XTL Biopharmaceuticals Ltd. and Yeda Research and Development Company Ltd. have strengthened their collaboration to develop a new therapy for systemic lupus erythematosus (SLE), called hCDR1. The two companies recently signed an amended agreement altering the development milestones featured in the License Agreement signed in January 2014.
XTL is a clinical-stage biopharmaceutical company dedicated to developing and commercializing therapeutic options for autoimmune diseases with unmet clinical needs, while Yeda Research and Development Company is the commercial arm of the Israeli Weizmann Institute of Science. The two companies announced they will extend their collaborative work on the development and commercialization of hCDR1 for patients with Lupus.
The amended agreement attests the time extension to achieve key development milestones, granting XTL an additional five months to deliver a full protocol for an upcoming clinical trial on hCDR1 to Yeda, as well as raise an aggregate of $5 million (from which only $1 million is missing). XTL also needs to initiate a hCDR1 clinical trial by January 2017.
“We are pleased with Yeda’s affirmation of their support and confidence in our ability to develop hCDR1 for the treatment of SLE. The amended agreement recognizes XTL’s efforts to date to advance hCDR1 to a clinical trial,” stated XTL’s CEO Josh Levine. XTL has assembled a world-class Clinical Advisory Board with leading names in SLE while reinforcing their Board of Directors with experienced people in the field of drug development and financial market.
In addition, the company also transfered the IND relating to hCDR1 from Teva Pharmaceutical Industries Limited to XTL, manufactured the drug substance for the upcoming trial, engaged in ongoing discussions with the U.S. Food and Drug Administration (FDA) to seek opportunities to strengthen hCDR1 intellectual property and optimize the regulatory pathway, while raising $4 million out of the aggregate amount of $5 million as required by the License Agreement. “We believe the amended agreement provides XTL with the time needed to properly develop our hCDR1 program and bring the product to an advanced clinical trial in the near future. We believe our operational plan and activities over the last several months should allow us to achieve the amended development milestones well within the revised timeline,” Levine added. Similarly, Yeda’s CEO Amir Naiberg, stated that the company is “encouraged by the progress that XTL has made to date with hCDR1. We look forward to XTL’s continued development of the drug for the treatment of SLE.”
hCDR1 is a novel compound found to ameliorate clinical manifestations of lupus via down-regulation of pro-inflammatory cytokines and apoptosis, up-regulation of the immunosuppressive cytokine TGF-beta, and the induction of regulatory T-cells.
Last August, XTL released the results of a Phase 2b study on the efficacy and safety of hCDR1 (Edratide) for the treatment of systemic lupus erythematosus (SLE). The study examined 340 SLE patients with active disease and the results showed the compound met the safety profile and was well-tolerated; however, the primary endpoints were not met, and the secondary predefined endpoint, BILAG, was met for the 0.5 mg hCDR1 arm in the intention to treat (ITT) cohort with trends in the 1.0 and 2.5 mg doses. “The recent publication of the encouraging results of a previous Phase 2b trial (the PRELUDE trial) on hCDR1 in a peer reviewed article in the Lupus Science and Medicine journal showing favorable safety and efficacy data on over 300 patients, further strengthens our commitment to advance the development of hCDR1 as soon as possible,” Levine said.