On January 26, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS” or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that an IND application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been accepted by China’s National Medical Products Administration ("NMPA") (Press release, Sellas Life Sciences, JAN 26, 2022, View Source [SID1234607422]). The IND, for a small Phase I clinical trial investigating safety, was submitted by SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"). 3D Medicines expects to initiate the trial by mid-2022 and will be responsible for all expenses related to executing the trial in China. The approval of the IND by the NMPA will trigger a milestone payment to SELLAS. The current clinical development plan provides for initiation of a Phase II clinical trial following receipt of satisfactory safety data from the Phase I study; the initiation of the Phase II study will also trigger a milestone payment to SELLAS. Total remaining potential milestone payments to SELLAS under the license agreement between the two companies could total $192.5 million, not including future royalties.
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"Acceptance from China’s NMPA of 3D Medicines’ IND application to initiate a Phase I clinical trial of GPS in patients with hematological malignancies in China marks an important regulatory milestone for SELLAS," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "The results of our own Phase I and II clinical trials in acute myeloid leukemia (AML), malignant pleural mesothelioma (MPM), multiple myeloma (MM), and relapsed ovarian cancer have been extremely encouraging. We look forward to expanding the reach of GPS outside the U.S. and Europe and we view 3D Medicines’ initiation of the clinical development program of GPS in China to be a key step in our plans to improve clinical outcomes for cancer patients, not only in China, but worldwide."
"In addition, we are exploring the possibility of 3D Medicines participating in SELLAS’ ongoing randomized, multi-center Phase III REGAL clinical trial currently underway in the U.S. and Europe in patients with AML who have achieved their second complete remission. Such participation would trigger a milestone payment to SELLAS. Furthermore, GPS has the potential to create synergies in combination with envafolimab, 3D Medicines’ PD-L1 product formulated for subcutaneous injection, which received marketing approval from the NMPA in China at the end of 2021. We, together with 3D Medicines, plan to explore the combination for advanced treatment for different types of cancers," concluded Dr. Stergiou.
About 3D189
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 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.