The South Korean biotech company Y-Biologics and the China-based biopharmaceutical company 3D Medicines have entered into a License Agreement granting 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, S.A.R., China, Macau, S.A.R., China and Taiwan, China).

Under the terms of this Agreement, Y-Biologics will 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. Both Parties will share part of IND development cost. In the meantime, 3D Medicines will have an exclusive right to develop, manufacture, and commercialize for YBL-013 in Greater China, with potential expansion collaboration opportunity in US and other regions.

YBL-013, a novel I/O therapeutic candidate which simultaneously targets CD3 on T cell and PD-L1 on cancer cell, is the first candidate developed based on Y-Biologics' proprietary T cell bispecific engager technology, namely 'ALiCE' (Antibody Like Cell Engager). The technology is the CD3-based bispecific antibody engineered to have a unique 2 versus 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. Notably, it shows a higher binding affinity to tumor antigens and activates mainly T cells around the tumor. This is an innovative technology that can significantly reduce the toxicity which current T cell bispecific antibodies have.

"We are very pleased to enter into this exclusive license agreement with Y-Biologics," said John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines. "We believe that YBL-013, bi-specific engager, a next generation T cell bi-specific engager, together with Envafolimab, the global first subcutaneous PD-L1 antibody to be launched in China, and other innovative products in our pipelines, could alter the treatment paradigm across various tumor types. We are committed to working closely with Y-Biologics to further advance the development of YBL-013, which has great potential to help patients living with cancer.

Young Woo Park, CEO of Y-Biologics, stated "We have focused our capabilities on the development of ALiCE, T cell bispecific engager technology, and we are extremely pleased that the output has emerged as the global license agreement. Through ALiCE technology, we will strengthen our novel therapeutic portfolio by presenting a variety of competitive novel I/O therapeutic candidates in the CD3-based T cell bispecific engager market, which is a key trend in the field of bispecific antibody. In addition, starting from China, we will put our efforts to present our highly skilled technology to an international market."

Meanwhile, Y-Biologics has licensed out YBL-001, which is an ADC candidate co-developed with LegoChem Bioscience, to Pyxis Oncology in early December. On the other hand, 3D Medicines recently licensed-in AVB-500 from Aravive and galinpepimut-S (GPS) from SELLAS Life Sciences for both hematological malignancies and solid tumors.

About ALiCE

ALiCE, a novel T cell bispecific antibody format, 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.

The targeting strategy is designed to have a higher binding affinity to a target cancer cell by two arms and a lower binding affinity to CD3 by one arm. Therefore, T cell activation occurs only near the tumor site when the ALiCE molecule bound to the target cancer cell, which is leading to reduced off-tumor toxicity.

ALiCE molecules appear to have more advanced target cancer cell killing mechanism in low doses than other T cell engagers 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. This clustering formation can generate strong T cell activation signaling and induce cancer cell killing potency.

ALiCE molecules can be formed as heterodimers by harnessing innate assembly mechanisms in mammalian cells and secreted into the culture medium. The molecules can be easily produced and purified with conventional manufacturing procedures.

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 next-generation 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. 

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.