Cullinan rebrands, halts lymphoma trial to reflect autoimmune refocus

It’s not unusual to see a CD19-focused cancer company dip its toe into the autoimmune space these days, but Cullinan Oncology is going one stage further with a name change to reflect this new approach.

Cullinan Therapeutics, as the biotech will now be known, is switching the focus of its CD19xCD3 T-cell engager, dubbed CLN-978. Even before today’s move, the company had been considering CLN-978’s potential in autoimmune diseases in the belief that the therapy may “address the limitations of CAR-T cell therapy.”

“The company believes that CLN-978 could offer a novel solution for patients and providers as a T cell engager designed to deliver potency with off-the-shelf convenience and subcutaneous dosing​,” Cullinan said in an April 16 release.

The biotech now plans to secure permission from the FDA in the third quarter of the year to study CLN-978 in systemic lupus erythematosus. Cullinan is also “planning for future development in other autoimmune diseases."

But the strategic shift means a phase 1 trial of CLN-978 in B cell non-Hodgkin lymphoma will be halted, the company announced this morning. Cullinan made the move despite revealing in the same release that the three patients dosed since the trial started in August 2023 have shown that CLN-978 was clinically active at the initial starting dose of 30 μg.

“Of the two patients with detectable B cells at baseline, both patients experienced rapid, deep, and sustained B cell depletion after administration of CLN-978,” the company said today. “These data show that CLN-978 can deplete peripheral B cells and demonstrate clinical activity in a tissue resident disease at a dose with a favorable safety profile.”

Two patients experienced cytokine release syndrome—a severe immune reaction that has haunted other biotechs' T-cell therapy trials—but, in both cases, this was limited to a grade 1 event, Cullinan noted.

While CLN-978 is being diverted to autoimmune disease, Cullinan also has a number of other oncology drugs in the clinic. They include a FLT3xCD3 T cell-engaging bispecific antibody called CLN-049 that is in a phase 1 study in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome. There is also a B7H4x4-1BB bispecific immune activator called CLN-418 in a phase 1 study for solid tumors and a IL-2 and IL-12 cytokine fusion protein called CLN-617 also in an early-stage trial for solid tumors.

Furthest advanced in the clinic is zipalertinib, a EGFR ex20ins inhibitor in collaboration with Taiho Oncology that's in a phase 2 trial in non-small cell lung cancer.

While the company didn’t name-check any of them in the announcement, CEO Nadim Ahmed said the biotech is still planning to “deliver multiple data catalysts from our ongoing oncology clinical programs throughout 2024.”

Along with the strategic and branding refocus, Cullinan brought in $280 million this morning via a private placement of its shares, which is estimated to stretch the biotech's cash runway through to 2028.

Cullinan is the latest company to start off in cancer before straying into the autoimmune space. Developers of CD19 cell therapies have surged into lupus over the past 18 months, attracted by data that suggest the treatments may cure the autoimmune disease.

A notable recent example has been Nkarta, which is continuing to explore the potential of a CD19-directed CAR NK prospect in lupus nephritis after its cancer candidate struggled in the clinic.