Shanghai (China), Daejeon (South Korea)，January 5^th 2021 - 3D Medicines Inc., a clinical stage biopharmaceutical company focusing on the development and commercialization of differentiated immuno-oncology drugs, and Y-Biologics, the South Korean biotech company, have entered into a license agreement, and 3D Medicines will obtain exclusive rights to develop, manufacture, and commercialize YBL-013, a T cell bi-specific engager based on ALiCE platform technology, in the Territory of Greater China (mainland China, Hong Kong, Macau and Taiwan) and will co-developed it across the globe. For 3D Medicines, acquiring this candidate drug will further improve its product layout in the field of immune-oncology, and build a highly competitive and complementary pipeline.

YBL-013, a novel I/O therapeutic candidate developed based on Y-Biologics’ proprietary T cell bispecific engager technology, namely ‘ALiCE’ (Antibody Like Cell Engager), simultaneously targets CD3 on T cell and PD-L1 on cancer cell. The technology is the CD3-based bispecific antibody genetically engineered to have a unique 2 by 1 structure with two Fab regions targeting for a tumor antigen and Fv region specific for CD3 by placing between T cell and cancer cell, specifically activating T cells around the tumor. This is an innovative technology that can significantly reduce the toxicity which current T cell bispecific antibodies might have.

John Gong, M.D., Ph.D. is signing the collaboration agreement

Under the terms of this agreement, Y-Biologics will share part of IND development cost, receive an upfront fee of $2 million and is eligible to receive up to $85 million in additional development, regulatory, commercialization and sales milestone payments as well as up to double-digit royalties on net sales in the territory. In the meantime, 3D Medicines will have an exclusive right to develop, manufacture, and commercialize for YBL-013 in Greater China, and its co-development and preferential assignment in other regions.

John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines, commented, “We are very pleased to enter into this exclusive license agreement with Y-Biologics and we believe that YBL-013, a bi-specific T cell bi-specific engager based on the unique molecular structure with differentiated advantage in safety and efficacy, together with Envafolimab, the subcutaneous PD-L1 antibody to be launched in China, and other innovative products in our pipelines, could provide better treatment options for patients with cancer. We are committed to working closely with Y-Biologics to further advance the clinical development and commercialization of YBL-013, and bring this drug with important potential to patients living with cancer in China as soon as possible. On top of that, we believe that the addition of YBL-013 into our portfolio marks an important step for 3D Medicines to improve our future competitiveness and achieve long-term growth strategies.”

Young Woo Park, CEO of Y-Biologics, stated: “We are excited to reach the license agreement on global co-development, and we will focus on the development of ALiCE, the T cell bispecific antibody platform. In the T cell bispecific antibody market based on CD3, we will provide more competitive novel I/O therapeutic candidates, which is also the main trend in the field of bispecific antibody. Besides, we will take the collaboration in Greater China as a start and devote ourselves to providing our advanced technology to the global market.”

About ALiCE

ALiCE, a novel T cell bispecific antibody format platform technology, is designed to overcome immune evasion in cancer. This format allows T cells to directly engage to target cancer cells and thereby activates the cytotoxic immune responses. The ALiCE molecules are engineered to have a unique 2 by 1 structure with two Fab regions targeting for a tumor antigen and Fv region specific for CD3 found on T cells.

ALiCE molecules appear to have more advanced target cancer cell killing mechanism in low doses than other T cell engagers/bispecific antibodies with 1 by 1 structure. The structural feature of bivalent binding and much higher binding affinity to tumor antigens allows T cell engagement to tumor cell efficiently. As a result, ALiCE molecule induces cancer cell killing potency in low doses while triggering T cell activation only near the tumor site, reducing off-tumor toxicity.

As for production procedures, ALiCE molecules can be formed as heterodimers by harnessing innate assembly mechanisms in mammalian cells and secreted into the culture medium with the help of ALiCE platform technology, reducing the incidence of mismatch and realizing easy production and purification with conventional manufacturing procedures.

About 3D Medicines Inc.

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 Y-Biologics

Founded in 2007, Y-Biologics is a biotech company focusing on the discovery and development of novel antibody therapeutics based on its human antibody library “Ymax®-ABL” & bispecific antibody platform technology “ALiCE” (Antibody Like Cell Engager).

With a diversity of 1011, Ymax®-ABL has highly competitive quality and quantity leading to higher singularity and probability of findings from the proprietary library. Based on Ymax®-ABL, Y-Biologics currently has developed more than 20 antibody candidates in various modalities. Following early work in discovery, the novel bispecific platform technology ALiCE, allows effective redirection of T cells onto tumor cells and thereby specifically kill the tumor cells giving very potent and long-lasting efficacy in the treatment of cancer patients. ALiCE has overcome the major drawbacks of currently available technologies such as excessive toxicity and low developability. Therefore, it has strong potential to further address those unmet needs in fields of immuno-oncology.

While focused on research initially, Y-Biologics recently started conducting joint development and investment through strategic alliances and providing various collaboration opportunities for global partnering.

For more information: http://ybiologics.com/eng/main/

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