Growing Focus on Meeting the Urgent Clinical Need for More Efficacious Therapeutic Agents for Severe Diseases to Drive Immunocytokines Market Revenue Growth

 

Immunocytokines are fusion proteins that consist of a cytokine moiety that is fused to a monoclonal antibody or antibody fragments. On binding to the target antigen, cytokines are released directly into the tumor microenvironment, in turn, achieving high local concentrations with minimal systemic side effects. Immunocytokines represent a new and emerging class of biopharmaceuticals that demonstrate a high potential for cancer therapy and therapeutics for other chronic diseases. Immunocytokines have shown tremendous success in activating and redirecting effectors to human tumors and induce long-term antitumor immunity. Immunocytokines act as a robust vehicle for facilitating the delivery of an immune-stimulatory payload to selected cells or cells present at the disease sites.

Immunocytokines combine the desired elements of two excellent modalities of immunotherapy such as recombinant monoclonal antibody and cytokine therapy. Immunocytokines were developed to improve the benefits to risk ratio of monoclonal antibodies and cytokines alone or in combination. Use of antibody-cytokine fusion proteins has proven to have potential in improving the therapeutic index of cytokines by concentrating the payload at the site of disease without causing adverse off-target effects. One of the best examples of immunocytokines is the antibody-mediated targeted delivery of IL-12 that has shown at least 20 times more potent activity as compared to untargeted IL-12 in mouse model of cancer. Antibody-cytokine fusion proteins or immunocytokines are divided into two categories; large fusion proteins with cytokines fused to heavy chain of antibodies and small fusion proteins based on fragments of antibodies. Over the recent past, numerous immunocytokines have progressed to clinical trials as a potential and promising treatment for cancer. Currently, the immunocytokines that are underway in clinical trials are based on IgG format or on single chain variable fragment (scFv). In the recent years, use of immunocytokines has expanded from cancer therapy to the treatment of chronic inflammatory conditions and autoimmune diseases.

In a breakthrough study led by Tobias Weiss, a senior physician and research at the University Hospital Zurich, it was found that immunocytokines shown tremendous promise in the battle with glioblastoma. The study published in Science Translational Medicine, the researchers shared details on the effects of immunocytokines and revealed the immunocytokines delivered systemically showed effectiveness in mice models and pilot human trials. The team created three immunocytokines based on the L19 antibody, which is highly specific to extracellular matrix of glioblastoma tumor. The immunocytokines were intravenously injected in fully immunocompetant mice that were pretreated with orthotopic GL-261 gliomas. The treatment showed a stable safety profile and was effective in decreasing blood perfusion in the tumor and accelerated tumor necrosis.

In 2021, Nammi Therapeutics, Inc. which is a LA-based immunotherapy firm, unveiled first two cancer drug candidates; one from each of its distinctive drug development platforms called Nammisomes and Masked ImmunoCytokines at the American Association for Cancer Research Conference. Increasing number of companies are working towards development of robust immunocytokines for reshaping cancer treatment across the globe. In November 2021, Bright Peak Therapeutics, Inc., which is a prominent biotechnology company engaged in development of next-generation cytokine immunotherapies, announced a licensing agreement with Livzon Mabpharm, Inc. to use LZM009, Livzon’s proprietary anti-PD-1 monoclonal antibody that is currently in late-stage clinical trial, for the development of PD-1 targeted immunocytokines.

Major companies in the market include Alkermes Plc, AstraZeneca Plc, CytImmune Sciences, Cytune Pharma, Altor Bioscience Corporation, Apeiron Biologics AG, Paladin Labs, Teva Pharmaceutical Industries Ltd., Valor Biotherapeutics, and Targa Therapeutics Corporation. In April 2021, Bright Peak Therapeutics, Inc. and Ajinomoto Co., Inc., announced a research collaboration and licensing agreement for the development of immunocytokines. Bright Peak will be leveraging Ajinomoto’s AJICAP, a proprietary site-specific bioconjugation technology to develop immunocytokines molecules. In June 2021, Bright Peak Therapeutics, Inc., announced it had raised USD 107 million in a Series B round of funding which the company plans to use to expand its immunocytokine platform and advance its pipeline of programs across IL-2, IL-8, and IL-7.   

Increasing Focus on Developing Leading Edge Technology for Clinicians and Patients to Drive Growth of Next-Generation Ultrasound Market

 

Over the recent years, ultrasound imaging has evolved into an extremely versatile diagnostic tool that caters to every discipline of medical care. Ultrasound diagnostics are widely used in clinical settings due to its ability to acquire diagnostically relevant images, efficient translation of these images into diagnostic conclusions, and enabling cost-effective production of highly complex ultrasound imaging arrays that can capture 3D volumes. Advancements in electronics in the recent years have led to extraordinary refinement in all aspects of ultrasound systems. Researchers have been working towards finding out reliable ways to incorporate many individual transducers into compact arrays. 2D array can be focused throughout a volume to make a 3D image which can be done in real time. This capability can enhance ultrasound to next-level and over the coming years, can potentially allow robotic surgeons to operate on a beating heart, reducing the need to rely on a heart-lung machine during surgeries.

Next-generation ultrasound consisting 2D arrays of ultrasonic transducers can help physicians perform minimally invasive treatments enabling simultaneous ultrasound imaging and surgical therapy. As the computer technology evolves, ultrasound machines are expected to get faster and have more storage memory. Probes can get smaller and development of insertable probes will allow for a better imaging of internal organs. Over the recent past, extensive research activities have been carried out to develop ultrasound imaging in combination with AR/VR display that can allow physicians and surgeons to observe inside of the human body while performing minimally invasive or non-invasive procedures such as biopsy. Combination of deep learning technology and ultrasound imaging can create cost-effective and affordable 3D MEMS ultrasound platform technology that can potentially make the next-generation ultrasound device more personal, autonomous, and efficient in collecting and processing of data. Micro-electromechanical systems or MEMS have enabled researchers to develop capacitive micro-machine ultrasonic transducer that are mostly made of silicon.

Development of new diagnostic ultrasound methods have led to development of open platform ultrasound scanners that can effectively facilitate practical evaluation of new ultrasound imaging methods. In a recent news, Israel-based Sofwave Medical Ltd. developed a new treatment called Sofwave, which is a next-generation non-invasive aesthetic treatment that can help tackle signs of ageing to tone and lift the skin. The technology has been cleared by the U.S. FDA in November 2021, for lifting of the eyebrows, neck, cheeks, and reducing fine lines and wrinkles. Sofwave utilizes ultrasound heat to stimulate renewal of collagen deep within the skin. It leverages Intense Ultrasound Beam technology to generate heat at a specific depth in skin to promote collagen growth and elastin development in the mid-dermal layer. This helps in plumping the skin, thickening the layer to achieve tightening effect while making the skin look healthier.

Major companies in the Next-Generation Ultrasound market include Samsung Electronics Co. Ltd., General Electric Company, Canon Medical Systems Corporation, Hitachi Ltd., Siemens Healthineers AG, Shenzhen Mindray Bio-Medical Electronics Co. Ltd., CHISON Medical Technologies Co. Ltd., Butterfly Network Inc., Medgyn Products Inc., and Claruis Mobile Health Corporation. In April 2022, Fujifilm Sonosite, Inc., which is a global leader in point-of-care ultrasound solutions (POCUS), announced a new addition to its next-generation POCUS portfolio, the new, premium Sonosite LX system that features the company’s clinical image and monitor that can extend, rotate, and tilt to enable enhanced and real-time provider collaboration.

Increasing Potential of Microneedle Patches as a Robust Tool for Transdermal Administration of Vaccine and Therapeutics to Drive Market Growth

Rapid advancements in nanotechnology have improved efficiency of microneedle patches through a shift from undissolving to dissolving microneedles. Microneedle patches can effectively deliver bioactive molecular of different physical size and hence are considered as robust drug delivery tools. Microneedle patches can also be coated or encapsulated with DNA vaccine, inactivated or live virus vaccine, and subunit antigen, among others. Microneedle patches have several advantages when used as drug and vaccine delivery vehicles such as pain-free and non-invasive route for reagent administration, no cold chain requirement for storage and transportation, low risk of needle-related injuries, and decrease in medical waste and transmission of blood-borne infectious diseases, particular in low-income and underdeveloped regions. Microneedle patches utilize the concept of microneedling to increase efficacy of active ingredients and use self-dissolving needles to penetrate the surface of the skin.

Microneedle patches, which are a highly efficient and versatile devices, have garnered extensive scientific and industrial attention over the past decade due to their attributes such as painless penetration, low cost, relative safety, and tremendous therapeutic efficacy. On the research front, microneedle patch has been used for minimally invasive evaluation of levels of inflammatory biomarkers and for efficient sampling of clavarial periosteum, which is a challenging site for biomarker detection, in mice. Use of microneedle patches for minimally invasive collection and analysis of biomarker levels in interstitial fluid has the potential to facilitate point-of-care (PoC) diagnostics and longitudinal monitoring. Increasing role of microneedles in revolutionizing the field of disease diagnosis and treatment, cosmetic applications, and immunobiological administration can open up new perspectives for development of advanced microneedles and contribute to revenue growth of the micro needle market.

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In a recent research study published in Immunotherapy, researchers at Michigan Medicine partnered with Moonlight Therapeutics to develop 1 cm x 1 cm arrays of 50 microneedles each which measure 700 μm and each array is coated in formulation of peanut protein. The study was aimed at determining the efficacy of peanut-coated microneedle patches in peanut allergy while comparing the results of this approach with epicutaneous immunotherapy with peanut. The researchers inserted these peanut-coated microneedles into the hairless skin of female mice that were already sensitized to peanuts and held them in place for nearly 5 minutes to enable dissolution of protein inside the skin. The treatment was administered once a week for 5 weeks and results found that 90% mice that received PN-MN treatment developed no allergic responses. Moonlight Therapeutics in now planning first clinical trial of this approach in human volunteers and researchers believe microneedle treatment can provide a new frontier in enhancing cutaneous immunotherapy and improve administration of next-generation therapeutics for treating peanut and other food allergies.

In a breakthrough scientific study, researchers found that using 3D-printed microneedle patches for drug delivery resulted in enhanced cargo retention on the skin, robust activation of immune cells, and generation of more potent and cellular immune responses as compared with conventional vaccination routes. Similarly, a team of researchers and scientists from University of Queensland tested a COVID-19 vaccine patch that is capable of delivering pain-free dosage and eliminates the need for cold chain transport. The microneedle patch that can deliver COVID-19 DNA vaccine into the skin was found to induce strong immune responses in cells and mice. Researchers believe these advancements and applications of microneedle patches can potentially replace syringes over the coming years and is expected to drive market growth going ahead.

Prominent companies in the market include 3M Company, Becton Dickinson and Company, Zosano Pharma Corporation, Raphas Co. Ltd., Nanopass Tech, Corium International, Inc., Valeritas, Inc., Nitto Denko Corporation, Microdermics, Inc., Sanofi S.A. Recently, in April 2022, CGBIO, which is a total healthcare provider based in Seoul, South Korea, acquired a 12.3% stake in Daewoong Therapeutics, which is a bio-venture company that has developed a transdermal drug delivery system based on microneedle patches. The former is trying to develop cosmetics, medical devices, and medicine using microneedle technology and is expected to benefit from in-house technology of Daewoong Therapeutics.  

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