Laekna, Innovent get FDA go-ahead for solid tumors research

Jan. 10, 2022

Shanghai-based Laekna Therapeutics announced the approval of an investigational new drug application for a combination therapy for patients with solid tumors that have not been responsive to treatment.

The investigational therapy was developed from a collaboration between Laekna and Innovent Biologics to evaluate the combination of Innovent’s PD-1 inhibitor sintilimab and Laekna’s pan-AKT inhibitor afuresertib. The phase 1/2 study will evaluate the efficacy and safety of the combination of afuresertib, sintilimab and chemotherapy.

The hope is that the trials will ultimately yield a new treatment option — AKT inhibitors — for patients with specific solid tumors refractory to treatment with PD-1/PD-L1 inhibitors.

The study will focus on specific solid tumors, including non-small cell lung cancer, gastric cancer, esophageal cancer, cervical cancer, and endometrial cancer.

The partnership between the Laekna and Innovent Biologic was announced in July 2021. Laekna, which is based out of Shanghai and New Jersey, is an emerging innovative biotech focused on developing new therapies to treat cancer and liver diseases. Jiangsu, China-based Innovent specializes in the development, manufacturing and commercialization of cancer and other medicines.

In May 2021, the U.S. FDA accepted the BLA to review sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer.

“The success of this study is expected to benefit more cancer patients resistant to immunotherapies,” said Dr. Yue Yong, chief medical officer of Laekna.