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Callidus Biopharma, Inc. was founded in mid 2010 to develop superior recombinant enzyme replacement therapies (ERTs) for certain rare metabolic diseases called lysosomal storage disorders (LSDs). The company was founded on initial seed investments and was able to make some technical progress but raising capital for conducting early-stage research proved to be very challenging during that difficult economic period.

A strategic partnership was formed with WuXi AppTec in 2011 that provided both financial and technical support. WuXi Venture Fund led the initial $1 million investment that was crucial for enabling various needed work streams. Within a short time, the tiny start-up biotech company successfully created novel ERTs with optimized protein and carbohydrate structures for vastly improved drug targeting to key disease-relevant tissues to demonstrate preclinical proof of concept. WuXi Venture Fund subsequently invested another $2 million the following year to complete early preclinical development work and to initiate cell line development and protein manufacturing. While WuXi AppTec is not a traditional manufacturer of recombinant lysosomal enzymes like Genzyme, Biomarin or Shire, there were various synergies and capabilities that made WuXi AppTec a very attractive partner. WuXi AppTec was an integrated company that provides custom services for all essential tasks and activities: cell line development, upstream process development for optimizing the cell culture process and improved productivity and yields, downstream process development to refine protein purification process, viral clearance, formulation and lyophilization of drug product with analytical support throughout the entire process. WuXi AppTec also had invested heavily in their infrastructure to build state of the art facilities and assembled a knowledgeable and capable staff.

By leveraging WuXi’s experience and capabilities, Callidus was able to rapidly advance its drug development program for Pompe disease to develop a superior ERT that was shown to be significantly better than standard of care in preclinical animal efficacy studies. WuXi helped to develop a robust manufacturing process for producing ERT at large scale to enable IND-enabling animal toxicity studies and clinical trials. Importantly, the manufacturing process was highly scalable and maintained the critical quality attributes that are needed for efficient drug targeting.

Callidus was subsequently acquired by Amicus Therapeutics, Inc. at the end of 2013 for $130 million if all milestones are met. Since the initial $15 million payment comprised of Amicus stock, Callidus shareholders are already realizing gains from the significant increased value of Amicus stock (approximately 4-fold) over the past year. The strategic partnership between Callidus and WuXi has been very successful by every measure and is a great example for how WuXi can help companies grow and succeed in the most productive and cost efficient manner. The WuXi Venture Fund has proven to be a very effective method to help start-up companies by not only providing capital to fund their early- stage research, but also by leveraging WuXi’s vast drug development platforms to accelerate their drug development programs.