November 30, 2015
|Avg. Volume (3 mo.)||1.2M|
Income Statement Snapshot
|Net Loss (LFY)||(A$2.4M)|
Balance Sheet Snapshot
*Includes proceeds from A$3.0 million equity raise.
Imugene (“Imugene,” “IMU,” or the “Company”) is an immune-oncology biopharmaceutical company developing HER2 positive gastric and breast cancer immunotherapies. The Company’s lead product is HER-Vaxx, a proprietary HER2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu. HER-2/new 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 I study in patients with breast cancer and the next stage of development will be a Phase Ib/II study in patients with gastric cancer. Imugene’s corporate headquarters are located in Melbourne, Australia with the scientific team in Vienna, Austria.
Imugene’s current market cap of A$14.6 million is far below the average market cap of U.S. companies with early stage cancer trials. The Company is entering a Phase Ib/2a trial with its potential blockbuster drug for gastric cancer, which is the second leading cause of cancer death in the world. HER-Vaxx exhibited strong Phase I results in breast cancer and has a potentially superior mechanism of action as compared to earlier generation t-cell immunotherapies.
- Next generation HER2 cancer immunotherapy therapy using B-cell peptides
- Potentially superior to t-cell vaccines. HER-Vaxx induces the patient to produce its own antibodies against the target, as opposed to t-cell vaccines which produce antibodies from vaccines manufactured outside the body
- This novel approach can cause immune memory, strengthening the immune system response over time
- HER-Vaxx targets three sites (polyclonal response) as opposed to one (monoclonal response) site in currently approved HER2 therapies
- Phase I results displayed a strong antibody and overall immune system response in a patient population in poorer condition than the typical target HER2 population
- 8/10 patients developed anti-HER-2 antibodies, and the antibodies displayed potent anti-tumor activity
- Positive, broad immune system response (increase in Th1 cytokines, increase in memory T & B cells post vaccination, decrease in T reg cells)
- Positive results were seen in metastatic breast cancer patients; other HER2 vaccines have been approved for patients with early-stage breast cancer
- Positive Phase I results provide the basis for a Phase Ib/II trial in HER2 positive gastric cancer
- Projected to begin Phase 1b trial in 1H16, with results reported in late 1H17
- Projected to begin randomized, controlled, double-blinded Phase II trial in 2H17, with results reported in 2H19
- Gastric cancer is the second leading cause of cancer death worldwide (738,000 deaths, or 10.4% of cancer cases)
- Novel mimotope technology platform allows IMU to reverse engineer any antibody and induce a potent antibody response to an identified oncology target
- Four mimotopes (including two checkpoint blockades) to be complete by May 2016