#Spain #Barcelona #CAR-T therapy #Gyala Therapeutics #CD84

Gyala Therapeutics Launches a Revolutionary CAR-T Therapy

In a significant advancement in the field of hematological malignancies, Gyala Therapeutics has unveiled its pioneering CAR-T therapy known as GYA01. This groundbreaking treatment targets the CD84 receptor and has shown remarkable efficacy in preclinical studies, particularly against challenging forms of leukemia such as Acute Myeloid Leukemia (AML) and T-cell Acute Lymphoblastic Leukemia (T-ALL).

Promising Preclinical Results

The findings of Gyala's preclinical research have been published, marking the first report detailing CAR-T cells specifically engineered to target the CD84 protein. The results reveal that GYA01 not only exhibits potent cytotoxic activity against AML and T-ALL cell lines but also proves effective against aggressive B-cell lymphoma samples. Animal model studies further strengthen these claims, demonstrating the therapy's ability to eradicate disease and extend survival rates.

The therapy showed substantial proliferation of T-cells, derived from both healthy donors and patients, demonstrating a favorable memory phenotype without necessitating genetic editing to protect against the destruction of the patient’s natural cells.

Significance of CD84 as a Target

The study emphasizes that CD84 is consistently overexpressed in AML and T-ALL—especially concerning high-risk subtypes like AML with TP53 mutations or MECOM gene rearrangements. Notably, CD84 is also present in high levels in Chronic Lymphocytic Leukemia (CLL) and aggressive B-cell lymphomas, while exhibiting minimal expression in healthy tissues. This specificity aligns it as a promising therapeutic target, justifying GYA01's potential expansion beyond current CAR-T cell therapies limited to certain B-cell malignancies.

Future Clinical Trials and Funding

Gyala Therapeutics is gearing up to initiate a Phase I clinical trial with GYA01 for patients with AML by the second half of 2025. This trial will take place in collaboration with the Hospital Clínic in Barcelona and Hospital La Fe in Valencia. The CEO of Gyala, Claudio Santos, emphasized the urgency of offering new treatment options to patients with aggressive leukemias who lack viable alternatives.

To proceed with these clinical trials, Gyala secured €3 million in funding from Invivo Partners, Nara Capital, and CDTI Innvierte. This investment showcases the potential for collaboration between experienced investors and Spanish academic excellence to foster clinical innovation based on scientific advancements.

Academic Foundations of GYA01

Established in 2020 as a spinoff from the Hospital Clínic of Barcelona and the August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Gyala Therapeutics embodies over a decade of research in CAR-T therapies led by Dr. Manel Juan. The institutions involved have successfully treated more than 500 patients with CAR-T therapies, including two notable treatments, ARI-0001 and ARI-0002h, which have received exceptional authorization in Spain. The continuity of this research underscores Spain's position as a leader in CAR-T therapy innovation, spanning from academic inquiry to clinical application.

Conclusion

Gyala Therapeutics is on the forefront of developing state-of-the-art immunotherapies to address unmet medical needs in blood cancer treatment. With GYA01 targeting CD84, the company aims to revolutionize treatment options for AML, T-ALL, and other hematological cancers. As they move toward clinical trials, the anticipation around GYA01's potential to offer hope to patients continues to grow.