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Therapeutic antibodies for treating chemotherapy induced peripheral neuropathic pain

Award Number: R44CA241513
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/25/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2025

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Therapeutic antibodies for treating chemotherapy induced peripheral neuropathic pain - ABSTRACT Chemotherapy-induced peripheral neuropathy (CIPN) is an often long-lasting neurological condition that arises frequently in cancer patients who receive broadly used chemotherapies such as taxanes. CIPN causes abnormal pain and other symptoms that can limit chemotherapy dosage and significantly impact quality of life for years. There are no drugs that prevent CIPN or treat it well. Duloxetine is the only clinically proven efficacious pain- reducing agent, though it can cause significant side effects and its efficacy limited to a subset of patients. Opioids are used off-label, but also carry serious side effects. Thus, there is a critical unmet need for drugs that safely and effectively treat or prevent CIPN. Peripheral Cannabinoid 2 receptors (CB2) are a promising target for CIPN treatment. CB2 is constitutively expressed on inflammatory immune cells and induced in peripheral neurons in neuropathic conditions. Its activation has powerful neuroprotective, anti-inflammatory, and analgesic effects. Rodent models of CIPN show that small molecule CB2 agonists alleviate neuropathic pain behavior, and when administered prophylactically suppress CIPN both during dosing and for 100 days after. Several companies have developed small molecule CB2 agonists that, unfortunately, are rapidly cleared, penetrate the blood-brain barrier and/or have off-target effects (notably cognitive ones) mediated by the CB1 receptor. Abalone Bio used its proprietary Functional Antibody Selection Technology (FAST) to isolate a selective CB2-activating nanobody (VHH), which we converted into a VHH-Fc fusion lead antibody, ABt140, for in vivo studies. Phase I SBIR results show that ABt140 rapidly and durably reversed allodynia in mice with CIPN. In this Phase II SBIR project, Abalone Bio will first improve ABt140’s immunogenicity and manufacturability by rational engineering, and then the FAST platform will be used to increase its potency to select durable agonists from millions of computationally- designed variants. We will select 1 lead and at least 2 alternates using in vitro and in vivo assays. Using the paclitaxel CIPN mouse model, we will assess the lead’s ability to prevent CIPN development, reduce in nerve damage and inflammation, show no impairment of motor skills, and not affect chemotherapy’s anti-tumor efficacy. Finally, we will determine the lead antibody’s half-life and tissue distribution in mice, and using blood markers and organs appearance and weight, we will assess its toxicity at high doses. Successful completion of these aims will de-risk the project sufficiently to advance Abalone’s antibody drug to IND-enabling studies and eventually first in human trials for painful CIPN. Abalone’s drug may also have broad utility for other neuropathic pains and inflammatory conditions.


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: 2025 ( Subtotal = $0 )
2025	2022	ABALONE BIO, INC.	1250 45TH ST	EMERYVILLE	CA	94608	ALAMEDA	USA	Cancer Treatment Research	000	3	8/28/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	ABALONE BIO, INC.	1250 45TH ST	EMERYVILLE	CA	94608	ALAMEDA	USA	Cancer Treatment Research	001	3	5/21/2024	NON-COMPETING CONTINUATION	$0
2024	2022	ABALONE BIO, INC.	1250 45TH ST	EMERYVILLE	CA	94608	ALAMEDA	USA	Cancer Treatment Research	000	3	4/22/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,063,128 )
2022	2022	ABALONE BIO, INC.	1250 45TH ST STE 520	EMERYVILLE	CA	94608	ALAMEDA	USA	Cancer Treatment Research	000	3	4/18/2022	NON-COMPETING CONTINUATION	$1,063,128
														Subtotal = $1,063,128

Issue Date FY: 2021 ( Subtotal = $915,873 )
2021	2021	ABALONE BIO, INC.	2600 HILLTOP DR, BLDG B, RM C332	RICHMOND	CA	94806	CONTRA COSTA	USA	Cancer Treatment Research	000	2	5/4/2021	COMPETING CONTINUATION	$915,873
														Subtotal = $915,873

Grand Total All Awards = $1,979,001

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Therapeutic antibodies for treating chemotherapy induced peripheral neuropathic pain

Award Number: R44CA241513

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/25/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2025

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