Caris Life Sciences and Threshold Pharmaceuticals Inc have announced that they have entered into a development and commercialization agreement to utilize Caris’ patented and proprietary ADAPT Biotargeting System™ to develop a tissue-based clinical diagnostic assay for pancreatic cancer patients to predict the likelihood of response to evofosfamide, Threshold’s lead drug candidate for the potential treatment of patients with cancer. Under the terms of the agreement, Caris is eligible to receive several million dollars in clinical development milestones and undisclosed downstream royalty payments.
Through Caris’ proprietary ADAPT Biotargeting System, Threshold may gain access to a diagnostic tool that will enable physicians to determine which patients would be most likely to benefit from treatment with evofosfamide. “We are pleased to work with Threshold Pharmaceuticals to support the development of their novel potential therapy, which has shown promising results in this difficult-to-treat disease,” said Bart Howe, Executive Vice President of Business Development and Corporate Strategy at Caris.
“Our innovative and revolutionary ADAPT Biotargeting System is uniquely positioned to support the pharmaceutical clinical development process by identifying complex molecular signatures that can predict a patient’s likelihood of response to a particular therapy.” “Since it is well understood that patients exposed to the same chemotherapy often respond differently, we look forward to working with Caris and their innovative ADAPT Biotargeting System to help physicians identify those patients most likely to benefit from evofosfamide,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold.
“We remain optimistic about the potential role of evofosfamide for the treatment of cancer, and we continue to pursue discussions with Japanese regulatory authorities regarding potential registration pathways for evofosfamide and other development opportunities with evofosfamide.” Caris and Threshold will work together, leveraging tumor samples and outcomes data from the previously completed Phase 3 MAESTRO study in patients with advanced pancreatic cancer, to develop a novel, multiplexed diagnostic assay designed to classify a patient’s likely clinical outcome from the use of evofosfamide.
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a DNA cross-linking agent that is preferentially activated under hypoxic tumor conditions, a feature of many solid tumors. In December 2015, Threshold announced that a Phase 3 study (MAESTRO) of evofosfamide had not met its primary endpoint. However, data from the MAESTRO study demonstrated meaningful improvement in overall survival in a subgroup of 116 patients from Japan, in which the risk of death was reduced by 48 percent for patients receiving evofosfamide compared to patients in the control arm.
Caris’ ADAPT Biotargeting System is a proprietary platform that uses libraries of synthetically manufactured molecules trained to bind to biological targets of interest in order to characterize complex biological systems. Currently being utilized in discovery research, advanced diagnostics and drug development programs across multiple diseases, the ADAPT Biotargeting System also has potential utility in drug delivery, disease monitoring and direct therapeutic applications.