The Imugene Limited (ASX: IMU) share price is on course to end the week on a positive note.
In morning trade, the clinical stage immuno-oncology company’s shares are up 8.5% to 38 cents.
This latest gain means the Imugene share price is now up 280% in 2021.
Why is the Imugene share price jumping?
Investors have been bidding the Imugene share price higher today after the release of a positive announcement relating to its oncolytic virotherapy candidate, CHECKvacc.
CHECKvacc, also known as CF33-hNIS-antiPDL1, is Imugene’s novel chimeric orthopoxvirus with robust anti-cancer activity including triple-negative breast cancer (TNBC) xenografts.
According to the release, the City of Hope independent cancer research and treatment centre near Los Angeles has received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a Phase I clinical trial of CHECKvacc (CF33-hNIS-antiPDL1).
The FDA approval of the IND allows Imugene and City of Hope to start patient recruitment and dosing in a Phase 1 clinical trial for TNBC patients.
The company advised that the purpose of this study is to evaluate the safety and initial evidence of efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The trial will involve a dose escalation, followed by an expansion to 12 patients at the final dose, the recommended phase 2 dose.
Leading the trial will be Principal Investigator, Dr Yuan Yuan MD, PhD. Dr Yuan said “Our team is excited to be part of this important study and the search for effective new treatments for triple negative breast cancer as there are limited options for patients.”
“A crucial step forward”
Imugene’s MD & CEO, Leslie Chong, appears to be very pleased with the news.
She said: “City of Hope and Dr Yuan Yuan receiving their IND approval for CHECKvacc from the FDA is a crucial step forward for Imugene. The start of our CF33 OV study is a significant milestone for clinicians treating patients faced with the challenge of triple-negative breast cancer. Accomplishing this goal speaks to the perseverance and dedication of Imugene’s and City of Hope’s clinical and research teams as we continue to build on our clinical and commercial potential.”
The post Imugene (ASX:IMU) share price jumps 8% on FDA update appeared first on The Motley Fool Australia.
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Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.
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