On April 06, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that an Investigational New Drug ("IND") application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been approved by China’s National Medical Products Administration ("NMPA") (Press release, Sellas Life Sciences, APR 6, 2022, View Source [SID1234611511]).
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SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"), submitted the IND, for a small Phase I clinical trial investigating safety, earlier this year. 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 triggered a $1 million milestone payment to SELLAS, which the Company expects to receive in the second quarter of 2022. 3D Medicines’ 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 $191.5 million, not including future royalties.
"We are pleased that the 3D Medicines’ IND application filed earlier this year is now approved by China’s NMPA which allows 3D Medicines to move forward with their planned Phase 1 clinical trial. This marks the beginning of development of GPS in China which is an important milestone for SELLAS," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS.
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.