Earnings release
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ASX Announcement IMUGENE Quarterly Activities and Cash Flow Report Quarter ended 31 March 2021 SYDNEY , Australia , 23 April 2021 : Imugene Limited ( ASX : IMU ) , a clinical stage immuno - oncology company , is pleased to announce its Quarterly Cash Flow report ( Appendix 4C ) for the quarter ended 31 March 2021 . Key highlights this quarter include : • $ 29.4m cash balance as at 31 March 2021 Quarterly research and development expenditure was $ 3.9m • HER - Vaxx presentation at the American Association of Cancer Research ( AACR ) • CF33 presentation at the American Association of Cancer Research ( AACR ) • PD1 - Vaxx cohort 2 enrolment completed Imugene included in the All Ordinaires for the S & P Dow Jones Indices Update on Clinical Trials HER - Vaxx Recruitment of the Phase 2 trial was completed in January 2021. Imugene's Chief Medical Officer Dr Rita Laeufle presented on the HER - Vaxx cancer immunotherapy program at the American Association for Cancer Research ( AACR ) 2021 Annual Meeting . The abstract presentation was entitled ' A PHASE 1B / 2 OPEN - LABEL STUDY WITH RANDOMIZATION IN PHASE 2 OF IMU - 131 HER2 / NEU PEPTIDE IMMUNOTHERAPY PLUS STANDARD OF CARE CHEMOTHERAPY IN PATIENTS WITH HER2 / NEU OVEREXPRESSING METASTATIC OR ADVANCED ADENOCARCINOMA OF THE STOMACH OR GASTROESOPHAGEAL JUNCTION . The AACR presentation , which was subsequent to the end of the quarter highlighted and presented the following new data ; • Treatment with HER - Vaxx clearly demonstrates that all patients develop high levels of HER2- specific antibodies early in the treatment protocol . • Analysis of the antibody data reveals high levels are maintained during the treatment and maintenance phases , with only minimal booster injections of HER - Vaxx required to maintain the high levels . The constant and high HER2 antibody levels correlate with the early separation of the Kaplan Meier ( KM ) Curves for overall survival ( OS ) and progression free survival ( PFS ) clinical trial endpoints . The Kaplan Meier Curve provides a recognised statistical estimation of the survival function which visually represents the probability of an event occurring for each treatment arm at a respective time interval . Overall , this interim data is suggestive that the treatment is effective and well tolerated with an overall survival benefit that is superior to chemotherapy alone . Final tumour response , correlation of antibodies with tumour response , and final PFS and OS data is expected to read out in 2021 . PD1 - Vaxx : The first - in - human , Phase 1 , multi - centre , dose escalation study of PD1 - Vaxx is recruiting patients with non- small cell lung cancer who has progressed from previous therapies . Medical investigators are testing three different doses of PD1 - Vaxx . The primary goal of the Phase 1 trial is to determine safety and an optimal biological dose as a monotherapy ( mOBD ) . Efficacy , tolerability and immune response will also be measured . Determination of mOBD will be made by the Cohort Review Committee ( CRC ) and requires successive dosing within cohorts of at least 3 patients each . IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM info@imugene.com