The phase I/II trial will recruit up to 42 participants with inoperable leiomyosarcoma or dedifferentiated liposarcoma
Uxbridge, UK – 28 May 2020 – Immodulon, the immuno-oncology company, today announces that the Company has received confirmation from the US Food and Drug Administration (FDA) that its Investigational New Drug (IND) application has been approved for IMM-101, in combination with two other drugs, for the treatment of advanced sarcoma. The acceptance of the IND allows the Company to initiate a phase I/II study at a centre of excellence in the US, designed to evaluate whether IMM-101 is safe and effective in combination with the US standard of care chemotherapy and an approved immune checkpoint inhibitor in advanced leiomyosarcoma or dedifferentiated liposarcoma. Further details will be announced following the start of the study.
Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
“The FDA’s acceptance of our IND is a crucial milestone for IMM-101 and for patients with advanced sarcoma for whom there is still a high unmet medical need. Advanced sarcoma is a devastating cancer and a leading cause of cancer death, which has unfortunately experienced little improvement in survival rates over the past decades. Despite successes in other cancers, the positive effects of immune checkpoint inhibitors have not been shown in advanced sarcoma. We look forward to commencing this study and reporting results in due course.”
The phase I/II trial is a two-part safety and efficacy study that will enroll up to 42 patients with either advanced leiomyosarcoma or dedifferentiated liposarcoma. The primary objective of the trial is to determine whether IMM-101 is safe in combination with chemotherapy and an immune checkpoint inhibitor. Secondary objectives include overall survival and progression free survival.
Sarcomas are a diverse and rare type of cancer that typically develop in the connective tissue of the body, such as blood vessels, nerves, muscles, fat (“soft tissue sarcomas”), and bones (“osteosarcomas”). There are currently more than 50 sub-types of soft tissue sarcomas known and approximately 35% of the newly diagnosed soft tissue sarcomas are leiomyosarcomas or liposarcomas. According to the American Cancer Society an estimated 13,000 patients will be diagnosed with soft tissue sarcoma in the US this year, and more than 5,000 of those patients will not survive the disease. The 5-year survival rate for advanced sarcoma is approximately 16%.
IMM-101 is a multitargeted, systemic immunomodulator, which contains heat-killed whole cell Mycobacterium obuense with the ability to activate early stage dendritic cells and skew their maturation into a specific direction. IMM-101 activated dendritic cells induce Type I immune responses resulting in the generation of cytotoxic T cells, which are essential for killing cancer cells. In addition, IMM-101 treatment
results in the activation of various other immune cells involved in controlling cancer. Following promising results in advanced melanoma and metastatic pancreatic cancer, IMM-101 is currently evaluated as combination therapy in several cancer settings, including a phase I/II study in advanced melanoma, and a phase I/II study in locally advanced pancreatic cancer.
About Immodulon Therapeutics
Immodulon Therapeutics Ltd. (London, UK) is a privately-owned clinical-stage immuno-oncology company primarily focused on the development of safe, effective and novel treatments for cancer. Its lead drug candidate, IMM-101, has shown promise in early clinical trials, demonstrating potential for the platform. It contains heat-killed whole cell Mycobacterium obuense which activates dendritic cells and other cells of the innate immune system by several mechanisms, including via Toll-like receptors. Its mechanism of action should not only make this product applicable to a range of cancers but, in combination with immune checkpoint inhibitors and other standard-of care treatments, it is expected to enhance their efficacy without increasing the safety burden for the patient.