EMA’s created Priority Medicines (PRIME) regulatory initiative for products which the European agency rules they are of unmet needs. PRIME makes them eligible for support, possible regulatory applications and potential accelerated reviews. PRIME has accepted Adaptimmune’s (ADAP) drug NY-ESO-targeting T-cell therapy. The drug became the 8th accepted for EMA’s PRIME program.
The PRIME status has been awarded to Adaptimmune’s NY-ESO-targeting T-cell therapy for the treatment for certain patients with inoperable or metastatic synovial sarcoma, a rare soft tissue cancer. The PRIME status is restricted to the use of the drug 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.
With that status, Adaptimmune is eligible to receive extra support from the EMA, including engaging in early discussions on its program, which the EMA believes would improve trial designs.
Other privileges for Adaptimmune include: Receiving EMA guidance on its regulatory strategy, in addition to scientific advice and potential accelerated assessment depending on the merits of its application.
This news might be might be big for Adaptimmune for the following reasons:
– Adaptimmune drug was selected from among 35 drugs, 27 of them were denied the EMA PRIME privileges.
– Of nine requests processed at the same time as Adaptimmune, the EMA regulator rejected seven.
– The EMA acceptance points to the importance of Adaptimmune NY-ESO-targeting T-cell therapy and to the relevance of Adaptimmune Science and technology.
– Selecting Adaptimmune drug, the EMA put this development-stage firm in the same basket with the other selected large firms’ drugs, including Novartis’ leukemia drug CTL019; Merck’s (MRK) Ebola vaccine and Biogen’s (BIIB) Alzheimer’s disease drug aducanumab.
Other Small Firms’ selected drugs, include DNAtrix Therapeutics drug for recurrent glioblastoma and the Swiss firm Novimmune’s drug NI-0501, for its hemophagocytic lymphohistiocytosis drug, NI-0501.
ADAP is now trading at $8.29 UP $0.17
We have almost completed a study assessing the value of Adaptimmune’s science, technology and products. The study has also assessed it as a possible investment opportunity. We will soon post the outcome of our study at the Prohost website.
Among the stocks that plummeted as a result of a failed drug in clinical trials, some are still backed by strong technologies, other scientific fundamentals and good managements. Of these firms some that extremely discounted and can rebound. We are bringing some of these firms to your attention in tomorrow’s posting. The posting will include the assessment of the firms left unassessed in Prohost Letter #397 Part 2.
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