Through strategic licensing, acquisition and independent R&D, Beike Biotechnology has gained a strategic position in the immunotherapy field. Beike has multiple international cutting-edge and innovative immunotherapy technologies and products becoming available to the public shortly. Our strategic immunotherapy partner Altor Biosciences has partnered with the National Cancer Institute (NCI) to further develop ALT803, our proprietary interlukin superagonist for cancer treatments, via their Cancer Moonshot 2020 program, allowing for two developmental drugs to be combined for use in clinical trials.
ALT803 is considered the most promising interleukin drug for cancer treatment by the National Cancer Institute. Furthermore, MAR-based (MHC Antigen Receptor) antibodies, bi-specific antibodies, MCAR-T, MCAR-NK cell therapy and the like have advantages over the regular CAR-T, TCRT and Bi-specific antibodies in treating hematologic and solid tumors and virally infected disease. Below are detailed descriptions of a few of these technologies as well as a timeline of availability for each.
ALT803, IL-15 Super Agonist
As a result of encouraging pre-clinical studies, the NCI considers IL-15 as one of the most promising therapeutic agents in cancer treatment. ALT803 is a recombinant human super agonist interleukin-15(IL-15). It is a potent immunotherapeutic agent capable of activating immune cell responses against hematologic and solid tumors and virally infected cells. ALT803 is currently in clinical development and is being evaluated by Altor Biosciences in four U.S.-based clinical trials in various cancer indications. Besides the ALT803 therapeutic drug, Beike is also developing an 803 cell culture medium. The 803 cell culture medium will significantly enhance the persistence of T and NK cells ex vivo and in vivo.
Related: In 2014, Beike signed a strategic partner agreement with Altor Bioscience Corp, licensing in ALT-803, the IL-15-based immunotherapeutic agent.
Related: Altor BioScience Corporation Partners with the National Cancer Institute to Further Develop Altor’s ALT-803 and ALT-801 Cancer Immunotherapeutics
In 2015, Beike acquired Nanjing Abingen Biotech Co. Ltd., an innovative immunotherapy developer with a strong portfolio of proprietary technologies and products. Based on this licensing and acquisition, and through corporate restructuring, capital expansion, and program combination, Transimmune Biotech Inc. was incorporated in 2015. Transimmune, as a Beike’s affiliated company, will provide to the market a series of innovative immunotherapeutic programs.
MAR-based Antibody
Transimmune has developed a unique technology platform for discovery antibodies that binds not only cell surface antigens, but also intracellular antigen fragments. This class of antibody is called MHC Antigen Receptor, or MAR. As a class of antibody, MAR technology will have many applications in treating diseases. Also in the pipeline, Transimmune will launch a series of bi-specific antibody fusion protein drug candidates, BiAT bi-specific antibodies. Those drug candidates will use MAR as the target binding end combined with T cell engagers.
MAR-based Cell Therapy
In the past few years, T cell chimeric antigen receptor (CAR-T) technology has led to a revolution in the oncology field and changed the landscape of medical oncology. CAR-T technology uses genetic engineering to have T cells express antigen receptors, enhancing the T cells to target cell combinations and overcome immunotolerance. CAR-T has shown great potential in cancer treatment. CAR-T technology in its current form can only target cancer antigens on the cell surface. However, 80-90% of cancer targets are intracellular, which CAR-T cannot find to bind with. Based on MAR technology, Transimmune will launch a series of cell therapy products, including MCAR-T (MAR based CAR-T) and MCAR-NK. MAR-based CAR-T cell and CAR-NK cell therapy have a distinct advantage compared regular CAR-T – a much wider spectrum of target binding. Compared with TCR-T technology, it has better specificity and affinity, and is therefore safer as well.
Laboratory Reagent
Besides therapeutic products, Transimmune will also provide laboratory products to serve the cell therapy and cell banking industry, including cell freeze solutions and cell culture mediums.
Below is Beike’s product roll out timeline:
| Product Line | Outline | Launch |
|---|---|---|
| BiAT® Bi-specific Antibody | 1. BiAT®HER2/CD3 Bi-specific reagent kit, for CIK or T cell culture, applied to HER2 positive cancers. | To be launched for translational studies in H2/2016 |
| 2. BiAT®CD20/CD3 Bi-specific reagent kit, for CIK or T cell culture, applied to CD20 positive cancers, including a part of leukemia and lymphoma. | To be launched for translational studies in H2/2016 | |
| 3. BiAT® EGFR/CD3 Bi-specific reagent kit, for CIK or T cell culture, applied to EGFR positive cancers, including a part of lung cancer. | To be launched for translational studies in H2/2016 | |
| CSF Safe-A™ Cell Freeze Solution | Specifically developed for immune cell freezing and storage. To be launched for translational studies in H1/2016 | To be launched in H1/2016 |
| CAR-T Series | 1. CD19, for leukemia and lymphoma. Launch date: 2017 | To be launched in H1/2016 |
| 2. CD20, for leukemia and lymphoma. Launch date: 2017 | ||
| 3. CD19/CD20 dual targeting, for leukemia and lymphoma. Launch date: 2017 | ||
| MCAR-T Series | MCAR-T line, including MCAR-T/GP100 for solid tumor treatment. Available for clinical studies in 2017. | To be launched for translational studies in 2017 |
| MCAR-NK Series | MCAR-NK line, including MCAR-NK/GP100 for solid tumor treatment. | To be launched for translational studies in 2017-2018 |
| MAR Bi-specific Antibody Fusion Protein Line | Fusion proteins using MAR binding and T/NK cell engagers. | IND filing in 2018 |
| Special Designed Antibody and Fusion Protein Line | Antibodies and fusion proteins in special formats. | IND filing in 2018 – 2019 |