I-Mab Biopharma dosed its first patient in mainland China as part of its ongoing pivotal Phase II trial evaluating an experimental antibody therapy from Morphosys called MOR202 (TJ202) as a treatment for patients with relapsed or refractory multiple myeloma. This milestone was made possible thanks to China’s National Medical Products Administration (NMPA) and their decision to allow clinical trials occurring in Taiwan to expand to clinical investigational sites in mainland China.
What is MOR202?
MOR202, an experimental antibody developed by MorphoSys, binds to the CD38 surface molecule found in almost all multiple myeloma cells. Once bound to the target, the antibody delivers signals that direct the immune system to destroy the malignant cells. MorphoSys licensed this experimental therapy to I-Mab for development and commercialization in the greater China region. MOR202 is now under evaluation in previously treated multiple myeloma patients in two “registrational” clinical trials.
These primarily confirmatory studies are designed to establish an acceptable benefits/safety profile to support the regulatory approval process for a new therapy. The Phase II trial assess MOR202 and the corticosteroid dexamethasone in patients who received at least two prior lines of therapy—including a proteasome inhibitor and immunomodulator reports Ines Martins, PhD from Myeloma Research News. With the study ongoing, the sponsor seeks a total of 82 patients as reported in ClinicalTrials.gov. First and foremost, the study sponsor seeks to identify the patients who respond partially or completely to the therapy. Thereafter, I-Mab seeks to evaluate if the treatment can help patients achieve some stabilization of the disease as well as a few other targets including duration of response, time to disease worsening or death as well as overall survival. Moreover, the investigators and sponsor are mandated to study minimal residual disease—that is the presence of significantly small traces of cancer cells in the bone marrow after treatment which could lead to relapse. The study is scheduled to end December 2021.
The second pivotal clinical trial, an open-label, randomized Phase III trial evaluating the effectiveness of adding MOR202 to the standard Revlimid (lenalidomide) and dexamethasone treatment. The study team seeks to understand if adding MOR202 extends the time the participating patients (those multiple myeloma patients with previous treatment) live without the disease worsening. The hope behind this study was evidenced in a Phase I/II clinical trial where this particular combination of therapies produced positive outcomes for relapsed or refractory multiple myeloma patents. Myeloma Research News reported 65% of the patients in that previous trial responded favorably to the treatment.
This actively recruiting Phase III trial is planned to include 291 patients who are randomly assigned to receive the triple combination of MOR202, Revlimid, dexamethasone or Revlimid plus dexamethasone only. The study is planned to conclude July 2022.
Research Sites in China
The sponsor has contracted with 37 clinical research sites in China. They did not identify which site was the first to dose the patient. TrialSite News notes for those sponsors interested the sponsor lists the sites in ClinicalTrials.gov.
Who is I-Mab Biopharma?
I-Mab Biopharma is a China-based, clinical-stage biotech company with a focus on immune-oncology and immuno-inflammation. They strive to develop therapies to treat unmet medical need in the cancer and autoimmune disorder categories. They refer to themselves as a dynamic and fast-growing global biotech with an innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates driven by the company’s “Fast-to-POC (Proof of Concept) and Fast-to-Market development strategies through R&D capabilities and global partnerships.
Well recognized in the capital markets, they have successfully raised over $400 million in equity financing since its inception in 2016. In its recent $200 million Series C financing they raised one of the largest amounts ever by a biotech in China. The venture was founded by Jingwu Zang (their present CEO & Chairman).
Call to Action: Those interested in updates can sign up for the Daily Newsletter as TrialSite News will include any updates therein. Those sponsors interested in better understanding the clinical investigational networks in China reach out to use. We are working on profiles of these provider/sites.