by
Gus Iversen, Editor in Chief | May 28, 2015
1) The grant directly supports a significant portion of the costs of our Phase 3 trial, and, in turn, supports our efforts to complete development, seek approval for the therapy from the regulatory authorities and make the therapy available to patients. That result could be both a great achievement for the company as well as have life-sustaining implications for people with metastatic melanoma.
2) The grant, given it size and the entity awarding it (the independent and esteemed California Institute for Regenerative Medicine), represents a scientific validation of the promise of the NBS20 therapy. We hope that this, along with the preferred status offered to the candidate (Fast Track and Orphan Drug designations) and our trial (Special Protocol Assessment) by FDA, provide a clear signal to the investment community of the potential for NBS20 to be paradigm-changing in the treatment of melanoma.
DOTmed News: How did you get the grant?
DJM: After learning of the announcement of the CIRM 2.0 initiative, our team moved very quickly to apply for this grant and answer the questions of the reviewing committee to the best of our ability. It is no small achievement for a relatively small biotech to pursue and achieve a grant of this size and it is a testament to our team, our technology and the previous trial results that we were awarded this grant.
DOTmed News: What are the hurdles standing between the drug and the U.S. market?
DJM: The Phase 3 trial must complete enrollment of 250 patients, expected by the fourth quarter of 2016, and we must complete the interim analysis, which is expected to occur in the fourth quarter of 2017. If the interim analysis is successful, we project a Biologics License Application submission to the FDA in the second quarter of 2018, leading to potential commercialization, if the FDA approves, as early as 2018 in the best-case scenario. The Fast Track designation of our candidate supports a priority review schedule by FDA.
DOTmed News: Do you have plans to get the therapy approved in other countries?
DJM: We have taken initial steps in the European Union, including achieving Advanced Therapeutic Medicinal Product classification from the European Medicines Agency. We plan to enroll patients in Canada, New Zealand, and Australia as well.
DOTmed News: What makes this therapy special compared to other therapies already on the market?
DJM: This product candidate offers the hope to improve the long-term survival of patients with metastatic melanoma. Recent therapies for metastatic melanoma have been approved that have yielded strong response rates without demonstrating a substantial impact on survival.
NBS20 is intended to help the immune system target cancer or tumor-initiating cells, which are thought to rapidly proliferate cancer cells, fuelling tumor growth, and ultimately spreading the disease throughout the body. NBS20 uses the patient’s own immune cells and tumor-initiating cells to create a therapeutic vaccine. NBS20 is unique in targeting these cancer or tumor-initiating cells; other therapies, which target different tumor cells, may treat existing cancer but may not be as likely to prevent tumor recurrence.
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