PeproMene Bio, Inc. (PMB) has secured an $11 million investment from the Institute for Follicular Lymphoma Innovation (IFLI) to advance the clinical development of its novel BAFF-R CAR T-cell therapy, PMB-CT01, for patients with relapsed or refractory follicular lymphoma. The funding package includes $6 million upfront with an additional $5 million in conditional tranched funding.
The investment will support the expansion of PMB's Phase 1 clinical trial to include patients with relapsed or refractory follicular lymphoma, building on promising early results that demonstrated remarkable efficacy and safety profiles in heavily pretreated patients.
Promising Early Clinical Results
Initial data from the Phase 1 study has shown impressive outcomes. All six patients with non-Hodgkin lymphoma treated with PMB-CT01 achieved a 100% complete response rate while experiencing only low-grade treatment-emergent adverse events (Grade 1 cytokine release syndrome and Grade 1 immune cell-associated neurotoxicity syndrome).
Dr. Elizabeth Budde, the trial's principal investigator and associate professor of hematology at City of Hope, highlighted the significance of these findings: "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."
Dr. Budde further noted that "BAFF-R CAR T might outperform the FDA approved CD19 CAR T-cell therapies given its consistently favorable balance of efficacy-safety."
Addressing a Critical Unmet Need
The development of PMB-CT01 addresses a significant gap in current treatment options for B-cell malignancies, particularly for patients who relapse after receiving standard therapies including commercial CD19 CAR T-cell therapy.
"There is a significant unmet need for effective treatments following CD19 CAR T-cell therapy that are both safe and effective in heavily pretreated patients," said Hazel Cheng, COO of PeproMene Bio. "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."
Dr. Michel Azoulay, CMO of IFLI, expressed optimism about the therapy's potential: "PMB-CT01 shows tremendous potential in enhancing patient outcomes for Non-Hodgkin Lymphomas, particularly follicular lymphoma. We are thrilled to back PeproMene Bio in their exploration of PMB-CT01 for follicular lymphoma patients."
The Science Behind PMB-CT01
PMB-CT01 represents a first-in-class, BAFF-R targeted, autologous CAR T-cell therapy. BAFF-R (B-Cell Activating Factor Receptor) belongs to the tumor necrosis factor receptor superfamily and is expressed almost exclusively on B cells, making it an ideal target for B-cell malignancies.
A key advantage of targeting BAFF-R lies in its biological function. Since BAFF-R signaling promotes normal B-cell proliferation and appears essential for B-cell survival, tumor cells are unlikely to escape therapy through loss of the BAFF-R antigen—a common mechanism of resistance to current CD19-targeted therapies.
The BAFF-R CAR was engineered using anti-BAFF-R single-chain fragment variable antibodies combined with second-generation signaling domains CD3ζ and 4-1BB. Preclinical research has demonstrated that BAFF-R CAR T cells effectively eliminate human lymphomas and leukemias both in laboratory studies and animal models.
Originally developed at City of Hope, one of the largest cancer research and treatment organizations in the United States, PeproMene Bio has licensed the intellectual property relating to PMB-CT01 and is advancing its clinical development.
About the Organizations
PeproMene Bio, Inc. is a clinical-stage biotech company based in Irvine, California, focused on developing novel therapies for B-cell malignancies and autoimmune disorders. Beyond PMB-CT01, the company is also developing BAFF-R Bispecific T Cell Engagers and BAFF-R CAR NK cells.
The Institute for Follicular Lymphoma Innovation (IFLI) is a global, non-profit, private foundation dedicated to accelerating the development of innovative treatment options for patients with follicular lymphoma. IFLI supports cutting-edge research through grants, project-based partnerships, and venture philanthropic investments to advance novel therapeutics and biomarkers for follicular lymphoma treatment.
