PeproMene Bio Submits IPO Prospectus Highlighting First-in-Class BAFFR-Targeted CAR-T Therapy PMB-CT01 with Durable 100% CR in r/r B-NHL and Promising Activity in r/r B-ALL

Nov 24, 2025 12:10 CST Updated 12:10

PeproMene Bio

Developer of New Therapies for Cancer and Immune Diseases

Recently,PeproMene Bio stated that itsBAFFR CAR-T Candidate DrugThe Phase 1 clinical research results of PMB-CT01 have been selected.Abstracts for the 2025 American Society of Hematology (ASH 2025) Annual Meeting will be availableOral presentation at the ASH 2025 Annual Meeting.

BAFFR CAR-T inRelapsed and Refractory B-cell Non-Hodgkin Lymphoma (r/rB-NHL）Continued 100% CR from previous reports, with no recurrence to date.; InRelapse and DifficultyTherapeuticAcute B Lymphoblastic Leukemia (r/r B-ALL) demonstrated good initial safety and efficacy,Patients who achieved remission remained in remission without recurrence as of the data cutoff.。

BAFFR CAR-T

BAFFR CAR-T byCity of Hope pioneered.

BAFFRIt is a member of the tumor necrosis factor (TNF) receptor superfamily.BAFFR asThe main receptor of BAFF, which is almost exclusively expressed on B cells, and specifically participates in B lymphocyte differentiation and B cellSurvival. EspeciallyIt isThe widespread expression of BAFFR on malignant B cells makes it a high-value potential tumor target.Dr. Larry W. Kwak's laboratory discovered a new type of humanized anti-BAFFR Monoclonal Antibody Exhibits High Binding Affinity and Cytotoxic Activity Against Various B-Cell Tumor Cells.

At the same time, due toBAFFR signaling promotes normal B-cell proliferation and B-cell survival, making it less likely for tumor cells to be lost.BAFFR antigen, thereby evading treatment(Usually, CD19 CAR-T therapy results in tumor recurrence due to the loss of CD19 antigen.), this feature also makesBAFF-R Becomes the Next-Generation Promising Target for CAR-T in B-Cell Malignancies and a Potential Target Option for CD19 CAR-T Treatment Failures.

PMB-CT01 is aFirst-in-class BAFFR-targeted autologous CAR-T cell therapy.Vice President of City of Hope Comprehensive Cancer CenterDeputy Director and Founder of PeproMene Bio, Dr. Larry W. KwakLaboratory invention. PeproMene Bio obtained the intellectual property license related to PMB-CT01 from City of Hope in 2017.

Image source: Reference 2

The CAR of PMB-CT01 containsSingle-chain variable fragment antibody against BAFFR combined with a second-generation signaling structure containing CD3ζ and 4-1BBField. The study found,BAFFR CAR-T cells are able to kill in vitroHuman lymphoma and leukemia cells, and kill diagnosed lymphoma and leukemia cells in vivo.

Currently,PMB-CT01 is in Phase 1 clinical stage and is currently undergoing two Phase 1 clinical studies, respectively targetingRelapsed and Refractory B-cell Non-Hodgkin Lymphoma (r/rB-NHL）（PMB-102;NCT05370430）、Relapse and DifficultyTherapeuticAcute B Lymphoblastic Leukemia (r/r B-ALL）（PMB-101;NCT04690595）。

Extended Reading:BAFF-R CAR-T：CR 100%

B-NHL：100% CR, no recurrence to date

According to the published ASH 2025 abstract.

InBAFFR CAR-T Candidate DrugPMB-CT01 Therapyr/r Phase 1 Study of B-NHLPMB-102In China, a total of 7 patients receivedPMB-CT01 Treatment. Diagnosis includesDiffuse Large B-Cell Lymphoma (MCL, n=4),CD19- and CD20- negativeT-cell/histiocyte-rich large B-cell lymphoma(THRLBCL,n=1)、Marginal zone lymphoma (MAL, n=1) andFollicular Lymphoma(FL,n=1). The median age of the patients was 62 years (range 41-75), including 6 male patients. The patients had previously received 1-10 lines of treatment, including CD19 CAR-T therapy (n=4) and one CD3/CD20 bispecific antibody therapy. Three patients received DL1 treatment (dose of 50×10⁶ CAR-Tcells), 4 patients received DL2 treatment(Dose of 200×10⁶ CAR-T cells）。

In terms of safety: PMB-CT01 demonstratedGood Tolerability ProfileNo dose-limiting toxicity (DLT) occurred. Only grade 1 CRS and grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) were observed in all patients, with no occurrence of CRS or ICANS of grade ≥2.

Efficacy: The first 7 patients achieved complete remission within 1-3 months after infusion (100% CR), including patients who had previously received CD19 CAR-T treatment and CD19-negative patients.Patients showed durable responses without recurrence, and the longest duration of remission was up to 32 months.(Median duration of response was 17 months, range 3-32 months). In MCL patients, 3 patients tested positive at 1 month and ≥6 months post-treatment.Minimal Residual Disease (MRD) Negative. Significant CAR-T cell expansion was observed in all tested patients.

PeproMene Bio, Inc. stated that, given the currently observed favorable safety and durable remission, it is expected that200×10⁶The recommended dose for future research will be CAR T cells. Once the recommended Phase 2 dose is determined, three histological expansion cohorts, including FL, MCL, and LBCL, will be initiated simultaneously. Additionally, the company expects to present the results of the dose-escalation portion of the study, involving nine patients, at the ASH 2025 meeting.

B-ALL: CR 67%, Good Safety

According to the published ASH 2025 abstract.

In BAFFR CAR-T Candidate DrugPMB-CT01 Targetingr/r B-ALIn a Phase 1 study of L patients who were either ineligible for CD19-targeted therapy or had previously received CD19-targeted therapy without success, enrollment is still ongoing, with six patients already registered. The median age of the patients is 36 years (31-59), including four male patients. The median number of prior treatment lines for these patients is 5 (2-5), and all patients have undergone previous treatments.Four of the patients treated with blinatumomab had previously received CD19 CAR-T therapy, and four patients were CD19-negative.

In terms of safety: As of now,Not yet observedDose-Limiting Toxicity（DLT）。Well Tolerated, no CRS ≥ grade 3 occurred. Four patients experienced CRS, with only one case of grade 2 and the rest being grade 1; only one case of grade 1 occurred.ICANS, which has been alleviated without intervention.

Efficacy:Four out of six patients achievedComplete Remission with Undetectable Minimal Residual Disease (MRD)（CR：66.67%）; Of the 4 patients with remission, 3 were CD19-negative at the time of enrollment in the study, whichThree patients have been successfully convertedAllogeneic Hematopoietic Stem Cell Transplantation (HCT）。

At the data cutoff (median follow-up time was 180 days, range: 39-655),All four patients in remission remain in remission.Significant CAR-T expansion was observed in all six patients, with peak levels occurring between Day 11 and Day 21 post-infusion. As of the current data collection, CAR-T cells have persisted for up to six months.

The results showed,BAFFR CAR-T Demonstrates Good Initial Safety.BAFFR CAR-T in patients previously treated with CD19-targeted therapy and with limited treatment optionsr/r B-ALL patients, showing good activity. Notably,BAFFR CAR-T Successfully Transitions Patients to Potentially Curative Hematopoietic Stem Cell TransplantationStage.

Summary

Tumor recurrence after CD19 CAR-T therapy has been a key focus of research, leading to the development of various treatment strategies, including dual-targeting of CD19/CD20 and sequential CAR-T therapies with different targets.

But according toAccording to the data reported by PeproMene Bio, Inc., its acceptancePatients treated with BAFFR CAR-T who achieved remission remain in remission without tumor recurrence.Its potential prospects are positive.

References:

1.https://www.prnewswire.com/news-releases/daten-zu-pmb-ct01-baffr-car-t-von-pepromene-bio-fur-zwei-mundliche-prasentationen-auf-der-67-jahrestagung-2025-von-ash-ausgewahlt-302622381.html

2.https://pepromenebio.com/science/

3.https://meetings-api.hematology.org/api/abstract/vmpreview/295724

4.https://meetings-api.hematology.org/api/abstract/vmpreview/290680