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Pemphigus-specific T cell engagers for pemphigus targeted immunotherapy

Award Number: R43AI151635
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/14/2019
PERIOD OF PERFORMANCE END DATE: 07/31/2021

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Pemphigus-specific T cell engagers for pemphigus targeted immunotherapy - ABSTRACT. Pemphigus (pemphigus vulgaris (PV) and pemphigus foliaceus (PF)) is an acquired autoimmune disease in which IgG antibodies target the keratinocyte desmosomal cadherin proteins desmoglein-3 and desmoglein-1, resulting in intraepithelial, mucocutaneous blistering. Nearly all PV and PF patients (96%– 100%), but no unaffected individuals, demonstrate detectable anti-DSG3 and anti-DSG1 reactivity, respectively. PV is a potentially fatal autoimmune disorder with a mortality rate of 75% on average without treatment with corticosteroids. Current methods for pemphigus treatment require general immune suppression to reduce overall antibody production, but this approach impairs protective immune responses, which can lead to potentially fatal infections and secondary cancers. We propose a novel approach for targeted immunotherapy of PV by directing patient's T cells to specifically seek out and kill the pemphigus-specific B cells, while sparing the beneficial immune cells that protect from infection. As a proof-of-principle, in phase I, Multi-specific T-cell Engagers or MuTE – IgG-like recombinant proteins consisting of a well-characterized anti-CD3 antibody OKT3 with mutated human IgG4 Fc, and human desmoglein-1 and desmoglein-3 extracellular domains will be produced. The T-cell mediated target elimination of anti-desmoglein specific B cells by MuTE will be validated in cell-based assays and in mouse models. Phase II work will focus on scale-up of biologics production, obtaining the preclinical in vivo pharmacodynamics, pharmacokinetics and toxicity data in animal models necessary for submission of an IND.


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: 2022 ( Subtotal = $0 )
2022	2019	ABZYME THERAPEUTICS, LLC	321 JONES BLVD, STE 300	POTTSTOWN	PA	19464	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	4/6/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $280,352 )
2019	2019	ABZYME THERAPEUTICS, LLC	321 JONES BLVD, STE 300	POTTSTOWN	PA	19464	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	8/13/2019	NEW	$280,352
														Subtotal = $280,352

Grand Total All Awards = $280,352

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Pemphigus-specific T cell engagers for pemphigus targeted immunotherapy

Award Number: R43AI151635

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/14/2019

PERIOD OF PERFORMANCE END DATE: 07/31/2021

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