The Japanese Patent Office has issued a decision to allow the patent which will provide commercial rights for ACTIVATE in Japan through to 2033.
This technology uses a patient’s own cancer cells combined with an immune-stimulant designed to re-educate the immune system to target cancer cells in existing and new tumours.
Japanese Patent Application No. 2015-549902 is titled ‘Vaccines for the treatment or prevention of cancer and compositions for enhancing vaccine efficacy’.
Corresponding patent granted in Australia
A corresponding patent has been granted in Australia and Regeneus is pursuing corresponding patents for grant in other key territories including the U.S. and Europe.
The patent supports the company’s RGSH4K clinical programs for humans and Kvax clinical programs for animal health.
Phase I safety study for humans
RGSH4K is being tested in a phase I safety study in humans on a wide range of tumours being conducted through the Northern Cancer Institute at St Leonards in Sydney.
Patients have been treated in all three dose levels without any safety concerns.
This ACTIVATE Trial is expected to complete recruitment and report on the study results in the first half of 2018.
Study for canine osteosarcoma treatment
Kvax has been the subject of a successful U.S. study for the treatment of canine osteosarcoma.
Results showed that Kvax administered after limb amputation is safe and well tolerated.
It appears to confer increased progression free interval and improved survival compared to historically treated dogs with osteosarcoma treated with limb amputation only.
Kvax is also the subject of a study for the treatment of canine lymphosarcoma in combination with chemotherapy.
This is being conducted at the Small Animal Specialist Hospital at North Ryde in Sydney.
The technology was developed by researchers at the Bill Walsh Translational Cancer Research Laboratory at St Leonards.
This is the research arm of the Medical Oncology Department at Royal North Shore Hospital and is part of the Kolling Institute of Medical Research.
Animal survival extended significantly
In a pre-clinical brain tumour model conducted by researchers, vaccination led to remission rates of up to 60% and significantly extended survival in all vaccinated animals.
Re-challenging animals in remission demonstrated 100% tumour rejection indicating acquired immunity.
Regeneus is a clinical-stage regenerative medicine company using patented and scalable stem cell and immuno-oncology technologies to develop a portfolio of novel cell-based therapies.
The company has more than 70 patents or patent applications across multiple patent families relating to its regenerative medicine products.
Last week Regeneus was issued a notice of allowance by the United States Patent Office for a patent related to Sygenus for the treatment of acne.
The patent covers the composition, manufacture and use of the secretion stem cell technology platform, known as Sygenus.