Gyala Therapeutics has published pre-clinical results demonstrating the efficacy of its CAR-T therapy, GYA01, in Leukemia. The study is the first to show pre-clinical data of CAR-T cells targeting the CD84 protein, validating GYA01 as a promising therapy for AML and T-ALL and positioning CD84 as a novel target with broad potential across hematological cancers.

AML represents about 30 percent of adult Leukemias, with roughly 145,000 new cases annually worldwide. While chemotherapy induces remission in many patients, nearly half relapse. T-ALL, though rare, accounts for 15 percent of paediatric ALL and up to 25 percent in adults. Children often respond well to chemotherapy, but adult survival remains only ~40 percent. For relapsed or refractory patients, therapeutic options are extremely limited.

The study confirms that CD84 is consistently overexpressed in AML and T-ALL, including high-risk subtypes such as TP53-mutated or MECOM-rearranged AML. CD84 is also highly expressed in chronic lymphocytic Leukemia and aggressive B-cell lymphomas, with limited expression in healthy tissues—making it a compelling target beyond the B-cell malignancies where CAR-Ts are currently approved.

"The preclinical evidence confirms that GYA01 is a highly promising CAR-T therapy, supports CD84 as a pan-hematological target, and establishes a strong foundation for advancing to clinical trials," said Dr Nela Klein-Gonzalez, Chief Medical Officer, Gyala Therapeutics, and lead author of the publication.

The programme leverages the expertise of Hospital Clinic Barcelona, a pioneer in CAR-T therapies under the leadership of Dr Manel Juan, as well as key contributions from Hospital La Fe, which performed CD84 expression analyses in AML and healthy bone marrow samples.

Claudio Santos, PhD, CEO, Gyala Therapeutics, added, "Our next goal is to launch a clinical trial of GYA01 in AML patients at Hospital Clinic Barcelona and Hospital La Fe in Valencia, bringing this therapy to patients with aggressive Leukemias who lack alternatives."

To initiate the Phase-I trial, Gyala secured a €3 million financing round with participation from Invivo Partners (its founding investor), Nara Capital and CDTI Innovación through the Innvierte programme. This investment exemplifies how collaboration between seasoned investors and Spain's academic excellence can translate breakthrough science into clinical innovation.