5PD - Cell-based immunotherapy combining encapsulation cell technology and irradiated autologous tumor cells: A novel technology platform that is both saf...

Date 20 November 2015
Event ESMO Symposium on Immuno-Oncology 2015
Session Poster Discussion session
Topics Cancer Immunology and Immunotherapy
Presenter nicolas Mach
Citation Annals of Oncology (2015) 26 (suppl_8): 1-4. 10.1093/annonc/mdv513
Authors N. Mach1, D. Migliorini1, R. Vernet2, M. Belkouch2, P. Luy2, V. Ancrenaz1, C. Py1, J. Grogg3, P. Harboe-Schmidt3, N. Bouche4
  • 1Dpt Des Spécialités De Médecine, Hopitaux Universitaires de Genève Unité de recherche clinique du centre d'Oncologie, 1211 Geneva - Geneva/CH
  • 2Cell Therapy Lab, Oncology Division, Hôpitaux Universitaires de Genève - HUG, 1211 Geneva - Geneva/CH
  • 3Clinical Research, MaxiVAX SA, 1206 Geneve - Geneva/CH
  • 4Life Sciences, Swiss Federal Institute of Technology /Lausanne, 1015 - Lausanne/CH

Abstract

Aim

Providing a wide, tumor specific antigenic repertoire and standardized, sustained, local delivery of potent adjuvant at the vaccination site is a major challenge in clinical oncology. Combining the sc implantation of irradiated, autologous tumor cells and biocompatible capsules containing GM-CSF secreting allogeneic cells recapitulates the protective, tumor specific immunity obtained with irradiated tumor cells engineered to produce gm-csf in murine models. Encapsulation cell technology (ECT) allows the stable, local release of gm-csf without detrimental systemic effects. MVX-ONCO-1, combines ECT for the sc delivery of huGM-CSF at the vaccination site, a key factor for successful immunization and irradiated autologous tumor cells. MVX-ONCO-1 is the first in men clinical trial assessing safety and feasibility of this innovative cell-based immunotherapy.

Methods

Primary Endpoints: Safety and Feasibility. Population: 15 patients, advanced cancers progressing despite standard therapies. Treatment: Subcutaneous immunization combining lethally irradiated autologous tumor cells(4x106) and 2 macrocapsules containing cells genetically engineered to release stable quantity of GM-CSF over 7 days (>20 ng/24 hours). 6 sc implantations are performed at week 1-2-3-4-6-8

Results

As of September 8, all 15 patients have been treated. Vaccination was processed successfully for all patients. All cell therapy products met the GMP criteria. Out of 172 capsules implantations, 1 presented with technical issue after removal. Stable level of GM-CSF was observed in all explanted capsules tested. No treatment related SAE or systemic AE have been reported. No SUSAR were observed. Toxicity is limited to local discomfort. 7 out of 13 evaluable pts had some clinical benefit (SD > 3 months, decrease serum tumor marker, prolonged survival).

Conclusions

MVX-ONCO-1 is the first personalized anti-tumor immunotherapy based on ECT. It is both safe and reliable. This innovative therapy is applicable to any tumor type. Phase 2 trials are planned in several tumor types as well as combination with immune check-point inhibitors.

Clinical trial identification

NCT02193503

Disclosure

N. Mach: MaxiVAX SA: minority stock holder Inventor of MVX-ONCO-1. All other authors have declared no conflicts of interest.