#USA #Irvine #B-ALL #PeproMene Bio #B-NHL

PeproMene Bio's PMB-CT01 Selected for Two Presentations at ASH 2025

PeproMene Bio, Inc., a biotechnology firm focusing on innovative treatments for relapsed and refractory (r/r) B-cell malignancies, has announced a significant achievement: two of its abstracts detailing Phase 1 study results on PMB-CT01 (BAFFR-CAR T) will be presented at the forthcoming 2025 American Society of Hematology (ASH) Annual Meeting. This recognition underscores the potential impact of PMB-CT01 in the treatment landscape for challenging B-cell cancers.

Promising Results in Difficult-to-Treat Cases

The released abstracts reveal crucial findings regarding the safety and effectiveness of PMB-CT01 in patients suffering from heavily pretreated cases of r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) and r/r B-cell Non-Hodgkin Lymphoma (B-NHL). Highlighting patients who failed prior therapies or have transitioned to CD19-negative tumors, the interim results reinforce the target efficacy of BAFF-R, which aids in overcoming CD19 antigen loss while ensuring lower toxicity levels.

Key Findings

In the realm of r/r B-NHL, PMB-CT01 has demonstrated exceptional safety tolerability. Notably, no instances of Grade ≥ 1 Cytokine Release Syndrome (CRS) or Grade ≥ 1 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) occurred. As for efficacy, all seven initial participants achieved a Complete Response (CR) within one to three months following treatment, inclusively of those previously treated with CD19 CAR T therapy and those who were CD19-negative. Remarkably, remissions have persisted for over 32 months (median: 17 months) by the time of data cutoff.

In patients with r/r B-ALL, four out of six treated achieved undetectable Minimal Residual Disease (MRD-) and complete remission, with three of these responders being CD19-negative at enrollment. This cohort successfully transitioned to allogeneic hematopoietic cell transplant (HCT) with a curative focus. Importantly, no Dose-Limiting Toxicities (DLTs) were documented, with only one patient experiencing a Grade 2 CRS.

Statements from PeproMene Bio

Dr. Hazel Cheng, COO of PeproMene Bio, expressed her enthusiasm regarding the findings, stating, "The consistent and durable activity observed across both B-ALL and B-NHL, notably in patients who have exhausted previous treatment pathways or are CD19-negative, strongly underscores BAFF-R as a compelling alternative target. These results highlight PMB-CT01’s potential to fulfill significant unmet needs in high-risk relapsed cancer cases."

Upcoming Presentations

The presentations at the ASH 2025 meeting are scheduled as follows:

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

- Presenter: Elizabeth Budde, M.D., Ph.D.
- Date/Time: December 6, 2025, at 2:45 PM

• - Abstract Title: BAFFR-CAR T cells show promising safety and anti-leukemia efficacy in r/r B-cell ALL patients

- Presenter: Ibrahim Aldoss, M.D.
- Date/Time: December 8, 2025, at 11:00 AM

These presentations are anticipated to outline the potential of PMB-CT01 as a viable treatment option for patients facing significant health challenges due to B-cell malignancies.

About PMB-CT01

PMB-CT01 represents a pioneering approach in CAR T cell therapy by targeting the BAFF-R expressed primarily on B cells, which is critical for their survival. This reduces risks associated with the loss of antigen, a common problem in malignancies treated with conventional CAR T therapies. Currently, PMB-CT01 is under evaluation through Phase 1 trials specifically aimed at combating r/r B-NHL and r/r B-ALL.

Forward-Looking Statements

This announcement includes forward-looking statements that may involve risks and uncertainties relating to clinical developments, regulatory outcomes, therapeutic potentials, and commercialization initiatives. PeproMene Bio does not undertake any obligation to revise or update these statements unless required by law.

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