nih-gov/heal.nih.gov/funding/awarded/export?combine=antibody&page&_format=csv

"Project #","Project Title","Research Focus Area","Research Program","Administering IC(s)",Institution(s),Investigator(s),Location(s),"Year Awarded",Summary
1UG3DA058544-01A1,"Antibody-based therapy for fentanyl-related opioid use disorder","Novel Therapeutic Options for Opioid Use Disorder and Overdose","Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose",NIDA,"MCLEAN HOSPITAL","DESAI, RAJEEV INDRAJIT (contact); BREMER, PAUL T","Belmont, MA",2023,"no summary"
1UG3DA057850-01,"Development of a Monoclonal Antibody to Reverse Overdose from Fentanyl and Its Analogs: From Manufacturing to Clinical Trials","Novel Therapeutic Options for Opioid Use Disorder and Overdose","Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose",NIDA,"UNIVERSITY OF WASHINGTON","PRAVETONI, MARCO; COMER, SANDRA D","Seattle, WA",2022,"The widespread availability of fentanyl and other potent synthetic opioids has dramatically increased opioid-related fatal overdoses. This project will develop and manufacture immune molecules (monoclonal antibodies) to reverse and treat overdose from fentanyl by keeping it out of the brain. This research will advance promising results in animal studies (preventing and reversing fentanyl- and carfentanil-induced breathing problems and irregular heartbeat) to clinical testing in people with opioid use disorder and others at high risk of opioid overdose from accidental or deliberate exposure to fentanyl and fentanyl-like drugs."
1U01DA056240-01,"IND-Enabling Program for a Long-Acting Anti-Methamphetamine Monoclonal Antibody for Treating Methamphetamine Use Disorder","Novel Therapeutic Options for Opioid Use Disorder and Overdose","Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose",NIDA,"INTERVEXION THERAPEUTICS, LLC","STEVENS, MISTY WARD","Little Rock, AR",2022,"There are currently no medications approved by the U.S. Food and Drug Administration to treat methamphetamine use disorder, even though risky patterns of methamphetamine use and overdose deaths have increased in recent years. Research using animal models shows that immune molecules that latch onto methamphetamine (anti-methamphetamine antibodies) show promise in blocking the effects of the drug. This project aims to identify a long-acting monoclonal antibody targeted to methamphetamine and conduct development and safety studies to prepare for future testing of the antibody treatment in humans."
3R61NS127285-01S1,"Investigating the Contributions of Voltage Gated Sodium Channels to Oxaliplatin Induced Neuropathy","Cross-Cutting Research",,NINDS,"UNIVERSITY OF CALIFORNIA AT DAVIS","YAROV-YAROVOY, VLADIMIR M","Davis, CA",2022,"Many molecular gates known as ion channels control the flow of electrical signals to sensory neurons and are thus key mechanisms and targets for understanding and interrupting pain signals. Recent breakthroughs in structural and computational biology shave illuminated specific molecular shapes of ion channels, which permits the improved design and refinement of small, stable protein-like molecules (peptide antigens). These peptides can stimulate an immune response that can then be targeted with a bioengineered antibody to match the peptide antigen. This project will test bioengineered antibodies in a rat model of chemotherapy-induced peripheral neuropathy within a region of the rat spinal cord that transmits signals to and from the brain."
1UG3NS123958-01,"Development of a CCKBR-targeting scFv as Therapy for Chronic Pain Patients","Preclinical and Translational Research in Pain Management","Development and Optimization of Non-Addictive Therapies to Treat Pain",NINDS,"UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR","WESTLUND-HIGH, KARIN N (contact); ALLES, SASCHA R","Albuquerque, NM",2021,"Cholecystokinin B receptor (CCKBR) is a molecule found in the brain that helps regulate anxiety and depression but also influences the development of tolerance to opioids. CCKBR levels are also increased in models of nerve injury-induced (neuropathic) pain. Therefore, targeting CCKBR may offer a new approach to treating neuropathic pain and the associated anxiety and depression. Researchers have developed mouse antibodies that can inactivate CCKBR. However, to be usable in humans without causing an immune response, these antibodies need to be modified to include more human sequences. This project will use a fragment of the CCKBR antibody, modify it with the addition of human antibody sequences, and then select the clones that bind most strongly and specifically to human CCKBR. These will then be tested in cell and animal models of neuropathic pain to identify the most promising candidates for further evaluation in humans."
1R43NS124421-01A1,"Development of Nav1.7 Monoclonal Antibodies for Treating Pain","Cross-Cutting Research","Small Business Programs",NINDS,"INTEGRAL MOLECULAR","RUCKER, JOSEPH BENJAMIN","Philadelphia, PA",2021,"Many current pain relief treatments rely on use of opioid drugs. This research is conducting preclinical development on a non-addictive, non-opioid therapeutic that uses antibodies to target the sodium channel Nav1.7. This channel is known to be one of the primary routes for generating pain signals – thus it is a target for reducing pain. The antibody approach offers potential for greater specificity than small molecule approaches, potentially resulting in fewer side effects."
1U01DA051071-01A1,"Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl Overdose","Novel Therapeutic Options for Opioid Use Disorder and Overdose","Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose",NIDA,"CESSATION THERAPEUTICS, LLC","Bremer, Paul T.","San Jose, CA",2020,"Opioid use disorder (OUD) is a significant public health problem in the United States. Particularly troubling is the rapid evolution of an opioid epidemic within the past decade, characterized by a surge in unintentional overdose deaths involving synthetic opioids, such as fentanyl. The current standard of care for opioid overdose is reversal with opioid antagonist naloxone. Naloxone is effective at reversing overdose from prescription opioids and heroin, but less effective when combating fentanyl, due to fentanyl?s high potency. Therapeutic monoclonal antibodies (mAbs) against fentanyl could overcome this problem by specifically preventing the drug from entering the central nervous system, averting overdose and attenuating opioid-induced respiratory depression. This study will develop and design of laboratory protocols needed to establish a Good Manufacturing Practice (GMP) process, quality assurance protocol, and stability profile for a new human mAb against fentanyl. Subsequent production of current GMP material will enable Good Laboratory Practice (GLP) toxicology studies in rats and dogs and eventually a Phase I/IIa clinical trial. This material will also be used in final opioid-induced respiratory depression studies in mice and non-human primates to confirm therapeutic efficacy of final drug product. If successful, these activities will enable filing for an investigational new drug application for this mAb candidate with the FDA."
1R43DA046998-01,"DEVELOPMENT OF A MULTIPLEX PEPTIDE ARRAY TO IDENTIFY PATIENTS WITH AN AUTOANTIBODY SIGNATURE FOR CHRONIC PAIN","Cross-Cutting Research","Small Business Programs",NIDA,"Affinergy, LLC","Darby, Martyn","Durham, NC",2019,"One of the most widely used treatments for chronic pain is opioid analgesics. Importantly, there is evidence of a pathological interaction between opioids and the immune system that can contribute to both opioid tolerance and elevated levels of pain. Chronic pain conditions for which opioids are most often prescribed have been shown to involve dysregulation of the immune system, which may contribute to pathological effects of opioid use in these patients. To address this unmet need, this study aims to develop a reliable, cost-effective, and non-invasive in vitro diagnostic assay for chronic pain with an underlying inflammatory pathology, as a blood test available in primary care settings, with the hope that doctors can use the test to identify which patients might benefit less from opioids and be more likely to become addicted."
1R43DA047722-01,"PERIPHERALLY-RESTRICTED AND LONG-ACTING MAS1(LA-MAS1) AGONISTS FOR PAIN","Cross-Cutting Research","Small Business Programs",NIDA,"Peptide Logic, LLC","Riviere, Pierre","SAN DIEGO, CA",2019,"This project seeks to develop a first-in-class (FIC), peripherally restricted and long-acting drug with potential to reduce or replace opioid for moderate to severe pain, and that will be non-addictive, safe, and convenient to use. The program is based on strong scientific evidence showing that activation of a receptor called MAS1 produces opioid-independent and peripheral pain relieving activity in a wide range of animal models of chronic pain, including inflammatory, neuropathic, and bone cancer pain. This project focuses on the development of potent, stable, and specific molecules that stimulate MAS1. Researchers will then attach peptides that stimulate MAS to antibody carriers that make them last longer and selectively affect only the peripheral nervous system, which could allow for once a week or twice a month dosing while maintaining the drug’s efficacy and reducing potential side effects, and test the resulting molecule in animal models."
1R61NS113329-01,"Discovery of Biomarker Signatures Prognostic for Neuropathic Pain after Acute Spinal Cord Injury","Preclinical and Translational Research in Pain Management","Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions",NINDS,"UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON","HERGENROEDER, GEORGENE W","Houston, TX",2019,"Debilitating neuropathic pain occurs in 40 percent to 70 percent of people who suffer from spinal cord injury (SCI). There are no distinguishing characteristics to identify who will develop neuropathic pain. The objective of this research is to develop a biomarker signature prognostic of SCI-induced neuropathic pain (NP). The aims of the project are to (1) identify autoantibodies in plasma samples from acute SCI patients to CNS autoantigens and determine the relationship between autoantibodies levels to the development of NP, (2) identify the autoantibody combination with maximal prognostic accuracy for the development of NP at six months after SCI, and (3) develop and optimize an assay to simultaneously measure several autoantibodies and independently validate the prognostic efficacy for NP using plasma samples collected prospectively. Establishing a panel will refine the prognostic value of these autoantibodies as biomarkers to detect who are vulnerable to NP and may be used to for development of nonaddictive pain therapeutics."
2R44DA045410-02,"Peripherally-Restricted Long-Acting Somatostatin Receptor 4 (LA-SSTR4) Agonists for Pain","Cross-Cutting Research","Small Business Programs",NIDA,"PEPTIDE LOGIC, LLC","RIVIERE, PIERRE","San Diego, CA",2019,"The proposed SBIR Phase II program seeks to select a first-in-class, peripherally-restricted, and long-acting somatostatin receptor 4 (LA-SSTR4) agonist clinical candidate for development as a novel non-addictive analgesic able to replace opioids for the treatment of moderate-to-severe chronic pain. The program is based on strong scientific evidence showing that activation of peripheral SSTR4 produces broad spectrum analgesic activity and pursues a unique therapeutic strategy.   Unlike opioids, SSTR4 agonists do not induce constipation, respiratory depression, dependence, addiction, or abuse. Finally, unlike SSTR2 and SSTR5, SSTR4 expression in the pituitary and pancreas is very low, supporting that selective SSTR4 agonists are unlikely to perturb peripheral endocrine functions. The preceding SBIR Phase I program has already established the feasibility of conjugating a short-acting, potent, and selective peptide SSTR4 agonist to the antibody carrier. The resulting LA-SSTR4 agonist lead series has high agonist potency and selectivity for SSTR4 and has demonstrated antinociceptive activity in an animal pain model. The proposed SBIR Phase II program seeks to: optimize the existing lead series and select a clinical candidate for development,  validate and prioritize the indication(s) for clinical development using disease-relevant mouse pain models, and characterize the pharmacokinetics and safety/toxicology profile of the clinical candidate in rat and non-human primates to help design subsequent investigational new drug (IND)-enabling studies."
1UG3DA048351-01,"A Phase I/IIa Clinical Trial Testing the Safety and Immunogenicity of a Heroin Vaccine and its Efficacy Against Morphine Challenge.","Novel Therapeutic Options for Opioid Use Disorder and Overdose","Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose",NIDA,"HENRY M. JACKSON FDN FOR THE ADV MIL/MED","MATYAS, GARY R","Bethesda, MD",2019,"In order to address the opioid crisis, this group has developed a candidate heroin/opioid vaccine that induces antibodies that bind heroin/opioid upon injection and subsequently prevent the drug from crossing the blood-brain barrier and interacting with the brain's µ-opioid receptor. They completed pre-clinical testing of the vaccine candidate in mice and rats and demonstrated that the animals were protected from subcutaneous and intravenous heroin challenge. Ongoing durability studies have demonstrated that antibody titer and protective efficacy were maintained 6 months after the last vaccination. This project proposes to advance the development of the vaccine candidate by conducting a Phase I/IIa human clinical trial, by performing vaccine synthesis, nonclinical studies, and then a clinical trial. The supplemental award will allow for testing the efficacy of fentanyl haptens and of the combination heroin–fentanyl vaccine."