The Silicon Review
Our mission is to build a pipeline of B-cell peptide cancer vaccines and therapeutics.
Imugene is a clinical stage immuno-oncology Australian biopharmaceutical company developing HER-2+ gastric and breast cancer immunotherapies.
The Company’s lead product is HER-Vaxx, a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu. HER-2/neu is a known and validated receptor over-expressed on various tumors including gastric, breast, ovarian, lung and pancreatic cancers. HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer.
Imugene has an option on a specific Mimotope technology, using peptide mimics of conformational epitopes that are commonly recognized by an antibody with antitumor activity, for use in cancer vaccines. These are currently in early research stages.
Imugene acquired HER-Vaxx and the Mimotope technology through the acquisition of Biolife Science Qld Limited in late 2013. Much of HER-Vaxx’s early research was conducted in Europe and the scientific team is located in Austria while the corporate headquarters are located in Melbourne, Australia.
Prime Product: HER-Vaxx
Specifically, the Company’s lead product is the HER-2+ cancer immunotherapy HER-Vaxx, which has now entered a Phase Ib/II clinical trial for gastric cancer.
HER-Vaxx is a HER-2+ cancer immunotherapy that mobilizes a polyclonal antibody response against the tumor receptor HER-2. The HER-2 receptor is expressed on the surface of tumors including gastric, breast, ovarian and pancreatic cancers. This is the same receptor targeted by the monoclonal antibody Herceptin®, which has been successfully marketed for several years in the treatment of cancers expressing this receptor.
HER-Vaxx, since it mobilizes the innate immune system of the patient, is expected to exert a more effective and more durable anti-tumor response than Herceptin® at an anticipated lower cost. HER-Vaxx has already completed a Phase I trial in breast cancer where it was shown to be safe and tolerable and gave strong indications of immunogenicity. A Phase II trial in gastric cancer is now in preparation.
HER-Vaxx has shown success in stimulating the production of lifesaving HER-2 antibodies in early-stage cancer patients enrolled in the initial clinical trial. Its further development is directed towards providing a natural, potentially more potent alternative to Roche’s popular injectable antibody, Herceptin®, which have become one of the world’s bestselling cancer drugs with annual sales in excess of $US6.7 billion.
Imugene is also developing a B cell vaccine, KEY-Vaxx, targeting PD-1 and specifically the same PD-1 binding region of Keytruda®.
HER-Vaxx has successfully completed a Phase 1 study in breast cancer and has commenced in 2017 a Phase 1b/2 study in HER2+ gastric cancer. Gastric or stomach cancer is the second most common cause of cancer-related death in the world and the fourth most commonly diagnosed cancer, with over 1,000,000 new cases diagnosed each year.
The Roadmap Ahead
Imugene in partnership with the Medical University of Vienna is working to discover and develop mimotope-based immunotherapies against validated and new oncology targets. This partnership has the potential to create game-changing B Cell peptide vaccines that would replace or augment conventional monoclonal antibody therapies.
Imugene is also building a pipeline of small molecule immuno-oncology drugs. Arginine is a critical amino acid for the health of cancer-fighting T-cells and depletion of it limits the effectiveness of T-cells to fight tumors.
The Thought Leaders
Leslie Chong, Managing Director, and CEO: Chong most previously was a Senior Clinical Program Lead at Genentech, a member of the Roche family, in the head office in San Francisco. She has over 17 years of experience in leading clinical and department development in oncology. Most recently, she was the clinical operations program lead for the approved MEK inhibitor in cell-signaling targeted therapy, cobimetinib/Cotellic.
Prior to Genentech, Chong was one of the clinical operation head at Exelixis, in development of 14 compounds and molecules. She has also been a member of the clinical operation department at GSK and PPD.
Leslie believes that early development and research innovation has the ability to bring transformative medicine to patients in need.
Paul Hopper, Executive Chairman: Paul Hopper has more than 20 years’ experience in international public company markets, with a focus on start-up and rapid growth companies where he has served as either Chairman, Non-Executive Director or CEO. His focus has been primarily in the life-sciences sector, steering around fourteen public companies in the US, Australia, and Asia.
Paul is an advisor at the Los Angeles-based Cappello Group where he is Head of the Life Sciences and Biotechnology Group responsible for mergers and acquisitions and capital raisings focusing on the biotechnology and life sciences sectors.
He is a Non-Executive Director of Prescient Therapeutics Ltd, Chairman of Viralytics Ltd and founder of Pathway Oncology.