CMAB Biopharma (Suzhou) Inc. (“CMAB”), and Laekna Therapeutics Shanghai Co., Ltd. (“Laekna Therapeutics”), today announced a strategic collaboration agreement in Suzhou BioBAY for speedup of Immune Checkpoint Inhibitor (ICI) drug candidate to the clinical trial and future commercialization.
According to the agreement, CMAB will provide a full spectrum of CMC services based on the recognized global quality standards 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 manufacturinto support IND filing in China and in the US. 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 US. "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."
Located in Suzhou Biotech Industrial Park (BioBAY), CMAB is currently the fastest growing pure-play biopharmaceutical CDMO company in China. It is committed to using disruptive technologies to meet its customer’s needs as quickly as possible. Dr.
Yongzhong Wang, CEO of CMAB, said: "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.”
Founded in December 2016, Laekna Therapeutics is a biotech company dedicated to the development of small molecule and antibody-targeted drugs. Headquartered in Zhangjiang, Shanghai,Laekna has established an international operation and R&D team in both China and the United States, focusing on developing new breakthrough targeted therapies to treat cancer and liver diseases. The company has built an internationally influential platform and pipeline for new drug research and development, targeting to develop the innovative first-in-class and best-in-class drugs.
While vigorously carrying out the research and development of new drugs with independent intellectual property rights, Laekna has continuously enriched its product pipeline through the introduction of clinically proven new drug candidates. Since 2017, Laekna has successively cooperated with Novartis AG, signing three product licensing agreements and obtaining the global exclusive development, production and marketing rights of small molecule tumor treatment candidate CFG920 (LAE001), two oral pan AKT inhibitors Afuresertib（LAE002） and Uprosertib（LAE003）and anti PD-L1 antibody drug LAE005.
CMAB Biopharma Inc. is a flexible full-service CDMO dedicated to providing bespoke development and manufacturing services for antibodies and biologics for clients in China and across the globe. Our adaptable, service-oriented business enables clients to take their innovative concepts for tomorrow's medicines from DNA to cGMP product today.
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