Weekly in Asia 2019｜JULY-2

20190715-0721 Weekly in Asia

Kyoto University CiRA & Takeda Collaboration on iPSC-derived CAR T Cell Therapy Enters Process Development Toward Clinical Testing

Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that takes a patient’s T-cells, which are then genetically modified in the laboratory to focus more intensely on the patient’s specific cancer cells and are then reinfused into the patient.

In 2015, Takeda Pharmaceutical Company and The Center for iPS Cell Research and Application (CiRA) at Kyoto University signed a 10-year joint research contract to develop induced pluripotent stem (iPS) cell-derived CAR T-cell therapy (iCART), a program that uses a clonal master iPS cell bank to create CAR-T therapies tailored to each patient on demand.

On July 16, 2019, Kyoto University transferred the first novel iCART therapy to Takeda, as the program begins process development toward clinical testing. Under the agreement, Takeda will obtain global rights to develop and commercialize the iCART product, while CiRA will receive various milestone payments. The iCART program is expected to move towards to the clinic in 2021.

About the Center for iPS Cell Research and Application (CiRA) at Kyoto University
CiRA was established on April 1, 2010, serving as the world’s iPS cell research institute. CiRA’s research groups are dedicated to fundamental science of cell reprogramming and human development, clinical applications, and bioethics, with the overall goal of applying iPS cells to realize regenerative medicine and drug discovery.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan that focuses its R&D efforts on four therapeutic areas: oncology, gastroenterology, rare diseases and neuroscience.

Ascentage Pharma declares first patient dosed in Phase I clinical trial of APG-2575 trial in China

APG-2575 is a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma, a clinical-stage biopharmaceutical company. It is designed to treat hematologic malignancies by selective blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Ascentage Pharma announced on July 14, 2019 that it initiated a phase I clinical trial of APG-2575 in China for treating hematologic malignancies, which is the first domestic Bcl-2 selective inhibitor entered the clinical stage.

Ascentage previously initiated a multi-center Phase I dose-escalation study of APG-2575 as a single agent in multiple hematologic malignancies in the United States and Australia in August 2018, a trial designed for people with various types of blood cancer, including acute myeloid leukaemia (AML), non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). Preliminary trial data showed that APG-2575 was well tolerated with a favorable safety profile. The therapeutic also showed promising anti-tumour activity in relapsed / refractory CLL.

About Ascentage Pharma

Ascentage Pharma Group Corporation, Ltd., a clinical-stage biopharmaceutical company, engages in the discovery and development of small-molecule targeted therapeutics for addressing cancers, hepatitis B, and age-related diseases. The company was founded in 2009 and is based in Shanghai, China.

I-Mab Receives IND Approval for TJC4, A Differentiated Fully Human CD47 Antibody, to Initiate Clinical Trials in China

On July 13th, Chinese clinical stage biotech company I-Mab’s innovative pipeline TJC4, a differentiated fully human CD47 monoclonal antibody developed for the treatment of advanced malignant tumors, received investigational new drug (IND) application from the National Medical Products Administration (NMPA).

CD47 is a cell surface glycoprotein over-expressed in various cancers and delivers a “don’t eat me” signal to tumor-engulfing macrophage through its ligand, signal regulatory protein alpha (SIRPα). Inhibition of CD47 by TJC4 enables macrophage to engulf cancer cells. TJC4 binds to a unique epitope on CD47 that leads to minimal red blood cell binding. Robust pre-clinical and toxicological studies including those in monkeys demonstrated the hematologic safety advantage and excellent anti-tumor activities of TJC4.

About I-Mab

I-Mab Biopharma Co., Ltd. develops and manufacture pharmaceutical products, such as monoclonal antibodies, immune cytokines, bispecific antibodies, tumor innovative drugs, and other products.

Sosei Heptares Enters Into Multi-target Research Collaboration and License Agreement with Genentech

G protein-coupled receptors (GPCRs) are an important target class that play roles in many serious diseases. Perturbation of GPCR function contributes to the pathophysiology of various neurodegenerative diseases, several fertility disorders, and even carcinomas.

On July 16, Japan headquartered Sosei Heptares Corporation announced a multi-target research collaboration and license agreement with Genentech, a member of the Roche Group, to discover and develop novel medicines that modulate GPCR targets.

The collaboration will combine Sosei Heptares’s proprietary GPCR-focused structure-based drug design with Genentech’s expertise directed towards multiple GPCR targets across various diseases. Under the terms of the agreement, Sosei Heptares is eligible to receive US$26 million in upfront and near-term payments, in addition to future milestone payments that may exceed US$1 billion. Sosei Heptares is also eligible to receive royalty payments on the net sales of potential future medicines resulting from the collaboration. Genentech will be responsible for developing and commercializing potential new medicines and will obtain its exclusive global rights.

About Sosei Heptares

Sosei Heptares is an international biopharmaceutical company focused on the design and development of new medicines originating from its proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities.

About Genentech

Genentech is a biotechnology corporation which manufactures and distributes therapeutic agents. The company offers products including Herceptin, Tykerb, and Boniva. Genentech was founded in 1976 and became a subsidiary of Roche in 2009.

EdiGene’s Knock-out Cell Lines and Lysates Portfolio Acquired by Abcam

On July 16th, Abcam, a Cambridge, UK based global innovator in life science reagents and tools, announced the acquisition of the entire live cell line and lysates portfolio of China-based EdiGene, a biopharma applying CRISPR/Cas9 genome editing and high throughput genetic screening to discover drug targets. Financial terms of the transaction were not disclosed.

EdiGene’s proprietary high throughput cell editing platform is a diploid library of over 2,800 single clonal knockout (KO) cell lines targeting over 2,600 genes in commonly used human cancer cell lines, including Hela, HEK-293T, HCT116, HepG2, MCF7, SF268, A549, etc. This platform can be applied to validate quality of antibody, study biological pathways and screen diseases.

About Abcam

Abcam produces and distributes research-grade antibodies and associated protein research tools worldwide. Its products are used in the areas of cancer, cardiovascular, cell biology, developmental biology, epigenetics, immunology, metabolism, microbiology, neuroscience, signal transduction, and stem cells.

About EdiGene Inc

EdiGene Inc was founded in 2015, and is now headquartered in Beijing. Edigene leverages proprietary platforms to develop gene-editing therapies for a wide range of diseases, and to conduct high-throughput genome screening to enable dissection of functional big data in biological contexts.

References
https://www.cira.kyoto-u.ac.jp/e/pressrelease/news/190716-150000.html
https://www.takeda.com/newsroom/newsreleases/2019/first-ipsc-derived-car-t-cell-therapy-created-by-kyoto-university-cira-and–takeda-collaboration-enters-process-development-toward-clinical-testing/
https://www.ascentagepharma.com/press-releases/ascentage-pharma-announces-first-patient-dosed-in-phase-i-clinical-trial-of-apg-2575-in-china-as-the-first-china-made-bcl-2-inhibitor/
http://www.i-mabbiopharma.com/en/article-315.aspx
https://soseiheptares.com/news/539/129/Sosei-Heptares-enters-into-multi-target-research-collaboration-and-license-agreement-with-Genentech.html
http://www.edigene.com/new/14.html

Author

GeneOnline