Affimed N.V. (AFMD), a clinical-stage immuno-oncology company, Wednesday announced that it has received Fast Track Designation from the U.S. Food and Drug Administration for combination therapy of AFM24 with Atezolizumab for EGFR Wild-Type non-small cell lung cancer or NSCLC.
In pre-market activity on the Nasdaq, Affimed shares were gaining around 11 percent to trade at $4.66.
The Fast Track designation has been given to the combination of its innate cell engager or ICE AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic NSCLC not harboring any activating EGFR mutations (EGFR wild-type) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy.
The company plans to present data from the AFM24-102 study in this patient population at the upcoming annual meeting of the American Society of Clinical Oncology on June 1.
Fast Track is a process designed to facilitate the development and expedite the review of new drugs to treat serious conditions and fill an unmet medical need.
The FDA's decision is based on initial activity observed in the first evaluable patients of the phase 2 part of the AFM24-102 study of AFM24 in combination with atezolizumab in heavily pretreated patients with NSCLC EGFRwt.
Wolfgang Fischer, Chief Operating Officer at Affimed, said, "The clinical data of AFM24 in combination with the checkpoint inhibitor atezolizumab is compelling. We're observing meaningful responses in patients resistant to prior checkpoint inhibitor treatment. The Fast Track designation emphasizes the belief in the potential of this combination therapy to address currently unmet needs of patients with this devastating, life threatening disease who have exhausted all standard of care options, including chemotherapy and checkpoint inhibitors."
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