Adaptimmune ($ADAP) has become one of the first companies to have a drug accepted into the EMA’s Priority Medicines (PRIME) regulatory initiative. The scheme, which to date has accepted 8 drugs while rejecting almost 30, is designed to ensure developers of products with the potential to address major unmet needs receive support with regulatory applications and potentially accelerated reviews.
The EMA has awarded PRIME status to Adaptimmune’s NY-ESO-targeting T-cell therapy as a treatment for certain patients with inoperable or metastatic synovial sarcoma, a rare soft tissue cancer. The PRIME status is limited to the use of the T-cell therapy in HLA-A0201, HLA-A0205 or HLA-A0206 allele positive patients who have been through chemotherapy and have tumors that express the NY-ESO-1 antigen.
As Adaptimmune advances its candidate through development in this indication, it will receive extra support from European regulators. The EMA has committed to engaging in early discussions with firms on its PRIME program, a strategy it thinks will improve trial designs. Adaptimmune will also benefit from a dedicated point of contact at the EMA, guidance on its regulatory strategy, scientific advice throughout development and, depending on the merits of its application, potentially accelerated assessment.
The EMA has shown a willingness to limit these benefits to the candidates it views as most deserving. The PRIME nod for Adaptimmune brought the total number of assets accepted into the program up to eight, half of which are in oncology indications. To put that figure into context, the EMA has rejected 27 requests to join PRIME and dismissed two before even starting to formally review the submissions. Of the nine requests EMA processed at the same time as Adaptimmune, the regulator rejected seven.
The other successful applicant was Texas-based DNAtrix, which snagged a spot on the program for its treatment for recurrent glioblastoma. In the two previous months in which PRIME has been active, the EMA accepted requests for Novartis’ ($NVS) leukemia drug CTL019, Merck’s ($MRK) Ebola vaccine and Biogen’s ($BIIB) Alzheimer’s disease hopeful aducanumab. The only other European biotech on PRIME is Novimmune, which picked up a nod for its hemophagocytic lymphohistiocytosis drug, NI-0501.