The Imugene Limited (ASX: IMU) share price is on course to start the week with a gain.
In early trade, the immuno-oncology company's shares are up 4% to 53.5 cents.
Image source: Getty Images
Why is the Imugene share price charging higher?
The catalyst for the rise in the Imugene share price on Monday has been the release of two positive announcements this morning.
In respect to the first announcement, the company revealed that it has received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA (CF33-hNIS, HOV2).
This allows Imugene to start patient recruitment and dosing in a Phase 1 clinical trial for the MAST (Metastatic or Advanced Solid Tumors) study in multiple solid tumour type patients.
Imugene's Managing Director and CEO, Leslie Chong, commented: "Imugene receiving this IND approval for VAXINIA from the FDA is a crucial step forward. The start of our VAXINIA OV study is a significant milestone for clinicians treating patients faced with the challenge of solid tumour cancers. 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."
What else was announced?
Also boosting the Imugene share price was news that it has received FDA IND approval to initiate a new phase 2 clinical trial of its immunotherapy candidate, HER-Vaxx.
This allows Imugene to start patient recruitment and dosing for the nextHERIZON study in HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction, also known as Advanced Gastric Cancer (AGC).
Leslie Chong commented: "Imugene receiving this IND approval for HER-Vaxx from the FDA is another important step forward. To achieve two IND's for our programs (OV and B Cell) concurrently is an outstanding result for the team."
It certainly has been a big month for the company. Last week it was announced that the Imugene share price would be added to the S&P/ASX 200 Index (ASX: XJO) at the quarterly rebalance later this month.
