In developing any antibody-drug conjugate, the linker — the hyphen between the antigen-binding antibody and the cancer-killing drug — is of utmost importance. Link too much payload to the antibody too loosely, and you risk triggering off-site toxicity while the ADC is circulating through blood; link too little, and it falls short of the goal to kill off cancer cells from within. And while a host of drugmakers have followed Seattle Genetics’ lead into new linker technology, in some cases deploying engineering the antibodies, there’s still much to be learned about controlling the resulting ADCs.
Dutch biotech Synaffix believes it has the tools to do precisely that. Judging from a $125 million licensing pact it just signed off on, China’s Miracogen does, too.
“The first generation of ADCs in the Chinese market were predominantly biosimilars or biobetters of Kadcyla,” Synaffix CEO Peter van de Sande told me. But regulatory reforms have imposed “pressure on more first-in-class and best-in-class products in China that is driving innovation and driving a need for increased therapeutic index” — the combined measure of efficacy and safety.
Synaffix first got started five months ago, taking an antibody from Miracogen and putting it through its two platforms, resulting in a prototype ADC within a month. Having tested the candidate in preclinical models, the Chinese partner is now ready to go for clinical trials — thus the need for a development and commercial license, said Anthony DeBoer, Synaffix’s director of business development.
Coming out of Radboud University, the GlycoConnect technology relies on glycans as an anchoring point in antibodies, enzymatically removing them to create space for the payload, which is attached through copper-free click chemistry. HydraSpace, meanwhile, is Synaffix’s way of extending their ADCs’ half lives.
These are technologies that ADC Therapeutics and Mersana have previously bought into, van de Sande said, allowing the company to refine the manufacturing processes for the enzymes and small molecules involved in the process.
The partnership with Miracogen marks Synaffix’s first inroads into Asia, added to key endorsements from some ADC experts. Mary Hu, Miracogen’s CEO, was a former exec at Seattle Genetics alongside one of her VPs.
Synaffix does not yet have a pipeline of its own, but van de Sande is looking for more partnerships — not just in the ADC field but for other modalities such as cell therapy and radiopharmaceuticals as its tech is “perfectly catered for incorporating any molecules of interest to a glycan protein in an antibody” for targeted delivery.
Image: Peter van de Sande. SYNAFFIX
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