In a significant advancement for personalized cancer treatment, Alloplex Biotherapeutics' SUPLEXA has shown promising results in a first-in-human trial. The therapy involves retraining a patient's own immune cells to combat advanced-stage cancer, offering new hope for those who have exhausted standard treatment options.
How SUPLEXA Works
SUPLEXA operates by isolating immune cells from the patient's blood, reactivating their cancer-fighting capabilities in a laboratory setting using Alloplex's proprietary ENLIST technology, and then reintroducing them into the patient. This process aims to reverse the immune suppression often caused by cancer, enabling the enhanced immune cells to target and destroy cancer cells while improving the patient's overall immune health. A complete course of SUPLEXA therapy requires only a single 50 mL blood draw.
Clinical Trial Results
The Australian study, which will have its full results presented at the 2024 SITC conference in November, reported no treatment-related serious adverse events. Striking results were observed particularly in patients with advanced colorectal cancer (CRC) and renal cell carcinoma (RCC). In CRC patients, one achieved a complete response (CR), another a partial response (PR), and a third stable disease (SD). According to Dr. Frank Borriello, Founder and CEO of Alloplex Biotherapeutics, some patients sustained a strong clinical response for up to two years.
Among the ten RCC patients, one experienced a partial response (PR), and six achieved stable disease (SD), while only three had progressive disease (PD). Patients with other solid tumors, including melanoma, breast, and lung cancer, also demonstrated long-term stable disease 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. Principal Investigator Assoc. Professor Rohit Joshi noted that SUPLEXA allowed patients to continue with their normal lives, pursue hobbies, and spend more time with family and friends.
Future Development
With encouragement from the FDA, Alloplex Biotherapeutics plans 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, aiming to enhance patient outcomes by leveraging the complementary mechanisms of SUPLEXA and ICIs.
The first-in-human clinical trial enrolled 35 patients with various advanced cancer types across three clinical sites in Australia. It was an open-label, single-agent, basket study that concluded in June 2024.
