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Encouraging data from NewLink immunotherapeutic study

  • Data from a 25-patient Phase 2 clinical trial evaluating NewLink Genetics' (NLNK) dorgenmeltucel-L HyperAcute immunotherapy in combination with pegylated interferon-alpha 2b for advanced metastatic, progressive, refractory or recurrent melanoma shows that the combo is capable of inducing complete and durable clinical responses with tumor regression and immune activation.
  • Of the sixteen patients with Stage IV disease, two had a complete response as defined by RECIST criteria, one had stable disease and four had no evidence of disease (NED) after resection. Of the nine patients with stage II/III disease, three remained NED and one stage IIC patient had slow progressive disease (PD) with a single site resected is currently NED.
  • Twelve of the 25 subjects are still alive. All evaluable patients (21/21) seroconverted.
  • The complete response rate was 12.5% in patients with metastatic disease and the responses were durable.
  • Shares are up 10% premarket on fairly good volume.
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