Keith Flaherty, M.D., Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School has been named the Principal Investigator.
Joining Flaherty are Jennifer Wargo of the Department of Surgical Oncology at MD Anderson, Michael Davies of the Department of Melanoma Oncology at MD Anderson, Paul Chapman in the Melanoma/Sarcoma Service at Memorial Sloan Kettering and Rene Gonzalez of the Division of Medical Oncology at University of Colorado.
Keith Flaherty, Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Henri and Belinda Termeer Center for Targeted Therapies, Massachusetts General Hospital said: "Based on the scientific and translational research behind SCIB1, I believe there is a compelling case for further investigation in both the metastatic and adjuvant melanoma settings. Despite meaningful recent advances in the treatment of this disease there still remains a significant unmet medical need. I am very excited to be working with Scancell and my other colleagues in the investigator team to bring this innovative treatment to patients."
Paul Chapman, Dept. of Medicine, Memorial Sloan Kettering Cancer Center added: "SCIB1 represents a potentially important complement to checkpoint inhibitor therapy. Despite the unquestionable clinical utility of anti-PD-1 drugs, only around 30% of patients respond to treatment.
"Available data supports testing the hypothesis that the use of SCIB1 in combination with these agents may increase the number of patients responding to treatment and prolong progression free survival without the additional burden of significant further side effects."
Scancell joint CEO Richard Goodfellow said: "The latest data on SCIB1, both in terms of the unprecedented survival of Stage 3/4 melanoma patients with resected disease, combined with anti-tumour responses in late stage patients and compelling animal data showing the potential value of a SCIB1/checkpoint inhibitor combination regimen sets the stage for an expanded clinical trial programme. We are delighted to have secured the help and support of such a prestigious group of US specialists, led by Dr Flaherty."
The clinical study will assess the impact of adding SCIB1 to a checkpoint inhibitor in patients with late stage melanoma. The aim will be to improve the objective response rates of anti-PD-1 ("checkpoint inhibitor") monotherapy without adding additional toxicity. It is expected that the trial will enrol approximately 80 Stage 3/4 metastatic melanoma patients and commence in the second half of 2016, ending around 18 months later.