1st human trial to test LBL-034 for hard-to-treat myeloma in US, China
LBL-034 is bispecific antibody designed to simultaneously bind to GPRC5D, CD3
Nanjing Leads Biolabs is planning to launch a first-in-human clinical trial to test LBL-034, an antibody-based therapy designed to trigger the immune system to destroy cancer cells, in people with relapsed or refractory multiple myeloma in the U.S. and China.
Leads Biolabs has received approval to launch the trial from the U.S. Food and Drug Administration and China’s National Medical Products Administration.
“We adhere to our tradition of innovation and aim to deliver an important, novel and effective treatment option for patients with poor prognosis of relapsed/refractory multiple myeloma,” Charles Cai, MD, PhD, chief medical officer of Leads Biolabs, said in a company press release.
Urgent need for more effective treatments for RRMM
Myeloma is a cancer caused by the uncontrolled growth of certain white blood cells. While many treatments are available, people with myeloma often will fail to respond to treatment (refractory) or will experience a recurrence of the cancer after initial treatment success (relapsed).
“Despite recent progress and continuous advancements in multiple myeloma, the time between recurrences has been steadily decreasing, particularly as the number of treatment lines increases,” Cai said. “In light of this challenging reality, the urgent need for more effective and innovative treatment options has never been more evident.”
LBL-034 is a bispecific antibody, or an antibody that’s designed to simultaneously bind to two distinct molecular targets. One of these targets is GPRC5D, a protein normally found at low levels in healthy cells, but highly present at the surface of myeloma cells.
The other target is CD3, a protein that’s present at the surface of T-cells, a type of immune cell that is capable of destroying cancer cells. By simultaneously binding to both GPRC5D and CD3, the experimental therapy aims to direct T-cells to kill myeloma cells.
“LBL-034 adopts a unique molecular design, which enables the drug to specifically bind to GPRC5D-expressing tumor cells with high affinity, and reduces the risk of non-specific activation of T-cells, thereby enhancing anti-tumor efficacy and reducing potential risk” of immune-mediated side effects, Cai said.
‘Robust anti-tumor activities and good safety profile in pre-clinical studies’
The experimental therapy has shown “robust anti-tumor activities and good safety profile in pre-clinical studies,” Cai added.
The upcoming trial seeks to enroll multiple myeloma patients who have failed to respond to or relapsed after prior treatments, including but not limited to at least one proteasome inhibitor and one immunomodulator.
The study will be open-label, meaning both researchers and participants will be aware of the treatment participants receive. It will comprise a first part meant to test increasing doses of LBL-034 and a second part in which the best dose will be evaluated in a larger group of patients.
The trial’s main goal will be to evaluate the therapy’s safety, tolerability, and efficacy, while identifying an optimal dose for a future Phase 2 trial.