IRVINE, California, December 20, 2022 /CNW/ — PeproMene Bio, Inc., a clinical biotechnology company developing novel therapies for the treatment of cancer and immune disorders, today announced that the first patient has been treated for stage 1 relapsed or refractory B-cell non-Hodgkin’s lymphoma (r /r B-NHL) clinical trial PMB-CT01 (BAFFR-CAR T cells) achieved a complete response 1 month after treatment. The trial is taking place 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 complete recovery and no immune effector cell-associated neurotoxicity syndrome (“ICANS”). “This patient with mantle cell lymphoma was 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 minimally negative for residual disease,” he said. Elizabeth BuddeMD, Ph.D., City of Hope Associate Professor, Division of Lymphoma, Division of Hematology and Hematopoietic Transplantation and principal investigator of this single-center dose-escalation trial (NCT05370430).
“Despite the high initial efficacy of CD19-CAR T cell therapy for B-cell lymphoma and leukemia, there is a significant unmet medical need for those patients who unfortunately relapse,” he said. Larry W. Kwak, MD, Ph.D., Vice President and Deputy Director of City of Hope’s Comprehensive Cancer Center and Scientific Founder of PeproMene and Paid Chair of its Scientific Advisory Board. Kwak has an ownership stake in PeproMene. “Since BAFF-R is a novel tumor target for B-cell malignancies, I hope that BAFFR-CAR T therapy will offer a clinically relevant, new option for these patients.”
“The acceptable safety profile and early complete response of our first B-NHL patient treated with PMB-CT01 is an unprecedented milestone in the development and evaluation of PMB-CT01. These initial clinical outcomes are supported by preclinical data from City of Hope published in Science Translational Medicine 2019 ., which showed that PMB-CT01 (BAFFR-CAR T cells) can overcome the loss of CD19 antigen in B-cell malignancies,” he said Hazel ChengPh.D., COO of PeproMene.
PMB-CT01 is a first-in-class BAFFR-targeted, autologous CAR T cell therapy. BAFF-R (B cell activating factor receptor), a member of the tumor necrosis factor (TNF) receptor superfamily, is the major receptor for BAFF that is expressed almost exclusively on B cells. Because BAFF-R signaling promotes normal B-cell proliferation and appears to be required for B-cell survival, it is unlikely that tumor cells could evade the immune response by losing the BAFF-R antigen. This unique characteristic makes BAFF-R CAR T therapy a great potential for the treatment of B cell malignancies. The BAFF-R CAR-T was constructed using an anti-BAFF-R scFv (variable single chain fragment) antibody with a 2nd generation signaling domain containing CD3ζ and 4-1BB. Our research revealed that BAFFR-CAR T cells kill human lymphomas and leukemias in vitro as well as in animal models. PeproMene has licensed the intellectual property related to PMB-CT01, from City of Hope.
PeproMene is a clinical biotechnology company in Irvine, California developing new therapies for the treatment of 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’s lymphoma (B-NHL; NCT05370430 ). in phase 1 clinical trials. PeproMene is also developing BAFFR Bispecific T Cell Engager and BAFFR-CAR NK cells. For more information, please contact Hazel Cheng, Ph.D. Pepromene Bio Inc. at [email protected] or visit www.pepromenebio.com.
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SOURCE PeproMene Bio, Inc.
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