Therapeutic Anti-IgD mAb Biologic

Autoimmune diseases, allergies and chronic inflammations affect about 1-15% of the world population, with rising prevalences, high healthcare burdens and socio-economic impacts costing hundreds of billion dollars annually (Miller FW, Curr. Opin. Immunol., 2023). 

The 2025 Nobel Prize for Medicine for the discovery of peripheral immune tolerance by regulatory T cells by Prof M. Brunkow, Prof F. Ramsdell, and Prof S. Sakaguchi highlights the critical role of the immune tolerance mechanism that was embedded in the human immune system to protect us from autoimmune diseases, allergies, GvHD, transplant rejections, and other chronic inflammatory conditions. The manifestations of chronic inflammation in these conditions typically arise from an imbalance between autoreactive inflammatory and immune tolerance responses of the host.

Despite significant advances in treatments achieved with therapeutic monoclonal antibodies (mAb) biologics and small molecule inhibitors, between 20- 50% of all patients will fail to respond or eventually developed resistance to the current treatments and will need a new therapeutic approach. The current therapeutic paradigm and approaches primarily target the suppression of inflammation by blocking pro-inflammatory cytokines or intracellular signaling pathways with small molecule inhibitors (collectively known as immunosuppressants) without addressing the deficiency of immune tolerance side of the equation to address the root cause of disease etiology. These immunosuppressants also pose serious risks of infections and immuno-compromises due to their broad and non-specific natures, and as an ongoing medication for life.  These current clinical challenges represent a significant unmet patient need. An ideal therapy should aim to induce, reset and rebalance immune tolerance responses without compromising the host’s immune defense.

Anti-IgD mAb is a first-in-class, disease-modifying therapeutic mAb that binds to immunoglobulin D (IgD) expressed on B cells to activate the immune responses to engage and harness our body’s inbuilt regulatory immune tolerance mechanisms and anti-inflammatory feedback responses to resolve the key underlying causes of human autoimmune diseases, allergies and chronic inflammations. The modes of action (MoA) of anti-IgD mAb are distinctively different from the current therapeutic approaches with immunosuppressants. Anti-IgD mAb is designed to activate a particular immune response, rather than suppressing it, to engage and harness our body’s inbuilt immune tolerance mechanisms and intrinsic regulatory feedback anti-inflammatory responses.

Anti-IgD mAb restores the balances between the immune tolerance and pro-inflammatory states by: 1) activating regulatory T cells and regulatory B cells, 2) inducing anergic and regulatory phenotypes in B cells, 3) selectively depleting harmful IgD+ mature B cells but spare the more tolerogenic immature B cells, and 4) promoting an anti-inflammatory Th2-phenotypic response to deliver a long last therapeutic effect with minimal compromises to the host’s protective immunity against infections (Nguyen TG, Int. Rev. Immunol., 2022). These MoA features of anti-IgD mAb have been shown to exert immuno-protective and beneficial effects against a wide range of chronic inflammations and immune-mediated conditions in human.  MoA by anti-IgD mAb are also designed to be adaptable to other potential platforms.

    IMT aims to develop anti-IgD mAb as an innovative, paradigm shifting, and disease-modifying mAb treatment for human chronic inflammations and immune-mediated conditions including autoimmune diseases, allergic conditions, graft versus host diseases (cGVHD), organ transplant rejections, chronic obstructive pulmonary diseases (COPDs), stroke-induced inflammations, acute coronary syndromes, cardiovascular inflammations (atherosclerosis, myocarditis) and neuroinflammations (Strokes, Alzheimer’s and Parkinson’s diseases), where MoA of inducing immune tolerance via regulatory T cells, regulatory B cells and anti-inflammatory Th2 responses have been widely shown in experimental models and in patients to exert immuno-protective and beneficial effects against these immune-mediated conditions.

    The novel therapeutic effects of anti-IgD mAb was discovered demonstrated by IMT Chief Scientific Officer and Founder, Dr Tue (Tommie) Gia Nguyen, during his postdoctoral research works. The novel therapeutic efficacies, safety profile and MoA of anti-IgD mAb was demonstrated in clinically relevant mouse models of rheumatoid arthritis, atopic and allergic contact dermatitis.  These findings on therapeutic efficacies, MoA and safety profile of anti-IgD mAb have been recently confirmed and corroborated by other independent studies in various mouse models of other autoimmune and allergic conditions. The peer-reviewed publications and corroborating evidence relevant to anti-IgD mAb technology are available on IMT Research Publications link.

    IMT is currently looking for funding from family offices, investment funds, venture capitals, and accredited professional investors to advance the clinical development of our humanized anti-IgD mAb to human clinical trials.  IMT is also looking for partnerships/collaborations with pharmaceutical and biotechnology companies. Please contact IMT if interested in this investment opportunity.  

    Clinical Development of Therapeutic Anti-IgD mAb

    IMT Business & Product in Development

    Our business goal is to advance the humanized anti-IgD mAb to human clinical trials as a first-in-class, disease-modifying treatment for human chronic inflammations including autoimmune diseases, allergies, graft versus host diseases (GVHD), organ transplant rejection, chronic obstructive pulmonary diseases (COPDs), cardiovascular inflammations (atherosclerosis, myocarditis) and neuroinflammations (Strokes, Alzheimer’s and Parkinson’s diseases).

    The key product and asset of IMT is a first-in-class humanized anti-IgD mAb therapeutic drug that is designed to activate our body’s immune system to engage and harness our inbuilt immune tolerance mechanisms and anti-inflammatory Th2 responses to induce long lasting disease remission.

    IMT will utilize its research insights, know-how and intellectual properties (IP) in the biology of IgD and anti-IgD mAb in relevance to human diseases to design and to produce a humanized anti-IgD mAb drug that leverage on a unique combination of clinically proven therapeutic target (B cells), modes of actions (immune tolerance and anti-inflammatory Th2), and mAb biologic modality (renowned for its blockbuster successes) that differentiate anti-IgD mAb technology from the current therapeutics in the market to address their current unmet patient needs.  This technological leverage will thereby enable anti-IgD mAb a competitive edge to compete and gain market shares in the targeted market segments of early-stage refractory patients with moderate to severe autoimmune diseases, allergies, and others immune-mediated conditions who fail to respond to currently available treatments.

    IMT Business Case & Investment Opportunity

    IMT business model and strategic pathways aim to achieve its commercialization and business goals via licensing or strategic partnerships with major pharmaceutical and biotech companies that will fund the development of anti-IgD mAb from clinical trials to market approvals in major markets for therapeutic antibody biologics.

    Autoimmune diseases, allergic reactions, and chronic inflammations affect approximately 1–15% of the global population, with increasing prevalence, substantial healthcare burdens, and profound socio impacts costing hundreds of billions of dollars annually (Miller FW, Curr. Opin. Immunol.,2023). Between 20-50% of patients fail to respond or eventually develop resistance to the currently available drug treatments. The market for therapeutic treatments of human autoimmune diseases and allergic conditions currently has a market value of >US$200 billion p.a. in sales revenues and the annual sales of the blockbuster therapeutic antibodies for these conditions exceed US$115 billion p.a. with significant unmet patient needs and growing demands for a novel therapeutic approach with better efficacy and less adverse side-effects that anti-IgD mAb technology aims to address.

    Based on our market and technology assessment, anti-IgD mAb has the potential of gaining market share in the unmet medical needs segment that potentially equates to >US$5b in annual sales revenue in the current market of therapeutic antibody treatments for these human conditions if it gains regulatory and market approvals. 

    IMT is currently looking for funding from family offices, investment funds, venture capitals, and accredited professional investors to advance the clinical development of our humanized anti-IgD mAb to human clinical trials.  IMT is also looking for partnerships/collaborations with existing pharmaceutical and biotechnology companies. 

    IMT aims to raise US$19 million in capital to create and produce a humanized anti-IgD mAb to proceed to human trials within 2-4 years in Phase 1a/1b targeting 1-2 diseases (RA, lupus, psoriasis or IBD) in the multi-indication targets by anti-IgD mAb to assess and validate safety profile, MoA and early evidence of efficacy. IMT currently offers 10-20% of equity plus 2  seats on the Board of Directors (including CEO position) for US$19 million in capital funding and vested options (negotiable).

    Market and Technology Risk Mitigations

    Therapeutic anti-IgD mAb leverages on compelling pre-clinical research evidence of therapeutic efficacy and mode of actions of anti-IgD mAb treatment in clinically relevant animal models of various human autoimmune diseases and skin allergic inflammation that have been published by peer-view and recently have been confirmed and corroborated by other independent studies.

    Therapeutic anti-IgD mAb is designed as a first-in-class, disease-modifying immunomodulating therapeutic mAb that leverages on renowned blockbuster success of humanized mAb biologic modality and clinically proven therapeutic targets of B cells and clinically validated MoA of immune tolerance and anti-inflammatory Th2 responses that have been clinically proven safe, effective, protective and approved in multiple human diseases.

    Anti-IgD mAb targets a very large global market of >US$200 billion in annual sales with a growing demand for a new treatment with a novel therapeutic approach that differentiates anti-IgD mAb from current therapeutic mAb to address their significant unmet patient needs. This represents a significant and attractive commercial opportunity for the clinical development of anti-IgD mAb.  

    Risk Assessments & Mitigations

    Our therapeutic anti-IgD mAb will be designed and developed with multiple indications targeting a range of chronic inflammatory conditions to achieve its market shares and sales revenue to justify its substantial cost of clinical development.

    The nature of commercial development of therapeutic anti-IgD mAb by IMT is a high-risk high-return investment venture that is intrinsic to all therapeutic drug developments.  Industry reviews showed therapeutic mAb technology has a 22-25% probability of success in market approval (Kaplan & Reichert, mAb, 2019).  Based on our market and technology assessment, IMT has developed a business and technology risk mitigation strategy to minimize the binary risk on investment due to technologically failure in human clinical trials.  Our therapeutic anti-IgD mAb leverages on unique technological advantageous features that will enable anti-IgD mAb to compete and gain market shares in a very large global market segment with significant unmet needs and demands.  To further minimize risks of investment, IMT will use its know-how, scientific insights and technological knowledge to strategically develop and design anti-IgD mAb as a platform that is adaptable to other modality platforms and enable it to be utilized for at least one therapeutic application in human.

    Investing in the clinical development of therapeutic anti-IgD mAb will not only offer substantial financial returns but also support and advance our scientific research efforts to bring a potentially lifesaving treatment for a range of chronic diseases to the clinics to address the current significant unmet patient needs.

    Investment in new drug development is a high risk, high costs and highly technical venture that require experienced professionals.  IMT recommends that investors seek independent scientific, investment and legal advice for all matters related to investment opportunities proposed by IMT.  For further information that may assist with due diligence and business assessment, contact IMT.

    Inquiries

    Contact IMT for all inquiries regarding due diligence information, IMT technology assessment, collaborations, and investment opportunities.

    Note: IMT business proposals may contain ‘forward-looking’ statements. IMT investment opportunity aims at professional and sophisticated investors with understanding of the risks involved in biotechnology investment. IMT recommends that investors seek independent advice for scientific and investment matters related to IMT technology and investment opportunities. For more details and inquiries to assist with due diligence assessments, please contact IMT.