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Lokon Pharma receives FDA Fast Track Designation for LOAd703 for the treatment of Pancreatic Cancer
Lokon Pharma AB, a clinical stage biotechnology company focused on gene engineering of the tumor microenvironment (TME) to treat cancers with unmet medical need today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company´s product candidate LOAd703 for the treatment of pancreatic cancer.
“We are excited to share the news that LOAd703 has been granted Fast Track designation by the FDA. A Fast Track designation is intended to expedite the development and review of drugs that have the potential to fill an unmet medical need in treating serious conditions. Lokon will now benefit from more frequent interactions with the FDA and if relevant criteria are met, LOAd703 may be eligible for additional expedited programs offered by the FDA, to make LOAd703 available to patients as soon as possible”, said Åsa Holmgren (Regulatory Affairs).
This is an important milestone for Lokon Pharma, said Dr. Angelica Loskog (CEO/CSO). She continues, “Pancreatic cancer is a remaining challenge within immune oncology. Lokon’s LOAd703 gene engineers the TME to express strong immune activators and thereby induces an inflammation that can sensitize these patients to traditional immunotherapy with checkpoint blockade antibodies. LOAd703 is currently evaluated in combination with gemcitabine and nab-paclitaxel plus an anti-PD-L1 antibody in pancreatic cancer and a randomized phase II study is on the way.”
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About Lokon Pharma
Lokon Pharma AB is a leading Swedish biotech company in the rapidly expanding field of tumor microenvironment (TME) gene engineering and is focused on the clinical development of its first, virus-based, product, LOAd703, for cancers with high unmet medical need. LOAd703 (delolimogene mupadenorepvec), is the first clinical candidate from the LOAd platform.
Further information can be found at: www.lokonpharma.com
