GAIA-102 / GAIA BioMedicine, Nobelpharma - LARVOL DELTA

Metabolic Alterations in Highly Activated NK-like Cells (GAIA-102) Through Cryopreservation (ASGCT 2025) - P1, P1/2 | "GAIA-102 exhibits high metabolic flexibility and reserves at harvest, with respiratory capacity of mitochondria and compensatory function of glycolysis notably impaired through cryopreservation. Further investigation is warranted, specifically targeting mitochondrial respiration and glycolysis mechanisms. Disease Focus of Abstract:Cancer Solid Tumors"

Metabolic Disorders • Oncology • Solid Tumor

NK-like Cells (GAIA-102) Induce Antitumor Adaptive Immunity via the Host NK derived IFN-γ (ASGCT 2025) - "GAIA-102 treatment led to a significant increase in mIFN-γ secretion in tumors, whereas no substantial level was detected in other immune organs. Notably, the marked rise in Ki67+CD8+T cells observed on day 7 was completely abolished following mIFN-γ blockage. By day 17, tumor-specific tetramer-positive CD8+ T cells also diminished, emphasizing the crucial role of mIFN-γ in tumor control."

IO biomarker • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CCR6 • CD8 • CXCR3 • IFNG

Phase I trial of intraperitoneal infusion of GAIA-102 of NK-Like CD3-negative cells for gastric/pancreatic cancer (ESMO 2024) - "The phase I component employs a 3 + 3 design, consisting of a single-agent cohort and a combination cohort with pembrolizumab, involving a 4-week treatment regimen with GAIA-102 administered intraperitoneally once to three times a week for three consecutive weeks, followed by a one-week treatment-free interval. The progress of the trial will be presented. A phase II trial is planned with 6-month survival as the primary endpoint."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Impact of monocytes on the proliferation of highly activated NK-like cells (GAIA-102) (IMMUNOLOGY 2024) - "Interestingly, eliminating monocytes from the culture markedly decreased GAIA-102 cell proliferation, a more substantial effect than when B cells were removed.[Conclusions] Our study suggests that monocytes may play a crucial role of GAIA-102 proliferation. Unraveling the impact of monocytes on this process will be a vital direction for future research."

Late-breaking abstract • CCR6 • CXCR3 • ITGA1

GAIA-102 cells, an off-the-shelf and highly activated NK-like cell product, elicit endogenous immune cell responses in solid tumor model (IMMUNOLOGY 2024) - "ELISPOT assays demonstrated dose-dependent enhancements in CT26-specific T lymphocytes(CTLs) response in GAIA-102 treated mice. [Conclusion] GAIA-102 therapy can stimulate the recruitment of effector APCs and enhance the CTLs response, aligning with our preclinical findings."

Immune cell • Late-breaking abstract • Preclinical • Oncology • Solid Tumor • CD4 • CD8 • IL2

Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Kyushu University | N=36 ➔ 56

Enrollment change • CNS Tumor • Gastrointestinal Cancer • Germ Cell Tumors • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

Pseudoprogression and subsequent shrinkage of refractory/relapsed pediatric solid tumors induced by GAIA-102: an interim report of the single-agent cohort in Phase I clinical trial (SITC 2023) - P1 | "Conclusions Pseudoprogression and subsequent tumor shrinkage were observed in NB (2 of 6 patients, 33. 3%) by sole treatment of GAIA-102, suggesting the potential POC indicating that GAIA-102 may induce antitumor acquired immunity in a clinical setting."

Clinical • IO biomarker • P1 data • CNS Tumor • Gastrointestinal Cancer • Hepatoblastoma • Neuroblastoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Solid Tumor • HLA-C • KIR2DS2

The Essential Role of K+ and Ca2+ for Maintaining Cytotoxic Activity of Cryopreserved GAIA-102, a Newly Developed Activated NK-Like Cells (ASGCT 2023) - "Based on these results, we concluded that Ca2+ and K+ have an essential role for maintaining the cytotoxic activity of cryopreserved GAIA-102."

CNS Tumor • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Abundant Expression of IFNγ by GAIA-102, an Off-the Shelf and Highly Activated NK-Like Cell Product, Induces MHC Class I Expression (ASGCT 2023) - "We clarified that GAIA-102 could upregulate the MHC-I expression of tumor cells, by increasing IFNγ secretion in response to tumor cells. We concluded that GAIA-102 might enhance acquired immunity through IFNγ-mediated mechanism."

Chronic Myeloid Leukemia • CNS Tumor • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor • CD8 • IFNG

GAIA BioMedicine and TreeFrog Therapeutics Announce Collaboration for the Expansion of Allogeneic NK-like Cells Against Solid Tumors (GlobeNewswire) - "GAIA BioMedicine...and TreeFrog Therapeutics...today announced they have entered into a collaboration for the expansion of donor-derived NK-like cells....In our case, TreeFrog’s C-Stem™ technology could enable the massive expansion of GAIA-102 (NK-like cells) in conventional stirred-tank bioreactors, while maintaining its desired function and phenotype. In the process of further developing our adoptive immune cell therapy programs and expanding their therapeutic reach, C-Stem™ could constitute an alternative platform for large-scale GMP manufacturing."

Licensing / partnership • Oncology • Solid Tumor

Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas or Malignant Pediatric Solid Tumors With Lung Metastases (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Kyushu University

New P1 trial • CNS Tumor • Gastrointestinal Cancer • Germ Cell Tumors • Lung Cancer • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

GAIA-102-PD: GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: Kyushu University

New P1/2 trial • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CCL20 • CXCL10 • CXCL11 • CXCL9