Immuno-oncology company Imugene (ASX: IMU) is set to move into the next phase of trials for its proprietary cancer vaccine, known as HER-Vaxx.
The company said that it is now preparing to commence a Phase 2 study of its HER-Vaxx cancer vaccine in gastric cancer patients in early 2019 after completing a Phase 1b study that confirmed “no safety issues” whole showing “an increase of antibody levels at all dose levels”.
The Phase 1b lead-in study tested three doses of HER-Vaxx in combination with the current standard of chemotherapy care – Cisplatin and Fluorouracil or Capecitabine.
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.
“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,” said Leslie Chong, managing director and CEO of Imugene.
The immuno-oncology company said it will report top-line results before the end of this year and plans to start its Phase 2 randomised trial in early 2019.
Completion of Phase 1b and moving into Phase 2 are important milestones which are expected to help Imugene to achieve its ultimate goal – to provide treatment options for patients with advanced gastric cancer that have limited options available.
Moving into the next phase of development
With Phase 1b complete, Imugene says preparations for Phase 2 have already commenced with the next phase expected to ramp up testing of Imugene’s HER-Vaxx treatment.
Imugene has confirmed that 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 primary endpoint is overall survival with a supplementary secondary endpoint set as “progression-free survival”, with the study to be conducted at sites across Asia, Eastern Europe and India where clinicians and patients have difficulty accessing treatments such as Herceptin and Perjeta – two of the markets benchmark drugs marketed by Swiss pharmaceutical company Roche.
Research and development boost
Just last week, Imugene received a significant financial boost in its ongoing research and development (R&D) schedule, in the form of a $1.85 million tax refund provided by Australia’s R&D tax incentive scheme.
The tax incentive effectively subsidises immuno-oncology research activities undertaken by Imugene during the past financial year.
The Australian government currently provides assistance to active biotech and pharmaceutical companies by providing various R&D tax incentives including a refundable tax offset of up to 43.5%.
The thinking behind this support is that financial assistance alleviates the capital expenditure burden biotech companies often face when bringing new drugs to market.
The tax rebate comes during what the company has called its “most significant period of R&D expenditure” with R&D cash outflows totalling $1.65 million last year which means the tax refund more than compensates Imugene for its recent research spend.
At the current time, Imugene is deemed as a “clinical stage immuno-oncology company” which develops a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.
Its work, therefore, qualifies for government tax rebates and the previously mentioned 43.5% tax offset.
One of the key differentiators Imugene wants to prove and get into market is its unique platform technology that seeks to harness the body’s immune system to generate antibodies against tumours – potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody therapies.
Furthermore, its product pipeline includes multiple immunotherapy B-cell vaccine candidates aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies.
“Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become a foundation treatment for cancer,” the company said.