FDA approves Imugene to commence human trial for lung cancer immunotherapy

Biopharma company Imugene (ASX: IMU) is now on their way towards commercialisation of their lung cancer treatment with approval from the US Food and Drug Administration (FDA) to commence human trials.

With the project name PD1-Vaxx in the US, the approval enables Imugene to commence recruiting patients for a clinical trial of the treatment on non-small cell lung cancer patients.

“Receiving our IND approval for PD1-Vaxx from the FDA is a crucial step forward for Imugene,” said Imugene CEO, Leslie Chong.

“The start of our USA study is a significant milestone for Imugene and also clinicians treating Americans faced with the challenge of lung cancer.

“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential.”

The Phase I trials will commence at the Hackensack University Medical Center in New Jersey while additional trials are planned to commence at the Mayo Clinic in Phoenix Arizona and Ohio State University Medical Center. Upon completion of these trials. Imugene is expecting to determine the optimal dose as a monotherapy while also measuring immune response and efficacy.

PD1-Vaxx is a B-cell immunotherapy which is designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction which can produce anti-cancer responses.

Although not yet generating revenue, Imugene has been well supported by institutional investors that raised $26m in capital for Imugene through FY20, with the Company expecting to have four of their products undergoing clinical trials by the end of FY21.