Pharma Focus America

PeproMene Bio, Inc. Successfully Completes First Dose Cohort in B-NHL Phase 1 Clinical Trial of PMB-CT01 (BAFFR-CAR T Cells) and Initiates Second Dose Cohort

Monday, September 11, 2023

PeproMene Bio, Inc., a clinical-stage biotech company specializing in the development of novel therapies for cancers and immune disorders, has reached a significant milestone in its phase 1 clinical trial for relapsed or refractory B-cell Non-Hodgkin Lymphoma (r/r B-NHL) with PMB-CT01, also known as BAFFR-CAR T Cells. The trial's first dose cohort has been successfully completed with no observed Dose Limiting Toxicity (DLT), allowing the study to proceed to the next cohort.

The PMB-102 trial is being conducted at City of Hope, one of the largest cancer research and treatment institutions in the United States, where PeproMene licensed the intellectual property related to PMB-CT01. In the first cohort of the trial, the administration of 50x106 PMB-CT01 has been well-tolerated. Among the three treated patients, all experienced only grade 1 cytokine release syndrome (CRS), and two had grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) with full recovery. Notably, the Overall Response Rate was 100%, with two patients achieving Complete Response and one achieving Partial Response one month after treatment. Two patients with mantle cell lymphoma had previously progressed after conventional CD19 CAR T-cell treatment before enrolling in PMB-CT01.

Dr. Elizabeth Budde, the principal investigator of the trial and an associate professor at City of Hope, expressed excitement about the minimal toxicity and high response rate observed in heavily pretreated patients who had failed multiple prior lines of therapy, including FDA-approved CD19 CAR T-cells.

Dr. Larry W. Kwak, Vice President and Deputy Director of City of Hope's Comprehensive Cancer Center and PeproMene's scientific founder, highlighted the potential of BAFFR-CAR T therapy to address the unmet medical needs of patients who relapse after CD19-CAR T treatment. Unlike CD19, BAFF-R signaling is essential for B cell growth and survival, potentially limiting the capacity of B cell tumors to evade therapy by losing BAFF-R expression.

Hazel Cheng, Ph.D., COO of PeproMene, expressed encouragement regarding the acceptable safety profile and preliminary efficacy observed in the first dose cohort of PMB-CT01-treated B-NHL patients. All three treated patients, including those who had progressed after CD19 CAR T therapy and one with CD19/CD20 negative lymphoma, responded positively to PMB-CT01 treatment. These clinical outcomes align with preclinical research data from City of Hope published in Science Translational Medicine in 2019, demonstrating that PMB-CT01 (BAFFR-CAR T Cells) can overcome CD19 antigen loss in B-cell malignancies.

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