813P - The novel cancer vaccine, consisting of genetically modified allogeneic tumor cells and immunomodulator MGN1601: updated results of a phase 1-2 stud...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Renal Cell Cancer
Cancer Immunology and Immunotherapy
Presenter Ingo Schmidt-Wolf
Authors I. Schmidt-Wolf1, S. Hauser2, S. Weikert3, V. Grünwald4, M. Schroff5, M. Schmidt6, E. Weith6, M. Tschaika6, B. Wittig7
  • 1University of Bonn, Bonn/DE
  • 2Department Of Urology, University of Bonn, Bonn/DE
  • 3Clinic For Urology, Charite, Berlin/DE
  • 4Clinic For Hematology, Hemostasis, Oncology, Hannover Medical School, 30625 - Hannover/DE
  • 5Board, Mologen AG, 14195 - Berlin/DE
  • 6Clinical Development, Mologen AG, 14195 - Berlin/DE
  • 76foundation Institute Molecular Biology And Bioinformatics, Freie Universität Berlin, Berlin/DE

Abstract

Background

MGN1601 consists of two active pharmaceutical ingredients: genetically modified allogeneic tumor cells expressing IL-7, GM-CSF, CD80 and CD154 and a TLR9 agonist, synthetic DNA-based immunomodulator dSLIM®. The first-in-man phase 1–2 clinical trial (ASET trial) has been conducted in patients with advanced renal cell carcinoma failed previous therapy lines and without further available standard therapy.

Methods

The ASET study is a multicentric, open, single-arm phase 1-2 clinical study and consists of the treatment, extension and follow up phases. The safety, efficacy and immunogenicity parameters were evaluated based on clinical and laboratory assessments, monitoring of patients' quality of life (QoL) with QLQ-C30, immunological tests, and central radiological investigations according to RECIST 1.1 as well as immune related Response Criteria.

Results

Ten of nineteen study patients completed the treatment per protocol (TPP). Two patients with disease control after 12-weeks continued treatment in the extension phase. One of them is still under therapy showing tumor remission since 48 weeks. The second patient developed radiological PD after 60 weeks of treatment. Seven patients from the TPP population are still alive with stable disease for up to 65 weeks. Evaluation of the QoL showed that patients of the TPP group have improved median symptom score from 45.8 to 58.3 in course of treatment. Drug-related AE included mild fever, edema, exanthema, pruritus, intermittent arthralgia, fatigue, and moderate soft tissue infection. Local reactions on injection site consisted mostly of redness up to 50 mm, which were available up to 7 days. The local reactions have no negative impact on the quality of life and daily activities of the patients. Six of ten TPP patients showed significant improvement in the immune status in lymphocyte transformation test.

Conclusions

The allogeneic tumor cell-based cancer vaccine MGN1601 shows promising efficacy and a favourable safety profile in the late stage mRCC patients. A phase 2 clinical study in mRCC patients with MGN1601 as third-line therapy is under development.

Disclosure

M. Schroff: Board member of Mologen.

M. Schmidt: Mologen employee.

E. Weith: Mologen empoyee.

M. Tschaika: Mologen employee.

B. Wittig: Member of Scientific Advisory Board of Mologen.

All other authors have declared no conflicts of interest.