Imugene gains guidance for KEY-Vaxx Immunotherapy development

By Meagan Evans. Published at Mar 21, 2019, in Biotech

Imugene Limited (ASX:IMU) has now received and accepted the minutes of its Pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA) for its KEY-Vaxx cancer immunotherapy.

Imugene’s team met with a seven member panel of the FDA Division of Regulatory Project Management Office of Tissues and Advanced Therapies in Washington DC on 8 February 2019.

The purpose of the meeting was to obtain regulatory guidance and agreement of the preclinical, chemistry, manufacturing and controls and clinical development plan to be included in an IND for Imugene’s PD-1 targeting KEY-Vaxx immunotherapy.

The meeting was aimed at seeking guidance on the studies required for Phase 1 clinical development of KEY-Vaxx. Topics addressed included the anticipated clinical indication and the treatment of cancers that overexpress PD-L1 including but not limited to non-small cell lung cancer.

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.

KEY-Vaxx is a B-cell peptide cancer vaccine designed to treat tumours such as lung cancer. It does this by interfering with PD-1/PD-L1 binding and interaction, to produce an anti-cancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

Imugene Managing Director and Chief Executive Officer Leslie Chong said, “The meeting was productive and provided Imugene with a clear roadmap for a successful IND submission and subsequent clinical development of KEY-Vaxx.”

“The FDA panel members encouraged Imugene to pursue the planned IND submission and subsequent clinical studies.”

This announcement comes a week after news that Imugene had dosed the first patient in an open-label, randomised multi-centre Phase 2 study with its HER-Vaxx (IMU-131) cancer vaccine for the treatment of HER-2 positive gastric cancer patients.

This start of the Phase 2 study is an important milestone for Imugene and medical professionals seeking treatments for patients with advanced HER-2 positive gastric cancer who often have very few medical options.

S3 Consortium Pty Ltd (CAR No.433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information only. Any advice is general advice only. Neither your personal objectives, financial situation nor needs have been taken into consideration. Accordingly you should consider how appropriate the advice (if any) is to those objectives, financial situation and needs, before acting on the advice.

Conflict of Interest Notice

S3 Consortium Pty Ltd does and seeks to do business with companies featured in its articles. As a result, investors should be aware that the Firm may have a conflict of interest that could affect the objectivity of this article. Investors should consider this article as only a single factor in making any investment decision. The publishers of this article also wish to disclose that they may hold this stock in their portfolios and that any decision to purchase this stock should be done so after the purchaser has made their own inquires as to the validity of any information in this article.

Publishers Notice

The information contained in this article is current at the finalised date. The information contained in this article is based on sources reasonably considered to be reliable by S3 Consortium Pty Ltd, and available in the public domain. No “insider information” is ever sourced, disclosed or used by S3 Consortium.