IRVINE, Calif., Nov. 20, 2025 /PRNewswire/ -- PeproMene Bio, Inc., a clinical-stage biotechnology company developing novel therapies for relapsed and refractory (r/r) B-cell malignancies, announced that two abstracts from its ongoing Phase 1 studies of PMB-CT01 (BAFFR-CAR T) have been accepted for oral presentations at the 2025 American Society of Hematology (ASH) Annual Meeting.
The abstracts showcase the emerging safety and efficacy profile of PMB-CT01 in heavily pretreated r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) and r/r B-cell Non-Hodgkin Lymphoma (B-NHL), including patients who failed prior CD19-directed therapy or presented with CD19-negative disease. Interim results from the Phase 1 dose-escalation studies (NCT04690595, NCT05370430) support BAFF-R as a differentiated target designed to overcome CD19 antigen escape while maintaining durable activity and low toxicity.
r/r B-NHL
Safety:
PMB-CT01 demonstrated an exceptionally favorable tolerability profile. No Grade ?1 Cytokine Release Syndrome (CRS) and no Grade ?1 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Efficacy:
All the first 7 patients achieved a Complete Response (CR) at 1-3 months post-infusion, including those previously treated with CD19 CAR T therapy and those with CD19-negative disease.
Durability:
Remissions have remained ongoing for up to 32+ months (median 17 months) at data cutoff.
r/r B-ALL
Efficacy:
Four of six enrolled patients achieved an undetectable Minimal Residual Disease (MRD-) Complete Remission (CR)
High-Risk Population:
Three of the four responders were CD19-negative at enrollment. All three successfully transitioned to allogeneic hematopoietic cell transplant (HCT) with curative intent.
Safety:
No Dose-Limiting Toxicities (DLTs) were observed. Only one patient experienced Grade 2 CRS, with no Grade 3 CRS reported.
"The consistent and durable activity seen across both B-ALL and B-NHL, particularly in patients who have exhausted CD19 CAR T options or present with CD19-negative disease, strongly supports BAFF-R as a highly effective and safe alternative target," said Hazel Cheng, Ph.D., COO of PeproMene Bio. "These data highlight PMB-CT01's potential to address critical unmet needs in high-risk relapsed disease."
ASH 2025 Oral Presentations
Abstract Title: BAFFR-CAR T cells demonstrate durable responses and manageable toxicities in r/r B-cell lymphomas…
Abstract: abs25-7079
Date/Time: December 6, 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: abs25-2035
Date/Time: December 8, 11:00
AM
Presenter: Ibrahim Aldoss, M.D.
(Dates/times are placeholders.)
About PMB-CT01
PMB-CT01 is a first-in-class BAFF-R-targeted autologous CAR T cell therapy. BAFF-R is expressed almost exclusively on B cells and is essential for B-cell survival, reducing the likelihood of antigen-loss escape. PMB-CT01 is being evaluated in Phase 1 trials for r/r B-NHL and r/r B-ALL.
Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties, including risks related to clinical development, regulatory outcomes, therapeutic potential, and commercialization. PeproMene Bio undertakes no obligation to update forward-looking statements except as required by law.
Media/Investor Contact:
Hazel Cheng, Ph.D.
PeproMene Bio, Inc.
Hazel.Cheng@pepromenebio.com
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