On July 31, 2018 Laekna Inc., a biotechnology company headquartered in Shanghai, reported the signing of an agreement with Novartis Pharma AG for exclusive global rights to develop and commercialize two oral Novartis clinical-stage oncology assets (Press release, Laekna Therapeutics, JUL 31, 2018, View Source;article_id=32 [SID1234530438]). The candidates are oral pan-Akt kinase inhibitors. Over ten clinical Phase I/II studies for afuresertib (ASB183) and uprosertib (UPB795) have been conducted in several cancer indications including ovarian and gastric cancer, multiple myeloma, melanoma, and other indications. These trials demonstrated positive proof-of-concept results for clinical efficacy and tolerable safety profiles in cancer patients. Novartis will have an equity stake in Laekna, along with upfront and development milestone payments, and royalties on future sales. Details of the terms of the agreement were not disclosed.
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The Pten/PI3K/Akt signaling axis is one of the most critical oncogenic pathways driving cancer growth. Inhibiting this axis has been proven to be effective for many cancer patients, and early clinical results for afuresertib and uprosertib are extremely promising. Laekna has mapped out several clear registration paths for NDA approval potentially as the first in class medicine.
In 2017, Laekna struck its first deal with Novartis, acquiring global rights to develop a CYP17 inhibitor (CFG920), an oral androgen inhibitor, to treat prostate cancer. Before the in-licensing, Novartis had reported positive results from a proof-of-concept study of CFG920 in patients with metastatic castration-resistant prostate cancer.
"Novartis is a global leader in oncology drug innovation. This is the second licensing agreement between Laekna and Novartis, adding to the previous licensing of CFG920 less than a year ago", says Dr. Chris Lu, founder and CEO of Laekna. "We have demonstrated to Novartis that Laekna is a valuable collaborator with our strong commitment, experienced team and financing support from the top investment partners."
"We are dedicated to developing these products rapidly through the regulatory process and into commercialization, with the goal of ultimately benefitting patients around the world," added Amy Xie, VP Operations at Laekna.