#USA #Irvine #CAR-T therapy #PeproMene Bio #PMB-CT01

Exciting Developments in Cancer Treatment

PeproMene Bio, Inc. has recently made headlines by publishing remarkable results from a Phase 1 clinical study of its innovative CAR-T cell therapy, PMB-CT01, in the prestigious journal, The Lancet. This study indicates promising outcomes for patients suffering from relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL), particularly those who did not respond to prior treatments involving CD19 CAR-T therapies.

In this groundbreaking study, which included nine participating patients, an impressive 80% achieved complete response (CR), showcasing deep and lasting remission. Notably, four among those had previously witnessed progression after undergoing conventional CD19 CAR-T therapy. As of the data cutoff point, all patients remained in complete remission without any relapse, with the longest duration of remission reported at 35 months, strongly suggesting a potential cure.

PMB-CT01 has shown a notably favorable safety profile, with all cytokine release syndrome (CRS) cases and the two instances of immune effector cell-associated neurotoxicity syndrome (ICANS) being limited to grade 1. Given such promising results, the Phase 1 study initially conducted at a single center in City of Hope is now expanding to include multiple medical centers across the United States. Furthermore, the first patient enrolled in this expansion who had advanced triple-hit B-cell lymphoma post-CD19 therapy also exhibited a complete response during the initial disease evaluation.

Dr. Larry W. Kwak, the scientific founder of PeproMene Bio, commented, "The publication of this peer-reviewed data in The Lancet is a significant acknowledgment of this novel therapy. The absence of relapses strengthens our belief that PMB-CT01 could become a groundbreaking CAR-T therapy option for blood cancers previously considered untreatable. Its outstanding safety profile could facilitate outpatient administration, improving access for underserved patients and possibly leading to new treatments for autoimmune diseases where B-cell depletion has proven effective."

Dr. Stephen Forman, a co-author of the publication and Director of the Hematologic Malignancies Institute at City of Hope, also praised the initial results. He remarked, “These early findings are especially encouraging for patients whose conditions have worsened following CD19 or CD20 targeted T-cell therapies. City of Hope will continue to support the study as a coordination and production site, helping with patient recruitment.”

The Institute for Follicular Lymphoma Innovation (IFLI) has committed up to $11 million for the clinical development of PMB-CT01 focused on patients with relapsed or refractory follicular lymphoma. Dr. Mehrdad Mobasher of IFLI added, “For patients whose lymphoma recurs after CD19 targeted CAR-T therapy, this new target could signify a new opportunity. IFLI is proud to support PeproMene Bio in advancing the BAFF-R CAR-T cell treatment and sees the early and sustained responses as encouraging.”

Publication Details

• - Title: BAFF-R-CAR-T Therapy in Relapsed or Refractory B-Cell Lymphomas
• - Journal: The Lancet (Research Letter)
• - DOI: Link to the publication01329-2/fulltext)

About PMB-CT01

PMB-CT01 is an autologous CAR-T cell therapy that targets the B-cell activating factor receptor (BAFF-R), currently being explored in ongoing Phase 1 studies for relapsed/refractory B-NHL as well as relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). BAFF-R is predominantly expressed on B-cells, supporting their survival and reducing the chance of antigen loss, a critical factor in treatment resistance. PeproMene Bio has licensed intellectual property related to PMB-CT01 from City of Hope.

About PeproMene Bio

PeproMene Bio, Inc. is a clinical-stage biotechnology firm based in Irvine, California, dedicated to developing innovative therapies for cancer and immune diseases. For more information, please reach out via email to Hazel Cheng, Ph.D., Chief Operating Officer at PeproMene Bio, Inc. at email protected] or visit [pepromenebio.com.

This press release contains forward-looking statements that are subject to risks and uncertainties, including those related to clinical development, regulatory decisions, therapeutic potential, and marketing. PeproMene Bio does not undertake to update any forward-looking statements unless required by law.