CAR-T, Manufacturing

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.



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Biomanufacturing