On December 19, 2024 PeproMene Bio, Inc. (PMB) reported an $11M investment from the Institute for Follicular Lymphoma Innovation (IFLI) to support the clinical development of PMB-CT01 (BAFF-R CAR T cell therapy) in patients with relapsed or refractory (r/r) follicular lymphoma (Press release, PeproMene Bio, DEC 19, 2024, View Source [SID1234649224]). The investment includes $6M USD upfront and an additional $5M USD in conditional tranched funding. Building on the promising results of PMB’s Phase 1 study, the expansion phase will now include patients with r/r follicular lymphoma, further evaluating the safety and efficacy of BAFF-R targeting CAR T cells in heavily pretreated patients.

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BAFF-R CAR T cell therapy was developed by City of Hope to provide an alternative or follow-on treatment option for the significant number of patients with B-cell malignancies that relapse after receiving standard of care medication including commercial CD19 CAR T cell therapy.

"There is a significant unmet need for effective treatments following CD19 CAR T therapy that are both safe and effective in heavily pretreated patients," said Hazel Cheng PhD., COO of PMB. "We are deeply committed to the ongoing scientific and clinical development of this potentially promising new cell therapy in r/r follicular lymphoma and other types of B cell malignancies."

"It’s truly encouraging that all six patients with non-Hodgkin lymphoma treated with PMB-CT01 have demonstrated 100% CR rate and only low-grade treatment emergent adverse events, specifically Grade 1 CRS and Grade 1 ICANS)," said Elizabeth Budde M.D., PhD., the trial’s principal investigator and associate professor of hematology at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the U.S. "Most of the trial participants relapsed after CD19 CAR T therapy and/or presented with CD19 negative tumor. PMB-CT01 could therefore offer a viable therapeutic option for patients facing this challenging scenario. It is also noteworthy that BAFF-R CAR T might outperform the FDA approved CD19 CAR T cell therapies given its consistently favorable balance of efficacy-safety."

"PMB-CT01 shows tremendous potential in enhancing patient outcomes for Non-Hodgkin Lymphomas, particularly follicular lymphoma," stated Michel Azoulay, M.D., CMO of IFLI. "We are thrilled to back PeproMene Bio, Inc. in their exploration of PMB-CT01 for follicular lymphoma patients."

About PMB-CT01

PMB-CT01 is a first-in-class, BAFF-R 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 main receptor for BAFF and is expressed almost exclusively on B cells. Since BAFF-R signaling promotes normal B-cell proliferation and appears to be required for B-cell survival, tumor cells are unlikely to escape therapy via loss of the BAFF-R antigen. This unique characteristic makes BAFF-R CAR T therapy a highly promising option for treating B-cell malignancies. The BAFF-R CAR was constructed using anti-BAFF-R single-chain fragment variable (scFv) antibodies and second-generation signaling domains CD3ζ and 4-1BB. Our research has demonstrated that BAFF-R CAR T cells effectively kill human lymphomas and leukemias both in vitro and in animal models. PeproMene Bio has licensed intellectual property relating to PMB-CT01 from City of Hope.