Noxopharm (ASX:NOX) is focused on developing therapies for various cancer types and the prevention of sepsis, primarily with its lead drug candidate Veyonda®.
Veyonda® is showing early signs of being effective in the treatment of both cancer and septic shock. While our primary focus is on prostate cancer and other solid tumours, Veyonda® is also being examined for use in septic shock associated with moderate to severe COVID-19 and potentially other inflammatory conditions.
According to the World Health Organisation (WHO), over 20% of people will be diagnosed with cancer before the age of 75.[i]
Cancer is a leading cause of death globally, the incidence of cancer diagnoses and cancer death rates are growing worldwide. In 2020, there were an estimated 19.3 million new cancer cases globally, and almost 10 million cancer deaths .[ii]
It is estimated that by 2040, there will be 30.2 million new cancer cases per year, and 16.3 million cancer deaths.[iii]
Female breast cancer is the most commonly diagnosed cancer, followed by lung, colorectal, prostate and stomach cancers.[iv] Lung cancer is the leading cause of cancer death, with an estimated 1.8 million deaths, followed by colorectal, liver, stomach and female breast cancer.[iv]
The impact of the COVID-19 pandemic on future cancer rates is currently unknown. It is expected that due to health system closures, suspension in screening programs and reduced access to care there will be delays in diagnosis and treatment of cancer resulting in a short-term decline in cancer incidence followed by increases in advanced-stage diagnoses and cancer deaths.[v]
Prostate cancer is the second most common cancer in men worldwide and is the second leading cause of cancer death in men.[vi] According to the American Cancer Society,1 in 8 American men will be diagnosed with prostate cancer during their lifetime [vii] and in Australia it is the most common cancer amongst males and second most common cancer overall.[viii]
Despite significant advances in the treatment of prostate cancer many men still succumb to this disease. The fatality rates are largely due to the most advanced stage of the disease where the cancer has spread throughout the body and is no longer responding to hormonal treatments – metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC have limited survival prospects, with the median survival time being approximately 13 months.[ix]
At the latest stages of mCRPC, palliative radiotherapy may be offered to alleviate the patients’ symptoms but does not offer any curative prospects. In Australia, the AIHW estimates that 34% of all prostate radiotherapy doses are for palliative radiotherapy in advanced cancer.[x]
Sarcomas are a group of rare cancers that develop from cells in the body’s supporting tissues. They are complex malignancies that cannot be cured, once surgical removal is no longer possible.
In the US, each year, up to 16,000 new sarcoma cases are diagnosed, and up to 6,000 related deaths are recorded. Tragically, sarcoma is among the top 5 causes of cancer deaths for those aged under 20 years of age.[xi]
Surgery is the principal treatment for soft tissue and bone sarcomas, when the cancer is localised. Chemotherapy and/or radiotherapy are sometimes administered in addition, according to the type of sarcoma, its grade, its location and the results of the surgery.
Unfortunately, over the last few decades, outcomes for most types of sarcomas have not improved significantly and the standard-of-care treatment for metastatic soft tissue sarcoma remains doxorubicin, a chemotherapy that has been in use since 1969.
The unmet clinical need for more effective sarcoma treatment is substantial and regulators such as the FDA, through its Office of Orphan Products Development (OOPD) offer a range of incentives for drug development companies to develop products for rare diseases. These incentives include grants, tax incentives, research design assistance, FDA fee waivers, and 7-year market exclusivity.
Breast cancer is now the most common cancer diagnosis worldwide, with increasing rates in later life.
According to the WHO there were 2.3 million women diagnosed with breast cancer and 685 000 deaths globally in 2020. As of the end of that year there were 7.8 million women alive who were diagnosed with breast cancer in the past 5 years, making it the world’s most prevalent cancer.[xii]
Lung cancer is the most common cause of cancer death worldwide.
In the US the five-year survival rate for lung cancer is 60% when the disease is detected when it is still restricted to the lungs. Unfortunately, only 18% of lung cancer cases are diagnosed at an early stage, before spread has occurred. Once lung cancer has spread to distant parts of the body the five-year survival rate drops to 6%.[xiii]
Septic shock is a lethal condition associated with severe tissue damage associated with viral infections like COVID-19 as well as bacterial infections, extensive surgery and trauma.
According to a recent study, septic shock is responsible for an estimated 10 million deaths globally each year, accounting for about 20% of all deaths.[xiv] Currently there is no effective treatment for septic shock beyond supportive intensive care, including mechanical ventilation.
Sepsis is associated with a phenomenon known as cytokine release syndrome (CRS), or cytokine storm. This ‘storm’ leads to a life-threatening condition known as septic shock, associated with a broad range of long-term disabilities in both young and older patients, and death in severe cases. Septic shock is not specific to COVID-19, although the death rate from the pandemic in 2021 stands at over 4 million,[xv] many of which are believed to involve CRS and septic shock.
[ii] Bray F, Laversanne M, Weiderpass E, Soerjomataram I. The ever-increasing importance of cancer as a leading cause of premature death worldwide. Cancer. In press. https://doi.org/10.1002/cncr.33587
[iv] Sung, H, Ferlay, J, Siegel, RL, Laversanne, M, Soerjomataram, I, Jemal, A, Bray, F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021: 71: 209-249. https://doi.org/10.3322/caac.21660
[v] Maringe, C., Spicer, J., Morris, M., Purushotham, A., Nolte, E., Sullivan, R., Rachet, B., & Aggarwal, A. (2020). The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study. The Lancet. Oncology, 21(8), 1023–1034. https://doi.org/10.1016/S1470-2045(20)30388-0
[ix] Moreira DM, Howard LE, Sourbeer KN, Amarasekara HS, Chow LC, Cockrell DC, Pratson CL, Hanyok BT, Aronson WJ, Kane CJ, Terris MK, Amling CL, Cooperberg MR, Freedland SJ. Predicting Time From Metastasis to Overall Survival in Castration-Resistant Prostate Cancer: Results From SEARCH. Clin Genitourin Cancer. 2017 Feb;15(1):60-66.e2. https://doi.org/10.1016/j.clgc.2016.08.018
[xi] Gage MM, Nagarajan N, Ruck JM, et al. Sarcomas in the United States: Recent trends and a call for improved staging. Oncotarget. 2019;10(25):2462-2474. 2019 Mar 29. doi: 10.18632/oncotarget.26809
[xiii] National Cancer Institute. Surveillance, Epidemiology and End Results Program https://seer.cancer.gov/statfacts/html/lungb.html
[xiv] Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study Rudd, Kristina E et al. The Lancet, Volume 395, Issue 10219, 200 – 211. https://doi.org/10.1016/S0140-6736(19)32989-7