#USA #Irvine #PeproMene Bio #PMB-CT01 #ASH 2025

PeproMene Bio to Present PMB-CT01 Data at ASH 2025

In major news for the biotechnology sector, PeproMene Bio, Inc. has announced that data from its study PMB-CT01 (BAFFR-CAR T) will be showcased in two prominent oral presentations at the 67th Annual Meeting of the American Society of Hematology (ASH) in 2025. As a clinical-stage biotechnology company, PeproMene focuses on developing innovative therapies for malignant B-cell neoplasms, particularly in patients with relapsed and refractory conditions.

The accepted abstracts reveal significant insights regarding the emerging safety and efficacy profile of PMB-CT01, particularly among patients diagnosed with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (B-NHL). This is particularly relevant given the complexities involved in treating these patients, who often have a history of intensive therapeutic interventions, including those who were unresponsive to previous CD19-targeted therapies or diagnosed with CD19-negative diseases.

Highlights from the Study Results

The preliminary findings from ongoing phase 1 studies (NCT04690595, NCT05370430) indicate that the BAFF-R, targeted by PMB-CT01, provides a differentiated approach aimed at overcoming CD19 antigen escape, ensuring sustained activity with minimal toxicity.

Efficacy in Relapsed/Refractory NHL (B-NHL)

1. Safety: PMB-CT01 demonstrated an extraordinarily favorable tolerability profile, with no evidence of cytokine release syndrome (CRS) exceeding grade 1 or immune effector cell-associated neurotoxicity syndrome (ICANS) above grade 1.
2. Efficacy: Among the first seven patients, Complete Response (CR) rates were achieved between one and three months post-infusion, notably including patients previously treated with CD19 CAR T therapy and those with CD19-negative disease.
3. Durability: The remissions have lasted over 32 months (median of 17 months) at the conclusion of the data collection phase.

Efficacy in Relapsed/Refractory ALL (B-ALL)

1. Efficacy: Four out of six enrolled patients achieved a Complete Response (CR) with minimal residual disease (MRD) undetectable.
2. High-Risk Population: Three of the four responding patients were CD19-negative at the time of enrollment and successfully underwent allo-HCT with curative intent.
3. Safety: No dose-limiting toxicities (DLTs) were observed, and only one patient experienced grade 2 cytokine release syndrome, without any grade 3 instances reported.

Hazel Cheng, Ph.D., the Chief Operating Officer of PeproMene Bio, emphasized, "The consistent and durable activity observed in B-ALL and B-NHL, especially in patients who have exhausted options with CAR T-CD19 therapies or who present with CD19-negative disease, strongly supports BAFF-R as a highly effective and safe therapeutic alternative." This data underscores the potential of PMB-CT01 to meet critical unmet needs in high-risk relapsed disease.

Oral Presentations at ASH 2025

The two oral presentations scheduled include:

• - Abstract Title: BAFFR-CAR T cells demonstrate durable responses and manageable toxicities in r/r B-cell lymphomas…

Abstract ID: abs25-7079
Date/Time: December 6, 2025, 2:45 PM
Presenter: 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, 2025, 11:00 AM
Presenter: Ibrahim Aldoss, M.D.

Note: Dates and times are provisional.

About PMB-CT01

PMB-CT01 is the first autologous CAR T-cell therapy directed at BAFF-R, a receptor almost exclusively expressed on B-cells, playing a critical role in their survival to minimize antigen loss. This approach is currently under investigation in phase 1 trials targeting relapsed/refractory B-cell NHL and B-cell ALL, showcasing the potential to address significant clinical challenges.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties, including those associated with clinical development, regulatory outcomes, therapeutic potential, and commercialization. PeproMene Bio undertakes no obligation to update forward-looking statements unless required by law.