Abstract 194P
Background
The induction of immunogenic cell death by thermal ablation (TA) with local immunostimulation is a novel approach to address advanced, immune “cold”, treatment-refractory cancer. Glycated N-acetylglucosamine polymer, IP-001® , is a novel immune stimulant that drives the activation of innate immune cells through multiple pathways (Stimulator of Interferon Genes STING, Inflammasome, and others) and acts as an antigen depot, which may enhance downstream adaptive anti-tumor immunity. When combined with TA, IP-001 stimulated abscopal effects at distant, untreated tumors, and immune memory in animal models. Safety of IP-001 was tested in the phase IB part of the SAKK66/17 phase 1b/2 trial.
Methods
Patients (pts) with advanced solid tumors who have failed standard treatment received up to 6 four-week cycles of TA using a laser device (TRANBERG Thermal Therapy System) on an accessible lesion at a time followed by intratumoral injection of IP-001 (single dose of 4 ml, with possible de-escalation). Primary endpoint: Dose limiting toxicities (DLTs). Key secondary endpoints: Disease control per RECIST/iRECIST and safety.
Results
Four pts (2F/2M) were enrolled; 2 NSCLC; 1 leimyosarcoma; 1 follicular thyroid cancer FTC; median age=66-yrs. All pts were metastatic and had received multiple prior lines of chemo- and / or immunotherapies including nivolumab (n=2), olaratumab (n=1) and lenvatinib (n=2). Treatment related AEs of grade ≥ 2, included fatigue (50%), fever (25%), hypotension (25%), maculopapular rash (25%), increased CRP (25%) and abdomial pain (25%). No DLTs were observed and no SAEs were considered related to IP-001.
Conclusions
TA followed by IP-001 at a dose of 4 mL is well tolerated in pts with advanced solid tumors who have failed standard treatment. The combined use of thermal tumor ablation and IP-001® at a dose of 4 ml can safely be administered in patients with advanced solid malignancies with the potential to stimulate an abscopal effect via immune stimulation.
Clinical trial identification
NCT03993678.
Legal entity responsible for the study
Swiss Group for Clinical Cancer Research (SAKK).
Funding
Immunophotonics Inc.
Disclosure
M. Joerger: Financial Interests, Institutional, Invited Speaker, Clinical study activity: Basilea, Bayer, BMS, Immunophotonics, Innomedica, MSD, Novartis, Roche; Financial Interests, Institutional, Other, Clinical study activity: DaiichySankyo; Non-Financial Interests, Personal, Advisory Role: Novartis, AstraZeneca, Basilea, Bayer, BMS, Debiopharm, MSD, Roche, Sanofi. L. Alleruzzo: Financial Interests, Personal, Member of the Board of Directors: Immunophotonics Inc. S.K. Lam: Financial Interests, Personal, Officer: Immunophotonics Inc. D. Anderson: Financial Interests, Personal, Officer: Immunophotonics Inc. W. Chen: Financial Interests, Personal, Officer: Immunophotonics Inc. E. Baskin-Bey: Financial Interests, Personal, Officer: Immunophotonics Inc. T. Hode: Financial Interests, Personal, Member of the Board of Directors: Immunophotonics Inc. All other authors have declared no conflicts of interest.