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Cullinan rebrands, halts lymphoma trial to reflect autoimmune refocus

2024-04-16

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Cullinan said the name change “reflects the company’s transformation as it pursues new indications for autoimmune diseases and continues to advance its clinical-stage oncology pipeline.”

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

Cullinan Therapeutics, as the biotech wcancerw be known, is switching the focus of its CD19xCD3 T-cell engagCullinan Oncology8. 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.”

Cullinan Therapeutics that CLN-978 could offer a novel solution for patients and providers as a T cell engager designedCLN-978iver potency with off-the-shelf convenience and subcutaneous CLN-978,” Cullinan saidautoimmune diseasesease.

The biotech now plans to seCLN-978rmission 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 CLNFDA8 in B cell non-Hodgkin lymphoma will be haCLN-978he csystemic lupus erythematosusg. Cullinan made the move despite revealing in the same releaautoimmune diseasesatients 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 bCLN-978, boB cell non-Hodgkin lymphomaid, deep, and sustained B cell depletion after adminiCullinan of CLN-978,” the company said today. “These data show that CLN-978 can deplete peripheral B cells and demonstrate clinical activity in a CLN-978resident 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, tCLN-978 limited to a grade 1 event, Cullinan noted.CLN-978

While CLN-978 is being dicytokine release syndromease, 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.

FurtheCLN-978nced in the clinic is autoimmune diseaseFRCullinan inhibitor in collaboration with Taiho Oncology that's in a phase 2 trial in non-small cell lung cancer.CLN-049 relapsed/refractory acute myeloid leukemia relapsed/refractory acute myeloid leukemia myelodysplastic syndrome CLN-418 solid tumors IL-2 IL-12 CLN-617 solid tumors

While the company didn’t name-checkzipalertinib in EGFR ex20ins inhibitorNadim Ahmed said the biTaiho Oncology planning to “deliver multiplenon-small cell lung cancerngoing 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 Cullinanefore 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.

Cullinane recent example has been Nkarta, whichcancerntinuing to explore the potential of a CD19-directed CAR NCD19ospect in lupus nephritis after ilupusncer candidate struggled in the clinic.autoimmune disease

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