Sponsored

Imugene Limited (ASX:IMU) Marks a Major Breakthrough in HER-Vaxx Phase 2 Trial

Summary

  • Imugene Limited (ASX:IMU) has announced that the crucial clinical endpoint of Progression Free Survival (PFS) has been met in the Phase 2 trial of HER-Vaxx.
  • The final PFS read-out is likely to be released within months.
  • Imugene sees a significant market opportunity for HER-Vaxx, which is targeting patients with metastatic gastric cancer that over-express the HER-2/neu receptor.

Marking a significant breakthrough, Imugene Limited (ASX:IMU) has achieved a clinical milestone for its cancer immunotherapy, HER-Vaxx, which is in Phase 2 gastric cancer clinical trial. Imugene has recently informed that the second clinical endpoint for Phase 2 HER-Vaxx study, i.e., Progression Free Survival (PFS) has now been met.

In January this year, the Company completed the recruitment of patients to the Phase 2 HER-Vaxx clinical trial following the Independent Data Monitoring Committee (IDMC) review of interim analysis safety and efficacy data from the study.

Read More at Here’s Why Imugene (ASX:IMU) Grabbed Headlines on Thursday

Clinical Trial Milestone for HER-Vaxx

As per Imugene, the crucial clinical endpoint of PFS has been met in the Phase 2 trial after the occurrence of a statistically significant required number of PFS events. The Company added that the data from these 24 PFS events will now be evaluated, with the final PFS readout anticipated within months.

Progression-Free Survival and Overall Survival (OS) are the two crucial clinical endpoints of the Phase 2 study.

Last year, the interim data from the Phase 2 study of HER-Vaxx showed positive Overall Survival with a Hazard Ratio of 0.418. The interim analysis found the median OS as 14.2 months for patients receiving HER-Vaxx in combination with chemotherapy, as opposed to 8.8 months for patients treated with chemotherapy alone.

Must Read: Imugene Limited’s (ASX:IMU) HER-Vaxx Delivers Promising Results in Phase 2 Interim Analysis

All in all, the interim data suggested that the treatment with HER-Vaxx is effective & well tolerated, with an overall survival benefit that is better than standard-of-care chemotherapy alone.

Why is HER-Vaxx Trial Targeting HER-2 Positive Gastric Cancer?

Imugene’s Phase 2 HER-Vaxx study is designed to measure the immune response, safety, and efficacy in 36 patients with metastatic gastric cancer that over-express the HER-2/neu receptor. The Company chose HER-2 positive gastric cancer for the study as this type of cancer is not nearly as well served as breast cancer.

In the case of gastric cancer, there is a slightly lower number of patients who are HER-2 positive, and these patients have less access to the approved therapies. However, the disease is much more severe than breast cancer, offering a substantial market opportunity for Imugene’s HER-Vaxx.

The Company selected specific regions to conduct the Phase 2 clinical trial of HER-Vaxx due to the prevailing factors of higher rates of gastric cancer, access, and reimbursement of the standard of care.

Also Read: Imugene’s (ASX:IMU) Q4 2020 is All About HER-Vaxx and PD1-Vaxx Developments

The trial is being conducted at various sites across India and Eastern Europe, where clinicians face difficulty in accessing already approved antibody treatments like Herceptin® and Perjeta®.

As of 1:33 PM AEST, Imugene shares are trading at AUD 0.190.

Do Not Miss: Here is Imugene’s latest update on anti-cancer therapies HER-Vaxx & CF33


Disclaimer
The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Pty Ltd (Kalkine Media, we or us), ACN 629 651 672 and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary. Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyright to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated as or found to be necessary.
   
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK