Innovimmune Biotherapeutics Holding, LLC — Department of Health and Human Services SBIR Phase II: NIAID

Description

DESCRIPTION provided by applicant There are unmet medical needs in the limited biologic therapeutics for adults with rheumatoid arthritis RA associated with $ billion annual US health care and societal costs These are due to inadequate efficacy prohibitive costs poor adherence and safety issues infections andamp malignancies Oral small molecule based therapies are warranted due to their inherent lower safety risks lower costs and flexible drug delivery formulations Persistent safety findings of oral kinase inhibitors in development for RA justify a target selective approach that limits disease progression without the unwarranted toxicities associated with non specific generalized over immunosuppression Selective inhibition of macrophage migration inhibitory factor MIF has been target validated demonstrating unprecedented superior safety and efficacy in preclinical RA and several animal models The successful completion of the Phase I INV lead development research led to the discovery of highly potent and efficacious first in class best in class oral INV MIF inhibitors reported to date clearly differentiating INV compounds from early MIF inhibitors The INV team of drug discovery andamp development experts with an industry track record of successfully advancing andgt RA and autoimmune disease AD therapeutics will lead the proposed Phase II Clinical Candidate Selection research of INV to establish the optimal drug like properties and the preclinical Proof of Concept POC of INV in RA The Phase II goal is to select the best single clinical lead compound that could advance to the Phase III IND enabling phase and will be achieved by accomplishing the following specific aims of INV Compound Synthesis In vitro Biochemical Profile In vitro Pharmacology Screen In vitro ADMET Profile Establish the INV in vivo Mouse Pharmacokinetic PK Profile and Establish the INV in vivo Preclinical POC Efficacy in a Mouse Collagen Induced Arthritis CIA Model The successful selection of an INV clinical candidate in Phase II will advance to a Phase III Preclinical IND enabling research stage with a goal to complete the ICH M R requirements that will enable an FDA IND filing for RA and a Phase First in Human clinical study start Achieving these milestones would place INV in a position of strength as it seeks an outlicensing Mandamp A or codevelopment agreement with external stakeholders INV will seek potential industry development partners and investors during Phase II and thus securing a development partner early on to support the INV IND enabling and clinical development NDA approval and commercialization An FDA approval for INV as the first orally available target selective cytokine inhibitor with a potential for better potency and efficacy superior safety profile wider therapeutic index and cost effective oral immunotherapy convenient for RA patients would fulfill all critical unmet medical needs by contributing to overall patient mortality and quality of life improvements and reduced public health care and societal costs PUBLIC HEALTH RELEVANCE The projectandapos s goal is to develop the first target selective cytokine oral therapy that is safe and efficacious for rheumatoid arthritis RA and other autoimmune diseases AD with a small molecule macrophage migration inhibitory factor MIF inhibitor The primary objective of the SBIR Phase II proposal is the clinical candidate selection research of Innovimmuneandapos s proprietary oral MIF inhibitors An FDA approval of an oral MIF inhibitor with a potential for better potency and efficacy superior safety profile wider therapeuic index and cost effective oral immunotherapy convenient for RA and AD patients would fulfill all critical unmet medical needs by contributing to overall patient mortality and quality of life improvements and reduced public health care and societal costs