Beijing, China October 8, 2022- 3D Medicines Inc. announced today that the subject has been dosed in the Phase I clinical trial for 3D189 (also known as galinpepimut-S, or GPS), which is the first clinical trial in China for this product to assess the safety and immunogenicity of 3D189 in patients with hematological malignancies.The first dosing of the first participant was completed at the Institute of Hematology. 3D Medicines holds the exclusive license from SELLAS to develop, manufacture and commercialize 3D189 in China, Hong Kong, Macau and Taiwan region for all therapeutic and other diagnostic uses.
This is a phase I, open-label, single-arm, multi-center study in patients with acute myeloid leukemia in complete response, or patients with multiple myeloma, non-Hodgkin’s lymphoma, or higher-risk myelodysplastic syndrome who have received at least 1st-line standard therapy and achieved a complete response or partial response.
Dr Xiao Shen, the Chief Medicial Officer & Chief Stretegy Officer of 3D Medicines, comments that 3D189 targets Wilms Tumor 1 (WT1), which addresses 25 WT1 optimally selected epitopes, eliciting CD4 and CD8 immune responses across most HLA types. Two of the four peptides have a by-design single amino acid mutation embedded which increases their immunogenicity and helps to overcome tolerance. It’s the first treatment vaccine we are developing, an important step for 3D Medicines, thanks for all contributors. I believe it will potentially provide a significant benefit to various types of cancer as a chronic disease and fill the unmet medical needs.
Due to its antigen-specific cellular immune response, including cell-immunity-based memory and helper function via CD4+ cells and cytotoxic CD8+ cells, GPS is designed to prevent/delay relapses (by prolonging the progression-free interval) and eventually potentially prolong survival in these patients, which is evidenced by the encouraging preliminary results in Phase I and II clinical trials performed to date in acute myeloid leukemia (AML) (after first- and second-line therapy in patients in complete remission), malignant pleural mesothelioma (MPM) (after first-line therapy), high-risk multiple myeloma (MM) (after upfront therapy including auto transplant), and relapsed ovarian cancer (OC) (after second-line therapy).
The dose selection for 3D189 is based on the experience of GPS in clinical trials and a relatively small dose of subcutaneous injection seems sufficient to induce an adaptive T-cell response.
Combination of 3D189 and envafolimab has the potential to exert synergistic anti-tumor effects. 3D189 can enhance the ability of immune recognition and immune attack on tumor cells, while envafolimab can relieve the immunosuppressive signal, making it difficult for tumor cells to escape immune attack. In addition, 3D189 can induce immune memory response in CD4+T cells, thereby potentially eliminating residual tumor cells in the body and strengthening the immune surveillance against tumor cells, which will help to prolong the duration of clinical remission achieved from antitumor therapies or delay the time to tumor progression/recurrence. We believe that the combination of 3D189 and envafolimab may improve the clinical outcomes of patients with a variety of malignant tumors with a favorable safety and tolerability profile and help address the unmet clinical needs.
3D189, also known as SELLAS’ lead product candidate, GPS, is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein which is present and over-expressed in an array of hematological malignancies and solid tumors. When administered to a patient as a monotherapy or in combination with standard treatments, GPS’ induced immune response has the potential to recognize and destroy cancer cells and provide ongoing support and memory to the immune system so that it can continue to target and destroy recurring tumors and residual cancer cells. The immunotherapy has the potential to be a highly effective approach to prolonging survival by delaying or preventing recurrence in patients in complete remission or with minimal residual disease.
3D Medicines holds the exclusive license from SELLAS to develop, manufacture and commercialize 3D189 in China, Hong Kong, Macau and Taiwan region for all therapeutic and other diagnostic uses.
About 3D Medicines, Inc.
3D Medicines Inc. is a commercial-stage biopharmaceutical company with a mission to help people with cancer live longer and better. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines focuses on the development of differentiated immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3D Medicines has established a pipeline with both biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.
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About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and in combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing GFH009, a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc. for all therapeutic and diagnostic uses in the world outside of Greater China.
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