Revolutionary Anti-Cancer Bispecific Antibody LBL-034 Clears Hurdles: First-in-Human Clinical Trials Approved by FDA and NMPA!

Leads Biolabs is proud to announce today that its first-in-human Investigational New Drug (IND) application for LBL-034, an anti-GPRC5D/CD3 bispecific antibody, has been approved by both the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma. This marks the first GPRC5D-targeting antibody to be approved for marketing, and Leads Biolabs has owned the global intellectual property rights since its invention.

This groundbreaking single-arm, multicenter, open-label clinical study is giving new hope to patients with relapsed/refractory multiple myeloma. Participants have already gone through prior treatments such as a proteasome inhibitor and immunomodulator, and now have the opportunity to take part in this study to evaluate the safety and efficacy of a potential new therapy, LBL-034. This study will help researchers determine the recommended Phase II dose so that other multiple myeloma patients may also benefit from this innovative treatment.

At Leads Biolabs, we understand the urgent need for more effective and innovative treatment options for the growing population of patients with relapsed or refractory multiple myeloma. With this in mind, we are proud to introduce LBL-034, a unique molecular design drug that is specifically designed to bind to GPRC5D-expressing tumor cells.

In preclinical studies, LBL-034 demonstrated robust anti-tumor activities and good safety profile, making it an attractive option for patients with a poor prognosis. Our goal is to provide a much-needed option for those affected by this incurable malignant tumor and strive to build a bridge to health and hope.

About GPRC5D:

GPRC5D, a C-type 7-channel transmembrane receptor protein, is typically lowly expressed in healthy human tissues, yet is significantly overexpressed in patients with multiple myeloma. Intriguingly, the intensity of GPRC5D expression acts as an independent prognostic factor in multiple myeloma, where its overexpression has been linked to reduced overall survival. Consequently, GPRC5D stands as a potential target for the treatment of multiple myeloma -a vital breakthrough towards defeating plasma cell diseases.

About multiple myeloma:

Multiple myeloma is a deadly hematological malignancy that affects 10-15% of the population and accounted for 1.4% of all malignancies worldwide in 2020. A dismal figure, considering that the five-year survival rate for this disease remains around 25% in China, 33% in Japan, and 47% in the United States!

Despite this, recent developments in proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), selective nuclear output inhibitors, CD38-targeted antibodies, bispecific antibodies, and, most recently, CAR-T cell therapies offer promising new treatments.

While an eventual cure for multiple myeloma remains elusive, patients and physicians, alike, take solace in the optimism of a well-tolerated and ultimately curative treatment.

About LBL-034:

LBL-034 is an exciting breakthrough in medical treatment! This humanized IgG1 subtype asymmetric bispecific antibody targets both GPRC5D and CD3 and has the potential to dramatically shift the outlook of myeloma diagnosis.

By redirecting CD3+ T-cells to myeloma cells expressing GPRC5D, it induces T-cell-mediated killing that could provide a potential cure. And on top of that, Leads Biolabs owns the exclusive global intellectual property rights to this revolutionary discovery.

LBL-034 offers a new possibility in the fight against multiple myeloma. Clinical studies are in the pipeline to assess the efficacy and safety of this breakthrough GPRC5D-targeted immunotherapy. With the potential to revolutionize care for those battling this devastating disease, LBL-034 could be a game-changer in the treatment of relapsed or refractory multiple myeloma.

At Leads Biolabs, we are trailblazers of biotechnology, passionate about discovering the most exciting and innovative ways to combat the toughest battles of major diseases.

Our illustrious team of US-trained antibody drug developers, based here in Nanjing since 2014, have created a broad R&D portfolio, researching more than twenty unique molecules of immunotherapy for the treatment of cancers and other debilitating afflictions.

Our mission is to empower patients across the world with safe, effective and affordable therapies, providing access to groundbreaking drugs in our pursuit of unmet needs.

Leave a Comment