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-PeproMene Bio, Inc. announced the complete response of the first patient treated in its Phase 1 B-cell non-Hodgkin lymphoma (B-NHL) clinical trial of PMB-CT01 (BAFFR-CAR T-cells) in City of Hope

IRVINE, Calif., Dec. 21, 2022 /PRNewswire/ -- PeproMene Bio, Inc., a clinical-stage biotechnology company developing novel therapies to treat cancer and immune disorders, announced today that the first patient treated in its Phase 1 clinical trial of relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) of PMB-CT01 (BAFFR-CAR T-cells) achieved complete response one month after treatment. The trial is being conducted at City of Hope, one of the largest cancer research and treatment organizations in the United States.

During the first month of treatment, the patient experienced only low-grade treatment-emergent toxicities, including Grade 1 cytokine release syndrome ("CRS") with full recovery and no immune effector cell-associated neurotoxicity syndrome ("ICANS"). "). "This mantle cell lymphoma patient has been refractory to several prior lines of treatment, including chemoimmunotherapy, BTK inhibitor, Venetoclax, and CD19-CAR T therapy. We are pleased to see a deep complete remission that is disease-negative." minimal residual," said Elizabeth Budde, M.D., Ph.D., associate professor, City of Hope, Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation and principal investigator of this single-center dose-escalation trial (NCT05370430 ).

"Despite the high initial efficacy of CD19-CAR T cell treatment for B-cell leukemia and lymphoma, there is a significant unmet medical need for those patients who unfortunately relapse," said Larry W. Kwak, M.D., Ph .D., vice president and deputy director of the City of Hope Comprehensive Cancer Center and scientific founder of PeproMene and paid chair of its Scientific Advisory Board. Kwak has an equity interest in PeproMene. "Since BAFF-R is a new tumor target for B-cell malignancies, I hope that BAFFR-CAR T therapy offers a clinically significant new option for these patients."

"The acceptable safety profile and early complete response of our first BNHL patient treated with PMB-CT01 is an unprecedented milestone in the development and evaluation of PMB-CT01. These initial clinical results are supported by research data City of Hope preclinical study published in Science Translational Medicine in 2019, which demonstrated that PMB-CT01 (BAFFR-CAR T cells) can overcome CD19 antigen loss in B-cell malignancies," said Hazel Cheng, Ph.D. , Director of Operations for PeproMene.

About PMB-CT01 PMB-CT01 is the first autologous CAR T cell therapy targeting BAFFR. BAFF-R (B cell activation factor receptor), a member of the tumor necrosis factor (TNF) receptor superfamily, is the major BAFF receptor that is expressed almost exclusively on B cells. Since signaling Although BAFF-R promotes normal B cell proliferation and appears to be necessary for B cell survival, it is unlikely that tumor cells can escape immune responses through loss of BAFF-R antigen. This unique feature makes BAFF-R CAR T therapy a great potential treatment for B-cell malignancies. BAFF-R CAR-T was constructed using anti-BAFF-R scFv (single chain variable fragment) antibodies with the second generation signaling domains containing CD3ζ and 4-1BB. Our research has found that BAFFR-CAR T cells kill human lymphomas and leukemias in vitro and in animal models. PeproMene is licensed to the intellectual property related to PMB-CT01, from City of Hope.

About PeproMene PeproMene is a clinical-stage biotechnology company in Irvine, California, developing new therapies to treat cancer and immune disorders. PeproMene's lead candidate, PMB-CT01 (BAFFR-CAR T cells) is currently being investigated for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (B-ALL; NCT04690595) and B-cell non-Hodgkin lymphoma (B -NHL; NCT05370430) in Phase 1 clinical trials. PeproMene is also developing BAFFR bispecific Engager T cells and BAFFR-CAR NK cells. For more information, contact Hazel Cheng, Ph.D. from PeproMene Bio Inc. at hazel.cheng@pepromenebio.com or visit www.pepromenebio.com.

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