PeproMene Bio, Inc. Completes First Dose Cohort in Phase 1 Trial of PMB-CT01 for Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

PeproMene Bio, Inc. Announcement CompletedBCellular Non-Hodgkin Lymphoma(B-NHL)Phase IPMB-CT01（BAFFR-CAR TThe first dose cohort of the clinical trial (cell) has been completed, and the second dose cohort has begun.

Irvine, CaliforniaSeptember 11, 2023PR Newswire -- PeproMene Bio, Inc., a clinical-stage biotechnology company developing novel therapies for the treatment of cancer and immune diseases, today announced the completion of the first dosing cohort in its Phase I PMB-CT01 (BAFFR-CAR T-cell) clinical trial for relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). No dose-limiting toxicity (DLT) was observed, and the study has been approved to proceed to the next cohort.

The PMB-102 trial is ongoingCity of Hope(City of Hope), one of the largest cancer research and treatment institutions in the United States. PeproMene has acquired the intellectual property related to PMB-CT01 from City of Hope, which developed the therapy.

In the first batch of subjects, a dose of 50x10 was administered.⁶PMB-CT01 Demonstrates Excellent Tolerability. Among the 3 treated patients, all experienced only Grade 1 cytokine release syndrome ("CRS"), 2 patients had Grade 1 immune effector cell-associated neurotoxicity syndrome ("ICANS"), and have fully recovered. The overall response rate was 100% (2 complete responses, 1 partial response) at 1 month post-treatment. Prior to receiving PMB-CT01, two patients with mantle cell lymphoma had disease progression after traditional CD19 CAR T-cell therapy.

"We are surprised to see such minimal toxicity and yet such a high remission rate in heavily pretreated patients who had previously failed after receiving 3-10 therapies, including FDA-approved CD19 CAR T-cell therapy."Elizabeth BuddeThe principal investigator of this single-center dose-escalation trial (NCT05370430) is a medical doctor who is also an associate professor in the Department of Lymphoma and the Division of Hematology and Hematopoietic Cell Transplantation at City of Hope.

Vice President and Deputy Director of City of Hope Comprehensive Cancer Center, Founder and Chair of Scientific Advisory Board of PeproMene BioLarry W. Kwak"Although CD19-CAR T-cell therapy has shown high initial efficacy in treating B-cell lymphoma and leukemia, a significant number of patients still relapse after CD19-CAR T treatment, highlighting an unmet medical need," said Dr. Kwak, who holds equity in PeproMene Bio. "Unlike CD19, BAFF-R signaling is essential for B-cell growth and survival, so the loss of BAFF-R expression may limit the ability of B-cell tumors to evade treatment. I hope that BAFFR-CAR T therapy will offer patients a clinically meaningful new option."

Dr. Hazel Cheng, Chief Operating Officer of PeproMene Bio, said: "Although still in the early stages, we are encouraged by the preliminary observations of acceptable safety and initial efficacy in the first dose cohort of PMB-CT01 for the treatment of B-NHL patients. All three patients treated with PMB-CT01 responded, including two whose disease progressed after CD19 CAR-T therapy and one with CD19/CD20-negative lymphoma. These clinical outcomes are consistent with preclinical study data from City of Hope published in 2019 in Science Translational Medicine, which indicated that PMB-CT01 (BAFFR-CAR T cells) can overcome the loss of CD19 antigen in B-cell malignancies."