PeproMene Bio, Inc. (PMB) and the Institute for Follicular Lymphoma Innovation (IFLI) have announced that the first relapsed/refractory follicular lymphoma (r/r FL) patient treated with their novel BAFF-R targeting CAR-T cell therapy, PMB-CT01, has achieved complete remission one month after treatment.
The patient, who was treated at City of Hope as part of the phase 1 PMB-102 trial, had previously undergone seven lines of therapy, including chemoimmunotherapies, CD19 CAR-T cells, an investigational trispecific antibody, and an antibody-drug conjugate (ADC). Remarkably, the patient experienced no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following treatment.
Dr. Elizabeth Budde, the trial's lead principal investigator and associate professor of hematology at City of Hope, expressed enthusiasm about the results: "We are excited to report that a patient with r/r FL has achieved complete remission after treatment with PMB-CT01, bringing the total to seven patients—all achieving a 100% CR rate with durable responses and a manageable safety profile."
Novel Mechanism Targeting BAFF Receptor
PMB-CT01 represents a first-in-class autologous CAR-T cell therapy that targets the B-Cell Activating Factor Receptor (BAFF-R). Unlike CD19-targeted therapies, BAFF-R is critical for B-cell survival, making it less likely for tumor cells to escape therapy through antigen loss.
This unique characteristic could make BAFF-R CAR-T therapy particularly valuable for patients who have relapsed after CD19 CAR-T therapy or whose tumors no longer express CD19. According to Hazel Cheng, COO of PMB, "Most of the PMB-102 trial participants relapsed after CD19 CAR T therapy and/or presented with CD19 negative tumors. PMB-CT01 could present a viable alternative option for patients facing this challenging scenario."
The company reports that all seven r/r B-NHL patients treated with PMB-CT01 across various subtypes—including mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma—have achieved sustained complete responses lasting from 1 to 29+ months. Importantly, only grade 1 CRS and ICANS have been observed, suggesting a favorable safety profile.
Addressing an Unmet Need in Follicular Lymphoma
Follicular lymphoma represents approximately 20% of non-Hodgkin lymphoma cases in the United States and remains incurable with current standard therapies. Patients typically experience multiple relapses, with each subsequent remission becoming shorter.
Dr. Michel Azoulay, CMO of the Institute for Follicular Lymphoma Innovation, highlighted the significance of these results: "IFLI is dedicated to accelerating the development of innovative treatment options for patients with r/r FL. I am very excited that PMB-CT01 has shown promising efficacy and safety in this first FL patient."
Expanding Clinical Development
PMB-CT01 is currently being investigated in two phase 1 clinical trials: PMB-102 for relapsed/refractory B-cell non-Hodgkin's lymphoma (NCT05370430) and PMB-101 for B-cell acute lymphoblastic leukemia (NCT04690595).
Early results from both trials have demonstrated high activity and tolerability in heavily pre-treated patient populations. PeproMene Bio has licensed the intellectual property relating to PMB-CT01 from City of Hope and plans to advance the study into a multi-site expansion phase that will include r/r MCL, DLBCL, and FL patients.
About the Companies
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. Their pipeline includes BAFF-R CAR-T cell therapy and BAFF-R bispecific T cell engager therapy.
The Institute for Follicular Lymphoma Innovation (IFLI) is a global, non-profit foundation dedicated to accelerating innovative treatment options for follicular lymphoma patients. IFLI supports research and technology development through grants, partnerships, and venture philanthropic investments while promoting collaboration among researchers and institutions.
As the clinical development of PMB-CT01 progresses, this novel approach targeting BAFF-R could potentially address significant unmet needs for patients with relapsed/refractory B-cell malignancies, particularly those who have exhausted other treatment options including CD19-directed therapies.
