A first-in-human trial of SUPLEXA, a personalized immunotherapy developed by Alloplex Biotherapeutics, has shown promising results in patients with advanced-stage cancers. The treatment involves extracting, training, and reinfusing a patient's own immune cells to fight cancer. The Australian study, the full results of which will be presented at the 2024 SITC conference in November, demonstrated a strong safety profile and clinical benefits, especially in colorectal cancer (CRC) and renal cell carcinoma (RCC) patients.
Mechanism of Action
Dr. Frank Borriello, Founder and CEO of Alloplex Biotherapeutics, explained the rationale behind SUPLEXA: "Cancer often gains the upper hand by suppressing the immune system. Our approach flips the script: we isolate immune cells from this suppressive environment, we reactivate their inherent cancer-fighting abilities in a laboratory, and return them back to the patient." The process involves a single 50 mL blood draw, followed by ex vivo training of white blood cells using Alloplex's ENLIST technology. The enhanced cells are then infused back into the patient to target and destroy cancer cells while improving overall immune health.
Clinical Trial Results
The trial included patients with various cancer types who had exhausted standard treatment options. Remarkable results were observed in CRC patients, with one achieving a complete response (CR), another a partial response (PR), and a third experiencing stable disease (SD). According to Dr. Borriello, some patients sustained strong clinical responses for up to two years. In the RCC cohort, one patient achieved a PR, and six experienced SD, while only three had progressive disease (PD). Patients with other solid tumors, including melanoma, breast, and lung cancer, also demonstrated long-term SD with SUPLEXA.
Safety and Quality of Life
The study reported no treatment-related serious adverse events, which is expected given that SUPLEXA utilizes the patient's own immune cells. Although formal quality of life assessments were not conducted, patients reported improvements in well-being, pain reduction, and better symptom control. Principal Investigator Assoc. Professor Rohit Joshi noted that SUPLEXA allowed patients to continue with their normal lives and spend more time with family and friends.
Future Directions
Following encouragement from the FDA, Alloplex Biotherapeutics plans to initiate Phase 2 clinical trials of SUPLEXA in early 2025. This trial will combine SUPLEXA with immune checkpoint inhibitors (ICIs) in patients with a specific type of colorectal cancer. The goal is to determine whether SUPLEXA can enhance the effectiveness of ICIs, which are the standard of care for this cancer type, through complementary mechanisms.
