PeproMene Bio Announces Complete Response in First Patient with Relapsed/Refractory B-ALL Treated with PMB-CT01 in Phase 1 Clinical Trial

PeproMene Bio, Inc. Announcement in City of Hope Conducted PMB-CT01（BAFFR-CAR T Cell)1 In the clinical trial, the 1 The First Case of Relapsed and Refractory Acute in the Group B Lymphocytic Leukemia (B-ALL) The patient's condition has been completely relieved.

Irvine, CaliforniaJanuary 18, 2024PR Newswire -- PeproMene Bio, Inc., a clinical-stage biotechnology company developing novel treatments for cancer therapy and immune dysregulation, today announced that the first patient in Cohort 1 of the Phase 1 clinical trial of PMB-CT01 (BAFFR-CAR T cells) for relapsed and refractory acute B lymphoblastic leukemia (r/r B-ALL) achieved complete remission one month after treatment.

At the American Society of Hematology Annual Meeting held in San Diego last month, PeproMene Bio presented a clinical trial report on PMB-CT01 for relapsed/refractory non-Hodgkin lymphoma. The results announced today further supplement this trial. Associate Professor of the Lymphoma Division, Department of Hematology and Hematopoietic Cell Transplantation, City of HopeElizabeth BuddeDr. reported on the results of this trial, which caused a great sensation, as all three patients achieved durable complete remission with very low toxicity (https://ash.confex.com/ash/2023/webprogram/Paper183032.html)。

The trial was conducted at one of the largest cancer research and treatment institutions in the United States.City of HopeProceed, who is also the developer of this therapy.

During the first month of treatment, the patient only experienced mild treatment-related toxicity reactions, including Grade 1 cytokine release syndrome ("CRS"), which resolved without intervention, and no immune effector cell-associated neurotoxicity syndrome ("ICANS") occurred.

"The treatment outcome was very exciting for us. This patient had a relapse of B-cell ALL after receiving chemotherapy and blinatumomab. At the time of his relapse, he was CD19- and CD22-negative, which meant that his available treatment options were extremely limited." Associate Professor of Hematology and Hematopoietic Cell Transplantation at City of Hope and principal investigator of this single-center, dose-escalation and expansion trial (NCT04690595)Ibrahim T. AldossDr. said.

"He tolerated BAFFR-CAR T cell therapy very well, with only minimal expected toxicity. Additionally, he achieved complete remission and cleared minimal residual disease (MRD), indicating an excellent response to this effective treatment."

"The acceptable safety and complete response demonstrated by B-ALL patients after receiving PMB-CT01 treatment marks an extraordinary milestone in PeproMene’s development and evaluation of PMB-CT01. The preclinical study data from City of Hope, published in *Science Translational Medicine* in 2019, support these initial clinical outcomes, showing that BAFFR-CAR T cells can effectively eliminate various B-cell malignancies, including B-ALL and different subtypes of B lymphoma." — Chief Operating Officer of PeproMeneHazel ChengDr. said.

PMB-CT01 was developed by the Vice President and Deputy Director of the City of Hope Comprehensive Cancer Center, and the Scientific Founder and Chair of the Scientific Advisory Board of PeproMene Bio, Inc.Larry W. KwakInvented in Dr. Kwak's lab. Kwak is a stakeholder of PeproMene Bio, Inc.

City of Hope holds relevant rights to the compound "BAFFR(EQ)BBζ/EGFRt+ CAR T cells" being studied in this research.