Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer
SYDNEY, AUSTRALIA, May 16, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the US Food and Drug Administration (FDA), regarding the Company’s late-stage clinical development plans for its first-in-class soluble LAG-3 protein and MHC Class II agonist, eftilagimod alpha (“efti”), for the treatment of 1st line non-small cell lung cancer (NSCLC).
- SYDNEY, AUSTRALIA, May 16, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the US Food and Drug Administration (FDA), regarding the Company’s late-stage clinical development plans for its first-in-class soluble LAG-3 protein and MHC Class II agonist, eftilagimod alpha (“efti”), for the treatment of 1st line non-small cell lung cancer (NSCLC).
- This trial will be named TACTI-004 (Two ACTive Immunotherapies).
- Immutep CEO, Marc Voigt, commented: “In light of our compelling clinical data that efti has generated in combination with anti-PD-1 therapy, this meeting with the FDA is a critical step in our late-stage development process for 1st line non-small cell lung cancer.
- We are thankful for the positive feedback as we continue moving forward with our unique immuno-oncology approach for the many cancer patients impacted by this difficult disease.”
Immutep CSO, Dr. Frédéric Triebel, stated: “We are very pleased with our constructive dialogue with the FDA establishing a clear path forward for efti in front line non-small cell lung cancer.