At the 38th Annual Meeting of Society of Immunotherapy of Cancer (SITC2023), Interim Report of Phase I Clinical Trial of Pseudoprogression and subsequent shrinkage of refractory/relapsed pediatric solid tumors induced by GAIA-102

Fukuoka, JAPAN – November 4, 2023 – A groundbreaking interim report by Dr. Naonori KAWAKUBO, MD PhD, has highlighted the potential of GAIA-102 in the treatment of refractory/relapsed pediatric solid tumors at the 38th Annual Meeting of Society of Immunotherapy of Cancer (SITC2023), San Diego, CA.

Key Findings from the Study:

  1. About GAIA-102: This cell therapeutic has been prepared as an ‘off-the-shelf’ agent and exhibits a unique natural killer (NK) cell-like phenotype and is derived from mixed allogeneic peripheral blood mononuclear cells.
  2. Phase I Trial Design: A single-agent cohort of this basket trial adopts a 3+3 design. A primary focus lies in evaluating the safety and potential efficacy of repeated intravenous injections of GAIA-102.
  3. Result highlights: No dose-limiting toxicity has been observed. A significant observation includes pseudoprogression followed by shrinkage in some tumor foci of two neuroblastoma patients. The target lesions of rhabdomyosarcoma and Ewing sarcoma also showed central necrosis.

Presentation at the Annual Meeting:

  • Program: the 38th Annual Meeting
  • Session: Poster Hall
  • Scheduled for: November 4, 2023 (Saturday) 9:00~20:30 (PDT), San Diego Convention Center Hall A

About the Study:

This Phase I clinical study aims to gauge both the safety and proof of concept (POC) regarding the potential efficacy of GAIA-102, suggesting a treatment-mediated acquired immune response. The study has been registered under ID: NCT05608148, with the ethics approval from the Institutional Review Board of Kyushu University Hospital (Approval No.2022306).

Funding & Support:

This crucial research has received financial backing from the Japan Agency for Medical Research and Development (AMED). Additionally, GAIA BioMedicine Inc. has generously provided the test drug.

About GAIA BioMedicine:

GAIA BioMedicine, Inc., founded in 2015 by Prof. Yoshikazu YONEMITSU, MD PhD, as a spin-off venture of Kyushu University, is a clinical-stage and technology-driven biopharmaceutical company specializing in cell therapies for cancer using NK cells.

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