Regeneus (ASX:RGS) has further enhanced its intellectual property position through the grant of the Australian patent for its cancer vaccine technology that will support the company’s RGSH4K and Kvax clinical cancer programs.
The technology uses a patient's own cancer cells combined with an immunostimulant that is designed to re-educate the immune system to target cancer cells in both existing and new tumours.
Under the licence agreement from Northern Sydney Local Health District, Regeneus has exclusive rights to develop and commercialise the cancer vaccine technology for human and animal health applications in all major territories.
The patent provides commercial rights in Australia through to 11 April 2033.
The patent is also being pursued for grant in other key territories including the U.S., Japan and Europe.
In a pre-clinical brain tumour model conducted at the Bill Walsh Translational Cancer Labs which is part of the Kolling Institute of Medical Research, 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.
RGSH4K, which represents a cancer treatment option without many of the side effects of standard chemotherapy, is in a Phase 1 safety study in humans on a wide range of tumours.
Earlier this year, Regeneus safely dosed the first human patient in the RGSH4K clinical trial.
Kvax, which uses the technology for canine tumours, is the subject of a U.S. study for the treatment of canine osteosarcoma, which is fully recruited. Dr Phil Bergman, a renowned veterinary oncologist, of VCA in the USA is conducting the study.
Kvax is also the subject of a recently announced study for the treatment of canine lymphosarcoma in combination with chemotherapy being carried out at the Small Animal Specialist Hospital in Sydney.
The latest grant brings Regeneus' patent and patent applications to 49 across 14 patent families.
Progress on this front follows quickly on the securing of exclusive rights to commercialise world-first cell technology that allows high potency secreting stem cells for the first time ever to be individually identified and selected for the manufacture of next generation cell therapies for human and animal applications.
The technology will enable cellular therapies with high optimal potency secretion profiles to be selected to address the disease in question.
Under the collaboration and licence agreement, the technology's developer, researchers at Macquarie University who are part of the Australian Research Council’s Centre for Nanoscale Biophotonics, grant Regeneus an exclusive licence over key applications of the technology and Regeneus will provide funding for development of the technology and its applications.
This builds on the grant of a key patent last month underpinning Regeneus' Progenza technology, a new-generation cell therapy treatment for osteoarthritis.
This patent secures commercial rights for Progenza in Australia to 2032 and is also being pursued for grant in other key territories including the U.S., Japan and Europe.
Progenza technology is the subject of a Phase 1 study for the treatment of knee osteoarthritis in humans, which began in Q1 FY16 and is scheduled for final safety readout in Q4 FY16.
Grant of the latest cancer vaccine patent for Regeneus helps secure the company’s commercial exposure to its highly prospective RGSH4K and Kvax programs.
This progress emphasises the robustness of the company’s intellectual property portfolio, which has been significantly consolidated in recent weeks, notably with the securing of commercial rights to the Macquarie University high potency cell selection technology.
This is considered a significant breakthrough as the technology opens the door to better understanding and control of a whole host of diseases representing large global markets.
Rights to these emerging products put Regeneus in an important first-mover position within markets projected to grow at extremely fast rates in the coming years.
Progenza is targeting a global market valued at US$12 billion while the company’s oncology and skin care programs are focused on markets valued at US$33 billion and US$3 billion, respectively.
As marketing trials in the U.S. and Australia continue, Kvax is positioned to benefit from an animal oncology market valued at US$550 million.