An investigational drug antibody therapy for multiple myeloma called MOR202 (TJ202) is currently in clinical trials in Taiwan and now expanding to mainland China. I-Mab, a high-flying Chinese biotech start-up, licensed the intellectual property from German Morphosys in 2017.
China’s National Medical Products Administration (NMPA) recently approved the Investigational New Drug clearance. The ongoing Phase II and Phase III trials are being conducted in Taiwan by i-Mab—they own the exclusive rights for development and commercialization of MOR202 in China reports Alice Melao of Myeloma Research News.
The study, sponsored by i-Mab Biopharma, is conducting a Phase III, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in patients with relapsed or refractory multiple myeloma who received at least one prior line of treatment.
The study started in July 2019 and will run through July 2022. The sponsor is targeting 291 participants. The study is being conducted in dozens of research centers and sites in China.
The sponsor’s main goal is to understand the proportion of patients who respond to treatment. They also seek to assess the percentage of patients achieving stable disease or better, duration of response, time to disease progression or death and overall survival as secondary measure reports Alice Melao.
i-Mab Biopharma has licensed TJ202(MOR202) from Germany’s Morphosys AG. Morphosys was founded back in 1992 in Munich by Dr. Andreas Pluckthun and Dr. Simon Moroney. They purport to be one of the world’s leading biotechnology companies in the area of fully human antibodies.
In the deal for MOR202 back in 2017, i-Mab paid Morphosys $20 million upfront payment and secured tiered, double-digit royalties on net sales of MOR202 plus milestone payments of up to $100 million from i-Mab—i-Mab secured exclusive development and commercialization rights for MOR202 in China, Taiwan, Hong Kong, and Macau.
What is TJ202?
TJ202 (MOR202) is a human monoclonal HuCAL antibody directed against CD38 in clinical development for multiple myeloma and potentially autoimmune diseases. CD38 is one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells and is an established diagnostic marker for multiple myeloma.
Key activities of TJ202 (MOR202) are antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) mediated killing of cancer cells. The antibody doesn’t involve complement-dependent cytotoxicity or CDC; an additional immune mechanism involved in tumor cell killing. Additionally, pre-clinical data points to low NK-cell depletion.
Who is i-Mab Biopharma?
Also known as Tianzhenshi Biotechnology Company (Shanghai), i-Mab Biopharma has raised $400 million in three rounds since its inception in 2016 according to their website. Their recent $200 million Series C financing represents one of the largest amounts ever raised by biotech in China.
They position themselves as a dynamic and fast-growing global biotech venture focused on developing biologics of a novel or highly in the therapeutic areas of immune-oncology and autoimmune diseases. Their pipeline of more than 10 clinical and preclinical-stage drug candidates is driven by the company’s “Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The company positions itself to be on track to become a fully integrated end-to-end global biopharmaceutical company with cutting-edge discovery platforms, proven preclinical and clinical development expertise and world-class GMP manufacturing capabilities.