Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Laekna Therapeutics Shanghai Co., Ltd., an emerging innovative pharma company based in China's "Zhangjiang Pharma Valley" and New Jersey in the U.S., focusing on developing new ground-breaking innovative therapies to treat cancer and liver diseases, today jointly announced they have entered into a collaboration agreement to evaluate the combination of Innovent's PD-1 inhibitor sintilimab and Laekna's pan-AKT kinase inhibitor afuresertib.
Under the agreement, the two companies will work together to conduct clinical studies assessing the combination of sintilimab and afuresertib (LAE002) in patients with multiple types of solid tumors that have been refractory – or failed to respond – to treatment with PD-1/PD-L1 inhibitors. The trials will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination therapy. An investigational new drug (IND) application will soon be filed with the National Medical Products Administration (NMPA) in China.
Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, said, "Since our inception in 2011, Innovent has built a robust pipeline of assets with five innovative drugs approved for marketing. Many unmet medical needs still exist for cancer patients around the world. To help address this, Innovent explores multiple indications and combinations of therapies when developing its existing and new drug candidates. At the same time, we seek to work together with additional collaborative partners as the Chinese biopharmaceutical industry continues to rapidly expand. Innovent is impressed with Laekna's R&D pipeline and research team, and we look forward to our close collaboration and future possibilities produced by this clinical development agreement."
Dr. Yue Yong, Chief Medical Officer of Laekna, stated, "We hope our leading pipeline candidate afuresertib can potentially become a first-in-class targeted treatment in multiple types of cancer by demonstrating improved efficacy and acceptable safety in clinical trials. Notably, sintilimab was included in China's National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 inhibitor to be included in the list that year. In addition, sintilimab, in combination with pemetrexed and platinum chemotherapy, is currently being reviewed by the U.S. FDA for a potential BLA approval in the first-line treatment of nonsquamous non-small cell lung cancer. We now have the opportunity to explore the combination therapy of afuresertib and sintilimab in multiple types of solid tumors, with a particular focus on cancers that have commonly shown to be refractory to treatment with PD-1/PD-L1 inhibitors. We hope this combination therapy demonstrates results that can ultimately lead to it becoming a new treatment option for people with these difficult-to-treat cancers."
About Sintilimab
Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.
In China, sintilimab has been approved for four indications, including:<...
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