Harnessing the body’s own immune system is one of the most exciting ways forward in the ongoing battle against cancer. CAR-T cell therapy, an exciting new form of immunotherapy, has been the focus of our client Carina Biotech since the company’s inception. In February this year, Carina took a large step forward toward the clinic and received a “Safe to Proceed” letter from the US Food and Drug Administration (FDA). This letter means that Carina can proceed with clinical trials of their CAR-T cell therapy targeting advanced Colorectal Cancer.
Beginning as a start-up in 2016, Carina Biotech is an Adelaide-based Immuno Oncology company, focussed on CAR-T cell therapy. CAR-T cell therapy is a form of cancer treatment that involving modifying the body’s own immune cells to specifically target and kill cancer cells. Already an established industry in the United States, China, and Europe, the CAR-T cell industry is still only a fledgling industry in Australia. This puts Carina in a very favourable position as both a local success story, and as an example of how the right team and IP protection can help in a start-up’s journey from foundation to commercialisation – having already developed and transferred one proprietary targeted CAR-T to a UK-based company and now developing their lead CAR-T program.
Carina’s CNA3103 CAR-T cell is designed to target advanced colorectal cancer, the second deadliest cancer in Australia, and one of the most dangerous for young Australians. Unlike older members of the community, young Australians aren’t screened as often and usually don’t present with any symptoms until the cancer has reached advanced stages. Patients diagnosed with advanced colorectal cancer are generally given a nine-month terminal prognosis, and current treatments such as radiotherapy and chemotherapy aren’t curative, highlighting the need for new forms of treatment.
The CNA3103 CAR-T cell targets a protein known as LGR5, a market of rapidly dividing colorectal cancer cells. The patient’s white blood cells are modified to seek out this protein and destroy it, breaking down the targeted cancer cells. The US FDA approved a phase 1/2 clinical trial to test the safety, dosage requirements and preliminary efficacy of Carina’s LGR5 CAR T-cell. This means that Carina can begin recruiting patients. The clinical trial will be the first use of the CNA3103 CAR-T cell in humans and marks an exciting milestone not just for Carina Biotech, but also for the future of cell therapy as a form of cancer treatment.
So far, CAR-T cell therapy has shown remarkable success in treating blood cancers such as leukemia and lymphoma, however treatment of solid tumours has proved more difficult. Carina’s CAR-T clinical trials could mark a huge breakthrough and change the face of cancer therapy and treatment. Immunotherapies have provided patients, researchers and clinicians with exciting new opportunities for cancer treatment over the last decade and offer potential cures for cancers that have traditionally not responded to other treatments. CNA3103 is another piece in this much larger puzzle. It is hoped that the results of Carina’s clinical trials will bring the industry closer to more effective treatment for solid tumours and enhance understanding of CAR-T cells in this space.
Furthermore, approval by the US FDA should streamline approval from Australia’s Therapeutic Goods Administration (TGA) – welcome news for Carina’s small but dedicated team who have had to focus on meeting the exhaustive requirements for preclinical data and meeting the regulatory bodies’ administrative requirements.
Carina was founded by Dr Justin Coombs – a previous Phillips Ormonde Fitzpatrick Patent Attorney. As a result of this experience, Justin understood the integral role that IP plays when establishing a company in the biotech space, and instilled the importance of IP and its proper protection at a foundational level. This is something that is becoming increasingly important for new and emerging companies – the value of your IP cannot be understated. A strong portfolio can be an incredibly valuable asset as you grow, and having a team that properly understands your technology is just as important as the team of scientists carrying out the work. Our multi-disciplinary approach of always providing the attorney with the best matched skillset worked perfectly with what Carina has required. In particular, Dr Leigh Guerin and Dr Scott Whitmore in our Adelaide office have been very proud of the role that they’ve been able to play in assisting Carina get their CAR-T cell therapy to this stage.
The green light for CNA3103 for clinical trial is just the first big milestone for Carina as the company looks ahead to what lies in the future. The team already has plans to begin building on their other platforms related to maximising the efficacy of CAR-T cell therapy. Currently, Carina is working with others to develop a platform to increase the ability of CAR-T cells to locate and invade to cancers. Additionally, LGR5 is known to be associated with other forms of cancer meaning that Carina’s LGR5 CAR-T cell could be tested on other cancers, such as ovarian cancer.
Carina is a fantastic success story that demonstrates what the right team of leaders and researchers, in combination with the right IP protection, can achieve as Carina builds from humble foundations. We’re excited to watch Carina progress along their journey, however, their story also serves as testament to the value that a robust IP portfolio can provide, and how the right team of IP professionals can help you build one for yourself, or improve the one you may already have. Your IP team should be more than just attorneys and lawyers, they should be scientists, engineers, and industry experts who understand the breadth and depth of your technology. And we’re proud to have been able to provide this for Carina.