Alloplex Biotherapeutics' autologous SUPLEXA cell immunotherapy has shown promising results in a Phase I trial, offering hope for patients with advanced solid tumors and hematologic malignancies who have exhausted standard treatment options. The open-label, non-comparative, basket-design trial (NCT05237206) evaluated the safety, tolerability, and preliminary clinical efficacy of repeated intravenous infusions of SUPLEXA cell monotherapy.
Phase I Trial Results
The Phase I trial, conducted across three sites in Australia, enrolled 35 patients with measurable metastatic solid tumors and hematologic malignancies. The most notable outcomes were observed in patients with renal cell carcinoma (RCC) and advanced colorectal cancer (CRC).
In the RCC cohort, comprising ten patients, one achieved a partial response (PR), and six experienced stable disease (SD), resulting in a 60% stable disease rate. Among the three CRC patients, one achieved a complete response (CR), one achieved a PR, and the remaining patient had SD.
SUPLEXA Mechanism and ENLIST Platform
SUPLEXA cells are created using a patient’s own cells and the ENLIST immune cell training platform. This approach aims to reverse immune suppression often seen in cancer patients. According to Alloplex founder and CEO Dr. Frank Borriello, "Cancer often gains the upper hand by suppressing the immune system. Our approach flips the script: we isolate immune cells from this suppressive environment, reactivate their inherent cancer-fighting abilities in a laboratory and return them back to the patient."
Future Directions and Phase II Plans
Alloplex has received positive feedback from the US Food and Drug Administration (FDA) and plans to submit an Investigational New Drug (IND) application. The company intends to initiate Phase II clinical trials of SUPLEXA in early 2025.
The planned Phase II trials will explore the combination of SUPLEXA with immune checkpoint inhibitors (ICIs) in patients with a specific type of colorectal cancer. The goal is to determine whether SUPLEXA can enhance outcomes in patients treated with ICI-based standard of care (SoC).
Presentation at SITC
The full results of the Phase I trial are scheduled for presentation at the upcoming Society for Immunotherapy of Cancer (SITC) meeting, which will be held from November 7 to 9 in Houston, Texas.
