Gyala Therapeutics, a biotechnology company dedicated to creating next-generation treatments for blood cancers, has shared encouraging results from early studies of its new CAR-T therapy, GYA01. This therapy targets a protein called CD84, which is present in several types of leukemia and other blood cancers. These results are the first to show that CAR-T cells can successfully target CD84, making GYA01 a potential breakthrough for patients with forms of leukemia that are especially difficult to treat.
Leukemia is a cancer of the blood and bone marrow. Acute myeloid leukemia, or AML, is one of the most common types in adults, making up about 30% of adult leukemia cases. Each year, around 145,000 people worldwide are diagnosed with AML. While chemotherapy can help many patients achieve remission, nearly half of them relapse, meaning the cancer comes back. Another type, T-cell acute lymphoblastic leukemia (T-ALL), is less common but still a serious condition. It makes up about 15% of childhood cases of acute lymphoblastic leukemia and up to 25% of adult cases. Children often respond well to treatment, but adult survival rates remain low, with only about 40% living long-term. For patients whose disease returns or does not respond to treatment, options are minimal.
In laboratory and animal studies, GYA01 showed strong and precise activity against cancer cells from AML, T-ALL, and aggressive B-cell lymphomas. It was able to kill these cancer cells effectively, both in test samples and in animal models. In animals, the therapy not only eliminated the disease but also helped them live longer. The CAR-T cells used in GYA01 were able to grow and multiply well, whether they came from healthy donors or from patients themselves. Unlike some other CAR-T therapies, GYA01 did not require extra genetic modifications to prevent the cells from attacking each other, which is often a challenge in T-cell therapies.
The research also confirmed that CD84 is consistently present in AML and T-ALL, including in high-risk forms of AML such as those with TP53 mutations or MECOM rearrangements. CD84 is also found in chronic lymphocytic leukemia and aggressive B-cell lymphomas, but it is rarely seen in healthy tissues. This makes it a very promising target for therapy. Most CAR-T therapies currently approved are limited to B-cell cancers, so targeting CD84 could expand treatment options to a much wider range of blood cancers.
Gyala’s program benefits from the expertise of Hospital Clinic Barcelona, a leader in CAR-T therapy research under the guidance of Dr. Manel Juan. The hospital has already treated more than 500 patients with CAR-T therapies. Hospital La Fe also contributed by analyzing CD84 expression in both cancerous and healthy bone marrow samples.
To move forward with clinical trials, Gyala raised €3 million in funding. This investment came from Invivo Partners, the company’s founding investor, as well as Nara Capital and CDTI Innovación through Spain’s Innvierte program. This funding shows how collaboration between experienced investors and leading academic institutions can help bring scientific discoveries into real-world treatments.
Gyala was founded in 2020 as a spin-off from Hospital Clinic Barcelona and the August Pi i Sunyer Biomedical Research Institute, known as IDIBAPS. The company builds on more than ten years of CAR-T research led by Dr. Juan. Previous therapies developed by these institutions, such as ARI-0001 for adult acute lymphoblastic leukemia and ARI-0002h for multiple myeloma, have already been approved in Spain under special hospital exemptions. This strong foundation supports the development of GYA01 and highlights Spain’s growing role as a leader in turning academic research into clinical innovation.
KEY QUOTES:
“The preclinical evidence confirms that GYA01 is a highly promising CAR-T therapy, supports CD84 as a pan-hematological target, and establishes a strong foundation for advancing to clinical trials.”
Dr. Nela Klein-Gonzalez, Chief Medical Officer of Gyala Therapeutics and lead author of the publication
“Our next goal is to launch a clinical trial of GYA01 in AML patients at Hospital Clinic Barcelona and Hospital La Fe in Valencia, bringing this therapy to patients with aggressive leukemias who lack alternatives.”
Claudio Santos, PhD, CEO of Gyala Therapeutics
