PeproMene Bio, Inc. and the Institute for Follicular Lymphoma Innovation (IFLI) Announce The First Follicular Lymphoma (FL) Patient Treated with BAFF-R Targeting CAR-T Cells (PMB-CT01) Achieves a ...

20.05.25 16:22 Uhr

  • The first heavily pretreated r/r FL patient dosed at City of Hope with PMB-CT01 achieved a CR at one-month post treatment.

  • A Total of 7/7 r/r B-NHL patients including MCL, DLBCL and FL treated with PMB-CT01 have achieved a sustained CR (1 to 29+ months) with strictly grade 1 CRS and ICANS observed.

IRVINE, Calif., May 20, 2025 /PRNewswire/ -- PeproMene Bio, Inc. (PMB) a clinical-stage biotech company developing novel therapies to treat cancers and immune disorders, today announced that the first r/r FL patient treated in its phase 1 PMB-102 study, r/r B-cell non-Hodgkin's Lymphoma (r/r B-NHL) trial of PMB-CT01 (BAFFR-CAR T Cells), has achieved complete remission at one month post treatment. 

"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. Notably, this patient had previously undergone 7 prior lines of therapy including chemoimmunotherapies, CD19 CAR T cells, an investigational trispecific antibody, and an antibody-drug conjugate (ADC). Remarkably, the patient experienced no CRS or ICANS," said Elizabeth Budde M.D., Ph.D., the trial's lead 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.

Follicular lymphoma (FL) is the most common indolent (slow-growing) form of B-cell non-Hodgkin Lymphoma (NHL), accounting for 20% of NHL in the US.1 FL is considered incurable with current standard of care therapies.Patients often relapse and with each relapse, the remission and time to next treatment is shorter.3 Patients with r/r FL are in need of additional medical options. "IFLI is dedicated to accelerating the development of innovative treatment options for patients with r/r FL" stated Dr. Michel Azoulay, M.D., CMO of the Institute for Follicular Lymphoma Innovation. "I am very excited that PMB-CT01 has shown promising efficacy and safety in this first FL patient."

"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," said Hazel Cheng PhD., COO of PMB. "We are deeply committed to the development of this first-in-class BAFFR CAR T therapy and are excited to advance our study into a multi-site expansion phase that will include r/r MCL, DLBCL and FL patients."

[1] Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed February-2024.

[2]  Ghione, P., et al., Haematologica, 2023. 108(3): p.822-832. 

[3] Rivas-Delgado, A., et al., Br J Haematol, 2019. 184(5):753-759. .

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 PMB-CT01 (BAFFR-CAR T cells) is currently being investigated to treat relapsed and refractory B-cell non-Hodgkin's lymphoma (B-NHL; NCT05370430), B-cell, acute lymphoblastic leukemia (B-ALL; NCT04690595) in phase 1 clinical trials. Early results from PMB-101 and PMB-102 have demonstrated PMB-CT01 to be high activity and tolerable in heavily pre-treated r/r ALL and r/r NHL patient populations. PeproMene Bio has licensed intellectual property relating to PMB-CT01 from City of Hope.

About PeproMene Bio

PeproMene Bio, Inc. is a clinical-stage biotech company based in Irvine, California and is focused on the clinical development of novel therapies to treat B-cell malignancies and autoimmune disorders including BAFF-R CAR-T cell therapy and BAFF-R bispecific T cell engager therapy. Learn more at www.pepromenebio.com.

About iFLI

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 (FL). IFLI supports cutting-edge research and technology leading to the development and commercialization of novel therapeutics and/or biomarkers for the treatment of FL, and to understand the biology of FL. The foundation deploys its budget across grants, project-based partnerships, and venture philanthropic investments to achieve its innovation goals. IFLI promotes collaboration and works to enable data sharing and the exchange of knowledge and expertise among researchers and institutions advancing FL research. Learn more at www.i-fli.org.

Contact, PeproMene Bio, Inc.
John Fry, Business Development
john.fry@pepromenebio.com

Contact, IFLI
Laura DiCaprio, McDougall Communications
laura@mcdougallpr.com
+1 (585) 434-2153

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