A Novel Adenovirus-based Vaccine for the Treatment of Fentanyl Addiction

Background & Unmet Need

• Fentanyl is a highly addictive synthetic mu-opioid receptor agonist with a significant risk for lethal overdose
• Fentanyl is relatively simple to manufacture and often added to other addictive drugs (unbeknownst to the user), with fatal consequences
• The rate of fentanyl-related lethal overdoses has continued to rise in the United States and has reached as high as over 6,000 a month
• Naloxone is effective at reversing opioid overdose if promptly administered, but is not an effective treatment for opioid use disorder
• Buprenorphine-containing therapies SUBOXONE® and SUBLOCADE® are helpful tools for treating opioid dependence, but require either daily or monthly dosing, respectively
• Unmet Need: Long-acting therapy for durable treatment of opioid dependence

Technology Overview

• The Technology: Cornell inventors have devised an adenovirus-based vaccine conjugated with fentanyl analogs which causes the immune system to recognize and respond to fentanyl
• Adenoviruses are highly immunogenic, and coupling a small molecule to adenovirus capsid proteins results in a vaccine that induces an immune response to the presence of that molecule
• The antibodies generated in response to fentanyl sequester it in the blood and stop it from reaching the brain, preventing a lethal overdose
• PoC Data: Administration of the adenovirus-based vaccine conjugated with a fentanyl analog (dAd5-CF) resulted in high-titer levels of anti-fentanyl antibodies in mice within two weeks
• The anti-fentanyl vaccine dAd5-CF sequestered injected fentanyl within peripheral plasma and prevented fentanyl from reaching the brain, blocking the addictive effects of fentanyl

Technology Applications

• Prophylactic administration of an anti-fentanyl vaccine may prevent fatal overdoses resulting from inadvertent exposure to fentanyl and fentanyl analogs
• The anti-fentanyl vaccine can also be used to block the addictive and rewarding effects of fentanyl administration, for the treatment of opioid dependence

Technology Advantages

• The prophylactic vaccine provides long-lasting protection against the harmful effects of fentanyl within weeks
• Anti-fentanyl vaccine also prevents the addictive effects of fentanyl at doses insufficient to cause an overdose