LOAd703 Received FDA Fast Track Designation for Pancreatic Cancer / Amanda Brisco, and Angelica Sara Ingrid Loskog, Åsa Holmgren, Bambi Grilley, Benjamin Leon

LOAd703 has been granted FDA fast track designation for the treatment of patients with pancreatic cancer.

LOAd703 has been granted FDA fast track designation for the treatment of patients with pancreatic cancer.

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LOAd703, an oncolytic adenovirus with transgenes for 4-1BBL and TMZ-CD40L, has received FDA fast track designation for pancreatic cancer treatment.

Background Immune checkpoint inhibitor (ICI) resistance remains a clinical hurdle in malignant melanoma (MM). Remodeling the tumor microenvironment (TME) have been proposed a revenue to overcome ICI resistance. The present study aimed to test the hypothesis that treatment with LOAd703, a TMZ-CD40L/4-1BBL-expressing gene engineering vector, reprograms the immune landscape in ICI refractory MM patients to restore ICI responsiveness. Methods LOKON003 a multi-center, single-armed phase I/II clinical trial recruited 24 patients with confirmed stage IV cutaneous MM (n = 23) and mucosal MM (n = 1) who had progressed on one, or several, treatments with anti-PD-1 inhibitors with or without supplementary anti-CTLA-4 inhibitor or experimental immunotherapy treatment. LOAd703 (1 × 1011 or 5 × 1011 viral particles) was administered by ultrasound guided intratumoral injections and atezolizumab was administered intravenously (1200 mg). Patient

The decision follows safety data from the phase 1/2 LOKON001 trial evaluating LOAd703 in advanced pancreatic ductal adenocarcinoma.

LOAd703 has been granted FDA fast track designation for the treatment of patients with pancreatic cancer.

Reprograming the tumor microenvironment is a promising strategy to overcome resistance to immune checkpoint inhibitors (ICI) in patients with malignant melanoma. Here, the authors report a phase 1/2 study evaluating the combination of LOAd703 (viral-vector encoding CD40L and 4-1BBL) with atezolizumab (anti-PD-L1) in patients with ICI-resistant, malignant melanoma.

Lokon Pharma receives FDA Fast Track Designation for LOAd703 for the treatment of Pancreatic Cancer  Mynewsdesk