CREATE Medicines Inc. has announced first-in-human results from its phase 1 MYE Symphony trial evaluating MT-302, an mRNA-LNP-encoded TROP2-targeted in vivo CAR therapy in patients with advanced solid tumours.
“These data provide important mechanistic insights into how in vivo programmed myeloid cells behave within the tumour microenvironment,” said Rasha Cosman, head of the Early Phase Clinical Trials Unit at The Kinghorn Cancer Centre, St. Vincents Hospital Sydney.
“The degree of remodelling observed, combined with a manageable safety profile and repeat-dose feasibility, and early signal of anti-tumour activity in a heavily pre-treated population, is highly encouraging in tumour settings where immune infiltration has been historically limited. Seeing immune cells effectively reprogrammed inside the body to mount a targeted anti-tumour response represents a meaningful milestone and supports continued clinical advancement.”
Twenty-seven patients with advanced TROP2-positive solid tumours were treated with MT-302 across seven dose cohorts.
“These data represent the first demonstration of an in vivo CAR therapy achieving tumour penetration and measurable biological activity in patients with solid tumours,” said Matt Maurer, chief medical officer of CREATE Medicines.
“MT-302 showed proof-of-mechanism while maintaining a manageable safety profile and repeat dosing without preconditioning or immunosuppression.”
In this first-in-human study, MT-302 demonstrated tolerable repeat dosing, robust immunologic activity, direct tumour penetration by CAR myeloid cells and broad immune activation in heavily pre-treated patients. The company said the results provide clear proof-of-mechanism for in vivo CAR therapies in solid tumours and support advancement of MT-302 for front-line use. Dosing with MT-302 was recently initiated in the first ever front-line solid tumour trial with an in vivo CAR combined with a standard frontline regimen in the SPaCE-MT trial.
“This is a foundational moment for our platform and for the field of in vivo cell therapy,” said Daniel Getts, CEO and co-founder of CREATE Medicines.
“We have clinical evidence demonstrating that immune cells can be reprogrammed inside the body to mount a targeted anti-tumour response, paving the way for a new, highly versatile modality in the fight against solid tumours.”
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