Frexalimab

DUBLIN--( BUSINESS WIRE )--The "CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025" report has been added to ResearchAndMarkets.com's offering. CD40 targeted therapies have become a focal point in immunotherapy research, with growing attention on harnessing the potential of the CD40 receptor to treat a variety of diseases. While no CD40 targeted therapies have yet been approved for clinical use, some promising candidates are currently undergoing late stage clinical development. Moreover, additional candidates are slated to enter late-stage trials within the next year, expanding the pool of CD40 targeted therapies in clinical development. These ongoing research and clinical trials suggest that CD40 targeted therapies could become a vital treatment option for patients with prevalent diseases in the coming years. Global CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025 Report Highlights: First CD40 Targeted Therapy Approval Expected By 2027 CD40 Targeted Therapies In Clinical Trials: > 20 Therapies CD40 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase CD40 Targeted Therapy Research & Development Trends By Indication CD40 Targeted Therapy Market Trend Analysis By Region CD40 Targeted Therapies Proprietary Technologies By Company Historically, the primary focus of CD40 targeted therapies has been on autoimmune and inflammatory diseases. However, there is an increasing interest in exploring their potential for treating cancer and other conditions. More recent studies have expanded the scope of CD40 targeting to include infectious diseases, such as HIV and COVID-19, as well as neurodegenerative diseases like Alzheimer's and Parkinson's disease. Some research has also suggested that CD40 targeted therapies might be beneficial for diseases like cardiovascular conditions, where CD40's signaling pathway, although not directly involved in disease initiation, plays a role in disease progression and inflammation. Over the years, various strategies have been employed to target the CD40 receptor and its ligand. These include traditional monoclonal antibodies as well as next-generation molecular therapeutics such as small interfering RNA (siRNA). While antibodies are developed either as CD40 agonists or as antagonists, CD40 targeted siRNAs aim to reduce CD40 protein expression by degrading CD40 mRNA. Several other conventional and next-generation approaches are undergoing active research and clinical trials to assess their safety and efficacy. Nonetheless, antibody therapies remain the dominant approach in CD40 targeted research. Among the most advanced CD40/CD40L targeted antibodies are those for autoimmune and inflammatory diseases, with some entering phase 3 clinical trials. For example, Sanofi's Frexalimab, a promising anti CD40 antibody, is currently in phase 3 trials for autoimmune conditions. In the cancer domain, CD40 targeted antibodies are also making significant strides, with companies like Alligator Bioscience preparing to initiate phase 3 clinical trials for its lead candidate, mitazalimab, an anti-CD40 antibody for pancreatic ductal adenocarcinoma (PDA) and pancreatic cancer. The development of CD40 targeted therapies has been greatly facilitated by the advent of proprietary technologies and platforms. One notable example is GenMab's DuoBody platform, which enables the creation of bispecific antibodies that can target two different antigens simultaneously. This technology has been leveraged to develop several promising immunotherapies, including its CD40 targeted therapy, GEN1042/BNT312, currently in phase 2 trial for malignant solid tumors. As the field of CD40 targeted therapies evolves, the competitive landscape is becoming increasingly crowded, with many major pharmaceutical companies entering the arena. Notable players include Amgen, Sanofi, GenMab, BioNTech, and Biogen, all of which are investing heavily in this space. Collaborations between pharmaceutical companies and academic institutions have been essential in advancing the scientific understanding of CD40 targeted therapies, combining cutting edge research with clinical expertise to bring these therapies closer to market. In conclusion, while CD40 targeted therapies have not yet been approved for clinical use, they represent a promising and rapidly developing area of research across a wide range of diseases. As more therapies enter clinical trials and the competitive landscape intensifies, it is clear that CD40 targeted therapies could become a cornerstone of treatment for cancer, autoimmune diseases, infectious diseases, and beyond in the near future. Key Topics Covered: Introduction To CD40 Targeted Therapies Considering CD40 As Drug Target Over Other CD Markers History & Evolution Of CD40 Targeting Therapies CD40 Targeted Therapies - Mechanism Of Action Agonist Mediated Activation Of CD40 Signaling Antagonist-Mediated Inhibition Of CD40 Signaling CD40 Targeted Therapeutic Approaches Antibody Formats Fusion Proteins Peptides Nucleic Acids CD40 Targeted Therapy Research & Development Trends By Indication Cancer Neurological Diseases Autoimmune & Inflammatory Disorders Transplant Rejection Microbial Infections Global CD40 Targeted Therapy Market Outlook Current Market Trends & Developments Future Market Opportunities CD40 Targeted Therapy Market Trend Analysis By Region US Europe China Japan Australia CD40 Targeted Therapies Clinical Trials Insight By Company, Country, Indication & Phase Research Preclinical Phase I Phase I/II Phase II Phase III CD40 Targeted Therapies - Proprietary Technologies By Company Alligator Bioscience - FIND Technology & Neo-X-Prime Aprilbio - SAFA Platform Biocytogen - RenMice EnnoDC - Unnamed Platform Genmab - DuoBody Harbour BioMed - Harbour Mice & HBICE Kyowa Kirin - REGULGENT Strike Pharma - ADAC Technology Platform Global CD40 Targeted Therapy Market Dynamics Competitive Landscape Alligator Bioscience Amgen Biogen BioNTech Eledon Pharmaceuticals EnnoDC Genmab Innovent Bio Novartis Sanofi Tonix Pharmaceuticals UCB For more information about this report visit https://www.researchandmarkets.com/r/46sm5e About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

iStock, Polinmr As traditional fundraising methods falter for smaller firms, the rise of royalty deals is reshaping how companies access capital, offering an alternative that bypasses equity dilution and debt. The environment for biotech and smaller pharma companies to raise capital has been difficult in recent years. Investor confidence in the biotech industry has struggled since the highs seen during the pandemic, with the XBI index of stocks remaining largely flat over the last two years. Though there are signs that 2024 represents a resurgence in investment , with IPOs and M&A activity surpassing levels seen in 2023, the industry is still recovering from the flight of capital. Life science companies have reacted to the difficulty in sourcing capital in various ways, such as the broad industry move to downsize and restructure workforces to extend available cash reserves and a trend for companies to delay potential IPOs . In the background of such strategies, there has been a shift to an alternative option for sourcing capital, through royalty financing. Though they have been around for decades, royalty deals are a means of raising capital that involves an investor buying a percentage of future revenue from a drug manufacturer on specific single or multiple assets. In this way, a manufacturer can receive an upfront fee and potentially future milestone payments dependent on the development of the asset, which can then be used for short-term capital needs. This type of financing is distinct from an equity deal because it offers the company a non-dilutive means of raising funds for development or commercialization costs. It can also be a more flexible arrangement than taking on debt because there are no interest payments to meet nor is the deal itself dependent on the economic environment. The latter advantage is one of the major reasons that this type of deal is on the rise and why more can be expected in the future. George Shuster Jr., partner at law firm WilmerHale, told BioSpace that the number of such deals has grown “exponentially” in the last three years, following a steady increase over the last decade. WilmerHale earlier this month released an analysis of the surge in royalty financing in the “difficult” life sciences fundraising environment. “As royalty financing and monetization transactions gain momentum as alternatives to traditional debt and equity financing, life sciences companies may look to take advantage of these methods of fundraising to accelerate product development, launch clinical programs, or acquire additional assets,” the report found. Twin Drivers for Deals Previously, these types of deals were considered highly specialized transactions that only fit a narrow set of circumstances, according to Shuster. However, with the entry of a greater number of private credit investment funds, there has been more interest in creating novel transactions to expand their portfolios and to meet demand for capital, he said. In convergence with the rise of private investment has been the downturn in the overall market environment for supporting smaller companies and biotechs. Not surprisingly, royalty financing is a popular option for emerging biopharma. “The market for life sciences companies in equity transactions has slowed down to a point of all but drying up—not just at the IPO level, but really all the way down to much earlier stage financings,” Shuster explained. “And as that happened, the stock price for public life sciences companies has suffered. That means not only is it harder to get the equity financing in the door, but if you are going to raise equity financing, it is at very unattractive prices that would be extremely dilutive to the existing shareholders.” For companies seeking to complete royalty financings, part of the appeal is being able to raise capital without having to dilute existing shareholders, especially at the later stages of developing a product. For the investors, it is attractive to have a return from such deals that is not dependent on the stock market or interest rates, with the profit driven instead by the success of the product at the heart of the deal, according to Nathan Moore, partner at WilmerHale. As a result, the number and scale of such deals is increasing, with Royalty Pharma—a specialist buyer of royalties— striking deals potentially worth close to $2 billion in May 2024 alone. In one of those deals, Royalty Pharma paid $525 million to acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis. In return, Royalty will receive 100% of annual worldwide net royalties that ImmuNext would have received under its licensing deal with Sanofi, up to $2 billion. In a report based on 2022 data, management consulting firm ZS found that over the preceding four years, the average value of royalty deals increased more than twice as fast compared with other financing types, with the total value of royalty deals growing at a compound annual growth rate of 45%, compared with 25% for equity deals. “This suggests greater resilience against the macroeconomic factors impacting today’s equity market,” ZS concluded. Big Pharma on Sidelines Traditionally, it has been Big Pharma stepping in to snap up the rights to assets that are closing in on commercialization. Private investment companies entering into the market to swoop for these potential products would seem to be encroaching on this territory. Any products that proved to have potential in key therapeutic areas would then have a less attractive revenue potential for any would-be buyers. Shuster instead suggested that Big Pharma has been happy to take a backseat and allow other companies to take a risk in the short term, permitting private investments to fill the financial hole needed to get assets over the line. In this way, there is less pressure for Big Pharma to spread its investments across too many assets, and they still retain the opportunity to swoop in to acquire the company or product should it prove to be successful. With the economic environment being such a driver for these royalty deals, the question remains as to whether this trend will continue if the market becomes more friendly to traditional forms of investment. While a more open equity market could potentially see the need for this type of investment reduced, Shuster contends that it would not see completely disappear as a financing option. “This investment product will be sustained at levels above where it used to be because now there is a group of lenders who know how to do these transactions, and who know the pros and cons of these transactions,” Shuster concluded. “These companies know how to fit this in with other equity and debt financing strategies that they may have—once you have the tool in the toolbox, you’re going to continue to use it.”