CMAB Biopharma (Suzhou) Inc. and Laekna Therapeutics Shanghai Co. Ltd., have signed a strategic collaboration agreement in Suzhou BioBAY for the speedup of an Immune Checkpoint Inhibitor (ICI) drug candidate for clinical trials and future commercialization.
 
According to the agreement, CMAB will provide a full spectrum of CMC services for Laekna Therapeutics’ anti-PD-L1 antibody (LAE005). Services to be provided by CMAB include technology transfer, process development, GMP clinical drug substance and drug product manufacturing to support IND filing in China and in the U.S. These services will facilitate the global development and future commercialization of LAE005.
 
Laekna Therapeutics is a biotechnology innovation company focusing on the research and development of new generation of small molecules for target therapy and antibodies in the field of oncology and liver diseases. In February 2020, Laekna Therapeutics obtained the exclusive global development and commercialization rights for LAE005 from the Novartis group, Switzerland. At present, LAE005 has completed phase I clinical trials which confirmed the tolerability, safety and preliminary anti-cancer efficacy in different solid tumors, including triple negative breast cancer.
 
Laekna Therapeutics is applying for the permission of clinical trials for LAE005 both in China and in the U.S.
 
“We are looking forward to the results of clinical efficacy and safety of LAE005. In the recent years, cancer therapy has entered a brand-new era of immuno-oncology. The combination of anti-PD-L1 antibody and AKT inhibitor, such as LAE005 plus Afuresertib, is one of the most innovative therapies among many different combination therapies. Afuresertib is an AKT inhibitor of Laekna Therapeutics that is currently undergoing phase II global clinical trials in both China and the United States, which has great potential for the treatment of different cancers. Laekna Therapeutics is committed to bringing more safe, precise and personalized treatments to cancer patients globally, especially in China,” said Dr. Chris Lu, founder and CEO of Laekna Therapeutics, “We are pleased to work closely with CMAB to provide process development and production of clinical trial drugs for anti-PD-L1 candidate. The excellent technology, experience and service of CMAB assure us that they can support Laekna’s clinical and commercial needs for our innovative pipeline and that our joint efforts will surely accelerate the benefits to cancer patients worldwide.”
 
Dr. Yongzhong Wang, CEO of CMAB, added, “Since our establishment in 2017, CMAB has successfully helped many partners gain valuable milestones in the new drug development and has also successfully completed the production of cGMP batches for several different clinical candidates being developed by leading biopharmaceutical enterprises. Since 2019, CMAB has continuously hired high-quality talent at home and abroad. At present, CMAB has nearly 260 employees, forming a stable and experienced team. As a respectable enterprise in the industry, Laekna Therapeutics has built up an experienced Sino-US operational team in a few years, and successfully and efficiently introduced a number of clinically validated new product candidates. We are very happy to establish a strategic cooperation with Laekna Therapeutics. The CMAB team will make every effort to realize the global development and commercialization of LAE005, the first biopharmaceutical project of Laekna Therapeutics.”