Gyala Therapeutics Announces Promising Preclinical Results for Novel CAR-T Therapy

BARCELONA, Spain—Gyala Therapeutics, a Spanish biotechnology company, has announced the publication of preclinical data for its investigational CAR-T cell therapy, GYA01, which targets the CD84 protein for the treatment of blood cancers. This study is the first to provide preclinical evidence of a CAR-T therapy targeting CD84, positioning it as a novel and promising treatment for acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL).

Key Findings and Therapeutic Potential

The research confirms that CD84 is consistently overexpressed in high-risk forms of AML and T-ALL, with limited expression in healthy tissues. This makes it a compelling therapeutic target for a wide range of hematological cancers.

Key preclinical findings for GYA01 include:

• Strong and specific cytotoxicity against leukemia cell lines and patient samples.
• Significant efficacy in animal models, leading to disease eradication and prolonged survival.
• The ability to be manufactured from both healthy donor and patient cells without requiring gene editing to prevent fratricide, a common issue where CAR-T cells kill each other.

For relapsed or refractory patients with AML and T-ALL, therapeutic options are extremely limited, and the GYA01 program aims to address this urgent unmet need.

Next Steps and Collaborative Efforts

Gyala Therapeutics plans to initiate a Phase 1 clinical trial of GYA01 in AML patients at Hospital Clinic Barcelona and Hospital La Fe in Valencia. The company recently secured €3 million in financing from investors to support this advancement.

The development of GYA01 is built on more than a decade of CAR-T research from Hospital Clinic Barcelona, a leading institution in the field. This foundation, which includes the successful development of two CAR-T therapies already approved in Spain, highlights the country’s growing leadership in translating academic research into clinical innovation.