Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 14

762P - Personalized immunotherapy with encapsulated cell technology: Feasibility, safety and efficacy results from the first-in-human clinical trial in advanced relapsing solid tumors

Date

10 Sep 2022

Session

Poster session 14

Topics

Cell-Based Therapy;  Immunotherapy

Tumour Site

Presenters

Eugenio Fernandez

Citation

Annals of Oncology (2022) 33 (suppl_7): S331-S355. 10.1016/annonc/annonc1058

Authors

E. Fernandez1, R. Vernet2, E. Charrier3, D.M. Migliorini4, M. Urwyler2, M. Belkouch2, O. Von Rohr5, V. Saingier5, V. Ancrenaz6, N. Grandjean6, E. Lafferma6, E. Lavalliere6, O. Rubin7, J. Villard8, J.N. Grogg9, N. Mach10

Author affiliations

  • 1 Oncology Department, HUG - Hopitaux Universitaires de Geneve, 1211 - Geneva/CH
  • 2 Cell-based Immunotherapy Lab, Oncology, HUG - Hopitaux Universitaires de Geneve, 1205 - Geneva/CH
  • 3 Cell-based Immunotherapy Lab, Oncology, UNIGE - Université de Genève - Centre Médical Universitaire (CMU), 1205 - Geneva/CH
  • 4 Oncology, Hopitaux Universitaires de Geneve - HUG, 1211 - Geneva/CH
  • 5 Cell-based Immunotherapy Lab, Oncology, HUG - Hopitaux Universitaires de Genève, 1205 - Geneva/CH
  • 6 Clinical Research Unit, Oncology, HUG - Hopitaux Universitaires de Geneve, 1205 - Geneva/CH
  • 7 Clinical Cell Therapy Lab, HUG - Hopitaux Universitaires de Genève, 1205 - Geneva/CH
  • 8 Clinical Cell Therapy Lab, HUG - Hopitaux Universitaires de Geneve, 1205 - Geneva/CH
  • 9 R & D, MaxiVax SA, 1202 - Geneva/CH
  • 10 Oncology, HUG - Hopitaux Universitaires de Geneve, 1205 - Geneva/CH
More

Abstract 762P

Background

Preclinical data shows that sustained, local delivery of low doses of GM-CSF by irradiated, genetically engineered tumor cells at the immunization site leads to specific, long-lasting anti-tumor immunity in several tumor types. Providing sustained levels of GM-CSF SC in a clinical setting remains challenging. Encapsulated Cell Technology enables the sustained and controlled delivery of GM-CSF by allogeneic cells. MVX-ONCO is an active, personalized cancer immunotherapy combining irradiated autologous tumor cells and encapsulated, genetically engineered allogeneic cells producing GM-CSF. Here we report the final results of the phase I clinical trial of MVX-ONCO in solid tumors.

Methods

34 pts were enrolled in a single-arm clinical trial (NCT02193503) evaluating the feasibility, safety and efficacy of MVX-ONCO. The treatment regimen consists of 6 doses over 8 weeks (W1,2,3,4,6,8). Each dose consists of 2 capsules containing allogeneic cells producing GM-CSF, co-implanted SC with irradiated autologous tumor cells in healthy skin; capsules are removed after 1 week. All pts received at least 1 dose of MVX-ONCO.

Results

All pts are evaluable for feasibility, safety, and efficacy. Compliant preparation of both irradiated autologous tumor cells and encapsulated MVX cells was achieved in 30/34 pts (88%). No pts experienced any treatment-related systemic toxicities. Local hematoma at the implantation site was reported in a minority of pts. Some degree of disease control was observed in 20/34 pts, including prolonged survival in 2/2 R/M HNSCC pts; one pt achieved a PR correlated with immunostimulatory signals (+ve IFN-y ELISpot) and the second pt is currently in CR with no antitumor therapy for >3 years. Monitoring of circulating T cell reactivity and DTH positivity correlates with >6 months survival.

Conclusions

MVX-ONCO is feasible, safe, and well-tolerated. Preliminary efficacy data shows immune stimulation, intriguing prolonged survival, and tumor control including PR and CR as BOR in 2/2 R/M HNSCC pts. Single-agent efficacy phase 2 study is ongoing in this population. Concurrent use of anti-PD1 and MVX-ONCO should be tested in a subsequent clinical trial.

Clinical trial identification

NCT02193503.

Editorial acknowledgement

Legal entity responsible for the study

Oncology Division at Geneva University Hospital (Geneva, Switzerland) and MaxiVAX SA (Geneva, Switzerland).

Funding

MaxiVAX SA.

Disclosure

J.N. Grogg: Financial Interests, Institutional, Full or part-time Employment: MaxiVAX. N. Mach: Financial Interests, Personal and Institutional, Stocks/Shares: MaxiVAX. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.