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Preclinical evaluation of a novel small molecule STAT inhibitor

Award Number: R44AI125007
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: 01/01/2019
PERIOD OF PERFORMANCE END DATE: 07/31/2020

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Preclinical evaluation of a novel small molecule STAT inhibitor - Project Summary Problem statement: Asthma is one of the most common and burdensome of all chronic inflammatory diseases, causing almost lifelong respiratory symptoms to various degrees through a patient’s life due to severe airway inflammation, airway obstruction, and triggered hyper-responsiveness. Almost 10% of these individuals experience very severe, complex, and heterogeneous disease symptoms that remain intractable and treatment-resistant. Current therapy is often ineffective in severe asthma conditions. Importantly, long-term use of corticosteroids and long-acting β agonists (LABAs) is associated with disabling side effects, leading to worsening of the disease and excess asthma-related mortality. There is thus a clear unmet need for novel therapies that can significantly improve outcomes over current standard of care. Innovation: New therapies to treat asthma include monoclonal antibodies targeting cytokines and receptors of the IL4/IL13/JAK/STAT6 pathway. The pathway has been validated in clinical trials of dupilimab, an antibody that targets IL-4R receptor, and lebrikizumab, an anti-IL-13 antibody, among others. However, most biologics also have a significant risk of developing neutralizing immune reactions (anti-drug antibodies). Atrapos Therapeutics, LLC was founded in 2015 to develop and commercialize a first-in-class small molecule therapeutic technology developed by a team of academic scientists at the MD Anderson Cancer Center and Baylor College of Medicine. This technology uniquely targets a crucial intracellular pathway that drives the immune response in a host of chronic diseases, including asthma. The team successfully demonstrated the ability of the lead molecule (PM-43I) to significantly reduce the severity of established asthma in mice models. They also demonstrated the effectiveness of the molecule to prevent asthma in mice with no prior disease. An important differentiating factor from established immunosuppressant therapies in severe asthma (steroids) is the precision of the immunomodulation, whereby the antiviral immunity is unaffected, reducing the risk of secondary infections (a common problem with prolonged steroid therapy). Technology Development Status: We successfully met and expanded the Specific Aims of our Phase I proposal. PM-43I was shown to have activity primarily limited to the lung when delivered intranasally, and a greatly expanded toxicity assessment program unequivocally established the safety of the molecule at significantly high doses. Proposal: The long-term plan of this project is to develop PM-43I for clinical use in treatment of moderate to severe asthma. The goal of the work outlined in this grant proposal is to characterize, synthesize and test the drug product for this indication. Overall, the Specific Aims outlined in this proposal will help to complete the preclinical and product development work for PM-43I. While Atrapos has had some success in raising angel capital coupled with NIH funding, the successful awarding of this proposal would complete the remaining preclinical and product development of PM-43I required for regulatory (FDA and IRB) approvals for clinical translation.


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: 2021 ( Subtotal = $0 )
2021	2018	FANNIN PARTNERS, LLC	3900 ESSEX LN STE 575	HOUSTON	TX	77027	HARRIS	USA	Allergy and Infectious Diseases Research	000	3	2/6/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	FANNIN PARTNERS, LLC	3900 ESSEX LN STE 575	HOUSTON	TX	77027	HARRIS	USA	Allergy and Infectious Diseases Research	000	3	3/18/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = -$7 )
2019	2018	ATRAPOS THERAPEUTICS, LLC	3900 ESSEX LN STE 575	HOUSTON	TX	77027	HARRIS	USA	Allergy and Infectious Diseases Research	000	2	12/24/2018	COMPETING CONTINUATION	-$1,000,000
2019	2018	FANNIN PARTNERS, LLC	3900 ESSEX LN STE 575	HOUSTON	TX	77027	HARRIS	USA	Allergy and Infectious Diseases Research	001	3	12/24/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$999,993
														Subtotal = -$7

Issue Date FY: 2018 ( Subtotal = $1,000,000 )
2018	2018	ATRAPOS THERAPEUTICS, LLC	3900 ESSEX LN STE 575	HOUSTON	TX	77027	HARRIS	USA	Allergy and Infectious Diseases Research	000	2	8/20/2018	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $999,993

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Preclinical evaluation of a novel small molecule STAT inhibitor

Award Number: R44AI125007

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: 01/01/2019

PERIOD OF PERFORMANCE END DATE: 07/31/2020

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