Scancell Delays Melanoma Trial 9 to 12 Months to Whip Up New Batch of Cancer Vaccine

Scancell Delays Melanoma Trial 9 to 12 Months to Whip Up New Batch of Cancer Vaccine July 7, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Nottingham, UK-based Scancell announced that its clinical trial of SCLB1, a cancer vaccine, has been delayed by nine to 12 months because of shelf life problems.

The delay will affect eight patients who are involved in the study’s long-term extension arm. The company stated, “Ongoing quality control analysis has revealed that the stored drug product is … no longer suitable for further use.” Apparently its current stores of the drug are more than seven years old. The company will need to work with a contract manufacturer to make a fresh supply.

No new side effects were seen as a result of the drug’s age.

“The suspension of dosing affects eight patients in the long term extension arm of the Phase I/II trial, SBLB1 (out of the 35 patients that have been dosed), investigating SCLB1 as a monotherapy for the treatment of melanoma,” the company stated.

The study, SCLB1-001 was begun in 2010 and planned to run for six months. But the results were encouraging and the safety profile was so positive that several changes were made to the trial protocol that allowed for increased dosing, which led to some of the trial materials being stored too long.

Part of the changes also includes a new study of SCIB1 in combination with a checkpoint inhibitor. That trial was announced in December 2015. The company’s U.S. team was going to start a Phase II study of SCLB1 with an anti-PD-1 checkpoint inhibitor on Stage III/IV metastatic melanoma patients.

Despite the delay, the company provided an update on its Phase I/II study in malignant melanoma using SCIB1 on July 6. “SCLB1 continues to deliver compelling survival data in patients with resected Stage III/IV melanoma,” said Richard Goodfellow, Scancell’s chief executive officer, in a statement. “It is particularly interesting to note that there has only been one new case of disease progression since November 2013 in the resected patients receiving 4mg doses of SCLB1, which gives us hope that SCLB1 might offer curative potential in this currently untreated patient group.”

Of the current delay, Goodfellow said in a statement, “Patient safety has always been our primary responsibility. Although we have seen no new adverse events, it is unfortunate, but nevertheless appropriate, that we suspend dosing of SCLB1 at this time while we work as quickly as possible to secure new supplies of this promising potential treatment for melanoma. Starting further efficacy studies with SCLB1 is only possible due to the results we have seen so far in the long-running SCLB1-001 study and we would again like to convey our thanks to the patients in that trial for their participation and support over the past six years.”

SCLB1 is a human antibody molecule engineered to make two cytotoxic T cell antigens from melanoma antigens Tyrosinase-Related Protein 2 (TRP2) and gp100 plus two helper T cell epitopes. The expression of the molecules stimulates an immune reaction against cancer cells that express TRP2 and gp100 antigens.

Mike Mitchell, an analyst with Panmure Gordon, indicated that the delay was undoubtedly disappointing for the company, but that its therapeutics platforms “hold some very interesting opportunities and potential for cancer patients in otherwise difficult to treat indications.”

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