• Based on promising early clinical results from PeproMene Bio's PMB-102 Phase 1 study, they will receive $6M USD upfront plus an additional $5M USD in conditional tranched investments from the Institute for Follicular Lymphoma Innovation.
• Patients with relapsed/refractory follicular lymphoma will be included in the expansion phase of PeproMene Bio's PMB-102 Phase 1 study evaluating BAFF-R targeting CAR T cells (PMB-CT01) in adult patients with r/r B-cell Non-Hodgkin Lymphoma (B-NHL).

IRVINE, Calif., Dec. 19, 2024 /PRNewswire/ -- PeproMene Bio, Inc. (PMB) has announced 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. 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.

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."

For more information on PeproMene Bio, Inc. visit pepromenebio.com, and for more information on the Institute for Follecular Lymphoma Innovation visit i-fli.org.

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.

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. PeproMene's lead candidate, PMB-CT01 (BAFFR-CAR T cells) is currently being investigated to treat relapsed and refractory B-cell non-Hodgkin lymphoma (B-NHL; NCT05370430), B-cell, acute lymphoblastic leukemia (B-ALL; NCT04690595) in phase 1 clinical trials. PeproMene Bio is also developing BAFFR Bispecific T Cell Engager and BAFFR-CAR NK cells.

About iFLI

About The Institute for Follicular Lymphoma Innovation 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 to lead 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.

Media Contact, PreproMene Bio, Inc. John Fry, Executive Director Business Developmentjohn.fry@pepromenebio.comwww.pepromenebio.com

Media Contact, IFLILaura DiCaprioMcDougall Communicationslaura@mcdougallpr.com+1 (585) 434-2153