CK Life Sciences is deeply committed to R&D, with a strong focus on developing groundbreaking therapeutics for cancer and cancer supportive care, as well as innovative and accessible cancer diagnostic solutions. Guided by a steadfast dedication to innovation and the application of cutting-edge technologies, we aim to make transformative contributions that improve the lives of cancer patients and redefine the landscape of cancer treatment.
Our pharmaceutical R&D efforts are focused on advancing the development of therapeutic cancer vaccines and novel pain management products, while our cancer diagnostic R&D is targeted at the early detection of cancer using liquid biopsy.
Therapeutic cancer vaccines are a type of immunotherapy that works by harnessing the power of the body’s immune system to fight cancer. We have made significant progress in this field, with pipeline candidates in both clinical and discovery/preclinical stages of development.
How do Therapeutic Cancer Vaccines work?
Seviprotimut-L
Seviprotimut-L is a proprietary polyvalent melanoma cancer vaccine being developed by Polynoma LLC (Polynoma), an oncology-focused subsidiary of CK Life Sciences based in San Diego, United States. Comprising a combination of melanoma-associated antigens derived from three melanoma cancer cell lines, seviprotimut-L works by triggering the body’s immune system to develop antigen-specific antibodies and T cells to combat melanoma cells.
Seviprotimut-L is being tested for the adjuvant treatment of patients 60 years and younger with Stage IIB or IIC melanoma, following definitive surgical resection, to delay recurrence after the melanoma has been resected. Polynoma has received the green light from the U.S. Food and Drug Administration (“US FDA”) to initiate a pivotal Phase III clinical study for seviprotimut-L, under a Special Protocol Assessment agreement.
Results from the data analysis of an earlier clinical trial of seviprotimut-L were encouraging, suggesting enhanced recurrence-free survival (RFS) among those with Stage IIB/IIC melanoma, as well as those under the age of 60. Seviprotimut-L was well-tolerated with adverse events similar to those in patients given placebo. This data was presented at the Society for Immunotherapy of Cancer (SITC) 2019 annual meeting and at the American Society of Clinical Oncology 2020 meeting.
In the second quarter of 2020, Polynoma was granted Fast Track designation by the US Food and Drug Administration (US FDA) for seviprotimut-L for the adjuvant treatment of post-resection Stage IIB/IIC melanoma patients. Fast Track is designed to facilitate the development and expedite the review of drugs that treat serious or life-threatening conditions as well as fill an unmet medical need. Benefits of Fast Track designation include more frequent communication with the US FDA, a rolling submission of the marketing application, and eligibility for Priority Review and Accelerated Approval, if the relevant criteria are met.
Skin cancer is one of the most common cancers diagnosed in the United States and around the world. Amongst the different types of skin cancers, melanoma is the most serious and deadly form. Globally, there are approximately 350,000 cases of melanoma and nearly 60,000 deaths arising from melanoma every year. To date, melanoma remains an unmet medical need, as currently-approved therapies have significant toxicity, and the risk/ benefit ratio may not justify the use of these therapies in patients with earlier stages of melanoma.
The global market of melanoma exceeds US$1 billion and is projected to continue to grow exponentially over the next 5 years. There is at present no vaccine approved for the adjuvant treatment of melanoma.
For additional information on seviprotimut-L and Polynoma, please visit www.polynoma.com.
Other Cancer Vaccines
At the discovery and preclinical development stage, CK Life Sciences has a growing portfolio of therapeutic cancer vaccines designed to target diverse tumour antigens, immune checkpoint proteins, and other key components within the tumour-immune microenvironment. Highlights from preclinical studies of our investigational cancer vaccines have been presented at conferences such as the American Association for Cancer Research annual meeting.
AI-empowered Cancer Vaccine R&D
By leveraging the immense potential of artificial intelligence (AI) and strategically investing in cutting-edge enabling technologies, CK Life Sciences aims to propel the pace of progress in the field of cancer vaccines. We have an ongoing strategic R&D collaboration with XtalPi Inc., a Shenzhen-headquartered technology company specialising in drug discovery powered by AI and automation. By combining our respective strengths, we aim to develop an advanced cancer vaccine R&D platform to enhance the discovery and development of new cancer vaccines. Several advanced AI algorithms have been developed and used to design potential mutated neoantigen peptide cancer vaccines, which are now being screened through in vitro and in vivo experiments to verify their immunogenicity and anti-tumour efficacy.
The management of severe cancer pain generally involves the use of morphine and other opiates. This often results in undesirable side effects. Halneuron® is an analgesic based on the puffer fish toxin, tetrodotoxin (“TTX”), and has the advantage of being non-opioid and non-addictive, with quick onset of action and long-lasting effects.
Halneuron® acts by blocking Nav1.7 voltage-gated sodium channels and is potentially a first-in-class drug for the treatment of pain. Halneuron® is being researched as a platform pain management solution that can be used to address many different types of pain. As an initial indication, Halneuron® is currently being evaluated for the treatment for moderate to severe chemotherapy-induced neuropathic pain (“CINP”). A Phase IIB clinical trial of Halneuron® for the treatment of CINP is ongoing.
Development of Halneuron® is through Nasdaq-listed Dogwood Therapeutics (“DWTX”), formed after a merger between CK Life Sciences’ subsidiary WEX Pharmaceuticals and Virios Therapeutics in October 2024.
For additional information on Halneuron® and Dogwood Therapeutics, please visit ir.dwtx.com/news.
With the alarming rise in cancer rates, there is an urgent need for cancer early detection to enable earlier intervention and better patient outcomes. CK Life Sciences aims to develop innovative, non-invasive and cost-effective liquid biopsy tests that can be widely deployed.
CK Life Sciences has a strategic investment in Pharus, Inc. (Pharus), a cancer diagnostic company focused on the research, development, and commercialisation of liquid biopsy tests, based on analysing tumour-associated biomarkers in blood samples.
Pharus is making good progress in the R&D of their proprietary OncoSweep™ liquid biopsy tests for early detection of lung cancer and pancreatic cancer. In January 2024, Pharus signed a worldwide exclusive license agreement with City of Hope, a major U.S. cancer center, for proprietary microRNA biomarkers relevant to the early detection of pancreatic cancer.
For additional information on OncoSweep™ liquid biopsy and Pharus, please visit www.pharusdx.com.
Apart from our investment in Pharus, we also have several other ongoing in-house cancer diagnostic R&D projects.
