A cancer vaccine uses the immune system to help prevent or treat cancer.
There are two main types:
CRMY-VAC-100 is being developed as a cancer treatment vaccine, not as a routine preventive vaccine.
COVID-19 vaccines train the immune system to recognise a virus and help protect
against infectious disease.
Cancer treatment vaccines are designed for people who already have cancer. They aim to train the immune system to recognise particular markers found on cancer cells and respond more effectively.
Although both approaches involve training the immune system, the diseases they target and the way they are used are different.
Some vaccines can help prevent cancers caused by infections.
For example:
The HPV vaccine can reduce the risk of cervical and other HPV-related cancers.
The hepatitis B vaccine can reduce the risk of liver cancer associated with long-term hepatitis B infection.
These are preventive vaccines. They work by preventing infections that can eventually cause cancer.
They are different from cancer treatment vaccines such as CRMY-VAC-100, which is being developed for people who already have cancer.
Cancer Research Malaysia’s cancer vaccine candidate is called CRMY-VAC-100.
It is an investigational DNA-based therapeutic cancer vaccine designed to help the immune system recognise and attack cancer cells.
CRMY-VAC-100 targets two cancer-associated proteins called MAGED4B and FJX1. It uses a synthetic DNA platform known as doggybone DNA, or dbDNA, to carry the instructions for these targets.
CRMY-VAC-100 remains an experimental treatment candidate. Its safety and effectiveness in patients have not yet been established.
CRMY-VAC-100 is currently being developed to treat people who already have cancer.
Its first clinical development programme is intended to study whether the vaccine can help the immune system respond to existing cancer cells. The proposed Phase 1/2 clinical study would evaluate CRMY-VAC-100 together with pembrolizumab, an immunotherapy medicine, in patients with head and neck cancer.
Our first priority is to determine whether CRMY-VAC-100 is safe and shows benefit in the therapeutic setting.
After we demonstrate that the vaccine works in the treatment setting, we plan to investigate its possible role in cancer prevention. This could include studying whether it may help prevent cancer from returning and, where scientifically appropriate, whether it could benefit people at high risk of developing certain cancers.
These future preventive uses would require separate research and clinical trials.
CRMY-VAC-100 is not a breast cancer vaccine, and it is not a universal vaccine for every cancer.
In principle, CRMY-VAC-100 may be relevant to cancers that express the MAGED4B and FJX1 targets.
Its proposed first clinical development programme focuses on head and neck squamous cell carcinoma, including cancers arising in the oral and head and neck region.
We also have preclinical data showing activity in:
These are laboratory and animal findings, not proof that the vaccine is effective in patients with these cancers. We continue to generate more data to support the possible use of CRMY-VAC-100 in other cancer indications.
Each cancer type would need to be studied separately through appropriate clinical trials before the vaccine could be considered for patient use.
Many new cancer treatments have historically been developed using evidence generated mainly from Western populations.
However, Malaysians and Asians may experience different patterns of cancer, genetic risk factors, environmental exposures and tumour biology. Certain cancers, including oral, head and neck, and nasopharyngeal cancers, also have a particularly significant impact in Asian populations.
Our research aims to develop cancer vaccines that are specifically relevant to patients in our region, so that future treatments may be:
Conducting this research locally also helps Malaysia build expertise in cancer immunology, clinical trials, advanced manufacturing and regulatory science.
Think of the immune system as the body’s security team.
Cancer cells can sometimes avoid detection or hide from this security team. CRMY-VAC-100 is designed to show the immune system what particular cancer targets look like.
The vaccine carries DNA instructions for the MAGED4B and FJX1 proteins. After the vaccine is given, cells use these instructions to display/present the target proteins. This helps the immune system learn to recognise them.
The aim is for immune cells to identify and attack cancer cells carrying the same targets.
Whether this approach works safely and effectively in patients must still be determined through clinical trials.
CRMY-VAC-100 has demonstrated a favourable safety profile in preclinical studies, including laboratory and animal models, with no significant treatment-related toxicities observed at the doses tested.
These studies provide important evidence to support its advancement towards human clinical trials.
However, the safety of CRMY-VAC-100 in patients can only be fully established through carefully conducted clinical trials.
The proposed Phase 1/2 study is designed to evaluate:
Throughout the study, participants would be closely monitored under an approved clinical trial protocol. Safety data would be reviewed by the investigators and an independent safety-monitoring committee.
CRMY-VAC-100 has shown a favourable safety profile in preclinical studies. However, its side effects in humans are not yet known because it has not undergone clinical testing in patients.
Based on experience with other therapeutic cancer vaccines, possible reactions may include:
Injection-site discomfort
Fatigue
Fever or chills
Headache
Muscle or joint aches
Nausea
Other flu-like symptoms
The proposed clinical study would evaluate CRMY-VAC-100 in combination with pembrolizumab. Participants would therefore also be monitored for side effects associated with immunotherapy, including rare but potentially serious immune-related reactions that may cause inflammation in different organs.
Clinical trials are essential to determine the safety profile of the combination and ensure that any side effects are detected, treated and managed promptly.
No. CRMY-VAC-100 cannot currently be described as a cancer cure.
Laboratory and animal studies have produced encouraging findings, including evidence that the vaccine may work together with checkpoint inhibitor immunotherapy.
However, positive findings in research models do not always produce the same results in people.
Human clinical trials are needed to determine:
It is more accurate to describe CRMY-VAC-100 as a promising investigational cancer treatment candidate.
Not every person with cancer would necessarily be suitable for CRMY-VAC-100.
Suitability would depend on factors such as:
The type and stage of cancer
Whether the cancer expresses MAGED4B, FJX1 or both targets
The patient’s general health
Previous and current cancer treatments
Whether the patient meets the clinical trial’s eligibility criteria
A clinical trial team would need to assess every potential participant individually.
Even if CRMY-VAC-100 is approved in the future, doctors would still need to determine which patients are most likely to benefit.
Cancer vaccines are unlikely to replace all established cancer treatments.
Instead, they may become an additional treatment used together with:
Different treatments serve different purposes. Surgery may remove a tumour, while chemotherapy or radiotherapy may destroy cancer cells. A therapeutic vaccine aims to help the immune system recognise and respond to cancer.
The proposed CRMY-VAC-100 study would evaluate the vaccine together with pembrolizumab and standard cancer care. It is not designed to replace surgery or other established treatments.
No. CRMY-VAC-100 is not currently available as an approved treatment at Malaysian hospitals or elsewhere.
It remains an investigational cancer vaccine candidate.
Before it could become available to patients, it would need to complete several important stages:
Clinical-grade vaccine manufacturing
Quality-control and stability testing
Regulatory and ethics approvals
A Phase 1/2 clinical study
Larger clinical trials, if the early findings are encouraging
Review and approval by the relevant health authorities
A major next step is securing sufficient funding for vaccine manufacturing, regulatory preparations and the proposed Phase 1/2 clinical study.
Without this funding, the clinical development programme cannot proceed as planned.
Cancer treatment development may take many years, and not every candidate successfully completes clinical trials. It is therefore too early to provide a reliable date for public availability.
There is currently no active CRMY-VAC-100 clinical study recruiting patients.
Cancer Research Malaysia is working to secure the funding and partnerships required to support:
Patient recruitment could only begin after sufficient funding has been secured, the required approvals have been obtained, and the vaccine, hospital site and clinical research team are ready.
If the study opens, participation would not be available to everyone. Potential participants would need to meet specific medical and study criteria and complete an informed-consent process.
Future recruitment information would be announced through official Cancer Research Malaysia, participating hospital and recognised clinical trial channels.
Donating to the research programme would not guarantee eligibility or access to the clinical study. Patients should not delay or change their current treatment while waiting for an experimental vaccine.
The term “cancer vaccine” covers many different products and approaches.
Some approved vaccines prevent infections linked to cancer, such as HPV and hepatitis B vaccines. Other vaccines are being developed to treat particular cancers by targeting specific proteins or genetic changes.
There is no single vaccine that can prevent or treat every cancer.
A vaccine developed for one cancer cannot automatically be used for another. Each vaccine may target a different cancer type, protein, mutation or patient population.
Research in Malaysia remains important because it allows us to:
CRMY-VAC-100 was developed developed from Malaysian research identifying tumour-associated antigens that are highly expressed across several cancers common in Asia.
New cancer treatments must go through many carefully controlled steps because patient safety comes first.
These steps may include:
Laboratory research
Preclinical activity and safety studies
Clinical-grade manufacturing
Quality and stability testing
Regulatory review
Ethics approval
Early clinical trials
Larger clinical trials
Patient follow-up
Data analysis
Health authority review
Early Phase 1 and Phase 2 studies focus on safety, side effects, dose, immune response and early evidence of anti-cancer activity.
Each stage depends on the results of the stage before it. If safety concerns arise or the treatment does not show enough potential benefit, the programme may need to be changed, delayed or stopped.
Turning a laboratory discovery into a treatment for patients is complex and expensive.
Funding is needed for:
Without sufficient funding, CRMY-VAC-100 cannot progress into the proposed Phase 1/2 clinical study as planned.
Funding does not guarantee that the vaccine will succeed. It enables researchers to conduct the carefully controlled studies required to find out whether CRMY-VAC-100 is safe and whether it may benefit patients.
A cancer vaccine is not a magic injection that prevents or cures every cancer.
CRMY-VAC-100 is a Malaysian-developed, DNA-based therapeutic cancer vaccine candidate designed to help the immune system recognise the MAGED4B and FJX1 cancer-associated targets.
It is being developed initially for oral and head and neck cancer. Preclinical research also supports continued investigation in nasopharyngeal, lung and liver cancers.
CRMY-VAC-100 is not currently available to patients, and its safety and effectiveness in humans have not yet been established.
More funding, clinical-grade manufacturing, regulatory approvals and properly conducted clinical trials are needed before researchers can determine whether CRMY-VAC-100 could become a future cancer treatment.
Important reminder: CRMY-VAC-100 is an investigational cancer vaccine candidate. It has not been approved for routine clinical use. Patients should speak with their treating doctors before making decisions about cancer treatment.
