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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.
AstraZeneca announced on July 26, 2016 that its project launched in collaboration with Moderna Therapeutics for a messenger RNA (mRNA)-based therapy will begin Phase I clinical trials. Product candidate AZD8601 modulates the expression of vascular endothelial growth factor-A (VEG-A), so the hope is that control of the expression of this protein in charge of angiogenesis will have future applications for the treatment of heart disease, diabetic wound healing, and other ischemic vascular disease. The first-in-human trial for the candidate will focus on vascular regeneration of the heart, also known as cardiogenesis.
“This marks a significant milestone for both Moderna and AstraZeneca as our first partnered mRNA program reaches the clinic. It is a validation of our shared vision to harness the potential of mRNA therapeutics to address serious unmet needs with the goal of improving patients’ lives,” noted Moderna CEO Stéphane Bancel in a press release.
Promoting vascular regeneration may have important implications for the aforementioned conditions, but overexpression of VEGF-A has also been associated with a poor prognosis in some cancers, specifically in breast cancers. Some cancer medications actually seek to counteract the action of VEGF-A, such as the monoclonal antibody bevacizumab, which was approved by FDA in 2004. There are also a few anti-VEGF medications for the treatment of eye-related diseases that are characterized by retinal occlusion.
Under the terms of an earlier collaboration agreement, originally forged in 2013 but amended in 2016, AstraZeneca holds exclusive access to select any target of its choice in cardiometabolic diseases, as well as select targets in oncology, over a period of up to five years for subsequent development in mRNA. Moderna also has antisense collaborations with Alexion, Merck, and the Defense Advanced Research Projects Agency (DARPA) that have garnered up to $550 million in funding. It also has a partnership with the Bill & Melinda Gates Foundation to advance the development of a novel, affordable combination of mRNA-based antibody therapeutics to help prevent HIV.
According to a Moderna press release, Moderna has eight additional mRNA development candidates (other than AZD8601) that are advancing through studies across a pipeline composed of Moderna’s internally led programs and partnered programs, with many of these candidates scheduled to enter the clinic in 2016.