I-Mab Biopharma is expanding to mainland China its ongoing clinical studies assessing MorphoSys‘ investigational antibody therapy MOR202 (TJ202) as treatment for people with multiple myeloma, the company announced.
The decision comes after an Investigational New Drug clearance issued by China’s National Medical Products Administration (NMPA). The ongoing Phase 2 and Phase 3 trials are being conducted in Taiwan by I-Mab, which holds exclusive rights for development and commercialization of MOR202 in the greater China region.
“Receiving two investigational new drug (IND) clearances for TJ202/MOR202 from the China NMPA marks an important milestone for us and demonstrates I-Mab’s capability and commitment to the advancement of immunological technology for the market,” Jingwu Zang, MD, PhD, founder and chairman of I-Mab Biopharma, said in a news release.
“We will move forward with the clinical development of TJ202/MOR202 in China to bring it to the market as efficiently as possible,” he added.
MOR202 is an engineered antibody that binds to the CD38 surface molecule, found in virtually all multiple myeloma cells. Once bound to its target, the antibody delivers signals that instruct the immune system to kill the malignant cells.
In a prior Phase 1/2a trial (NCT01421186), investigators studied a combination of MOR202 and dexamethasone, alone or with an approved immunomodulatory agent (IMiD) — Revlimid (lenalidomide) or Pomalyst (pomalidomide) — in patients with relapsed or refractory multiple myeloma.
Findings showed that a combination of MOR202, Revlimid, and dexamethasone was the most effective for these patients, with 65% of them responding to the regimen. The objective response rate to the Pomalyst regimen was 48%, while 28% of patients responded to a combination of MOR202 and dexamethasone.
The findings led I-Mab to design two additional trials of MOR202: a Phase 2 trial (NCT03860038) assessing MOR202 in combination with dexamethasone, and a Phase 3 trial (NCT03952091) studying MOR202 plus Revlimid and dexamethasone versus the combination of Revlimid and dexamethasone.
The Phase 2 trial is still recruiting and is expected to include 82 myeloma patients who have failed at least two prior lines of treatment, including a proteasome inhibitor and an IMiD.
Its main goal is to determine the proportion of patients who respond to treatment, but researchers will also assess the percentage of patients achieving stable disease or better, duration of response, time to disease progression or death, and overall survival as secondary measures.
The Phase 3 trial (NCT03952091), also recruiting, will include 291 myeloma patients who received at least one prior line of treatment. The study will determine whether adding MOR202 to standard Revlimid and dexamethasone extends the time patients live without disease worsening compared to standard therapy alone.
“We are very pleased that our partner I-Mab now also received the IND clearances for TJ202/MOR202 for China, allowing the expansion of the clinical development of TJ202/MOR202 in multiple myeloma to mainland China,” said Malte Peters, MD, chief development officer of MorphoSys.
“There is a high need for alternative treatment options for patients with multiple myeloma in the Chinese region and we look forward to the further development of TJ202/MOR202 by our partner I-Mab in this indication,” Peters added.