On July 28, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that the European Medicines Agency (EMA) has granted access to its newly-established Priority Medicines (PRIME) regulatory initiative for the company’s SPEAR T-cell therapy targeting NY-ESO for the treatment of HLA-A0201, HLA-A0205, or HLA-A0206 allele positive patients with inoperable or metastatic synovial sarcoma who have received prior chemotherapy and whose tumor expresses the NY-ESO-1 tumor antigen (Press release, Adaptimmune, JUL 28, 2016, View Source [SID:1234514096]). Schedule your 30 min Free 1stOncology Demo! The PRIME initiative provides support to optimize regulatory applications and accelerate the review of medicines that address a high unmet need.
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"Access to the PRIME initiative represents an important regulatory opportunity for us. It can provide early engagement on the development program with potential for accelerated assessment of data to companies like Adaptimmune who are developing new treatment modalities for patients in Europe with few or no treatment options," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "Our NY-ESO SPEAR T-cell therapy may help to address the significant unmet medical need of metastatic or unresectable synovial sarcoma. We look forward to working closely with the EMA throughout its clinical evaluation."
Adaptimmune recently announced that the European Commission had designated its NY-ESO SPEAR T-cell therapy as an orphan medicinal product for the treatment of soft tissue sarcoma. The company has already received orphan drug designation and Breakthrough Therapy designation for its NY-ESO SPEAR T-cell therapy from the U.S. Food and Drug Administration.
The PRIME initiative focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. The criteria for the PRIME initiative require a medicine to show its potential to benefit patients with unmet medical needs based on early clinical data. The initiative offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications, and provides appointment of a rapporteur, early dialogue on the overall development plan and regulatory strategy, scientific advice at key development milestones, a dedicated point of contact, and the potential to qualify products for accelerated assessment at the time of an application for marketing authorization.
Adaptimmune’s SPEAR T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with solid and hematologic cancers.