Gyala Therapeutics Announces Promising CAR-T Therapy for Leukemias

What's Happening?

Gyala Therapeutics has unveiled preclinical results of its CAR-T therapy, GYA01, targeting the CD84 protein, showing strong efficacy in treating acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL). The biotechnology company, based in Barcelona, Spain, has secured €3 million in financing to launch a Phase I trial in AML patients in the second half of 2025. The study demonstrates significant cytotoxicity against AML, T-ALL, and aggressive B-cell lymphoma cell lines, as well as primary patient samples, positioning CD84 as a novel target with broad potential across hematological cancers.

Why It's Important?

The development of GYA01 represents a significant advancement in the treatment of hard-to-treat leukemias, offering hope to patients with limited therapeutic options. AML accounts for about 30% of adult leukemias, with a high relapse rate following chemotherapy. T-ALL, though rare, poses challenges in adult survival rates. The promising preclinical results of GYA01 could lead to improved outcomes for patients with aggressive leukemias, potentially transforming the landscape of hematological cancer treatment.

What's Next?

Gyala Therapeutics plans to initiate a Phase I clinical trial of GYA01 in AML patients at Hospital Clinic Barcelona and Hospital La Fe in Valencia. The trial aims to bring this therapy to patients with aggressive leukemias who lack alternatives. The company has secured financing from Invivo Partners, Nara Capital, and CDTI Innovación to support the trial, exemplifying collaboration between investors and academic institutions to translate breakthrough science into clinical innovation.

Beyond the Headlines

The development of GYA01 highlights the potential of targeting CD84 as a pan-hematological target, with implications beyond B-cell malignancies where CAR-T therapies are currently approved. The study underscores the importance of academic-to-clinic innovation, leveraging expertise from institutions like Hospital Clinic Barcelona to advance CAR-T research. The success of GYA01 could pave the way for new immunotherapies targeting other overexpressed proteins in hematological cancers.