The Promise of Vaccine in Fighting Cancer: Megatrend in Oncology 2023

This News Covers

• Who is Dr. James Gulley?
• Is there a vaccine for cancer?
• Who is leading research into cancer vaccines?
• Does vaccine cover all types of cancers?
• Example of a trial for cancer vaccine?
• What guidelines are in place for a vaccine on cancer?
• What are the leading causes of cancer?
• Which countries have the best cancer care facilities?
• What is the size of cancer related treatment market?
• What is cancer immunotherapy and what are its' use cases?

In a significant breakthrough, scientists have made promising strides in the development of a cancer vaccine that holds the potential to save millions of lives worldwide. The vaccine, currently being tested in experimental treatments for breast and lung cancer patients, has shown encouraging improvements in cases of pancreatic cancer and melanoma, a deadly form of skin cancer. While the vaccine does not prevent cancer, it has demonstrated the ability to shrink tumors and prevent cancer recurrence, according to the National Cancer Institute in the U.S. This long-awaited advancement in cancer research is instilling hope in patients and healthcare professionals alike.

Dr. James Gulley, a renowned expert in immunotherapy for cancer, has been at the forefront of this cutting-edge research. As the Co-Director of the Center for Immuno-Oncology at the National Cancer Institute, Dr. Gulley has played a pivotal role in designing and conducting clinical trials to explore the potential of cancer vaccines and other immunostimulatory agents. His expertise and collaborative efforts have led to significant progress in the clinical development of various immunotherapy agents, such as Prostvac, avelumab, and bintrafusp alfa.

The vaccine's effectiveness lies in its ability to train the body's immune system to recognize cancer cells as a danger. Dr. Nora Disis, an expert from UW Medicine's Cancer Vaccine Institute, explains that the vaccine aims to teach the immune system's T cells to identify and target cancer cells. Once activated, these T cells can travel throughout the body, hunting down and eliminating cancer cells that would otherwise evade detection.

While further research is needed to optimize the vaccine's efficacy, scientists are gaining a deeper understanding of how it can effectively target and destroy cancer cells that manage to hide from the body's immune system. Dr. Gulley emphasizes the need to improve the vaccine's performance, acknowledging that progress has been made but more work is required to maximize its potential.

This groundbreaking research offers a ray of hope for cancer patients and their families, paving the way for a potential revolution in cancer treatment. As the quest for effective immunotherapy continues, scientists, doctors, and patients eagerly anticipate further advancements in the fight against this devastating illness.

MarketsandMarkets welcomes these develpoments and our editors share their views.

Who is Dr. James Gulley?

Dr. James Gulley is an internationally recognized expert in cancer immunotherapy. With a background in microbiology and oncology, he leads the Center for Immuno-Oncology at the National Cancer Institute (NCI). Dr. Gulley has played a crucial role in the clinical development of various immunotherapy agents and has led numerous clinical trials from initial stages to phase 3. Notable achievements include the coordination of an international trial that resulted in the regulatory approval of avelumab and the investigation of bintrafusp alfa, a first-in-class bifunctional antibody targeting PDL1 and TGF-beta.

As Co-Director of the Center for Immuno-Oncology and Director of the Medical Oncology Service at the NCI, Dr. Gulley has contributed significantly to the advancement of combination immunotherapy studies and the understanding of rationally designed treatment approaches. His expertise has earned him recognition, including the Presidential Early Career Award for Scientists and Engineers and the Hubert H. Humphrey Award for Service to America. With over 200 clinical trials and more than 350 scientific papers or chapters to his name, Dr. Gulley continues to make significant contributions to the field of cancer immunotherapy.

Is there a vaccine for cancer?

There are certain types of vaccines associated with cancer prevention and treatment:

Preventive Cancer Vaccines: These are designed to prevent cancer from developing in healthy individuals. They do this by protecting against viruses known to cause cancer. The two primary preventive cancer vaccines approved by the U.S. Food and Drug Administration (FDA) are:

1. HPV Vaccine: Protects against certain types of human papillomavirus (HPV) known to cause cervical, vaginal, vulvar, and anal cancers, as well as genital warts.
2. Hepatitis B Vaccine: Prevents hepatitis B infection, which can lead to liver cancer if chronic.

Therapeutic Cancer Vaccines (Cancer Treatment Vaccines): Unlike preventive vaccines, therapeutic vaccines are meant to treat existing cancer. They do this by boosting the immune system's response to cancer.

1. Sipuleucel-T (Provenge): This is a personalized vaccine approved by the FDA in 2010 to treat certain types of metastatic prostate cancer. It's prepared using the patient's own immune cells to stimulate the immune system to target and attack the prostate cancer cells.
2. Bacillus Calmette-Guérin (BCG) vaccine: This is not a vaccine in the traditional sense, but rather a weakened strain of live bovine tuberculosis bacteria used to treat early-stage bladder cancer. It's introduced directly into the bladder to stimulate an immune response against cancer cells.

Research into cancer vaccines is an active field, and many experimental vaccines are being studied in clinical trials. These include vaccines for various types of cancer, such as bladder cancer, brain tumors, breast cancer, cervical cancer, colorectal cancer, kidney cancer, leukemia, lung cancer, melanoma, myeloma, pancreatic cancer, and prostate cancer.

Despite promising advancements, developing effective therapeutic cancer vaccines presents several challenges. For instance, cancer cells can suppress the immune system, appear "normal" to the immune system due to their origin from the person's own cells, and can be difficult to eliminate entirely using a vaccine alone, particularly in advanced stages. These and other challenges make the field of cancer vaccines a complex but vital area of ongoing research.

Who is leading research into cancer vaccines?

Dr. Nora Disis from the Cancer Vaccine Institute at UW Medicine in Seattle is one of the prominent researchers leading the study of cancer vaccines. Her team's work involves understanding how cancer evades the immune system and developing vaccines and immunotherapies that enhance the immune response to identify and eliminate cancer cells. A note: We have already covered information about Dr. James Gulley above and in addition there are scores of immunologists and research facilities who are leading the fight against cancer worldover.

Some of these vaccines utilize mRNA technology, similar to some COVID-19 vaccines, while others are aimed at preventing cancer by targeting high-risk individuals and treating them at an early stage.

One notable area of focus is personalized mRNA vaccines for melanoma patients, tailored to the specific mutations of the patient. These are more expensive to produce but offer the potential for targeted, effective treatment.

In addition to treatment vaccines, Dr. Disis's team and others are actively exploring preventive vaccines. For instance, preventive vaccines for liver cancer (Hepatitis B) and cervical cancer (HPV) have already proven effective.

Clinical trials focusing on breast, lung, and ovarian cancers at UW Medicine are underway, and preliminary results are expected soon. While the full impact of cancer vaccines on individual outcomes isn't fully understood yet, the initial successes in this field are inspiring hope for the future of cancer treatment.

Does vaccine cover all types of cancers?

Cancer is an umbrella term used to refer to a variety of related diseases with varied characteristics, manifestations, and responses to treatments. No single vaccine covers all types of cancer. The complexity of cancer and the diversity of cancer types make the task of creating a universal cancer vaccine quite challenging.

However, significant progress is being made in the field of cancer vaccines. Some vaccines have shown effectiveness in preventing certain types of cancer. For example, vaccines for human papillomavirus (HPV) can prevent infections that lead to cervical cancer and other types of cancer, and the Hepatitis B vaccine can prevent Hepatitis B infection that could potentially lead to liver cancer.

Several therapeutic cancer vaccines are also under development, designed to stimulate the immune system to attack cancer cells, potentially shrinking or eliminating tumors. Examples include vaccines for advanced bladder and prostate cancer.

Personalized cancer vaccines represent a significant breakthrough. These vaccines target the specific mutations found in an individual patient's tumor, potentially leading to more effective treatments. A significant amount of research is ongoing to develop personalized vaccines, with promising results being reported from early trials, including for pancreatic cancer.

Also, vaccines for cancer survivors are being explored. These vaccines are designed for patients in remission but at high risk of relapse.

In the case of mRNA vaccines, BioNTech and Moderna are exploring their potential in fighting various types of cancer. These vaccines use the same technology that proved successful in COVID-19 vaccines, signaling another significant development in the field.

The delivery of personalized cancer vaccines can be time-consuming and complicated due to the need for genetic sequencing and the creation of a unique vaccine for each patient. However, advancements are being made to expedite this process.

While the future of cancer vaccines appears promising, some experts express concerns about equitable access, especially for marginalized populations. Therefore, it's crucial to address issues of healthcare disparities to ensure all populations can benefit from these advancements.

The timeline for widespread availability largely depends on the results of ongoing clinical trials and funding availability for more extensive studies. Despite these challenges, researchers are optimistic that the coming decade will see a substantial increase in the development and approval of therapeutic cancer vaccines.

If patients are interested in vaccines that may exist for their cancer, it is advised they talk to their oncologist about potential options, and if possible, get a second opinion.

Example of a trial for cancer vaccine

The progress in the clinical trial of the cancer vaccine PDS0101:

PDS Biotechnology, a clinical-stage immunotherapy company, developed a cancer vaccine candidate called PDS0101. This vaccine met the efficacy threshold in the second stage of a Phase II trial, known as VERSATILE-002 (NCT04260126), that aimed to treat unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. PDS0101 was administered in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab).

The trial reported that 14 out of 54 patients in the immune checkpoint inhibitor (ICI) naïve arm experienced either complete response or partial response on two consecutive scans, which confirmed objective response. Additional patients are still undergoing imaging evaluation, with the company continuing to monitor efficacy and safety.

PDS0101 is a liposomal-based therapeutic vaccine designed to stimulate the immune system to respond to HPV16-infected tumor cells. It is injected subcutaneously and can be used alone or in combination with other immunotherapies and cancer treatments.

The primary endpoint in the VERSATILE-002 study is the best overall response of confirmed complete response (CR) or confirmed partial response (PR). Key secondary endpoints are progression-free survival (PFS), overall survival (OS) at 12 and 24 months, and safety and tolerability.

Dr. Lauren Wood, Chief Medical Officer of PDS Biotech, expressed satisfaction with achieving the efficacy threshold ahead of the full efficacy evaluation for this cohort. The company is now advancing towards its Phase III confirmatory randomized, controlled trial, VERSATILE-003.

VERSATILE-003 is set to evaluate the safety and efficacy of PDS0101 in combination with Keytruda versus Keytruda monotherapy. The combination will be assessed in ICI-naïve patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The primary endpoints for VERSATILE-003 are OS and PFS. The FDA granted a fast track designation to the trial in June 2022, and PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the FDA in Q3 2023.

What guidelines are in place for a vaccine on cancer?

Cancer vaccines can be broadly classified into two categories: preventive vaccines and therapeutic vaccines.

1. Preventive vaccines are used to prevent cancer in healthy people. These vaccines work by protecting the body against viruses known to cause cancer. For example, the Human papillomavirus (HPV) vaccine helps prevent cervical cancer, and the Hepatitis B vaccine can prevent liver cancer.
2. Therapeutic vaccines are designed to treat existing cancer by strengthening the body's natural defenses. The goal is to stimulate the immune system to attack and destroy cancer cells in the body.

The guidelines for cancer vaccines are generally the same as for any other type of medical intervention and typically involve these major steps:

1. Research and Development: The vaccine must be developed and studied in the lab. The development of cancer vaccines often involves understanding how the immune system interacts with cancer cells and leveraging that knowledge to create an effective vaccine. Some cancer vaccines, like those mentioned in the article, are using mRNA technology, similar to some COVID-19 vaccines.
2. Preclinical Trials: The vaccine is tested in animal models to assess its safety and effectiveness.
3. Clinical Trials: If the vaccine shows promise in preclinical trials, it proceeds to clinical trials in humans. These are typically conducted in multiple phases. Phase I focuses on safety, Phase II evaluates both safety and efficacy, and Phase III compares the new treatment with the current standard treatment.
4. Regulatory Approval: If the vaccine is found to be safe and effective in clinical trials, the developers can apply for approval from regulatory bodies like the Food and Drug Administration (FDA) in the United States.
5. Post-Marketing Surveillance: Even after the vaccine is approved, it is still monitored for safety and effectiveness in the general population.

Currently, researchers are exploring the potential for both preventive and therapeutic vaccines for different types of cancer, including melanoma, lung, breast, and ovarian cancers. Recruitment for these trials, particularly among high-risk individuals such as those with BRCA mutations, is ongoing.

It's important to remember that participation in these trials is voluntary and potential participants should be informed about the potential risks and benefits of participation. Also, because the science is still emerging, the full impact of cancer vaccines is not yet completely understood, but individual success stories inspire hope for the potential of these treatments.

What are the leading causes of cancer?

Cancer can be caused by various factors, and the specific causes can vary by type of cancer. However, certain behaviors and conditions are known to significantly increase the risk of developing many common types of cancer. These include:

1. Tobacco Use: Tobacco use, either from smoking or exposure to secondhand smoke, is a significant risk factor for many types of cancer, including lung, larynx, mouth, throat, esophagus, bladder, kidney, pancreas, cervix, colon, rectum, liver, stomach, and a type of blood cancer called acute myeloid leukemia.
2. Exposure to Ultraviolet (UV) Radiation: Exposure to UV radiation, from the sun or tanning beds, is a leading cause of skin cancer, including melanoma, which is the deadliest type of skin cancer.
3. Overweight and Obesity: Being overweight or obese is associated with an increased risk of many types of cancer, including endometrial (uterine) cancer, postmenopausal breast cancer, and colorectal cancer.
4. Overweight and Obesity: Being overweight or obese is associated with an increased risk of many types of cancer, including endometrial (uterine) cancer, postmenopausal breast cancer, and colorectal cancer.
5. Alcohol Consumption: Excessive alcohol use increases the risk of several types of cancer, including breast (in women), liver, colon, rectum, mouth, pharynx, larynx, and esophagus. Even low levels of alcohol consumption can increase the risk of certain types of cancer.
6. Infections: Certain viral infections can lead to cancer. For example, the human papillomavirus (HPV) is the leading cause of cervical cancer and can also cause cancers of the vagina, vulva, penis, anus, and oropharynx. Hepatitis B and hepatitis C viruses are leading causes of liver cancer.

In addition to these risk factors, the lack of regular screening for certain types of cancer can also contribute to high cancer rates. Regular screening can help catch cancers like breast, cervical, and colorectal cancer in their early stages, when they are most treatable. Lung cancer screening is also recommended for high-risk individuals.

The Centers for Disease Control and Prevention (CDC) is actively working to reduce these risk factors, promote early detection through screening, and improve the health of cancer survivors. Some of their initiatives include efforts to reduce tobacco use, increase sun protection, promote healthy nutrition and physical activity, reduce excessive alcohol use, promote vaccination against HPV and hepatitis B, and improve access to cancer screening services.

Which countries have the best cancer care facilities?

The best countries for cancer treatment are often judged by several factors, including the quality of their hospitals, their cancer survival rates, their investment in cancer research, the availability of the latest treatments, and their healthcare infrastructure. Here are some countries recognized for their exceptional cancer care facilities:

1. United States: The U.S. is home to some of the world's leading cancer hospitals, including the MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and the Mayo Clinic. These facilities conduct cutting-edge research and offer advanced treatments. The National Cancer Institute and other bodies also invest heavily in cancer research.
2. Germany: Germany is known for its advanced healthcare system and exceptional cancer hospitals like the University Medical Center Hamburg-Eppendorf and Heidelberg University Hospital.
3. Canada: Cancer care in Canada is highly rated, with top-notch facilities like the Princess Margaret Cancer Centre and the BC Cancer Agency. The country also has a robust research environment backed by organizations like the Canadian Cancer Society.
4. Australia: The Peter MacCallum Cancer Centre in Melbourne and the Chris O’Brien Lifehouse in Sydney are among Australia's leading cancer hospitals. The country also emphasizes cancer research through entities such as Cancer Council Australia.
5. Japan: With a highly advanced healthcare system, Japan offers excellent cancer care at facilities such as the National Cancer Center Hospital. Japan also stands out for its high rates of early cancer detection.
6. Sweden: The country is home to the renowned Karolinska Institute, which is at the forefront of cancer research and treatment.
7. Switzerland: Swiss hospitals like University Hospital Zurich provide top-tier cancer care and are involved in innovative cancer research.
8. United Kingdom: The UK boasts several renowned cancer hospitals, including The Christie in Manchester and the Royal Marsden in London. Cancer Research UK is also one of the world's leading cancer research organizations.
9. Netherlands: Dutch cancer care is highly esteemed, with the Netherlands Cancer Institute standing as one of the leading facilities in Europe.
10. France: Gustave Roussy is Europe's largest cancer center and is a world leader in patient care, research, and teaching.

What is the size of cancer related treatment market?

The global cancer therapy market was valued at approximately USD 158 billion in 2020, and it is expected to reach a revenue of USD 268 billion by 2026, growing at a Compound Annual Growth Rate (CAGR) of 9.15% over this forecast period.

This market growth is driven by factors such as increasing patient assistance programs (PAPs), increasing government initiatives for cancer awareness, rising prevalence of cancer worldwide, strong R&D initiatives from key players, and the increasing demand for personalized medicine.

The cancer therapy market is highly competitive and is dominated by major players such as Amgen Inc., AstraZeneca plc, Bayer AG, Bristol-Myers Squibb Company, Pfizer Inc, Novartis AG, and Johnson and Johnson.

The cancer therapy market can be segmented by therapy type (including chemotherapy, targeted therapy, immunotherapy, hormonal therapy, and other therapy types), cancer type (including blood cancer, breast cancer, prostate cancer, gastrointestinal cancer, gynecologic cancer, respiratory/lung cancer, and other cancer types), and end user (including hospitals, specialty clinics, and cancer and radiation therapy centers).

The fastest-growing segment in the forecast period is expected to be the targeted therapy segment. Targeted therapy is a treatment that works by targeting specific genes or proteins in cancer cells.

The North American market, particularly the United States, is currently the largest and is expected to continue to dominate the global market due to factors such as increased adoption of cancer therapy, growing burden of cancer, high concentration of key players, increasing FDA approvals, strategic alliances, and high investment in research and development activities.

What is cancer immunotherapy and what are its' use cases?

Cancer immunotherapy is a type of cancer treatment that harnesses the power of the immune system to fight cancer. It involves using substances, either made by the body or in a laboratory, to boost the immune system's ability to recognize and destroy cancer cells.

The use cases of cancer immunotherapy are vast and continue to expand as research progresses. Some of the common use cases include:

1. Melanoma: Immunotherapy has shown significant success in treating advanced melanoma, a type of skin cancer. Immune checkpoint inhibitors such as pembrolizumab (Keytruda) and ipilimumab (Yervoy) have been approved for the treatment of melanoma. 
2. Lung cancer: Immunotherapy has emerged as a promising treatment option for certain types of lung cancer. Immune checkpoint inhibitors, such as pembrolizumab (Keytruda), nivolumab (Opdivo), and atezolizumab (Tecentriq), have shown efficacy in treating advanced non-small cell lung cancer. 
3. Leukemia and lymphoma: Immunotherapy has been used to treat certain types of leukemia and lymphoma. Chimeric antigen receptor (CAR) T-cell therapy, which involves modifying a patient's T cells to express specific receptors that target cancer cells, has shown remarkable results in treating pediatric acute lymphoblastic leukemia (ALL) and certain types of non-Hodgkin lymphoma. 
4. Bladder cancer: Bacillus Calmette-Guerin (BCG) immunotherapy is commonly used for the treatment of early-stage bladder cancer. BCG is a weakened form of the tuberculosis bacterium that stimulates the immune system to destroy cancer cells in the bladder. 
5. Kidney cancer: Immune checkpoint inhibitors, such as nivolumab (Opdivo) and pembrolizumab (Keytruda), have shown efficacy in treating advanced renal cell carcinoma, the most common type of kidney cancer. 
6. Head and neck cancer: Immunotherapy has shown promise in the treatment of head and neck cancers, particularly those that express high levels of the programmed death-ligand 1 (PD-L1) protein. Immune checkpoint inhibitors like pembrolizumab (Keytruda) and nivolumab (Opdivo) have been approved for certain cases of head and neck cancer. 

These are just a few examples, and ongoing research is exploring the application of immunotherapy in various other types of cancer. Immunotherapy is often used in combination with other treatment modalities, such as chemotherapy, radiation therapy, and targeted therapy, to maximize its effectiveness.

References

1. Cancer Treatment Vaccine
2. PDS Biotech’s cancer vaccine hits the mark in Phase II trial
3. FDA Approvals in Oncology: January-March 2023
4. Cancer Signs and Symptoms
5. Immunotherapy for Endometrial Cancer