IN recognition of June as Cancer Immunotherapy Month, the Head and Neck cancer team in Cancer Research Malaysia (formerly known as Cancer Research Initiatives Foundation), would like to share the work we are doing in this sphere.
In 2016, Dr Julie Vose, president of the American Society of Clinical Oncology (Asco), declared, “No recent advance has been more transformative than the rise of immunotherapy, particularly over this past year, making immunotherapy the American Society of Clinical Oncology’s (Asco’s) Advance of the Year.”
This year (2017), Asco has once again named Immunotherapy 2.0 as the Advance of the Year, in recognition of the significant progress using cancer immunotherapy which has extended and improved the lives of patients, many of whom had few other effective treatment options.
Cancer immunotherapy has emerged as the new growth frontier for pharmaceutical companies involved in the clinical research and development of cancer drugs and therapeutics.
Globally, there are over 200 drugs or therapies in the clinical pipeline, mostly in pre-clinical, Phase I and Phase II.
So, what is immunotherapy and why is Cancer Research Malaysia (CRM) working on developing this treatment for head and neck cancers?
In its simplest explanation, cancer immunotherapy is a way to teach your immune system that cancer cells are the bad guys and need to be eliminated.
There are several types of cancer immunotherapy, for example cancer vaccines, that activate the immune system to attack cancer cells.
And then there are those, such as checkpoint inhibitors, that take the “brake” off the suppressive arm of the immune system.
Pembrolizumab and nivolumab, which have been approved by the United States’ Food and Drug Administration (US FDA) for use to treat head and neck cancers, are in the immune checkpoint inhibitors category.
In Malaysia, 9,419 cases of head and neck cancers were reported from 2007 to 2011, which is 9.1% of all cancer cases, making it the fourth most common cancer among Malaysians.
The annual incidence of head and neck cancers worldwide is more than 550,000 cases with around 300,000 deaths each year.
However, despite the fact that head and neck cancers are among the most common cancers in South and South-East Asian countries (Malaysia included), the majority of cancer drugs developed for targeted therapy are for cancers of the breast, colon and lymphomas.
This is because these diseases are more prevalent in Western countries.
Therefore, there is a huge gap in the development of targeted therapy for what is termed as “Asian Cancers”.
A little over 10 years ago, the team in CRM successfully identified several antigens (proteins) called MAGE4DB and FJX1 which head and neck cancers are dependent on in order to grow.
This ground-breaking discovery opens up the possibility of developing Malaysia’s first immunotherapy for head and neck cancers.
Just like vaccinations that we receive to alert our immune system about harmful infectious agents, the resulting peptide vaccine, which we are calling PV1, will alert, train and ramp up our immune system to fight head and neck cancer cells.
As PV1 is made to target cancer-specific proteins (which are not present in normal cells), normal cells will be spared.
This is a critical step during the development of cancer therapies in order to keep side effects to a minimum.
The development of PV1 will result in a medical intervention that creates “memory” immune cells, resulting in prevention of recurrent cancers.
It is also unique in several ways: As PV1 is a synthetic peptide vaccine, there is low risk of instability; it meets halal requirements; and it is non-invasive and administered to the patients via injections.
Therefore, PV1 can be integrated into patient care continuum relatively easily.
As PV1 works to trigger the immune system response, it can be coupled with checkpoint inhibitors, another type of immunotherapy, to create a continuous cycle of immune response.
Significantly, MAGED4B and/or FJX1 antigens have also been reported to be expressed in patients with lung, breast and prostate cancers; therefore, PV1 potentially can be used on these cancer patients worldwide.
On the other hand, as it is in the research and development phase, PV1 will require the highest investment commitment.
As a new drug, PV1 may take up to 12 years to move from laboratory into the market.
At the moment, PV1 is in its pre-clinical stage to evaluate its efficacy, toxicity and safety.
To take it to the next stage, a further investment of RM3mil is needed to complete critical tests required by regulatory bodies such as the National Pharmaceutical Regulatory Agency and the US FDA before PV1 can be used in clinical trials (the first testing in humans) by the anticipated date, that is end of 2018.
An enormous amount of talent, money and hours have been invested in this research programme, supported by various grants from, among others, the Science, Technology and Innovation Ministry Malaysia (MOSTI), Honjo International Scholarship Foundation, and L’oreal for Women in Science awards.
Funding has also come from CRM’s donors such as Yasayan Sime Darby and Petronas.
In addition, support from our clinical colleagues from the Oral Cancer Research and Co-ordinating Centre (OCRCC) and Oral Health Division of the Health Ministry was instrumental in ensuring the success of CRM’s cancer immunotherapy programme.
Ultimately, the end goal for CRM is to use our knowledge to develop markers for the early detection of cancers and novel therapeutic approaches for its prevention and treatment as we believe that, together, we can #reversecancer.
Learn more about PV1, our research programmes, outreach and fundraising activities and how you can help by visiting our website at www.cancerresearch.my or facebook.com/cancerresearchmalaysia.
PROF DR CHEONG SOK CHING
Senior Group Leader
Head and Neck Cancer Team
Cancer Research Malaysia