Say­onara No­var­tis: Ex-cell ther­a­py chief chal­lenges CAR-T lead­ers, moves to Carl June’s biotech start­up

Us­man “Oz” Azam

Three months af­ter No­var­tis de­clared its big biotech ex­per­i­ment in cell ther­a­pies ka­put and dis­solved the 400-per­son unit, its for­mer chief has now jumped ship to run a cell ther­a­py up­start which he is al­ready in­ti­mate­ly fa­mil­iar with.

Us­man ‘Oz’ Azam has tak­en the helm of Tmu­ni­ty Ther­a­peu­tics in Philadel­phia, which was found­ed by one of Penn’s star sci­en­tists, Carl June, with an eye to de­vel­op­ing new, cu­ra­tive cell ther­a­pies. It launched in Jan­u­ary with $10 mil­lion in back­ing from Penn Med­i­cine, the aca­d­e­m­ic med­ical cen­ter of the Uni­ver­si­ty of Penn­syl­va­nia, and Lil­ly Asia Ven­tures.

Azam gained a high pro­file in the Cell & Gene Ther­a­pies Unit at No­var­tis, right up un­til the phar­ma gi­ant stunned vir­tu­al­ly every­one in the field with its de­ci­sion to shut­ter the op­er­a­tion, just months ahead of its first planned CAR-T fil­ing. About 120 peo­ple were ter­mi­nat­ed and No­var­tis said at the time that Azam was leav­ing the phar­ma gi­ant.

The first CAR-Ts have demon­strat­ed some clear promise, but are al­so af­flict­ed by se­vere safe­ty is­sues and lim­i­ta­tions to their use in sol­id tu­mors. Tmu­ni­ty is part of a sec­ond wave of star­tups that will be chal­leng­ing No­var­tis, Kite and Juno with new and bet­ter tech­nolo­gies that ex­pect to im­prove safe­ty and ex­pand ef­fi­ca­cy to new pa­tient groups and new dis­eases out­side of on­col­o­gy.

“Oz brings the ide­al skill set and breadth of per­spec­tive to Tmu­ni­ty as we move our first T cell re­cep­tor and CAR pro­grams to­ward the clin­ic,” said Carl H. June, MD, co-founder and chief sci­en­tif­ic ad­vi­sor of Tmu­ni­ty Ther­a­peu­tics. “Oz shares our vi­sion to make Tmu­ni­ty the glob­al leader in trans­form­ing the lat­est in­sights about T cell bi­ol­o­gy and T cell en­gi­neer­ing in­to po­ten­tial­ly cu­ra­tive ther­a­pies for pa­tients.”

“I have had the op­por­tu­ni­ty to pur­sue the de­vel­op­ment of nov­el drugs and bi­o­log­ics for near­ly 20 years but I have nev­er been more ex­cit­ed about the po­ten­tial we have at Tmu­ni­ty to make a sig­nif­i­cant con­tri­bu­tion to the treat­ment of can­cer, HIV, and au­toim­mune dis­ease by de­liv­er­ing the promise of T cell med­i­cine,” said Azam. “To do so, we are cre­at­ing a busi­ness mod­el that rapid­ly and seam­less­ly in­te­grates re­search, trans­la­tion­al med­i­cine, man­u­fac­tur­ing sci­ence, qual­i­ty by de­sign, clin­i­cal de­vel­op­ment, and cus­tomer cen­tric ap­proach­es to fos­ter fur­ther suc­cess­ful com­mer­cial adop­tion of cell and gene ther­a­pies.”

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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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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In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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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.

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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