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.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months after Legend Biotech made the startling disclosure that founder and then-CEO Frank Zhang was placed under “residential surveillance,” its parent company revealed that he’s been formally arrested.

Zhang — who, since founding GenScript 18 years ago, has taken the CRO public and groomed Legend Biotech in-house until the J&J-partnered CAR-T player was mature enough for its own Nasdaq listing — is severing his final ties with both. He is resigning as board chair/non-executive director of GenScript and director of Legend.