- Imugene (IMU) receives US FDA Investigational New Drug (IND) approval for two new drug candidates
- The first approval gives Imugene permission to begin patient recruitment and dosing for the nextHERIZON study in advanced gastric cancer
- The second allows the initiation of a Phase 1 clinical trial of the company’s oncolytic virotherapy candidate, VAXINIA
- The company says achieving concurrent approvals for its programs is an outstanding result for the team
- Imugene last traded at 51.5 cents on December 10
Imugene (IMU) has received US Food and Drug Administration Investigational New Drug (IND) approval for two new drug candidates.
The first grants approval to initiate a new phase 2 clinical trial of its immunotherapy candidate, HER-Vaxx.
The approval gives Imugene permission to start patient recruitment and dosing for the nextHERIZON study in HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction, commonly known as Advanced Gastric Cancer (AGC).
The nextHERIZON study is designed to analyse the safety and efficacy of the drug to support the further development of HER-Vaxx in cancer after progression with trastuzumab. All patients must have received trastuzumab and progressed after one litre to be eligible for enrolment.
The company previously found increasing the number of cytotoxic immune cells within the tumour microenvironment (TME) via the use of immunotherapies such as HER-Vaxx has been promising.
Based on pre-clinical data, HER-Vaxx may also synergize with PD-1 targeting immune checkpoint inhibitor pembrolizumab and therefore serve as a potentially better tolerated and chemotherapy-free treatment opportunity in metastatic patients.
The second approval allows the initiation of a Phase 1 clinical trial of the company’s oncolytic virotherapy candidate, VAXINIA.
The approval allows Imugene to start patient recruitment and dosing in a Phase 1 clinical trial for a metastatic or advanced solid tumors study in multiple solid tumour type patients.
This is an open-label, dose-escalation, multi-centre phase I study evaluating the safety of CF33-hNIS,which can be administered via either intratumourally (IT) or intravenously (IV).
“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s and City of Hope’s research and development teams as we continue to build on our clinical and commercial potential,” said Imugene MD & CEO Leslie Chong.
“To achieve two INDs for our programs concurrently is an outstanding result for the team.”
Imugene last traded at 51.5 cents on December 10.