Next Investors logo grey

Imugene releases encouraging HER-Vaxx trial results


Published 02-APR-2019 10:22 A.M.


5 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), a leading clinical stage immuno-oncology company, has today released new data on the Phase lb study of its HER-Vaxx cancer vaccine at the American Association for Cancer Research (AACR) 2019 Annual Meeting in Atlanta, Georgia.

The poster (abstract number 8249) was presented by Professor Ursula Wiedermann from the Medical University Vienna, the lead-inventor of the HER-Vaxx cancer vaccine and member of IMU’s Scientific Advisory Board.

Wiedermann provided the update with a well-known research team at the Medical University Vienna.

Highlights of Professor Wiedermann’s presentation include:

  • 11 of 14 patients were evaluable for vaccine-specific immune responses and tumor response assessment
  • Of the three evaluable patients treated at the highest dose of 50 micrograms in cohort 3, all showed a partial response with two demonstrating greater than 40 per cent reduction in tumor size from baseline to day 56 (eight weeks)
  • Patients in cohort three who received the highest dose of 50 micrograms recorded high antibody levels which correlated with clinical responses and reduction in tumor size
  • Higher antibody (HER-2 specific IgG) levels were observed in patients in cohort two who received a 30 microgram dose compared to those in cohort one who received a lower 10 microgram dose, showing clear dose-dependence of HER-2 specific antibody production
  • Three of five patients in cohort two displayed moderate or little increase in antibody tests. In contrast, all patients in cohort three who received a 50 microgram dose showed a marked increase of HER-2-specific antibody levels after vaccination
  • Of the patients evaluable for best response, one showed complete response, five showed a partial response and four showed a stabilisation of their disease
  • Antibodies present in the serum of one cohort three patient at day 56 correlated with strong tumor reduction and showed capacity to inhibit HER-2 phosphorylation, one of the key mechanisms of antibody derived anti-tumor effects
  • Moreover, in patients with a marked decrease in tumor size, the percentage of T regulatory cells declined
  • The vaccine was well tolerated and safe with antibody responses at the highest dose of 50 micrograms with no significant local or systemic reactions
  • No serious adverse events related to administration of HER-Vaxx (IMU-131) were reported. A dose of 50 micrograms was recommended for further evaluation in the Phase II trial, featuring two arms of either HER-Vaxx plus chemotherapy or chemotherapy alone.

IMU Managing Director and CEO Leslie Chong commented on the update, “We are encouraged by the overall positive data from the Phase lb trial which clearly supports our B-cell platform cancer vaccine strategy for treating HER-2 positive gastric cancer.”

The abstract presentation was entitled ‘A Phase lb open label multicentre study with a HER-2/neu peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy shows safety, immunogenicity and clinical response in patients with a HER-2/neu overexpressing advanced cancer of the stomach’.

It was authored by Professor Wiedermann and researchers at the Medical University of Vienna in Austria and IMU.

More data

In addition, IMU announced that Dr Tanios Bekaii-Saab from the Mayo Clinic also presented new data on the KEY-Vaxx and B-Vaxx cancer vaccine programs at the AACR 2019 Annual Meeting.

The key finding of the KEY-Vaxx presentation demonstrated that it, combined with B-Vaxx, is more effective in reducing tumor growth in a validated mouse model of colon carcinoma versus either the PD-1 monoclonal antibody.

This vaccine combination was found to be safe and did not appear to exhibit toxicity or autoimmunity. IMU is now working to evaluate KEY-Vaxx and its potential efficacy in a range of cancers. Its KEY-Vaxx treatment is a B-cell peptide cancer vaccine designed to treat tumors such as lung cancer, by interfering with the PD-1/PD-L1 binding and interaction, and produce an anti-cancer effect similar to other immune checkpoint inhibitor monoclonal antibodies.

The presentations were entitled 'Development of a novel PD-1 vaccine and in combination with two Chimeric HER-2 peptide vaccine provides synergistic inhibition of tumor growth in a syngeneic Balb/c model challenged with CT26/HER-2 carcinoma cell line' and 'A phase 1 Active Immunotherapy Trial With a Combination of Two Chimeric Human Epidermal Growth Factor Receptor 2 (HER-2) B Cell Peptide Vaccine Emulsified in ISA 720 and Nor-MDP Adjuvant in Patients With Advanced Solid Tumors'.

They were authored by Dr Saab (Mayo Clinic Cancer Center, Phoenix, Arizona) and researchers including Professor Kaumaya at the Ohio State University, Colombus, Ohio (and others).

About IMU

IMU’s HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies and now in Phase I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

A Phase II HER-Vaxx study was initiated in March 2019.

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.