Dallas-based biotech Gradalis revealed new groundbreaking data from several ongoing clinical trials involving innovative, personalized and promising immunotherapy against a variety of cancers.
Safety and survival data from a series of 3-year Phase 1 and 2 clinical trials following 123 advanced cancer patients were recently presented, wherein 64 patients received personalized immunotherapy, while 53 did not. The results showed a direct correlation between survival of patients receiving therapy and activation of T cells against tumors, suggesting that the treatment was effective, with only mild adverse events.
Four other different studies were highlighted by Gradalis, revealing fundamental data from several clinical trials on distinct patient populations.
Overall, patients with various types of tumors receiving immunotherapy had enhanced T-cell activation against tumor tissue, which translated into patient survival. Data on advanced hepatocellular patients showed that the majority who received Gradalis’ personalized immunotherapy were able to mount effective T-cell responses against malignant cells, with no toxicity observed and with up to 1043+ days of survival after immunotherapy, justifying progression to a Phase 2 clinical study.
Five pediatric patients with advanced Ewing’s sarcoma also received personalized immunotherapy, with two of them receiving 8 and 4 doses, respectively, and succeeding in stabilizing the disease. Altough limited, such data demonstrates the safety and effectiveness of this study, with promising clinical relevance. Moreover, Phase 2 data in high-risk Stage III/IV ovarian cancer showed that 92% of patients receiving treatment had increased survival, correlating with the enhanced T-cell activation against tumor cells observed as early as one month after the beginning of immunotherapy.
Joseph M. Limber, President and Chief Executive Officer of Gradalis, stated “these data support the potential for Gradalis’ personalized therapeutic to transform the way cancer is treated.”
Based on this promising data, Gradalis will move forward with its personalized immunotherapy Phase 3 program currently focusing on the adjuvant treatment of patients with stage III/IV ovarian cancer after surgery removal and cycles of chemotherapy, a particular setting that has no current treatments approved. Therapies for hepatocellular carcinoma, colorectal cancer with liver metastases, and Ewing’s sarcoma are also being designed.
The data was presented on the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 17th Annual meeting of the American Society of Gene and Cellular Therapy (ASGCT).