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Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl Overdose

Award Number: U01DA051071
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl Overdose - Abstract. 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. A large contributor to this surge is the increased frequency of heroin and other illicit opioid being contaminated or “cut” with fentanyl and its analogs. The current standard of care for opioid overdose is treatment with opioid antagonist naloxone, which is considerably less effective when combating fentanyl due to fentanyl’s high potency and the short half-life of naloxone. As a novel approach, therapeutic monoclonal antibodies (mAbs) against fentanyl have been designed to reverse the pharmacokinetic distribution of the drug out of the central nervous system, averting overdose and attenuating opioid-induced respiratory depression. The Janda group at TSRI recently disclosed the generation and use of murine mAbs that were able to reverse fentanyl-induced behavior and prevent overdose lethality in mice. Recently, we have generated human mAbs with high-affinity for fentanyl and broad cross-reactivity to its analogs with negligible binding to structurally-unrelated medications such as buprenorphine and naloxone. Our lead mAb can reverse the antinociceptive effects of fentanyl in rodents and rhesus macaques and has shown a duration of action in non-human primates of over 2 weeks. Furthermore, the mAb can rescue mice from carfentanil-induced respiratory depression with similar efficacy to naloxone, but with a much more durable effect. Following our reengineering efforts to enhance stability for manufacturing, we have contracted with Selexis SA to produce a stable cell line. Under the aims of our grant, KBI Biopharma, a partner of Selexis SA, will undertake tasks in process development and GMP manufacturing to establish a manufacturing process, quality assurance protocol and stability profile for our antibody. Subsequent production of cGMP material will enable 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. In sum, these activities will enable us to file for an investigational new drug application for our mAb candidate with the FDA.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$714 )
2024	2021	CESSATION THERAPEUTICS, INC.	3031 TISCH WAY STE 110	SAN JOSE	CA	95128	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	2	10/12/2023	NON-COMPETING CONTINUATION	-$714
														Subtotal = -$714

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CESSATION THERAPEUTICS, LLC	3031 TISCH WAY STE 505	SAN JOSE	CA	95128	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	2	1/20/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,022,571 )
2021	2021	CESSATION THERAPEUTICS, LLC	3031 TISCH WAY STE 505	SAN JOSE	CA	95128	SANTA CLARA	USA	Drug Use and Addiction Research Programs	001	2	8/27/2021	NON-COMPETING CONTINUATION	$1,022,571
2021	2020	CESSATION THERAPEUTICS, LLC	3031 TISCH WAY STE 505	SAN JOSE	CA	95128	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	1	3/15/2021	NEW	$0
														Subtotal = $1,022,571

Issue Date FY: 2020 ( Subtotal = $6,107,502 )
2020	2020	CESSATION THERAPEUTICS, LLC	3031 TISCH WAY STE 505	SAN JOSE	CA	95128	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	1	9/25/2020	NEW	$6,107,502
														Subtotal = $6,107,502

Grand Total All Awards = $7,129,359

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Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl Overdose

Award Number: U01DA051071

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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