Imugene gets ethics approval to start Phase 1 clinical trial of immunotherapy candidate for lung cancer in the US
Site activation and patient recruitment will proceed after FDA IND approval scheduled for the fourth quarter of 2020.
Company
ASX:IMU
Imugene Ltd is a clinical stage immuno-oncology company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumours. The company's unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Imugene is supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.
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Site activation and patient recruitment will proceed after FDA IND approval scheduled for the fourth quarter of 2020.
The ethics approval represents the third independent review of PD1-Vaxx pre-clinical safety and efficacy data.
The FDA provided feedback on the non-clinical development pathway and adaptive phase one clinical development plans for VAXinia, IMU’s lead oncolytic virotherapy for treatment of solid tumours.
Last month, Imugene received Human Research Ethics Committee approval to begin a phase-I clinical trial of its cancer checkpoint immunotherapy candidate, PD1-Vaxx in Australia.
The ethics approval represents the second independent review of PD-1 Vaxx pre-clinical safety and efficacy.
Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of PD1-Vaxx required to commence human clinical trials.
The research has identified mimotope peptides that when incorporated into Imugene’s proprietary immunotherapeutic vaccine delivery platform generate antibodies.
HER-Vaxx is Imugene’s lead cancer immunotherapy candidate and is currently treating patients in a phase 2 study in gastric cancer.
The Independent Data Monitoring Committee’s role is to review study data and conduct a formal independent review of key data such as deaths, adverse reactions and laboratory results.
The first-in-human phase 1 study of Vaxinia is in patients with advanced or metastatic melanoma, non-small cell lung, TNBC, bladder, head and neck, gastric, colorectal and renal cell cancers.
The company is developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.
The company is developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors.
The company's lead product is HER-Vaxx, a therapeutic cancer vaccine for the treatment of gastric cancer and breast cancer.
The company is developing a range of treatments to activate the immune system of cancer patients.
The company's lead product is HER-Vaxx, a therapeutic cancer vaccine for the treatment of gastric cancer and breast cancer.
The clinical stage immuno-oncology company is developing a range of new treatments seeking to activate the immune system of cancer patients.
The company's lead product is HER-Vaxx, a therapeutic cancer vaccine for the treatment of gastric cancer and breast cancer.
The company's lead product is HER-Vaxx, a therapeutic cancer vaccine for the treatment of gastric cancer and breast cancer.
The company’s preclinical results present an effective treatment against Peritoneal carcinomatosis (PC) from pancreatic ductal adenocarcinoma (PDAC).
Pre-clinical milestones have been met with GMP manufacturing, including final sterile fill and finish as well as processes completed by FDA inspected and qualified contract manufacturing organisations in the US.