ITBMed

ITBMed, a biopharmaceutical company established in 2016, is focused on the clinical development of immunomodulatory biologics for organ and stem cell transplantation, as well as autoimmune diseases. The company was founded by David Berglund, Erik Berglund, David Sachs, and Stefan Berg. The firm's headquarters is in Stockholm, Sweden.

The company's core asset is Siplizumab (TCD601), a humanized monoclonal antibody that targets the CD2 receptor on T-lymphocytes and natural killer cells, thereby inhibiting their activation. This therapeutic candidate was originally developed by MedImmune (now part of AstraZeneca) under the name MEDI-507 and was explored for conditions like psoriasis. After MedImmune's interest waned, researchers at Massachusetts General Hospital advanced the program, leading to the formation of ITBMed. The company's primary business strategy revolves around advancing Siplizumab through comprehensive worldwide clinical trials to address the significant unmet need for safer and more effective immunosuppressive regimens. The ultimate goal is to offer a treatment that could allow for the complete discontinuation of lifelong immunosuppressive drugs for transplant patients, improving quality of life and reducing healthcare costs. ITBMed operates on a venture capital-backed model, securing significant funding to support its extensive research and development activities. The company has raised a total of $87 million over two funding rounds. A major equity financing of up to $67 million was completed in April 2018, led by Pablo Legorreta, the founder and CEO of Royalty Pharma. This was followed by a Series A round of $20 million in December 2021, with lead investors including 3E Bioventures Capital and Yonjin Capital.

ITBMed is conducting multiple clinical trials to evaluate Siplizumab's efficacy and safety. The ASCEND trial is a study for de novo renal transplant recipients, comparing Siplizumab in combination with other agents against the standard of care. The PANORAMA study is an adaptive trial evaluating different Siplizumab-based regimens combined with donor bone marrow cell infusion to induce immune tolerance in living donor kidney transplant recipients, with the aim of reducing or eliminating the need for anti-rejection medications. Another study in renal transplantation is the PERSPECTIVE trial. Beyond transplantation, the STRIDE study is a Phase 2 trial investigating Siplizumab's potential to preserve beta-cell function in adults recently diagnosed with Type 1 Diabetes.

Keywords: immunomodulation, monoclonal antibody, Siplizumab, TCD601, organ transplantation, kidney transplant, tolerance induction, autoimmune disease, Type 1 Diabetes, CD2 inhibitor, cell therapy, clinical-stage biopharmaceutical, venture capital, immunosuppression-free, biologics development, T-lymphocyte modulation, NK cell inhibition, regenerative medicine, biopharma