CAMBRIDGE, Mass., June 23 /PRNewswire/ -- Mersana Therapeutics, a platform-based cancer therapeutics company, today announced that it has initiated a Phase 1 clinical trial to study the safety and pharmacokinetics of XMT-1107 in patients with refractory advanced solid tumors. XMT-1107 is a novel anti-angiogenic fumagillin analog that employs Mersana's Fleximer® platform. Mersana's XMT-1001, a conjugate of Fleximer and camptothecin (CPT), is currently completing a Phase 1 study.
Mersana recently announced an exclusive licensing agreement for XMT-1107 with Teva Pharmaceutical Industries Ltd. for all indications, including cancer, on a worldwide basis, excluding Japan. Under the terms of this agreement, Mersana received a milestone payment from Teva for the initiation of the Phase 1 trial. Mersana also recently presented preclinical pharmacokinetic and metabolism data for XMT-1107 at the AACR 101st Annual Meeting 2010, demonstrating that pharmacokinetics of XMT-1107 were dose-proportional and that XMT-1107 exhibits enhanced biodistribution and sustained plasma exposure.
"XMT-1107 represents the second clinical application of Mersana's Fleximer platform in creating new drug candidates with superior qualities," said Julie Olson, Ph.D., President and CEO of Mersana. "Our preclinical studies have demonstrated that the Fleximer-linked drug XMT-1107 offers key important potential benefits over other fumagillin analogs that have undergone clinical trials. In laboratory studies, we have seen evidence of anti-tumor activity for XMT-1107 superior to that of other anti-angiogenic agents; additive activity in combination with other cancer agents; and an extended half-life relative to small molecule fumagillin analogs. We have demonstrated activity in a wide variety of cancer models, as well as a favorable preclinical safety profile. These key attributes may lead to broad promise for XMT-1107 in multiple oncology indications."
About the Phase 1 Trial
Patients with refractory advanced solid tumors will be enrolled in the open-label Phase 1 trial. The primary objective of this study is to determine the maximum tolerated dose of XMT-1107, given as an intravenous infusion once every three weeks. The secondary objective of this study is to assess the pharmacokinetics of XMT-1107.
XMT-1107 is a conjugate of Fleximer and a novel analog of fumagillin, an angiogenesis inhibitor with a mechanism of action distinct from agents that principally target vascular endothelial growth factor (VEGF). Fumagillin analogs had been shown to have anti-tumor activity in Phase 1 and 2 trials, but development was discontinued due to pharmacokinetic (PK) issues and reversible central nervous system (CNS) toxicity observed in patients. XMT-1107 has been demonstrated, in preclinical pharmacology studies, to have a significantly improved PK profile as well as no evidence of CNS toxicity. Additionally, in preclinical models, XMT-1107 has demonstrated efficacy as a single agent and in combination with other agents, including anti-angiogenics.
Fleximer is a novel, biodegradable and bio-inert polymer that can be chemically linked to small molecules, biologics and nucleic acids to enhance their pharmacokinetic and safety profiles. Fleximer has been proven to transform existing and experimental agents into new, patentable drugs with superior properties. The Fleximer platform has broad and versatile applications across therapeutic categories and enhances the delivery of small molecule, protein and nucleic acid-based therapeutics.
About Mersana Therapeutics, Inc.
Mersana Therapeutics employs its biodegradable polymer platform (Fleximer®) to create new and better medicines. We are advancing our own clinical-stage pipeline of novel compounds with the potential to address multiple oncology indications. The company has also developed a proprietary Fleximer-based siRNA delivery system that is currently in preclinical studies. Mersana Therapeutics has operations in Cambridge, MA and London, England. For more information, visit www.mersana.com.
Fleximer® is a trademark of Mersana Therapeutics, Inc.
SOURCE Mersana Therapeutics, Inc.