Imugene's gastric cancer immuno-oncology trial advances to Phase 2

By Meagan Evans. Published at Nov 13, 2018, in Biotech

Clinical stage immuno-oncology company, Imugene Limited (ASX:IMU), today announced preparations are underway to begin the Phase 2 study of its HER-Vaxx cancer vaccine in gastric cancer patients early next year.

Phase 2 follows on from the completion of the Phase 1b lead-in study that tested three doses of HER-Vaxx (IMU-131) in combination with current standard of care chemotherapy (Cisplatin and Fluorouracil or Capecitabine).

Encouragingly, medical researchers observed no safety issues and showed an increase of antibody levels at all dose levels.

HER-Vaxx is designed to produce an antibody response against a cancer growth signal receptor protein called HER2 and found on the cell surface in breast and gastric cancers.

The sequential dose escalation study in three groups of patients was designed to evaluate the safety, tolerability, immunology and clinical activity of HER-Vaxx in combination with standard of care chemotherapy and establish the optimal dose for a larger Phase 2 study.

Activities for Phase 2 preparation have already commenced. A new clinical batch of HER-Vaxx has been manufactured, delivered and is waiting in storage for distribution to study sites.

The Phase 2 study will test the efficacy, safety and immune response in 68 gastric cancer patients with metastatic gastric cancer overexpressing the HER-2 protein. The study will be randomised into two arms of either HER-Vaxx plus standard-of-care (chemotherapy) or standard-of-care alone. The primary endpoint is overall survival; secondary endpoint will be progression-free survival.

The Phase 2 trial will be conducted at sites across Asia, Eastern Europe and India where clinicians and patients have difficulty accessing treatments such as Herceptinâ and Perjetaâ marketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in many of these countries.

IMU’s Managing Director and CEO, Leslie Chong, said: “Clinicians at the trial sites observed no vaccine-related toxicities at any of the three doses. We are encouraged by the fact that all vaccinated patients developed increased antibody levels to the HER-2 target protein."

“We look forward to reporting the top-line results before the end of the year and starting the Phase 2 randomised trial early in 2019.”

“Completion of the Phase 1b dose escalating trial and start of the Phase 2 study are important milestones for Imugene, and the many medical professionals seeking treatments for patients with advanced gastric cancer who often have very few medical options," Chong noted.

This latest development comes on the heels of more positive news flow from IMU. Last week, the company revealed it has received a research and development (R&D) tax refund of $1.85 million as part of the Australian government’s R&D tax incentive scheme. This incentive recognises the important immuno-oncology research activities undertaken by IMU during the year.

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.

Australian ASX Small Cap stocks | Why Finfeed.com is Australia’s leading small cap publication

Founded seven years ago, Finfeed.com is Australia’s leading and longest standing website for investor and finance news, education and expert opinion.

Published by StocksDigital, Finfeed was created to report daily on the comings and goings of ASX listed stocks in the small cap market.

As the first digital publication dedicated specifically to this space, Finfeed soon became the most trusted publication in the market, quickly garnering over two million page views – a number that continues to rise.

Finfeed.com provides its readers with informative articles that tackle the latest in market moving #ASX small cap news, plus exclusive content you won’t find anywhere else. It is aimed at those with an interest in investing, market education, company performance, start-ups and much more.

Finfeed.com is the only media organisation operating under the strength of a Financial Services License and is backed by leading journalists and analysts all with brands of their own.

The website aims to inform, educate and entertain with content that drills down into the heart of financial matters.

Finfeed is a leading source of investor and market information, with everything investors need to know about how to invest written in a way that anyone can understand. 

Over the years, the website has expanded beyond exclusively reporting on small caps, to profile Australia’s leading ASX listed small, mid and large caps as well as some of the country’s most successful CEOs and business leaders to find out what makes them tick.

Every day you will find fresh content covering:

Fast Facts

Over 4,000 articles published

Over 2.3 Million Page Views and counting

Over 10,000 followers on social media

Subscriber list growing by 2% monthly

Thanks for subscribing!

X