New Age Vaccine Development

Healthcare | Apr, 2023

Vaccination is the most reliable way to reduce the likelihood of a pandemic or epidemic, reducing the outbreak of infectious diseases. Thanks to the rapid advancement in medical sciences and increasing adoption of technologies, vaccines are becoming more effective and providing positive outcomes. Never in our lifetimes has there been a greater emphasis on public health or a greater understanding of how information may influence patterns of health and well-being at all levels, from the personal to the societal. The COVID-19 pandemic accelerated the global adoption of digital health despite obstacles and risk aversion. The epidemic highlighted the need for innovative care models and faster information flow, which has resulted in a rapid rise in the use of digital health, particularly virtual care, in many nations.

Digital Vaccines

Enhanced focus on virtual healthcare leveraging advanced technologies has led to the rapid development of digital vaccines. A subcategory of digital therapeutics, digital vaccines aim to provide virtual care to patients via smartphones, tablets, and other devices. The rising incidence of chronic and neurological disorders has allowed the widespread scaling of frequent and personalized interventions at a low cost, which has fueled the growth of digital vaccines around the world.

The burden of chronic disorders is increasing at a rapid pace as patients struggle adhering to prescribed medications and implementing behavioral changes needed to stabilize the conditions. These challenges are creating a need for comprehensive disease management enabled by digital technologies. Hence, digital therapeutics have been gaining a lot of traction for personalized coaching, real-time customized health recommendations, medication adherence, etc. There is a growing body of evidence through various clinical studies that indicate that digital interventions work and improve patient outcome. Digital vaccines deliver evidence-based therapeutic interventions to improve the management of chronic diseases and provide patients with more treatment options. These vaccines present a promising solution for many chronic diseases such as Alzheimer's, type 2 diabetes, congestive heart failure, and cancer, among others.

New Advances in Digital Vaccines Market

Many players attempt to disrupt the disease management industry and create fresh, cutting-edge approaches to manage chronic illnesses. New-age start-ups provide more radical and unrestricted perspectives while incumbents offer a far more in-depth understanding of the issues. In the end, both start-ups and established players are essential for disrupting the market and scaling up solutions for wider audiences.

A bio and health tech startup, FriendsLearn has developed digital vaccines to non-invasively induce a neural response and immune response for lowering the risk of communicable and non-communicable diseases among kids. These digital tools have shown promising results for stimulating the brain-gut-immune system at the cellular biomarker level to reduce the risk of diseases like diabetes, cardiovascular disease, hypertension, cancer, ADHD, dementia, and COVID-19. The startup has harnessed machine learning-deep learning, neurocognitive computing, neural networks, gamification, AR/VR, and mobile app technology to build the digital vaccine. The gamified content delivered by mobile app called Fooya! has an appropriate compilation of neurocognitive training mechanisms. When the child uses sensory pathways like sight, touch, and hearing, a certain pattern of neural response is created in the brain, leading to transference. The gamified content trains the kid to make healthier choices that could help them make informed choices in terms of foods & beverages, which lead to lifestyle disorders such as obesity, diabetes, etc.

To provide patients with neurological injuries and conditions like stroke, traumatic brain injury, sclerosis, Parkinson's disease, etc. with engaging and immersive therapies in the convenience of their own homes, the digital neurology startup Mindmaze has developed a gamified digital neurotherapeutics. The FDA-cleared MindMotion platform help patients regain the functionality of their arms through movement-tracking games. As the burden of neurological disorders continues to rise, developing such technologies could help in better prevention and treatment strategies.

In May 2021, Northwell Health and Pear Therapeutics partnered to offer patients with opioid and substance use disorders digital therapeutics. FDA-approved Prescription digital therapeutics (PDTs) allow patients to have 24/7 access to evidence-based tools such as reSET and reSET-O to supplement their therapists' in-person or remote addiction therapy. The randomized controlled trials found that the real-world therapeutic engagement with reSET-O leads to better abstinence and retention in the treatment. Besides, both the products provide patients algorithm-driven cognitive behavioral therapy, fluency training, and contingency management as a complement to outpatient counselling. Therapists can simultaneously use this information to prepare for in-person and remote consultations.

The National Center for Telehealth and Technology of the US Department of Defense has launched a computer-based virtual world for military soldiers to deal with post traumatic stress disorder (PTSD). The participants can create a virtual avatar to play through scenarios that seem realistic to combat their mental health issues. The users are led through a role-playing scenario that resembles a crowded marketplace similar to that in Iraq or Afghanistan. During the scenario, the users monitor their reaction and stress levels and then they are sent via virtual flight home where they encounter everyday activities like shopping and face large crowds. Through the program, the users can navigate through different situations when they might not actually be comfortable in real life. The interactive simulations and experiences can really help the military personnel to learn about the causes and symptoms of PTSD.

According to TechSci Research report on “Digital Vaccine Market- Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028F, Segmented By Device Type (Smartphone, Tablets, Others), Application (Diabetes, Infectious Diseases, Cardiovascular Diseases, Others)”, the global digital vaccines is expected to grow at a formidable rate during the forecast period. The market growth can be attributed to the rapid emergence of cutting-edge technologies such as Internet of Things, virtual reality, smartphone apps, and artificial intelligence. Besides, rising need for needle-free vaccines in treating patients for various diseases and phobias and rising VC investment in digital vaccine startups are contributing to the market growth.

Digital Vaccine Market Drivers

Rise of Non-Communicable Disorders

Every year, 41 million people lose their lives to non-communicable diseases, according to World Health Organization statistics. Growing incidences of non-communicable diseases across all age groups and geographical areas are putting a lot of burden on healthcare facilities and leading to rising healthcare costs. Besides, lack of awareness and limited accessibility and affordability to the right treatment are contributing to rising mortality rates across the world. Prevalence of many lifestyle disorders such as diabetes, cardiovascular diseases, hypertension, etc. can be managed by making behavioral and lifestyle changes. Hence, rising lifestyle disorders and enhanced awareness among people for health can result in the greater adoption of digital vaccines by individuals and medical facilities alike.

Enhanced Focus on Personalized Medicines

Since most diseases today are classified on the basis of affected organ, the diagnosis reveals little about the nature of a particular patient’s illness. Personalized medicine or precision medicine require genetic, genomic, DNA, or molecular testing that helps to make a more accurate diagnosis and improve treatment. These biomarkers provide detailed cellular information driving a patient’s disease and enable healthcare practitioners to suggest beneficial therapies that lead to better outcomes. Digital vaccines provide customized treatments to patients based on their individual needs. Hence, rapid adoption of personalized medicines could fuel the growth of digital vaccines market.

Increase in Clinical Trials and Patents of Digital Vaccines

High investments for the research and development of digital vaccines have led to an increased number of clinical studies, most of which has demonstrated positive outcomes. Between 2020 and 2022, the VC investment in European Digital Therapeutics has grown to USD645 million, which reflects almost 9 times growth compared to 2016. As biopharma companies are realizing the untapped potential of digital vaccines, they are ready to invest in more clinical trial studies for further expansion.

Neoantigen Cancer Vaccines

Cancer is one of the leading causes of death around the world, accounting for nearly 10 million deaths in 2020, as per WHO statistics. Cancer is a serious threat to human health since it is usually difficult to treat even if it is discovered. Different patients react to different treatments in different ways, which has led to the growing need for developing personalized cancer treatments. The development and regulatory approval of tumor immunotherapies, such as cancer vaccines, adoptive cell therapy, and antibody-based therapeutics, especially for solid tumors, have been accelerated by recent developments in neoantigen research. Neoantigens cause an immune response that is not controlled by central and peripheral tolerance because they are recognized as non-self. The rapid advancement of next-generation sequencing and bioinformatic technology has allowed for the rapid identification and prediction of tumor-specific neoantigens and development of neoantigen cancer vaccines.

Neoantigen-targeted cancer vaccines work by stimulating or enhancing an immune response to the neoantigens found in a particular patient. Even though a cancer patient may already be naturally immune to some of these neoantigens, a vaccine can greatly enhance that immune response. The vaccine may occasionally induce defense against neoantigens. Then, the neoantigens present in the vaccine activate T-cells. Activated T-cells multiply, form any immune army to kill any cells that contain neoantigens that lead to cancer. Neoantigen vaccines consisting of lab-made versions of neoantigens along with adjuvant provide “danger signals” and alert the immune system of the threat. Personalized neoantigen vaccines utilize RNA, or DNA that contains the code of neoantigens, which instruct the cells in the body to translate the RNA or DNA code and make neoantigens, which further stimulates immune response. Clinical trials conducted with patients demonstrated that neoantigen-directed vaccines are safe and feasible.

However, recent work by international consortia has shown that by incorporating important regulating characteristics of immunogenicity, in silico predictions of immunogenic neoantigens can be significantly improved. Additionally, by consistently including additional mutation types found in the exome, such as deletions, translocations, and inversions, the neoantigen discovery space, which is currently largely limited to single nucleotide variants, can be significantly expanded. Epigenetics and ribosome profiling, two cutting-edge methods, may expand the discovery area beyond the exome. Biopsies from numerous tumors or tumor locations, serial tumor biopsies, or circulating cell-free tumor can all be used as methods to combat tumor heterogeneity by obtaining a potentially more comprehensive spectrum of tumor variants.

Likang Life Sciences has received approval by China’s Center for Drug Evaluation for the clinical trial of its personalized neoantigen-targeted vaccine. The Likang mRNA editing technology can encode multiple antigens at once while maintaining rapid and efficient expression, which makes it ideal for the development of personalized cancer treatments. The company claims that the combination of an mRNA vaccination and a DC vaccine represents a potential advancement in the field of personalized neoantigen treatment and offers patients a reliable and secure method of battling cancer.

Growing Collaborations for Neoantigen Vaccine Development

Global pharmaceutical companies, Moderna and Merck, have created a unique mRNA personalized cancer vaccine (PCV), mRNA4157, which combines proven and identified neoantigens, projected neoepitopes, and driver gene mutations into a single mRNA concatemer. In two clinical trials, the vaccine is being assessed as a monotherapy and combination therapy. The preliminary results of the clinical trial show that the vaccine, whether administered alone or in combination, was well tolerated by participants at all dosages examined and produced desired T cell responses, which were specific to neoantigens. Patients in the third stage of ongoing trial showed positive results with the personalized cancer vaccine, reducing the risk of cancer returning by 44% compared to the standard approach of removing the melanoma via surgery.

The United Kingdom government has announced to partner with one of the largest mRNA companies, BioNTech to trial personalized cancer vaccines and other diseases. The initiative aims to advance the mRNA vaccination technology that BioNTech gained notoriety for creating, and which proved to be effective at preventing COVID-related significant illness and death. By 2030, the government aims to provide 10,000 patients in UK with personalized therapies whose clinical trials are expected to start in the coming months.

In 2022, PhysIQ and CellCarta collaborated to potentially transform vaccine development through a more individualized and precise approach. As per the agreement, the company will launch the VIII (Vaccine-Induced Inflammation Investigation) study, which will focus on early, unique human reactions to vaccinations as pharmaceutical companies issue vaccines at a faster rate. Throughout this, medical-grade biosensors will be used to remotely monitor the physiology and immune system activation at all times. By spotting tiny changes just hours after vaccination, the cutting-edge artificial intelligence-based digital platform and immunologic biomarkers will make it possible to construct personalized baselines.

According to TechSci Research report on “Global Neoantigen Cancer Vaccine Market By Product (Personalized Neoantigen Vaccine, Off-the Shelf Neoantigen Vaccine), By Neoantigen Type (Synthetic Long Peptide (SLP), Nucleic Acid, Dendritic Cell, Tumor Cell), By Route of Administration (Intravenous, Intramuscular, Transdermal, Others), By Cell (Autologous, Allogenic), By Technology (RNA Sequencing, Whole Genome Sequencing, HLA Typing), By Delivery Mechanism (Liposomes, Virosomes, Electroporation, Gene gun, Others), By Application (Lung, Melanoma, Gastrointestinal, Brain Cancer, Others), By Region, Competition, Forecast & Opportunities, 2026”, the global neoantigen cancer vaccine is projected to grow at a significant rate. The growth can be attributed to factors such as rapid innovations in technology as well as infrastructural development. Besides, rising investments by governing bodies and healthcare providers is expected to boost the growth of global neoantigen vaccine market.