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PeproMene Bio's PMB-CT01 BAFFR-CAR T Data Presented at ASH 2025

PeproMene Bio, Inc., a clinical-stage biotechnology firm, has exciting news for the medical community. At the 67th Annual Meeting of the American Society of Hematology (ASH) in 2025, two abstracts from ongoing Phase 1 studies of PMB-CT01 (BAFFR-CAR T) received acceptance for oral presentations. These presentations will highlight the innovative approaches the company is taking to treat relapsed and refractory (r/r) B-cell malignancies, particularly in patients with limited treatment options.

The abstracts detail the emerging safety and efficacy profiles of PMB-CT01, specifically for patients suffering from heavily pre-treated acute r/r B-cell lymphoblastic leukemia (B-ALL) and r/r B-cell non-Hodgkin lymphoma (B-NHL), especially those who have previously failed CD19-targeted therapies or present with CD19-negative conditions. Initial findings from these Phase 1 dose-escalation studies (NCT04690595, NCT05370430) underscore BAFF-R as a differentiated target molecule that aims to overcome CD19 antigen escape while maintaining effective activity with minimal toxicity.

Notable Results from the Trials

r/r B-NHL Findings

• - Safety Profile: PMB-CT01 has demonstrated an exceptionally favorable safety profile. Notably, there were no instances of Grade >1 cytokine release syndrome (CRS) or Grade >1 immune effector cell-associated neurotoxicity syndrome (ICANS).
• - Efficacy: Among the first seven patients treated, all experienced a complete response (CR) within one to three months following infusion, including patients who had previously undergone CD19-CAR-T therapy, as well as those whose disease was CD19-negative.
• - Durability of Responses: Remissions have been sustained for over 32 months, with a median duration of 17 months at the time of data reporting.

r/r B-ALL Findings

• - Efficacy Metrics: Of the six patients included in the study, four achieved a minimal residual disease (MRD) negative complete remission (CR).
• - High-Risk Population: Notably, three out of four responders at the time of study entry were CD19-negative. All were successfully transitioned to allogeneic hematopoietic cell transplantation with curative intent.
• - Safety Observations: No dose-limiting toxicities (DLTs) were recorded throughout the trial. Only one patient experienced Grade 2 CRS, with no Grade 3 CRS occurrences.

Dr. Hazel Cheng, COO of PeproMene Bio, expressed enthusiasm regarding these findings, stating, "The consistent and durable activity observed in both B-ALL and B-NHL, particularly within the context of patients who have exhausted all CD19-CAR-T options or who have CD19-negative disease, supports BAFF-R as a highly effective and safe alternative target molecule." She emphasized the potential of PMB-CT01 to address significant unmet medical needs in high-risk relapsed diseases.

Presentations Scheduled for ASH 2025

Abstract Title: BAFFR-CAR T cells demonstrate durable responses and manageable toxicity in r/r B-cell lymphomas...
Abstract ID: abs25-7079
Date/Time: December 6, 14:45
Moderator: Elizabeth Budde, M.D., Ph.D.

Abstract Title: BAFFR-CAR T cells show promising safety and anti-leukemia efficacy in r/r B-cell ALL patients...
Abstract ID: abs25-2035
Date/Time: December 8, 11:00
Moderator: Ibrahim Aldoss, M.D.

These dates and times are placeholders and may be subject to change.

About PMB-CT01

PMB-CT01 is the first of its kind autologous CAR-T cell therapy targeting BAFF-R. This target is predominantly expressed on B-cells and plays a critical role in their survival, minimizing the likelihood of antigen loss. PMB-CT01 is currently undergoing Phase 1 studies focusing on r/r B-NHL and r/r B-ALL.

Forward-Looking Statements

This announcement includes forward-looking statements subject to risks and uncertainties, including those related to clinical development, regulatory outcomes, therapeutic potential, and marketability. PeproMene Bio does not undertake any obligation to update these forward-looking statements unless required by law.

For media and investor inquiries, please contact:
Hazel Cheng, Ph.D.
PeproMene Bio, Inc.
[email protected]