In a significant advancement for personalized cancer therapy, Alloplex Biotherapeutics' SUPLEXA has shown promising results in patients with advanced-stage cancers. This innovative treatment involves retraining a patient's own immune cells to target and combat cancer cells, offering new hope for those with limited treatment options. The first-in-human trial, conducted in Australia, revealed a strong safety profile and notable clinical benefits, particularly in patients with advanced colorectal cancer (CRC) and renal cell carcinoma (RCC).
How SUPLEXA Works
SUPLEXA operates on the principle of enhancing the body's natural defenses against cancer. Dr. Frank Borriello, Founder and CEO of Alloplex Biotherapeutics, explains, "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 begins with a single 50 mL blood draw from the patient. The white blood cells are then isolated and 'trained' ex vivo using Alloplex's proprietary ENLIST immune cell training technology. After about a month, these enhanced cells are infused back into the patient, where they target and destroy cancer cells while improving the patient's overall immune health.
Clinical Trial Results
The Australian study, the full results of which will be presented at the 2024 SITC conference, enrolled 35 patients with various advanced cancer types. The trial demonstrated that SUPLEXA was well-tolerated, with no treatment-related serious adverse events reported. In CRC patients, one achieved a complete response (CR), another a partial response (PR), and a third experienced stable disease (SD). Dr. Borriello noted that many patients sustained a strong clinical response for up to two years. Among the ten RCC patients, one achieved a PR, and six achieved SD, while only three experienced progressive disease (PD). Patients with other solid tumors, including melanoma, breast, and lung cancer, also demonstrated long-term SD with SUPLEXA.
Patient Experience and Quality of Life
While formal quality of life assessments were not conducted, patients reported improvements in their well-being, including reduced pain and better symptom control. According to Principal Investigator Assoc. Professor Rohit Joshi, "SUPLEXA has been a remarkable experience" for participating patients who had exhausted all standard treatment options. He added that it allowed them to continue with their normal lives, pursue hobbies, and spend more time with family and friends.
Path to Phase 2 Trials
With encouragement from the FDA, Alloplex Biotherapeutics is planning to initiate Phase 2 clinical trials of SUPLEXA in early 2025. These trials will combine SUPLEXA with immune checkpoint inhibitors (ICIs) in patients with a specific type of colorectal cancer. The goal is to determine whether SUPLEXA's mechanisms can enhance patient outcomes by amplifying the effectiveness of ICIs, which are the standard of care for this type of cancer.
