Cynata Therapeutics’ parallel approaches to market
08 October 2019
08 October 2019
In 2014, Cynata Therapeutics commenced technology transfer and product development, and simultaneously commenced consultation with regulatory authorities regarding the approval pathways for its cellular therapy products.
Despite a lack of guidance because the field was emerging, Cynata Therapeutics Limited (Cynata) was able to secure regulatory approval for a world-first clinical trial, based on a sound scientific rationale. The clinical trial was completed and showed remarkable outcomes for the patients enrolled in the clinical trial. Throughout this period, Cynata’s product development generated new intellectual property (IP), which is covered by a portfolio of patent applications wholly-owned by Cynata, in addition to the intellectual property in-licensed in 2014. In short, Cynata has demonstrated significant efficiency in successfully co-developing it's product, the IP covering it, and it's regulatory pathway to market.
In early 2014, when the Cymerus development program began, the lack of precedents and limited guidelines made obtaining regulatory approval for Cymerus allogeneic iPSC-derived mesenchymal stem cells (MSCs) challenging. The challenges included:
However, the absence of relevant precedents and guidelines represents an opportunity as well as a challenge, because one is not constrained by prejudice expressed as “that’s how it has always been done”, and new and unconventional approaches may be acceptable.
Cynata was provided the opportunity to develop its patent portfolio in concert with its applications for regulatory approval and clinical trials. In fact, since 2014 when Cynata in-licensed its initial iPSC/ MSC technology, Cynata has developed its own technology and application of that technology such that Cynata now owns five International PCT applications, two of which have recently entered the national/ regional phase, and has another provisional application pending.
The consequence of these parallel approaches is that Cynata is now well placed in the market with both clinical trials underway and IP underpinning the technology used in those clinical trials, ultimately resulting in commercial interest from third parties.
'Like many biotech companies, Cynata was established specifically to commercialise IP licensed from an academic institution, so IP has always underpinned all of the company’s activities. We have subsequently built value by filing a number of wholly-owned patent applications to completement the in-licensed IP, and we believe this has placed the company in a very strong commercial position'
Dr Kilian Kelly, Chief Operating Officer, Cynata Therapeutics