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MVX-ONCO-1 phase 1 final results of the first personalized cell-based immunotherapy using cell encapsulation technology

Date

09 Oct 2016

Session

Poster display

Presenters

Nicolas Mach

Citation

Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378

Authors

N. Mach1, R. Vernet2, M. Belkouch2, P. Luy2, V. Ancrenaz2, P. Teta3, N. Blazek2, N. Grandjean2, J. Wasem2, J. Grogg4, T. Perez5, D. Migliorini2

Author affiliations

  • 1 Oncology, Hôpitaux Universitaires de Genève - HUG, 1211 - Geneva/CH
  • 2 Oncology, Hôpitaux Universitaires de Genève - HUG, 1205 - Geneva/CH
  • 3 Oncology, Hôpitaux Universitaires de Genève - HUG, 1205 Geneve - Geneva/CH
  • 4 Clinical Operation, MaxiVAX SA, 1206 Geneve - Geneva/CH
  • 5 Clinical Operation, MaxiVAX SA, 1205 - Geneva/CH
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Background

Cell Encapsulation Technology (CET) allows the standardized release of GM-CSF by genetically modified allogeneic cells loaded within a capsule. We present the final results of the Phase I clinical trial assessing this patient specific, cell-based therapy, combining the implantation of irradiated autologous tumor cells and capsules containing allogeneic cells genetically engineered to produce huGM-CSF.

Methods

For this single center, first in human Phase 1 trial, 15 pts with progressing, solid tumors refractory to all standard treatments were enrolled. Immunizations was performed in healthy skin, distant from tumor deposits. Patients were treated with 6 sc immunizations (week 1-2-3-4-6-8) combining 4x106 irradiated autologous tumor cells and 2 capsules containing 8x105 MVX-1 cells, producing >20ng/24h of huGM-CSF. Capsules were removed after 8 days and analyzed for huGM-CSF production. Primary endpoints are safety and feasibility. Secondary endpoints include clinical outcome and immunomonitroing.

Results

15 patients are available for safety and feasibility. Tt is very well tolerated with only one G3 AE related to IMP. Main toxicity is G1-2 minor discomfort during caspules sc implantation. No treatment related SAE were reported. Clinical grade therapeutic products were successfully manufactured for all patients. 95% % of explanted macrocapsules showed good ex-vivo huGM-CSF production. >50% of patients (8/15) experienced either PR or SD including disappearance of lung metastasis, prolong survival. Correlation between positive DTH and OS was observed. Immunomonitoring by Elispot shows increased INFg production by PBMC after immunization.

Conclusions

MVX-ONCO-1 is the first personalized cell-based immunotherapy combining autologous tumor cells and sustained local production of GM-CSF at the vaccination site using cell encapsulation technology. This technology has a very good safety profile safe with no systemic SAE related to therapy. In this heavily pretreated population, clinical activity (partial response and stable disease ) was observed in >50 of patients.

Clinical trial identification

NCT02193503

Legal entity responsible for the study

Geneva University Hospital, Unité de recherche clinique de la Fondation Dr Henri Dubois-Ferrière Dinu Lipatti

Funding

MaxiVAX

Disclosure

N. Mach: I am the co-founder of MaxiVAX SA, I am the inventor of MVX-ONCO-1 I am a minority shareholder of MaxiVAX SA. All other authors have declared no conflicts of interest.

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