VANCOUVER, BEIJING & CAMBRIDGE, Mass.—Zymeworks is going transcontinental with its latest partnership, having signed a series of agreements with China-based BeiGene Ltd. Among the agreements is a strategic collaboration for the clinical development and commercialization of ZW25 and ZW49, Zymeworks' investigational HER2-targeted bispecific antibodies, as well as a deal that provides BeiGene with a license to Zymeworks' Azymetric and EFECT platforms for the global development and commercialization of up to three additional bispecific antibodies.
“Partnering with BeiGene was a key component of our development and commercialization strategy for ZW25 and ZW49,” said Dr. Ali Tehrani, president and CEO of Zymeworks. “This collaboration allows Zymeworks to leverage BeiGene’s resources and expertise to accelerate the development of our most advanced product candidates and broaden our reach globally including in a key region of the world.”
The license and collaboration agreements for the two compounds provide BeiGene with exclusive rights for the development and commercialization of ZW25 and ZW49, its preclinical-stage antibody-drug conjugate, in Asia (excluding Japan), Australia and New Zealand. BeiGene will assume full responsibility for clinical development and regulatory submissions in those areas. Zymeworks will retain full rights to both compounds outside of the given territories, and will collaborate with BeiGene on their global development in HER2-expressing solid tumors. BeiGene will enroll patients and provide clinical trial data from its aforementioned countries.
BeiGene will pay Zymeworks $40 million up front, with the potential for Zymeworks to receive up to $390 million in development and commercial milestone payments for ZW25 and ZW49 in Asia (excluding Japan), Australia and New Zealand.
“Zymeworks’ promising candidates ZW25 and ZW49 complement our oncology pipeline and further advance our mission to develop treatments for patients who often have limited options,” Dr. Xiaobin Wu, general manager of China and president of BeiGene, remarked in a press release. “Our deep clinical experience in China is an integral part of our business development efforts, as these trial data can be used to support global regulatory filings. We are excited by the clinical prospects of ZW25 and ZW49 in HER2-expressing cancers.”
ZW25 simultaneously binds two non-overlapping epitopes of HER2, which offers “dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface and potent effector function leading to encouraging anti-tumor activity in patients,” according to Zymeworks. The compound is being developed as a treatment for solid tumors expressing HER2, and has received Orphan Drug Designation from the FDA for treating gastric and ovarian cancers. ZW49 is an antibody-drug conjugate of ZW25 being developed as a best-in-class therapeutic for multiple indications, “especially those patients whose tumors have progressed or are refractory to HER2-targeted agents, and those that express lower levels of HER2 and are ineligible for treatment with current HER2-targeted therapies,” as noted by Zymeworks.
In a separate research and license agreement, Zymeworks has granted BeiGene global rights to research, develop and commercialize up to three bispecific antibody therapeutics against targets BeiGene will select, and BeiGene will be responsible for all associated activities for the given therapeutics. BeiGene will make an upfront payment for the agreement of $20 million, and Zymeworks could receive up to an aggregate of $702 million if all development and commercial milestones are met. Zymeworks also stands to receive tiered royalties on global sales of any products that result from this arrangement.
This is the second agreement centered on the Azymetric and EFECT platforms that Zymeworks has established this year, with the first being with LEO Pharma, announced in late October. All told, Zymeworks has eight agreements underway focused on its platforms, with the other partners consisting of Johnson & Johnson, Daiichi Sankyo, GlaxoSmithKline, Celgene, Lilly and Merck. (The partnership with Lilly is centered solely on the Azymetric platform.) Azymetric offers the ability to convert monospecific antibodies to bispecific antibodies, ones with low immunogenicity, long half-life and high stability. Zymeworks' EFECT platform is “a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions.”