PMB-CT01 / PeproMene Bio - LARVOL DELTA

Promising Safety and Anti-Lymphoma Efficacy of Autologous Pmb-CT01 (BAFFRCAR T Cell) Therapy in a First-in-Human Phase 1 Study (ASH 2023) - P1 | "The lymphodepletion regimen consists of cyclophosphamide 500 mg/m2/day and fludarabine 30 mg/m2/day for 3 days...All CRS events resolved with 2 doses of tocilizumab given to patient #1 and 1 dose to patient #2... PMB-CT01(BAFFRCAR T cell) treatment at DL1 was safe and demonstrated potent anti-lymphoma activity with a 100% ORR (2 CR, 1 PR) in patients with poor prognosis. CRS and ICANS were all grade 1 and reversible. Enrollment is ongoing at DL2, and additional clinical and correlative analyses will be presented at the meeting."

CAR T-Cell Therapy • Clinical • First-in-human • P1 data • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • CD19 • CD20

PeproMene Bio, Inc…announced the publication in The Lancet, one of the world’s leading medical journals, of results from its Phase 1 clinical trial evaluating PMB-CT01…in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. (PRNewswire) - "Seven of nine treated patients (80%) achieved a complete response (CR), including four of six patients who had progressed after conventional CD19-directed CAR T-cell therapy...All complete responses remained ongoing at the time of data cutoff, with no relapses observed and the longest ongoing complete response reaching 35 months...PMB-CT01 was remarkably safe, as all cytokine release syndrome (CRS) events and the two reported immune effector cell-associated neurotoxicity syndrome (ICANS) events were limited to Grade 1...the Phase 1 trial has expanded from a single clinical trial site at City of Hope, a cancer research and treatment organization, to multiple additional medical centers across the United States. The publication also reports that the first patient treated in the expansion phase—who had triple-hit high-grade B-cell lymphoma following progression after CD19-directed CAR T-cell therapy—also achieved a complete response at the first disease assessment."

Cytokine release syndrome • P1 data • Trial status • B Cell Non-Hodgkin Lymphoma

BAFFR-CAR T cells (PMB-CT01) show promising safety and anti-leukemia efficacy in relapsed/refractory B-cell ALL patients after CD19-targeted therapy failure, including CD19-negative disease (ASH 2025) - P1 | "Introduction: Immunotherapies targeting CD19, such as blinatumomab and CAR T cells, have shownremarkable efficacy in relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL)...DL-1 (de-escalation) and DL1 (starting dose) consist ininfusion with 20M and 50M CAR T cells, respectively, after lymphodepletion (LD) with cyclophosphamideonly... BAFFR-CAR T cell therapy demonstrated an excellent initial safety profile. Following LD withcyclophosphamide and fludarabine, the 50M dose demonstrated robust expansion and promisingactivity in heavily pretreated pts with r/r B-ALL who had failed prior CD19-targeted therapies and hadlimited treatment options. Treatment successfully transitioned pts to potentially curative transplant."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • IL6

Favorable Safety Profile and Durable Responses to Pmb-CT01 (BAFFR-CAR T Cell) Therapy in Patients with B-Cell Lymphomas Ineligible for or Who Failed CD19-Targeted Therapy, Including CD19-Negative Disease (ASH 2024) - P1 | "Conclusions : With a 100% CR rate, including durable responses at dose level 1 and a favorable initial safety profile, BAFFR-CAR T cells constitute a promising therapeutic option for patients with r/r B-cell malignancies who are ineligible for or have failed prior CD20- or CD19-targeted therapy, including with CD20 or CD19 antigen loss. The correlation of clinical responses with robust CAR T cell expansion and persistence, as well as polyfunctionality and low exhaustion marker expression, underscores the potential of BAFFR-CAR T cells in providing long-lasting remissions."

CAR T-Cell Therapy • Clinical • IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • CD4 • CD8 • HAVCR2 • LAG3 • PD-1

BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease (ASH 2025) - P1 | "PMB-CT01 demonstrated an exceptionally favorable safety profile and 100% CR rate in r/r B-NHL patients with poor-prognosis features, including CD19-negative disease and prior CD19 CAR T celltherapy. The durability of response at both dose levels supports the potential of BAFFR-CAR T cells as apromising therapeutic option in patients who are not candidates for or have relapsed after CD19-directed therapy. Continued enrollment and follow-up are ongoing, and updated clinical and correlativedata will be presented at the meeting."

CAR T-Cell Therapy • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • T Cell Histiocyte Rich Large B Cell Lymphoma • CD19

BAFF-R CAR T-cell therapy for relapsed or refractory B-cell lymphomas. (PubMed, Lancet) - No abstract available

Journal • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

DURABLE RESPONSES AND FAVORABLE SAFETY OF BAFF-R CAR T-CELLS (PMB-CT01) IN PATIENTS WITH RELAPSED/ REFRACTORY B-CELL LYMPHOMAS WITH PRIOR CD19-DIRECTED THERAPY FAILURE OR CD19-NEGATIVE DISEASE (EHA 2026) - P1 | "These results supported the selection of the RP2D and initiation of disease-specific expansion cohorts in MCL, LBCL, and FL. Enrollment in these cohorts is ongoing, and additional clinical and correlative analyses are underway."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • CD20

PeproMene Bio Announces Oral Presentation at EHA 2026 Highlighting Favorable Safety and Durable Responses with PMB-CT01 (BAFF-R CAR T-Cell Therapy) in B-cell Lymphomas, Including After Prior CD19 CAR T-Cell Failure (PRNewswire) - "Among the nine patients treated in this phase, PMB-CT01 demonstrated a promising safety profile with no dose-limiting toxicities, no grade >1 cytokine release syndrome (CRS), and no grade >1 immune effector cell-associated neurotoxicity syndrome (ICANS). Seven of nine patients (78%) achieved a complete response (CR). At the last data cutoff, no relapses had occurred and all responses remained ongoing, with the longest response exceeding 3 years....The trial is actively enrolling patients into expansion cohorts for mantle cell lymphoma, large B-cell lymphoma, and follicular lymphoma (FL). Importantly, the first patient treated in this expansion phase...achieved a CR at their first disease assessment."

Cytokine release syndrome • P1 data • Trial status • Follicular Lymphoma • Large B Cell Lymphoma • Mantle Cell Lymphoma

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: PeproMene Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Abstract Title: BAFFR-CAR T cells demonstrate durable responses and manageable toxicities in r/r B-cell lymphomas (PRNewswire) - "PeproMene Bio's PMB-CT01 BAFFR-CAR T Data Selected for...Oral Presentations at 67th ASH 2025 Annual Meeting....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."

P1 data • B Cell Non-Hodgkin Lymphoma

Abstract Title: BAFFR-CAR T cells show promising safety and anti-leukemia efficacy in r/r B-cell ALL patients (PRNewswire) - "PeproMene Bio's PMB-CT01 BAFFR-CAR T Data Selected for...Oral Presentations at 67th ASH 2025 Annual Meeting....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."

P1 data • B Acute Lymphoblastic Leukemia

Use of BAFFR CAR-T to treat B cell leukemia/lymphoma and auto-immune diseases. (ASCO 2025) - "The preclinical efficacy of BAFFR CAR-T cells was evaluated in vitro and in vivo. The results of this study suggest that BAFFR is an active and promising immunotherapeutic target for B-cell malignancies and auto-immune diseases. In the future, BAFFR CAR-T clinical trials will be conducted to treat B-ALL, lymphoma, and autoimmune diseases. It would be interesting to see whether BAFFR CAR-T can achieve similar or even better results than CD19 CAR-T in treating these diseases."

CNS Disorders • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Leukemia • Lymphoma • Multiple Sclerosis • Non-Hodgkin’s Lymphoma • Oncology • Psoriasis • Rheumatoid Arthritis • Rheumatology • TNFA

PeproMene Bio, Inc. and the Institute for Follicular Lymphoma Innovation (IFLI) Announce The First Follicular Lymphoma (FL) Patient Treated with BAFF-R Targeting CAR-T Cells (PMB-CT01) Achieves a Complete Response (The Manila Times) - P1 | N=27 | NCT06191887 | "PeproMene Bio, Inc...today announced that the first r/r FL patient treated in its phase 1 PMB-102 study, r/r B-cell non-Hodgkin's Lymphoma (r/r B-NHL) trial of PMB-CT01 (BAFFR-CAR T Cells), has achieved complete remission at one month post treatment....A Total of 7/7 r/r B-NHL patients including MCL, DLBCL and FL treated with PMB-CT01 have achieved a sustained CR (1 to 29+ months) with strictly grade 1 CRS and ICANS observed."

P1 data • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma

PeproMene Bio, Inc. and the Institute for Follicular Lymphoma Innovation Announce $11M Investment to Advance PMB-CT01 (BAFF-R CAR T cell therapy) for Relapsed/Refractory Follicular Lymphoma (PRNewswire) - "PeproMene Bio, Inc...has announced an $11M investment from the Institute for Follicular Lymphoma Innovation (IFLI) to support the clinical development of PMB-CT01 (BAFF-R CAR T cell therapy) in patients with relapsed or refractory (r/r) follicular lymphoma. The investment includes $6M USD upfront and an additional $5M USD in conditional tranched funding. Building on the promising results of PMB's Phase 1 study, the expansion phase will now include patients with r/r follicular lymphoma, further evaluating the safety and efficacy of BAFF-R targeting CAR T cells in heavily pretreated patients."

Financing • Trial status • Follicular Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

PeproMene Bio announced study demonstrating strong polyfunctionality of novel chimeric antigen receptor (CAR) T cells (Canada Newswire) - P1 | N=36 | NCT05370430 | Sponsor: PeproMene Bio, Inc. | "Researchers used a single-cell platform, which found that PMB-CT01 CAR T cells, had more polyfunctionality, which is T cells' ability to perform several functions at the same time, than CD 19 CAR T cells. PMB-CT01 cells also produced more stimulatory cytokines, which can spur the immune system, and effector cytokines, which can directly kill cancer cells....After receiving one infusion in City of Hope's Phase 1 trial using PMB-CT01 and experiencing minimal side effects, the man has been in complete remission over 18 months and continues to have undetectable cancer by sensitive molecular tests for minimal residual disease."

P1 data • Non-Hodgkin’s Lymphoma • Oncology

PMB-CT01 (BAFFR-CAR T cell) therapy to examine preliminary safety and clinical responses in patients with B-cell malignancies who are ineligible for or failed CD19-directed therapy, including CD19-negative disease. (ASCO 2024) - P1 | "The B-ALL patient had CD19/CD20/CD22-negative disease, and had received prior blinatumomab. With a 100% CR rate at 3 months in the first 4 patients and durable responses at dose level 1, BAFFR-CAR T cells are a promising therapeutic option for patients with r/r B-cell malignancies who are ineligible or failed prior CD19-targeted therapy, including with CD19 antigen loss."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • CD19 • CD22

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: PeproMene Bio, Inc. | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: Nov 2025 ➔ Nov 2026

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

PeproMene Bio, Inc. Announces Complete Remission of the Cohort 1 First Patient Treated for Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) in the Phase 1 Clinical Trial of PMB-CT01 (BAFFR-CAR T Cells) at City of Hope (PRNewswire) - "PeproMene Bio, Inc...announced that the cohort 1 first patient treated in its Phase 1 relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) clinical trial of PMB-CT01 (BAFFR-CAR T Cells) has reached complete remission at one-month post treatment....During the first month of treatment, the patient only experienced low grade treatment emergent toxicities, including grade 1 cytokine release syndrome ('CRS') resolved without intervention, and no immune effector cell-associated neurotoxicity syndrome ('ICANS')."

Trial status • B Acute Lymphoblastic Leukemia

City of Hope Scientists Present Promising New Research at American Society of Hematology Annual Meeting (Businesswire) - P1 | N=36 | NCT05370430 | Sponsor: PeproMene Bio, Inc. | "In an exciting reversal, all three patients had a complete response (100% complete response rate). All three patients experienced robust CAR T-cell expansion, peaking on day 12 in patient #1 and day 14 in patients #2 and #3. The therapy also cleared lymphoma cells from the bone marrow 28 days after CAR T cell infusion. While each patient developed low-grade side effects, these resolved safely with time or medication. No dose-limiting toxicities were seen."

P1 data • Hematological Malignancies • Lymphoma • Oncology

PeproMene Bio reports positive phase 1 results for CAR-T therapy (Korea JoongAng Daily) - P1 | N=36 | NCT05370430 | Sponsor: PeproMene Bio, Inc. | "PeproMene began its phase 1 clinical trial last year at City of Hope in two patients who relapsed on previous CAR-T therapy and one patient with large B-cell lymphoma who had chemotherapies prior. All three patients demonstrated a 100 percent response rate. Two patients have shown cancer-free remission one month after the CAR-T injection, and one has seen cancer-free remission 90 days after....The company plans to proceed with the clinical trial with dose level 2 with an additional three patients, according to Budde."

P1 data • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

PeproMene Bio, Inc. Announced Completion of the First Dose Cohort and Opening of the Second Dose Cohort in Its B-cell Non-Hodgkin Lymphoma (B-NHL) Phase 1 Clinical Trial of PMB-CT01 (BAFFR-CAR T Cells) (Canada Newswire) - P1 | N=18 | NCT05370430 | Sponsor: PeproMene Bio, Inc.| "PeproMene Bio, Inc...today announced that the first dose cohort of its phase 1 relapsed or refractory B-cell Non-Hodgkin Lymphoma (r/r B-NHL) clinical trial of PMB-CT01 (BAFFR-CAR T Cells) has been completed. No Dose Limiting Toxicity (DLT) was observed, and the study has been cleared to proceed with the next cohort....The Overall Response Rate is 100% (two Complete Response and one Partial Response) at one-month post treatment. Two patients with mantle cell lymphoma had progressed after conventional CD19 CAR T-cell treatment prior to enrollment on PMB-CT01."

P1 data • Trial status • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

PMB-BAFFR-102: BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: PeproMene Bio, Inc. | N=18 ➔ 36 | Trial completion date: Jun 2026 ➔ Jun 2028 | Trial primary completion date: Jul 2025 ➔ Jul 2027

CAR T-Cell Therapy • Enrollment change • Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: PeproMene Bio, Inc. | Trial completion date: Apr 2025 ➔ Nov 2026 | Trial primary completion date: Apr 2024 ➔ Nov 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

PeproMene Bio, Inc. Announced Complete Response of The First Patient Treated in Its B-cell Non-Hodgkin Lymphoma (B-NHL) Phase 1 Clinical Trial of PMB-CT01 (BAFFR-CAR T Cells) at City of Hope (PRNewswire) - "PeproMene Bio...announced that the first patient treated in its phase 1 relapsed or refractory B-cell Non-Hodgkin Lymphoma (r/r B-NHL) clinical trial of PMB-CT01 (BAFFR-CAR T Cells) has reached Complete Response at 1-month post treatment. The trial is taking place at City of Hope, one of the largest cancer research and treatment organizations in the United States....'The acceptable safety profile and early complete response of our first B-NHL patient treated PMB-CT01 is an unprecedented milestone in the development and evaluation of PMB-CT01.'"

Trial status • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: PeproMene Bio, Inc. | N=37 ➔ 24 | Trial completion date: Apr 2024 ➔ Apr 2025

CAR T-Cell Therapy • Enrollment change • Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19