SHANGHAI and NEW YORK, December 8, 2020 -- 3D Medicines, Inc., a clinical stage biopharmaceutical company focusing on the development and commercialization of differentiated immuno-oncology drugs, and SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS”), a late-stage clinical biopharmaceutical company focusing on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that they have entered into an Exclusive License Agreement granting rights to 3D Medicines to develop and commercialize SELLAS’ lead clinical candidate, galinpepimut-S (GPS) and candidate GPS+ at preclinical stage, across all therapeutic and diagnosis uses in the Greater China territory (mainland China, Hong Kong, Macau and Taiwan). For 3D Medicines, acquiring GPS, GPS+, and other earlier assets, including AVB-500, a new GAS6-AXL signal pathway inhibitor with high efficacy, and RMX1001 and RMX1002, two innovative non-opioid analgesics, marks another firm step forward in adapting to the trend of managing cancer as chronic illness, and building a pipeline targeting various areas of immunotherapy.

John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines, is signing the license agreement

Galinpepimut-S (GPS) is an innovative, potentially WT1-targeting immune-oncology drug in development for hematological malignancies and solid tumors characterized by an overexpression of the WT1 (Wilms Tumor Protein) antigen. In January, 2020, SELLAS commenced a pivotal Phase 3 clinical trial (the REGAL study) of GPS in patients with acute myeloid leukemia (AML) who have reached second complete remission.

According to terms of the agreement, SELLAS will potentially receive up to $202 million, inclusive of $7.5 million upfront license fee and milestone payments, and is entitled to receive royalties on Chinese sales on a tiered basis. 3D Medicines will acquire the exclusive rights to develop and commercialize GPS and GPS+ in Greater China across all indications, and SELLAS retains rights in the rest of the world, including United States.

John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines, commented, “We are very pleased to sign this exclusive license agreement with SELLAS. GPS and GPS+ are potential innovative immuno-oncology therapeutics and, the potential use as a monotherapy as well as in combination with our Envafolimab, an innovative subcutaneous PD-L1 antibody for which we have just filed the market approval in China, will provide better treatment options for tumor patients. The agreement also reflects the vision of 3D Medicines to help patients with cancer to live longer and better. The addition of GPS and GPS+ assets to our clinical portfolio increased the number of projects in Phase 2/3 studies or IND application stage to five, and we believe that it is of critical strategic significance in expanding our pipeline and improving our competitiveness.”

“We are excited to collaborate with 3D Medicines on the development and commercialization of GPS and GPS+ in China. This agreement represents an important achievement for SELLAS as we continue to progress our clinical development program for GPS and GPS+. 3D Medicines, an ambitious biopharmaceutical company with development, registration and commercialization capabilities with a focus on developing immuno-oncology drugs and an experienced team, is a wonderfully complementary partner in bringing the potential of GPS and GPS+ to patients in Greater China.” said Angelos Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS.

About Galinpepimut-S (GPS) and GPS+

Galinpepimut-S (GPS) and GPS+ are innovative immune-oncology drugs targeting Wilms Tumor 1 (WT1) which is ranked top 1 among cancer antigens by the National Cancer Institute. GPS consists of a mixture of four peptide fragments, targeting 25 carefully selected and validated WT1 antigenic epitopes, which is applicable across the majority of HLA types on a global scale. It can stimulate a strong immune response of the auto-immune system to the WT1 antigen. Both as monotherapy and in combination with checkpoint inhibitors, GPS can effectively kill tumor cells in the body and enhance the immune system's immune surveillance of tumor cells, which is potentially innovative immunotherapy targeting Wilms Tumor 1 (WT1). GPS+ is an addition of 3 peptide fragments to GPS in order to achieve better efficacy and more complete HLA coverage. GPS+ will soon come into clinical trials. GPS and GPS+ are off-the-shelf lyophilized formulations, administered subcutaneously to patients. GPS can be positioned either as a maintenance monotherapy in various clinical settings where the residual disease burden after prior debulking is very low, such as complete remission status in AML, or in combination with other therapeutic agents, most notably PD-1/PD-L1. In clinical trials, GPS has shown both as monotherapy and in combination with checkpoint inhibitors high rates of induction of immunogenicity and the ability to delay disease relapse with an overall low incidence of adverse events, mainly low grade local inoculation reactions. GPS is currently being evaluated in a Phase 3 clinical trial as monotherapy for AML patients who are in second complete remission and in Phase 1 and Phase 2 studies in combination with checkpoint inhibitors. GPS was granted Orphan Drug Product Designations from the U.S. Food and Drug Administration (FDA), as well as Orphan Medicinal Product Designations from the European Medicines Agency in AML, malignant pleural mesothelioma (MPM), and multiple myeloma (MM), as well as Fast Track Designation for AML, MPM, and MM from the FDA.

About 3D Medicines

3D Medicines, Inc. is a biopharmaceutical company at the stage of late clinical development and early commercialization. With the concept “Help people with cancer live longer and better,” aiming for the future long-term survival of tumor patients, 3D Medicines focuses on the development of differentiated immuno-oncology drugs, to help cancer patients live longer with better quality of life. 3D Medicines has built a pipeline with both innovative biological and small-molecule anti-tumor drugs, and a professional team with global development, registration and commercialization capabilities. For more information, please visit www.3d-medicines.com.

About SELLAS

SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapeutics 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 or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS’ second product candidate, nelipepimut-S (NPS), is a HER2-directed cancer immunotherapy with potential for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes triple negative breast cancer patients, following standard of care.

For more information on SELLAS, please visit www.sellaslifesciences.com.