NEW YORK – Aethlon Medical announced on Thursday that a $3.5 million grant from the National Institute for Dental and Craniofacial Research (NIDCR) will support a collaborative project with University of Pittsburgh's Hillman Cancer Center to explore if its Hemopurifier device can deplete circulating exosomes and make head and neck cancer patients more responsive to treatments.
The funds will be given over five years to University of Pittsburgh Medical Center and two other participating academic institutions, where experts in immuno-oncology will advance the development of Hemopurifier, which has breakthrough device status from the US Food and Drug Administration. The device will be used to profile exosome biomarkers and explore how clinical depletion of exosomes impacts patients with recurrent and metastatic head and neck cancer.
Theresa Whiteside at UPMC and Annette Marleau at Aethlon are principal investigators of the grant.
Exosomes are small extracellular vesicles that when released by tumor cells promote cancer growth. "Exosomes have emerged as major contributors to tumor-associated immune suppression and as significant barriers to cancer therapies," Whiteside said in a statement. "The overarching objective of this work will be to advance therapeutic capabilities and novel exosome-based predictive tools for head and neck cancer."
In preclinical cancer studies, the Hemopurifier has shown it can deplete circulating tumor-derived exosomes that appear to suppress the immune system, which in turn could hinder patients' ability to respond to immunotherapies. The FDA has accepted Aethlon's investigational device exemption application, enabling the start of an early feasibility study of Hemopurifier in head and neck cancer patients treated with pembrolizumab (Merck's Keytruda.)
"We believe that the real value of this [NIDCR] grant … is that this work will provide insights into the potential clinical benefits of depleting circulating exosomes using the Hemopurifier for improving the responses of patients to the standard immunotherapy treatments," Aethlon CEO Timothy Rodell said in a statement.