Gyala Therapeutics Advances First-in-Class CD84-Targeting CAR-T Therapy with €3 Million Funding for AML and T-ALL Treatment
Key Insights
Gyala Therapeutics (search) published preclinical results in Leukemia demonstrating strong efficacy of GYA01 (search), a first-in-class CAR-T therapy targeting CD84 (search) protein for acute myeloid leukemia and T-cell acute lymphoblastic leukemia.
The therapy showed significant cytotoxicity against cancer cell lines and primary patient samples, with robust expansion from both healthy donor and patient T cells without requiring gene editing.
The company secured €3 million in funding from Invivo Partners (search), Nara Capital (search), and CDTI Innvierte (search) to launch a Phase I trial in AML patients in the second half of 2025.
Gyala Therapeutics (search) has announced promising preclinical results for its first-in-class CAR-T therapy GYA01 (search), targeting the CD84 (search) protein for treatment of acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL). The study, published in Leukemia, represents the first preclinical demonstration of CAR-T cells targeting CD84, validating the approach as a potential breakthrough therapy for these challenging blood cancers.
The Barcelona-based biotechnology company secured €3 million in financing from Invivo Partners (search), Nara Capital (search), and CDTI Innvierte (search) to advance GYA01 (search) into a Phase I clinical trial for AML patients, planned to begin in the second half of 2025.
Addressing Critical Unmet Medical Needs
AML represents approximately 30% of adult leukemias, with roughly 145,000 new cases diagnosed annually worldwide. While chemotherapy can induce remission in many patients, nearly half experience relapse, highlighting the urgent need for more effective treatments. T-ALL, though rare, accounts for 15% of pediatric acute lymphoblastic leukemia cases and up to 25% in adults. While children often respond well to chemotherapy, adult survival remains only around 40%, with extremely limited therapeutic options for relapsed or refractory patients.
Strong Preclinical Efficacy Profile
The preclinical study demonstrated several key advantages of GYA01 (search):
- Strong and specific cytotoxicity against AML, T-ALL, and aggressive B-cell lymphoma cell lines, as well as primary patient samples
- Significant efficacy in animal models, successfully eradicating disease and prolonging survival
- Robust expansion from both healthy donor and patient T cells, with a favorable memory phenotype
- No gene editing required to avoid fratricide, simplifying the manufacturing process
The research confirmed that CD84 (search) is consistently overexpressed in AML and T-ALL, including high-risk subtypes such as TP53 (search)-mutated or MECOM (search)-rearranged AML. Additionally, CD84 shows high expression in chronic lymphocytic leukemia and aggressive B-cell lymphomas, with limited expression in healthy tissues, making it an attractive target beyond the B-cell malignancies where CAR-T therapies are currently approved.
Clinical Development Strategy
"The preclinical evidence confirms that GYA01 (search) is a highly promising CAR-T therapy, supports CD84 (search) as a pan-hematological target, and establishes a strong foundation for advancing to clinical trials," said Dr. Nela Klein-Gonzalez, Chief Medical Officer of Gyala Therapeutics (search) and lead author of the publication.
Claudio Santos, PhD, CEO of Gyala Therapeutics (search), outlined the company's immediate objectives: "Our next goal is to launch a clinical trial of GYA01 (search) in AML patients at Hospital Clinic Barcelona (search) and Hospital La Fe (search) in Valencia, bringing this therapy to patients with aggressive leukemias who lack alternatives."
Academic Foundation and Expertise
Founded in 2020 as a spin-off of Hospital Clinic Barcelona (search) and the August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Gyala builds on more than a decade of CAR-T research led by Dr. Manel Juan. The institutions have treated over 500 patients with CAR-T therapies, including ARI-0001 for adult ALL and ARI-0002h for multiple myeloma, both approved in Spain under hospital exemption.
The program leverages expertise from Hospital Clinic Barcelona (search), a pioneer in CAR-T therapies, as well as key contributions from Hospital La Fe (search), which performed CD84 (search) expression analyses in AML and healthy bone marrow samples.
Funding and Future Development
The €3 million financing round included participation from Invivo Partners (search) (the company's founding investor), Nara Capital (search), and CDTI Innovación through the Innvierte program. To date, Gyala has raised approximately €8 million through these investors and national innovation programs including NEOTEC and Public-Private Collaboration Projects.
This investment represents collaboration between seasoned investors and Spain's academic excellence to translate breakthrough science into clinical innovation, positioning Gyala to advance GYA01 (search) through clinical development for patients with limited treatment options.