Imugene gains guidance for KEY-Vaxx Immunotherapy development

|

Published 21-MAR-2019 12:30 P.M.

|

2 minute read

Hey! Looks like you have stumbled on the section of our website where we have archived articles from our old business model.

In 2019 the original founding team returned to run Next Investors, we changed our business model to only write about stocks we carefully research and are invested in for the long term.

The below articles were written under our previous business model. We have kept these articles online here for your reference.

Our new mission is to build a high performing ASX micro cap investment portfolio and share our research, analysis and investment strategy with our readers.


Click Here to View Latest Articles

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.



General Information Only

S3 Consortium Pty Ltd (S3, ‘we’, ‘us’, ‘our’) (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 and is for informational purposes only. Any advice is general advice only. Any advice contained in this article does not constitute personal advice and S3 has not taken into consideration your personal objectives, financial situation or needs. Please seek your own independent professional advice before making any financial investment decision. Those persons acting upon information contained in this article do so entirely at their own risk.

Conflicts of Interest Notice

S3 and its associated entities may hold investments in companies featured in its articles, including through being paid in the securities of the companies we provide commentary on. We disclose the securities held in relation to a particular company that we provide commentary on. Refer to our Disclosure Policy for information on our self-imposed trading blackouts, hold conditions and de-risking (sell conditions) which seek to mitigate against any potential conflicts of interest.

Publication Notice and Disclaimer

The information contained in this article is current as at the publication date. At the time of publishing, the information contained in this article is based on sources which are available in the public domain that we consider to be reliable, and our own analysis of those sources. The views of the author may not reflect the views of the AFSL holder. Any decision by you to purchase securities in the companies featured in this article should be done so after you have sought your own independent professional advice regarding this information and made your own inquiries as to the validity of any information in this article.

Any forward-looking statements contained in this article are not guarantees or predictions of future performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results or performance of companies featured to differ materially from those expressed in the statements contained in this article. S3 cannot and does not give any assurance that the results or performance expressed or implied by any forward-looking statements contained in this article will actually occur and readers are cautioned not to put undue reliance on forward-looking statements.

This article may include references to our past investing performance. Past performance is not a reliable indicator of our future investing performance.

 

Discover Small Cap
Biotech Stocks

Join thousands of other Investors following our stock commentary for Free

X