Imugene Ltd (PK)【IUGNF】株式ニュース

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IMUGENE LIMITEDACN 009 179 551WWW.IMUGENE.COMinfo@imugene.comASX Announcement Imugene’s HER-Vaxx shows positive Overall Survival with Hazard Ratio of 0.418in Ongoing Randomized Phase 2 Trial in AdvancedGastric Cancer.

•Interim analysis in the randomized Phase 2 showed statisticallysignificant overall survival Hazard Ratio (HR) of 0.418 (80% 2-sided CI: 0.186, 0.942); HER-Vaxx showed a reduced risk of death of 58.2% in the HER-Vaxxplus chemotherapy group as compared to chemotherapy alone.•Themedianoverall survival (OS) for patients receiving HER-Vaxx plus chemotherapy was 14.2 months, compared to 8.8months in patients treated with chemotherapy alone.•The Phase 2 data represent a clinical proof-of-concept signal for HER-Vaxx when added to chemotherapy and indicate that B-cell activating immunotherapyvaccines can induce clinically active antibody responses.•The Independent Data Monitoring Committee (IDMC) confirms a favourable survival outcomewith no added toxicityforHER-Vaxx combinedwith SOC chemotherapyover chemotherapy alone and advises to lower the number of patients required for study completion. Sydney, Australia, 23November2020:Imugene Limited(ASX:IMU),a clinical stage immuno-oncology company,is pleased to share positive interim data from its ongoing Phase 2 study of HER-Vaxx in Her-2/Neu overexpressing advanced/metastatic gastric/GEJcancer.HER-Vaxx Phase 2 interim analysis safety and efficacy data were reviewed at the IDMCmeeting.As a result of the review, theIDMC reported no safety concernsand viewed this preliminary data as strongly in favour of a HER-Vaxxsurvival effect. The interim analysis results from this clinical proof-of-concept study,which was designed with a specified 1-sided false positive probability of 0.10,showedtwice as many patients survived on the HER-Vaxx plus SOC chemotherapy treatment arm compared totheSOC chemotherapy control arm. This translated into an overall survival HR of 0.418 (80% 2-sidedCI: 0.186, 0.942) witha statistically significant 1-sided p-value of 0.083. There was no difference in safety eventsbetween the two treatment arms, suggesting that HER-Vaxx does not add toxicity to SOC chemotherapy. The longestHER-Vaxx treated patient remains on therapy and progression-free 16.3 months after dosing. Historical
2IMUGENE LIMITED ACN 009 179 551 data fromthe ToGA Phase 3 study which examined the effect of Herceptin plus chemotherapy versus chemotherapy alone in advancedgastric cancer, had an overall survival HR of 0.74for the intent-to-treat analysis. The study included thesame patient population of HER2 overexpressing patients in the HER-Vaxx Phase 2 study. The IDMC provided guidance that it is scientifically and ethically appropriate to reduce the overall number of patients required to complete the studygiven the strong signal observed in the data. Imugene’s MD & CEO, Mrs Leslie Chong said, “I am delightedto report that we have achieved this significant milestonefor patients with advanced gastric cancer. I am excited that the interim analysis favoured the survival outcome for HER-Vaxx and the IDMC suggested to shorten the study by lowering the number of patients. This data represents a clinical proof-of-concept for HER-Vaxx and supports our B-cell activating immunotherapy platform. I look forward to updating the market as the data matures.” Imugene’s HER-Vaxxis a B-cell peptide cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies, in Phase Iand now Phase 2 studiesto stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.The Phase 2 HER-Vaxx study is designed to measure the efficacy, safety and immune response in 68 patients with metastatic gastric cancer overexpressing the HER-2 protein. The study is randomised into two arms of either HER-Vaxx plus standard-of-care chemotherapy or standard-of-care chemotherapyalone. The primary endpoint is overall survival and secondary endpoint will be progression-free survival. Safety, tolerability and immune response will also be measured.The Phase 2 trial is being conducted at multiple sites across Eastern Europe and India where clinicians have difficulty accessing approved antibody treatments such as Herceptinâand Perjetaâmarketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in the countries selected. Full study details can also be found on clinicaltrials.gov under study ID: NCT02795988