We advance certain of our drug candidates through a combination of conducting our own in-house research and through the use of contract manufacturing and contract research organizations. Continuous pipeline growth and advancement of out-licensed drug candidates is dependent, in part, on several important co-development collaborations and strategic arrangements. Together with our collaborative partners, we are focused on developing our pipeline of next generation bio-therapeutics and novel orphan drugs in oncology based our core technologies.
Operating under Xenetic licenses within their home markets, our collaborators generate pre-clinical and clinical data related to our technologies across a wide spectrum of therapeutic areas. We retain all rights for major markets and co-own the clinical data which affords us to utilize the data in our decision making process regarding commercialization in major markets.
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Exclusive research, development and license agreement
We are working together with Shire (formerly Baxalta Incorporated) to develop a novel series of polysialylated blood coagulation factors, including Factor VIII. This collaboration relies on the PolyXen technology to conjugate PSA to therapeutic blood-clotting factors, with the goal of improving the pharmacokinetic profile and extending the active life of these biologic molecules. A successful program will result in the development of novel longer-acting therapies for the treatment of hemophilia A and B and other blood clotting disorders.
In 2015, Baxalta announced plans to initiate a first-in-human clinical trial of SHP 656 (BAX 826), an investigational, extended half-life recombinant Factor VIII treatment for hemophilia A. The SHP 656 compound is modified using proprietary polysialic acid (PSA) technology licensed from us. In place since 2005, this exclusive research, development and license agreement grants Shire a worldwide, exclusive, royalty-bearing license to our PSA patented and proprietary technology in combination with Shire's proprietary molecules designed for the treatment of blood and bleeding disorders. Under the agreement, we may receive regulatory and sales target receipts for total potential milestones of up to $100 million.
"Xenetic products provide hope of a longer-acting FVIII, which is the major goal of Baxalta." - Baxalta
Funding proof of concept trials and full clinical trial programs
We have partnered with Pharmsynthez, a leading Russian pharmaceutical company, to apply ImuXen and PolyXen technologies to six drug and vaccine candidates. We are providing scientific and technological knowhow to Pharmsynthez scientists to allow candidate optimization. Together, we will utilize our ImuXen technology to develop three enhanced vaccine candidates for relapse remitting, secondary progressive multiple sclerosis, HIV and anti-cancer indications. Similarly, the PolyXen technology will be used to develop three pharmaceutical candidates for the treatment of cystic fibrosis, acute myeloid leukaemia, non-Hodgkin's lymphoma and type 2 diabetes. A number of these product candidates target rare disease indications. Pharmsynthez will fund proof of concept trials and any full clinical trial programs in the Russian Federation, and we will have access to all relevant clinical data.