- PeproMene Bio, Inc. announces the completion of the first-dose cohort and the opening of the second-dose cohort in its Phase 1 B-cell non-Hodgkin lymphoma (B-NHL) clinical trial of PMB-CT01 (T-cell BAFFR-CAR)

IRVINE, Calif., Sept. 11, 2023/PRNewswire/ -- PeproMene Bio, Inc., a clinical-stage biotechnology company developing novel therapies to treat cancers and immune disorders, today announced that the first dose of its lymphoma cohort will not Phase 1 Relapsed or Refractory B-Cell Hodgkin (r/r B-NHL) clinical trial of PMB-CT01 (BAFFR-CAR T Cells) has been completed. No dose-limiting toxicity (DLT) was observed and the study was cleared to continue to the next cohort.

The PMB-102 trial is being conducted at City of Hope, one of the largest cancer research and treatment organizations in the country. PeproMene licensed intellectual property related to PMB-CT01 from City of Hope, which developed the therapy.

In the first cohort, the administration of 50x106 PMB-CT01 was extremely well tolerated. Among the three patients treated, all three experienced only grade 1 cytokine release syndrome ("CRS") and two had grade 1 immune effector cell-associated neurotoxicity syndrome ("ICANS") with complete recovery. The overall response rate is 100% (two complete responses and one partial response) one month after treatment. Two patients with mantle cell lymphoma had progressed after conventional CD19 CAR T cell treatment before enrollment in PMB-CT01.

"We are pleasantly surprised and excited to see such minimal toxicity associated with such a high response rate in heavily pretreated patients who have failed 3 to 10 prior lines of therapy, including FDA-approved CD19 CAR T cells," he said. Elizabeth Budde, M.D. , Ph.D., principal investigator of this single-center dose escalation trial (NCT05370430) and associate professor, City of Hope, Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation.

"Despite the high initial efficacy of CD19-CAR T cell therapy for B-cell lymphoma and leukemia, a significant number of patients still relapse after CD19-CAR T cell treatment, highlighting the medical need urgently needed treatment," said Larry W. Kwak, M.D., Ph.D., vice president and deputy director of City of Hope Comprehensive Cancer Center and scientific founder of PeproMene and paid chair of its Scientific Advisory Board. Kwak has an equity stake in PeproMene. "Unlike CD19, BAFF-R signaling is required for B cell growth and survival, so it may limit the ability of B cell tumors to evade therapy by loss of BAFF-R expression. A. I hope that BAFFR-CAR T therapy offers a clinically meaningful new option for patients."

"Although still in an early stage, we are encouraged by the initial observation of acceptable safety and preliminary efficacy in the first-dose cohort of B-NHL patients treated with PMB-CT01. All 3 treated patients (2 progressed after CD19 CAR T and 1 CD19/CD20 negative therapy) responded to treatment with PMB-CT01," said Hazel Cheng, Ph.D., Chief Operating Officer of PeproMene. "These clinical results are consistent with City of Hope preclinical research data published in Science Translational Medicine in 2019, which showed that PMB-CT01 (BAFFR-CAR T cells) could overcome the loss of CD19 antigen in malignancies of B cells."

About PMB-CT01

PMB-CT01 is the first autologous CAR T cell therapy targeting BAFFR. BAFF-R (B cell activating 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 BAFF signaling -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 the BAFF-R antigen. This unique feature makes BAFF-R CAR T therapy a highly potential treatment for B-cell malignancies. BAFF-R CAR-T was constructed using anti-BAFF-R scFv (single chain variable fragment) antibodies with second-generation signaling domains containing CD3ζ and 4-1BB. Our research has found that BAFFR-CAR T cells kill human lymphomas and leukemias both in vitro and in animal models. PeproMene has licensed intellectual property related to PMB-CT01, from City of Hope.

About Pepro Mene

PeproMene is a clinical-stage biotechnology company based in Irvine, California, developing novel therapies to treat cancers and immune disorders. PeproMene's lead candidate, PMB-CT01 (BAFFR-CAR T Cells) is currently being investigated in Phase 1 clinical trials to treat B-cell acute lymphoblastic leukemia (B-ALL; NCT04690595) and B-cell non-Hodgkin lymphoma refractory and relapsed (B-NHL; NCT05370430). PeproMene is also developing BAFFR bispecific 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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