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Fulamleucel - GAIA BioMedicine

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Drug Profile

Fulamleucel - GAIA BioMedicine

Alternative Names: GAIA-102; NPC-30

Latest Information Update: 10 Sep 2026

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At a glance

  • Originator GAIA BioMedicine
  • Developer GAIA BioMedicine; Kyushu University; Nobelpharma
  • Class Antineoplastics; Immunotherapies; Natural killer cell therapies
  • Mechanism of Action Immunologic cytotoxicity; Natural killer cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Gastric cancer; Non-small cell lung cancer; Pancreatic cancer
  • Phase I Neuroblastoma; Solid tumours

Most Recent Events

  • 31 Mar 2026 Nobelpharma intends to file for marketing authorisation of Fulamleucel for Neuroblastoma in Japan, in February 2028 (Nobelpharma pipeline, September 2026)
  • 06 Mar 2026 GAIA BioMedicine completes a phase-I/II trial in Non-small cell lung cancer(Monotherapy, Combination therapy, Late-stage disease, Second-line therapy or greater) in Japan (IV) (NCT05207371)
  • 06 Oct 2025 Phase-I clinical development is ongoing in Solid tumours and Neuroblastoma (Second-line therapy or greater, Monotherapy, In children, In adults, In infants, In adolescents, Metastatic disease, Combination therapy) in Japan (IV) (NCT05608148)

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