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

Gyala Therapeutics Introduces a Novel CAR-T Therapy

Gyala Therapeutics, a cutting-edge biotechnology firm specializing in next-generation immunotherapies for hematological cancers, recently announced the results of its groundbreaking CAR-T therapy, GYA01. This innovative treatment specifically targets the CD84 protein and has exhibited robust preclinical efficacy against challenging forms of leukemia, particularly Acute Myeloid Leukemia (AML) and T-cell Acute Lymphoblastic Leukemia (T-ALL).

Groundbreaking Preclinical Results

Preclinical studies have showcased GYA01’s potent cytotoxic effects on various cancer cell lines, including AML and T-ALL, demonstrating considerable promise in eradicating disease in animal models. Furthermore, its ability to extend survival times in these models solidifies its potential as a revolutionary therapeutic option for patients battling resistant forms of leukemia.

Encouragingly, GYA01 is noted for achieving substantial expansion from both healthy donor and patient-derived T-cells, all while maintaining a favorable memory phenotype without necessitating genetic modifications to prevent self-targeting. This unique feature distinguishes GYA01 as a significant advancement in CAR-T therapy, which otherwise faces challenges with existing methodologies.

CD84, the target of GYA01, has been found to be consistently overexpressed in AML and T-ALL, including high-risk subtypes such as TP53-mutated and MECOM-rearranged AML, reinforcing CD84's potential as a valuable target across various hematological malignancies.

Targeting a Significant Unmet Need

AML represents about 30% of leukemia cases in adults, with approximately 145,000 new diagnoses each year globally. While many patients respond to chemotherapy, almost half experience relapse. Meanwhile, T-ALL, though rarer, accounts for 15% of ALL cases in children and up to 25% in adults. Adults tend to have a 40% survival rate, calling for innovative treatment approaches for those with recurrent or refractory disease.

Dr. Nela Klein-Gonzalez, Chief Medical Officer at Gyala Therapeutics, commented, "These preclinical findings validate GYA01 as a promising CAR-T therapy and provide a solid foundation for transitioning into clinical studies." Claudio Santos, PhD, the company's CEO, further emphasized the urgency of initiating clinical trials that will make this therapy accessible to leukemia patients facing limited options.

Clinical Trials on the Horizon

To facilitate the upcoming Phase I clinical trial with AML patients, Gyala secured €3 million in funding from Invivo Partners, Nara Capital, and CDTI Innovación. The trial is set to occur in esteemed facilities such as the Hospital Clinic Barcelona and Hospital La Fe in Valencia, benefiting from their extensive experience and contributions to CAR-T therapy research.

Gyala Therapeutics was formed in 2020 as a spin-off from the Hospital Clinic Barcelona and the August Pi i Sunyer Biomedical Research Institute (IDIBAPS). The foundation of GYA01 is built upon over a decade of CAR-T research led by Dr. Manel Juan, who has overseen the treatment of more than 500 patients with CAR-T therapies, establishing Spain as a leader in this burgeoning field.

The company has raised around €8 million to date and strives to transform breakthrough scientific discoveries into clinical innovations that address urgent medical needs in hematological cancers.

For more information about Gyala Therapeutics and their latest advancements, visit www.gyalatx.com.