri­ah makes for tough com­pe­ti­tion. Back in Au­gust, No­var­tis said it got the in­ter­im re­sults it was look­ing for from a Phase II Kym­ri­ah tri­al in fol­lic­u­lar lym­phoma, and an­nounced plans to file with the FDA in 2021.

Look­ing to get a leg up in the CAR-T bat­tle, Kite re­leased more da­ta to bol­ster Yescar­ta at ASH in De­cem­ber, in­clud­ing in­ter­im re­sults from ZU­MA-12, a Phase II study as­sess­ing Yescar­ta as a first-line treat­ment in large B-cell lym­phoma. Af­ter a sin­gle in­fu­sion, 85% of pa­tients achieved a re­sponse, in­clud­ing 74% who saw a com­plete re­sponse. And with a me­di­an fol­low-up of 9.3 months, 70% of re­sponse-evalu­able pa­tients had on­go­ing re­spons­es, ac­cord­ing to Gilead.

The com­pa­ny al­so read out long-term re­sults from its Zu­ma-1 tri­al in large B-cell lym­phoma, in which pa­tients had a me­di­an over­all sur­vival of more than two years.

Tecar­tus, on the oth­er hand, is in var­i­ous on­go­ing stud­ies for adult acute lym­phoblas­tic leukemia (ALL), pe­di­atric ALL and NHL, and chron­ic lym­pho­cyt­ic leukemia.

A pre­vi­ous ver­sion in­cor­rect­ly re­ferred to the com­pa­ny as Kite Ther­a­peu­tics. A cor­rec­tion has been made.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.