Can tiny Mus­tang Bio com­pete on the CAR-T front with gi­ants like No­var­tis and Gilead? Man­ny Litch­man aims to find out

Now that No­var­tis and Gilead have picked up the first two ap­provals for CAR-T drugs, you can ex­pect to see ri­vals com­ing along who will probe for any weak­ness­es in their ap­proach, look­ing to com­pete on the next wave of per­son­al­ized cell ther­a­pies head­ed through the clin­ic.

The small crew at Mus­tang Bio — $MBIO, up 11% to­day — has some big am­bi­tions on that score, and to­day they’re adding some man­u­fac­tur­ing ca­pac­i­ty that the com­pa­ny be­lieves will be cen­tral to its abil­i­ty to even­tu­al­ly com­pete with these two gi­ants.

Man­ny Litch­man

Mus­tang has inked a lease deal with the UMass Med­i­cine Sci­ence Park in Worces­ter, MA, where they ex­pect to be­gin pro­duc­tion of their CAR-Ts next year. And they’ll be aim­ing to make these cell ther­a­pies for ear­ly-stage stud­ies for glioblas­toma and acute myeloid leukemia and a grow­ing sta­ble of pre­clin­i­cal ef­forts.

Look­ing for com­pet­i­tive ad­van­tages at this stage of the game will re­ly quite a lot on a “more stream­lined, more cost ef­fec­tive man­u­fac­tur­ing ap­proach,” CEO Man­ny Litch­man tells me. “Every­thing re­al­ly has cost in mind,” he adds, siz­ing up the first two ther­a­pies that come with hefty six-fig­ure price tags.

“Look in the black box of man­u­fac­tur­ing,” he says, and you can see “dozens of pa­ra­me­ters that can vary.”

There’s more reengi­neer­ing work to be done to make CAR-Ts bet­ter at com­bat­ting can­cers like glioblas­toma and AML, he adds. In­ves­ti­ga­tors, for ex­am­ple, have been bal­anc­ing the im­pact of quick ver­sus slow­er ac­tion of the ther­a­peu­tic — slow­er ac­tion ap­pears to be more durable — along with a mul­ti­tude of com­bi­na­tion ap­proach­es that need to be ex­plored.

There’s enough po­ten­tial in these new ap­proach­es to of­fer an open­ing for a com­pa­ny like Mus­tang to step in and ex­ploit new op­por­tu­ni­ties, he be­lieves.

Litch­man left the helm at Arv­inas, a pro­tein degra­da­tion biotech spun out of the lab of Yale’s Craig Crews, to take the lunge at CAR-T. It’s a field he knows some­thing about. As for­mer head of on­col­o­gy BD at No­var­tis, Litch­man was present at the cre­ation of the Penn/No­var­tis deal that set the phar­ma gi­ant down the path to­ward an his­toric CAR-T ap­proval. He was pro­gram head of CTL019 for awhile. And he’s fol­low­ing in much the same path that the pi­o­neers — along with Kite and Juno — did, let­ting the sci­en­tif­ic founders do the ear­ly-stage re­search work that will be used to set up the fast-paced piv­otal de­vel­op­ment pro­grams to come.

Stephen For­man

In Mus­tang’s case, that in­volves Stephen For­man’s lab­o­ra­to­ry at City of Hope Na­tion­al Med­ical Cen­ter and top re­searchers at the Fred Hutchin­son Can­cer Re­search Cen­ter, where Oliv­er Press and Bri­an Till have been build­ing a T cell ther­a­py which ex­press­es a CD20-spe­cif­ic chimeric anti­gen re­cep­tor. That work has ex­pand­ed Mus­tang’s pipeline to 6 clin­i­cal and pre­clin­i­cal ef­forts.

The Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Med­i­cine, rest­less­ly look­ing to make a clin­i­cal mark af­ter years in­vest­ing in labs, just days ago pro­vid­ed a $12.8 mil­lion grant to the City of Hope for the Phase I glioblas­toma study. And that comes on top of a $94.5 mil­lion raise in Feb­ru­ary from a pri­vate place­ment arranged by its par­ent com­pa­ny Fortress, which is build­ing a port­fo­lio of biotechs.

Try­ing to leapfrog in­to a clin­i­cal ri­val­ry in a com­plex are­na like this will cost much, much more than that. And Litch­man tells me he has plans to raise some­where be­tween $60 mil­lion and $100 mil­lion more next year.

Right now, Mus­tang has 5 full timers, a tiny boat­load of staffers com­pared to the jug­ger­nauts crewed by No­var­tis and Gilead’s Kite. Juno al­so has a much larg­er op­er­a­tion look­ing to make a come­back af­ter their lead ther­a­py was de­stroyed by its lethal tox­i­c­i­ty. But Litch­man plans to up that to about 20 over the next year, while the in­de­pen­dent sci­en­tists con­tin­ue to do the heavy lift­ing in the ear­ly stud­ies.

This is one race that Litch­man says is still very much just be­gin­ning. And it won’t be dom­i­nat­ed by a hand­ful of lead­ers.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

John Hood [file photo]

UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.