#USA #Irvine #PeproMene Bio #PMB-CT01 #BAFF-R

PeproMene Bio's Significant Announcement

PeproMene Bio, Inc., a clinical-stage biotech firm based in Irvine, California, has made headlines with the publication of its Phase 1 clinical trial results in The Lancet, one of the most prestigious medical journals worldwide. This pioneering study evaluated PMB-CT01, the first CAR T-cell therapy targeting BAFF-R, in patients suffering from relapsed or refractory B-cell non-Hodgkin lymphomas.

The clinical trial's findings are remarkable, showcasing that 80% of the patients treated achieved complete responses (CR), with four of these patients having previously experienced disease progression post conventional CD19 CAR T-cell therapy. Impressively, none of the patients experienced relapses at the data cutoff point, and the longest duration of a complete response reached an outstanding 35 months, suggesting a potential pathway towards long-lasting cures.

Safety Profile

In addition to efficacy, PMB-CT01 demonstrated a notably favorable safety profile. Incidents of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were restricted to grade 1 severity, illustrating the therapy's tolerability in patients. Such safety metrics are essential for considering outpatient treatment options, enhancing accessibility, especially for individuals from resource-limited backgrounds.

Expanded Clinical Trials

Encouraged by these results, PeproMene Bio is expanding the Phase 1 trial from a solitary clinical center at City of Hope, known for their cancer treatment and research, to include multiple additional medical centers across the United States. Following the trial's expansion, the first patient in this broader segment, diagnosed with high-grade B-cell lymphoma with triple mutation and prior progression on CD19 CAR T-cell therapy, also achieved a complete response at the initial disease evaluation.

Dr. Larry W. Kwak, M.D., Ph.D., the scientific founder of PeproMene Bio, expressed optimism regarding these findings—"The publication of these peer-reviewed results in The Lancet signifies a noteworthy affirmation of this innovative therapy. With no relapses, we believe PMB-CT01 represents a revolutionary CAR T-cell therapy option for blood cancers that were once deemed incurable. Its exceptional safety could allow for outpatient administration, thus broadening patient access and paving the way for new treatment avenues for autoimmune diseases where B-cell depletion has proven effective."

A Collaborative Effort

The trial's collaborative nature also involves the Institute for Follicular Lymphoma Innovation (IFLI), which pledged up to $11 million in December 2024 to support the clinical development of PMB-CT01. Dr. Mehrdad Mobasher, an executive partner at IFLI, remarked, "For patients whose lymphoma recurs following CD19-targeted CAR T therapy, a new therapeutic target could offer a fresh opportunity for treatment. IFLI is proud to support PeproMene Bio in advancing BAFF-R CAR T-cell therapy and is encouraged by these early, durable responses."

Further Reading

For those interested in delving into the specifics of the groundbreaking study, the publication titled "BAFF-R CAR T-cell therapy for relapsed or refractory B-cell lymphomas" can be accessed in The Lancet via the following link: Journal Access01329-2/fulltext).

About PeproMene Bio

PeproMene Bio, established in Irvine, California, is devoted to developing innovative therapies aimed at treating cancer and immune disorders. For further inquiries, you can contact Hazel Cheng, Ph.D., Chief Operating Officer at PeproMene Bio, Inc. via email at email protected] or visit their website at [pepromenebio.com.