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ePoster Display

1367TiP - IMPRINTER: An open label, multi-center, dose escalation/expansion, phase I study of IMU-201 (PD1-Vaxx), a B-cell immunotherapy, in adults with non-small cell lung cancer

Date

16 Sep 2021

Session

ePoster Display

Presenters

Rita Laeufle

Citation

Annals of Oncology (2021) 32 (suppl_5): S949-S1039. 10.1016/annonc/annonc729

Authors

R. Laeufle1, G. Richardson2, J.J.W. Park3, M. Gutierrez4, M. Boyer5, D. Carbone6, P. Savvides7, T. Bekaii-Saab8, P. Kaumaya9, T. Phan10, N. Ede11, L. Chong12, B. Nixon13, A. Good13

Author affiliations

  • 1 Consultant, Private Address - Dr. Rita Laeufle, 92109 - San Diego/US
  • 2 Medical Oncology, Cabrini Hospital Malvern, Melbourne/AU
  • 3 Medical Oncology, Macquarie University, Sydney/US
  • 4 Medical Oncology, Hackensack University Medical Center, New Jersey/US
  • 5 Medical Oncology, Chris O'Brian Lifehouse hosptial, Sydney/AU
  • 6 Medical Oncology, The James Comprehensive Cancer center, Columbus/US
  • 7 Medical Oncology, Mayo Clinic, Phoenix/US
  • 8 Medical Oncology Department, Mayo Clinic Cancer Center, 85054 - Phoenix/US
  • 9 Clinical Research, Comprehensive Cancer Center, Columbus/US
  • 10 Medical Research, Garvan Institute of Medical Research, Sydney/AU
  • 11 Clinical Research, Imugene, Melbourne/AU
  • 12 Biotech, Imugene, Sydney/AU
  • 13 Clinical Research, Imugene, Sydney/AU
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Abstract 1367TiP

Background

Therapies with monoclonal antibodies targeting PD-1 and its ligands are associated with remarkable outcomes in various cancers and, together with antibodies targeting CTLA-4, have revolutionized cancer treatment (Honey 2017). Some patients treated with PD-1/PD-L1 blockade may develop a primary or secondary resistance” to therapy (Sharma, Hu-Lieskovan et al. 2017). The hypothesis is that a polyclonal induced B-cell antibody response will be more effective or as effective with improved safety over current monoclonal antibody therapy. IMU-201 is being developed using an active immunization approach to treat cancers that overexpress programmed cell death ligand 1 (PD-L1) by inducing the production of anti-PD-1 antibodies through immunization of patients with a peptide epitope designed to stimulate polyclonal antibodies against PD-1 (Kaumaya et al. 2020).

Trial design

The IMPRINTER study is an open-label dose escalation/dose expansion study of IMU-201 as monotherapy treatment for PD-L1 expressing lung cancer, to evaluate safety, tolerability, and immunogenicity and assess the optimum biological dose (OBD) of IMU-201 to be used for further clinical development. All patients enrolled in the study must have previously received an immune checkpoint inhibitor for their underlying cancer and experienced disease progression. Between 12-22 patients will receive 3 doses of either 10 μg/dose, 50 μg/dose, or 100 μg/dose IMU-201 administered as PD1-Vaxx with Montanide ISA 720 VG adjuvant by intramuscular (IM) injection in the deltoid muscle prior to dose-limiting toxicity (DLT) assessment after 29 days on treatment. Dosing will occur on Day 1, Day 15, and Day 29. At Day 43, tumor progression is evaluated. Patients deriving clinical benefit, will continue treatment at Day 64 and every subsequent 63 days. Values and changes in humoral and cellular immunogenicity data including IMU-201 and PD-1 specific antibodies (IgG, IgM), vaccine-specific cytokine levels, and regulatory and effector T and B cells will be evaluated. The study has completed the second dose cohort and enrollment of the third cohort is scheduled.

Clinical trial identification

NCT04432207.

Editorial acknowledgement

Legal entity responsible for the study

Imugene Limited.

Funding

Imugene Limited.

Disclosure

R. Laeufle: Financial Interests, Personal, Full or part-time Employment: Imugene. T. Bekaii-Saab: Other, Institutional, Advisory Board: Imugene. P. Kaumaya: Financial Interests, Personal and Institutional, Advisory Board: Imugene. T. Phan: Financial Interests, Personal, Expert Testimony: Imugene. N. Ede: Financial Interests, Personal, Full or part-time Employment: Imugene. L. Chong: Financial Interests, Personal and Institutional, Member of the Board of Directors: Imugene. B. Nixon: Financial Interests, Personal, Full or part-time Employment: Imugene. A. Good: Financial Interests, Personal, Full or part-time Employment: Imugene. All other authors have declared no conflicts of interest.

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