Alloplex biotherapeutics receives FDA fast track designation for SUPLEXA in colorectal cancer indication

Designation recognizes the potential of SUPLEXA therapeutic cells in addressing high unmet need in patients with solid tumors

Alloplex Biotherapeutics Inc. (‘Alloplex’) announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SUPLEXA for the treatment of patients with colorectal cancer of the MSI-H phenotype.

The designation reflects a recognition by the FDA that SUPLEXA therapeutic cells have the potential to address significant unmet medical need in solid tumors and for SUPLEXA to provide meaningful clinical benefit in settings where current treatment options remain limited.

SUPLEXA is the first drug candidate to emerge from the proprietary ENLIST immune cell training platform developed at Alloplex. The ENLIST platform differentiates itself by activating patient-derived immune cells without genetic modification. This streamlined approach is specifically designed to restore and amplify endogenous anti-tumor activity, providing a fundamentally different pathway for treating solid tumors

Key benefits of Fast Track Designation include:

• More frequent engagement with the FDA to align on clinical development strategy
• Rolling review of regulatory submissions, allowing completed sections of the BLA/NDA to be reviewed as they are ready
• Eligibility for Priority Review and Accelerated Approval, subject to relevant criteria.

“This designation represents a pivotal regulatory milestone for SUPLEXA and validates our platform’s potential to transform solid tumor oncology,” said Dr. Frank Borriello, Scientific Founder and Chief Executive Officer of Alloplex Biotherapeutics. “By moving beyond the limitations of genetic engineering, we are pursuing a more natural, yet more powerful, way to harness the immune system. We look forward to working closely with the FDA as we transition into the clinic to bring this new class of therapy to patients who have exhausted standard options.”

In parallel with ongoing development, Alloplex confirms it has submitted its US IND package for SUPLEXA in CRC-MSI-H and continues to progress preparatory clinical activities.

About Alloplex Biotherapeutics

Alloplex Biotherapeutics is a clinical-stage biotechnology company developing SUPLEXA, an autologous, non-engineered cellular therapy platform designed to restore and enhance the body’s innate immune response against solid tumours. The company intends to advance SUPLEXA in multiple oncology indications with a focus on scalable manufacturing, cost efficiency, and rapid clinical translation. It is also developing SUPLEXA variants as potential therapeutic approaches for autoimmunity applications.