Xenetic Biosciences (XBIO) has entered into a Right to Sublicense Agreement with Baxalta Incorporated, Baxalta US Inc., and Baxalta GmbH, wholly-owned subsidiaries of Shire plc (SHPG). Pursuant to the Sublicense Agreement, Xenetic granted to Baxalta the right to grant a nonexclusive sublicense to certain patents related to the Company's PolyXen technology that were previously exclusively licensed to Baxalta pursuant to an agreement between the Company and Baxalta in connection with products relating to the treatment of blood and bleeding disorders. As part of the Sublicense Agreement, Baxalta agreed to pay Xenetic a one-time payment of $7.5M and single digit royalty payments based upon net sales of the products covered under the sublicense throughout the term of the agreement.
Xenetic Biosciences announced that it has appointed Jeffrey Eisenberg as CEO. M. Scott Maguire will continue to serve Xenetic during the management transition. Eisenberg joined the Xenetic management team in December 2016 as COO and has served on the company's Board of Directors since July 2016.
Xenetic Biosciences announced that its 2017 Annual Meeting of Stockholders, scheduled for Thursday, October 5, 2017, will be rescheduled to a later date in 2017. Updated materials and date for the rescheduled meeting are currently being considered by the company's Board of Directors. Stockholders will receive new proxy materials and vote on the updated proposals to be set forth in Xenetic's definitive proxy statement on Schedule 14A, which will be amended or supplemented to include the updated proposals. Such amendment or supplement to the proxy statement will be filed with the Securities and Exchange Commission and mailed to the company's stockholders as soon as reasonably practicable. A new record date for the Annual Meeting has yet to be approved but will be included in the updated proxy materials, along with the time and location of the Annual Meeting.
Xenetic Biosciences announced that its 2017 Annual Meeting of Stockholders, scheduled for Wednesday, August 16, was convened and dismissed, without any business being conducted, due to lack of the requisite quorum. The Annual Meeting has now been rescheduled for Thursday, October 5, at a place and time still to be determined by the Board of Directors, in order to allow additional time for stockholders to receive new proxy materials and vote on the updated proposals to be set forth in Xenetic's definitive proxy statement on Schedule 14A, which will be amended or supplemented to include the updated proposals. Such amendment or supplement to the proxy statement will be filed with the Securities and Exchange Commission and mailed to the Company's stockholders as soon as reasonably practicable. A new record date for the Annual Meeting has yet to be determined but will be included in the updated proxy materials, along with the time and location of the Annual Meeting.
In May 2017, Xenetic (XBIO) along with its strategic collaborator, Shire (SHPG), announced data from Shire's Phase 1/2 program of SHP656, its PSA-Recombinant Factor VIII, which was being developed as a long-acting therapeutic for the treatment of hemophilia A, utilizing Xenetic's PolyXen platform technology to conjugate polysialic acid to therapeutic blood-clotting factors. Despite not achieving the principal objective of once-weekly dosing in this Phase 1/2 study, the Company's PolyXen technology demonstrated that it works as a platform to successfully extend the circulating half-life of rFVIII with no drug-related serious adverse events reported to date. Including the company's own studies with a polysialylated erythropoietin candidate, this is the second instance in which PolyXen platform technology has been demonstrated, in a human clinical trial setting, to confer extended half-life to a biotherapeutic, while maintaining pharmacological activity and a favorable safety and tolerability profile. Moving forward, Xenetic believes data from Shire's SHP656 program, although discontinued, continues to support the broad utility of its proprietary PolyXen technology platform, and expects the growing body of data from this platform will enable the company to build a pipeline of partnerships utilizing this proven technology. Expected Next Steps: Pursue business development activities to identify target molecules to explore partnerships utilizing PolyXen delivery platform; and Explore other potential applications of the PolyXen platform technology within the Shire portfolio.
In the second quarter of 2017, the company commenced patient enrollment for its Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of endometrial cancer. The study targets a population of patients who have either failed progestin monotherapy or who have been identified as having progesterone receptor negative tumors. The primary objective of the open-label, multi-center, single-arm, two-period Phase 2 study is to assess the antitumor activity of XBIO-101 in conjunction with progestin therapy as measured by Overall Disease Control Rate in women with recurrent or persistent endometrial carcinoma not amenable to surgical treatment or radiotherapy who have either failed progestin monotherapy or who have been identified as PrR-. Secondary objectives include assessments of efficacy and safety/tolerability parameters. The study is expected to enroll up to 72 women with recurrent or persistent endometrial cancer not amenable to surgical treatment or radiotherapy but suitable to be treated with progestins. All subjects determined to be PrR- at screening, as well as those subjects who experience disease progression after at least 4 weeks of progestin monotherapy, will receive XBIO-101 in combination with continued progestin treatment. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria. Xenetic has also filed a protocol under its existing Investigational New Drug application to expand the development of XBIO-101 into a biomarker study related to the treatment of triple negative breast cancer. Expected Upcoming Milestones: Commence patient dosing in the Phase 2 clinical study evaluating XBIO-101 in conjunction with progestin therapy for the treatment of progestin resistant endometrial cancer in Q3 2017; and Announce interim data from Phase 2 study before the end of 2018.