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IMUGENE RECEIVES ETHICS APPROVAL TO START PHASE 2 nextHERIZON CLINICAL TRIAL OF CANCER IMMUNOTHERAPY HER-VAXX
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SYDNEY, Australia, 10 May 2022: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase 2 clinical trial of its immunotherapy candidate, HER-Vaxx in Australia.
Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of HER-Vaxx required to commence its nextHERIZON clinical trial in Australia.
nextHERIZON is an open-label, multi-center, signal generating, Phase 2 clinical trial designed to assess the safety and efficacy of HER-vaxx in combination with chemotherapy or pembrolizumab in patients with metastatic HER-2/neu over-expressing gastric or gastroesophageal junction adenocarcinomas who have previously progressed on trastuzumab. The study’s primary endpoints are safety and response rate. Secondary endpoints include duration of response, progression free survival, overall survival, and biomarker evaluation.
The Australian component of the Phase 2 trial will be conducted under Australia’s Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities. The first hospital to receive ethics approval is the Queen Elizabeth Hospital, Adelaide Australia under the direction of Principal Investigator Dr Tim Price. Additional clinical sites will be opened in Australia, and also in the US under Food and Drug Administration (FDA) investigational new drug (IND) approval in December 2021.
Imugene MD & CEO Leslie Chong said “The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of HER-2+ gastric cancer and we look forward to further evaluating HER-Vaxx in combination with pembrolizumab in a relapsed/refractory metastatic setting.”
Full study details can also be found on clinical trials.gov under study ID: NCT05311176
IMUGENE RECEIVES ETHICS APPROVAL TO START PHASE 2 nextHERIZON CLINICAL TRIAL OF CANCER IMMUNOTHERAPY HER-VAXX
_______________________________________________________________________________________
SYDNEY, Australia, 10 May 2022: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase 2 clinical trial of its immunotherapy candidate, HER-Vaxx in Australia.
Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of HER-Vaxx required to commence its nextHERIZON clinical trial in Australia.
nextHERIZON is an open-label, multi-center, signal generating, Phase 2 clinical trial designed to assess the safety and efficacy of HER-vaxx in combination with chemotherapy or pembrolizumab in patients with metastatic HER-2/neu over-expressing gastric or gastroesophageal junction adenocarcinomas who have previously progressed on trastuzumab. The study’s primary endpoints are safety and response rate. Secondary endpoints include duration of response, progression free survival, overall survival, and biomarker evaluation.
The Australian component of the Phase 2 trial will be conducted under Australia’s Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities. The first hospital to receive ethics approval is the Queen Elizabeth Hospital, Adelaide Australia under the direction of Principal Investigator Dr Tim Price. Additional clinical sites will be opened in Australia, and also in the US under Food and Drug Administration (FDA) investigational new drug (IND) approval in December 2021.
Imugene MD & CEO Leslie Chong said “The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of HER-2+ gastric cancer and we look forward to further evaluating HER-Vaxx in combination with pembrolizumab in a relapsed/refractory metastatic setting.”
Full study details can also be found on clinical trials.gov under study ID: NCT05311176