Drug Development

UPDATED: Regeneron leaps into the blockbuster race to develop off-the-shelf immune cell cancer therapies

A year ago, Sanofi agreed to pay Regeneron $1.8 billion-plus to partner on its anti-PD1 checkpoint program. Today, biotech heavyweight Regeneron is jumping into CAR-Ts and TCR tech, determined to leap directly into a blockbuster brawl with a plan to emerge as a leader in the fast-growing immuno-oncology field. And it’s made the latest in a handful of rare biotech deals to partner on the technology it needs.

Regeneron selected the startup Adicet Bio for its collaboration. A new face in immuno-oncology, the biotech popped up only last January with a hefty $51 million A round to get started. But it’s helmed by Aya Jakobovits, the founding president and CEO of Kite Pharma, a leader in developing personalized CAR-Ts.

Aya Jakobovits

Aya Jakobovits, Adicet Bio

If it was any other biotech other than Regeneron, the news might spur a little mocking from some of the sideline observers who have been watching the frontrunners present a slate of top personalized CAR-Ts down the final stretch to a likely near-term set of approvals. It may appear late to the party, but Regeneron is a top industry R&D player; a major biotech outfit that is well financed, relentlessly focused with a track record that now includes a list of major drugs that are either on the market or close to it. And it’s looking to catch the next wave forming offshore of I/O.

Jakobovits gets a modest $25 million upfront to get started on engineering a pipeline of immune cells with chimeric antigen receptors and T cell receptors, a one-two approach aimed at zeroing in on both surface antigens found specifically on targeted cancer cells as well as intracellular targets. There’s a support package for research as well, with additional funds to back up the collaboration, but no one is disclosing any of that this morning.

Both companies emphasize that they’re concentrating on off-the-shelf drugs that will be primarily focused on solid tumors, the new new thing in immuno-oncology where first-gen hematological immunotherapies have encountered hard barriers.

“There’s a lot of room left to wind up as a leader,” says Michael Aberman, the strategy exec at Regeneron. His company wasn’t the first to tackle checkpoints, nor the first in cell therapies. But “it’s very early in the first wave to know how that’s going to play out. There’s a lot of challenges left ahead and a lot of opportunities. And we’re talking a novel approach.”

The pact with Regeneron covers a “broad pipeline,” Jakobovits tells Endpoints, emphasizing that the key to creating a safe, effective immune cell therapy is being “specific to the tumor target.” But Jakobovits, who set up the company as a partner at Orbimed, is very careful to stay inside some narrow boundaries on explaining exactly what distinguishes their work.

I/O investment specialist Brad Loncar says the deal highlights some key points. Regeneron, he says:

1) Sees the promise in cell therapy, which not all companies do. For example, Gilead’s CEO said the idea makes him very uncomfortable. Many bears believe it will never be commercially viable. So for a company with the scientific credibility of Regeneron to take a small dive in says something.

2) Understands that it’s too late to be a player in the autologous (personalized) approach or doesn’t believe it can be economically viable. All of the commercial opportunity has already been taken up by existing players.

3) Believes the off the shelf approach is scientifically viable, which not everyone does.

I’d say the main point is that it’s a good sign for the whole field of cell therapy when a company as credible as Regeneron feels like they need to be a player in this area. Most people don’t appreciate the fact that cell therapy is basically version 1.0 right now and there are many improvements that will be made over the coming years. It has the chance to be very special and I’m sure Regeneron sees that.

A technology arms race of a kind has taken shape as various companies sort out how off-the-shelf therapies can eventually replace the first generation lab-crafted personalized therapies that extract cells from patients, reengineer them into cancer treatments and the infuse them back into patients. Just days ago Jakobovits’s former company Kite executed a deal with UCLA for allogeneic tech from the lab of Gay M. Crooks.

Regeneron’s not-so-secret weapon in the new front on cancer includes its unique VelocImmune mouse models, which are described as “the largest mammalian genetic engineering project ever accomplished.” It helped them develop REGN1979, a bispecific antibody therapy that R&D chief George Yancopoulos has highlighted excitedly for its ability to target the B cell marker, CD20, and the CD3 component of the T cell receptor, which triggers redirected killing of B cells. Its anti-PD-1 antibody is REGN2810. Any targeting molecules that come out of this new collaboration can be redirected into any other programs Regeneron has, including its pact with Sanofi.

Regeneron doesn’t do many of these pacts, says Aberman. There was the Intellia deal back in April that brings CRISPR-Cas9 gene editing tech, Avalanche’s gene therapy pact, and now Adicet. But they expect a lot out of the few deals they do with the select biotechs they want to work with.

For Jakobovits, the deal also allows her to push the quick expansion of he new biotech. The staff of 14 is slated to double, with additional input coming from her Israeli subsidiary.

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