Slide 1: Updated Survival Analysis from OVATION-2 Trial of IMNN-001 in Advanced EOC
A Phase I/II study of the Safety and Efficacy of IP IMNN-001 in combination with N/ACT in patients newly-diagnosed with advanced EOC: Updated Survival Analysis from OVATION-2 Trial P. Thaker, D. Richardson, A. Hagemann, R. Holloway, M. Reed, M. Bergman, B. Pothuri, S. DePasquale, J. Scalici, A. Bega
Slide 2: Key Takeaways
2 Key Takeaways • OVATION-2 is a randomized, controlled study of IMNN-001, an IL-12 gene immunotherapy, intraperitoneally delivered in combination with neo/adjuvant chemotherapy (N/ACT) in newly diagnosed advanced epithelial ovarian cancer (EOC) • The IMNN-001 nanoparticle-encased gene delivery syst
Slide 3: Background
3 Background Immune approaches in EOC IMNN-001: MoA IMNN-001: Local IP delivery Immunotherapy is considered an IMNN-001 is a novel IL-12 gene IMNN-001 is an IL-12 DNA-based plasmid attractive approach for the treatment of therapy investigational product encased in a lipopolymer nanoparticle EO
Slide 4: OVATION-2 Phase I/II Study in EOC N/ACT +/- IMNN-001
4 OVATION-2 Phase I/II Study in EOC N/ACT +/- IMNN-001 Study Schema (NCT03393884) Consort Diagram SoC N/ACT alone (control arm) R 1:1 IMNN-001+N/ACT (experimental arm) A 15-patient safety lead-in phase 1 monitored a 100 mg/m2 dose of IMNN-001 given IP in combination with N/ACT SoC before opening t
Slide 5: Demographics and Exposure
Demographics and Exposure 5 Demographics (ITT Population) Demographics Control arm Experimental arm Characteristics N/ACT IMNN-001 + N/ACT Overall well-balanced [only somewhat higher risk (N=54) (N=58) group in the IMNN-001 arm (ECOG and stage)] Age (years) Mean (SD) 64.4 (8.3) 64.2 (10.6) Weight
Slide 6: Safety
Safety 6 Safety (Safety Population) Control arm Experimental arm Subjects with at Least One, n (%) (N/ACT) (IMNN-001 + N/ACT) n=58 N=59 Most TEAEs and Serious TEAS related to TEAEs 56 (96.6) 59 (100) STEAEs 21 (36.2) 43 (72.9) treatment were gastrointestinal and cytopenias TEAEs of special interes
Slide 7: Results Efficacy: PFS (Primary endpoint) and Response
Results Efficacy: PFS (Primary endpoint) and Response 7 ITT Response, ITT IMNN-001 Δ3 mo to SoC PFS (14.9 vs 11.9) HR: 0.79 IMNN-001 increased R0 and CRS 3 N/ACT IMNN-001 + N/ACT Endpoint n=54 N=59 Objective Response Rate n (%) PFS 31 (57.4) 31 (53.4) (ORR=CR+PR) prior surgery Best Overall Respo
Slide 8: Results Efficacy: OS
Results Efficacy: OS (13 mo benefit at 31 mo FU) 8 ITT PARPi treated#$ 24 months follow-up IMNN-001 Δ 11.1 mo to SoC OS (40.5 vs 29.4) HR:0.74 IMNN-001 vs SoC (NE vs 37.1) HR:0.41 no ss OS OS IMNN-001+N/ACT IMNN-001+N/ACT SoC N/ACT SoC N/ACT IMNN-001 Δ 13 mo to SoC OS (46.0 vs 33.0) HR:0.69
Slide 9: Limitations and supportive data
9 Limitations and supportive data A remarkable 13-month numerical benefit in OS is detected in this IMNN-001’s benefit signal is further supported by: study with the addition of IMNN-001 to SoC 1L treatment in EOC; 1) Benefit observed in all subgroups analyzed however, this study was not powered
Slide 10: Conclusions
10 Conclusions OVATION-2, a randomized controlled Phase I/II study of IMNN-001, an IL-12 gene immunotherapy, delivered intraperitoneally in combination with neo/adjuvant chemotherapy in newly-diagnosed advanced epithelial ovarian cancer (EOC), was safe and yielded clinically meaningful benefits to
Slide 11: Acknowledgements
11 Acknowledgements To the patients and their families who made this trial possible To the clinical study teams for their excellent work The study is supported by IMUNON Inc. PRESENTED BY: Premal H. Thaker, MD
Slide 12: Lay Summary Slide
12 Lay Summary Slide • What did this research tell us? This OVATION-2 study is a clinical trial exploring the effects of adding an immunotherapy (IMNN-001, a delivery interleukin-12 system) to standard of care chemotherapy (CT) for women with newly-diagnosed advanced stage ovarian cancer. IL-12 is a