NEW YORK R&D CENTER FOR TRANSLATIONAL MEDICINE AND THERAPEUTICS, INC.

JBDNWL5M9D43

6XU64

2025-08-08

NEW YORK R & D CENTER FOR TRANSLATIONAL MEDICINE & THERAPEUTICS INC

2024-08-12

2013-06-19

6XU64

Active

Non-Manufacturer

2024-08-12

2029-08-12

2025-08-08

DAVID T. FUNG

2025-04-10

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Department of Defense

A NOVEL TREATMENT TO MITIGATE COMPLICATIONS OF ACL RECONSTRUCTION

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2024-06-20

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Department of Health and Human Services

EXOSOME DRUG FOR TENDINOPATHY - PROJECT SUMMARY TENDINOPATHY IS AN AGE-RELATED TENDON DISORDER CHARACTERIZED BY TENDON DETERIORATION AND IS ASSOCIATED WITH PAIN, SWELLING AND IMPAIRED PERFORMANCE, AND OFTEN LEADS TO TENDON RUPTURE. GIVEN THAT THERE IS NO DISEASE- MODIFYING THERAPEUTIC ON THE MARKET, OUR CENTRAL GOAL IS TO DEVELOP AND COMMERCIALIZE A NOVEL BIOLOGIC AS AN EFFECTIVE AND SAFE TREATMENT FOR TENDINOPATHY. THE PRODUCT TO BE DEVELOPED IS ALTENEX, A DISEASE-MODIFYING BIOLOGIC DRUG CONSISTING OF EXOSOMES GENERATED BY ALLOGENEIC HUMAN BONE MARROW-DERIVED MESENCHYMAL STEM CELLS (BM-MSCS) GROWN ON A NOVEL SPECIALIZED 3D SCAFFOLD FOR THE TREATMENT OF TENDINOPATHY. ALTENEX IS AN EXCITING OUTCOME FOR OUR EFFORT IN DEVELOPING A STEM CELL-BASED BIOLOGIC PRODUCT BASED ON A SCALABLE PRODUCTION PROCESS. HUMAN BM-MSCS FROM A READILY AVAILABLE STEM CELL BANK ARE CULTURED ON UNIQUELY ENGINEERED “NANOPRIME” SCAFFOLDS FABRICATED WITH ELECTROSPUN ALIGNED POLYCAPROLACTONE (PCL) FIBERS. THESE MASS-PRODUCED SCAFFOLDS EMULATE THE 3D MICROENVIRONMENT THAT CARRIES THE PHYSICAL CUES TO “GUIDE” THE MSCS TOWARD TENOCYTIC DIFFERENTIATION AND, IN DOING SO, SECRETE EXOSOMES WITH THERAPEUTIC POTENTIAL IN TENDINOPATHY. IN OUR PRELIMINARY STUDIES, ALTENEX PRODUCED FROM XENO-FREE DEVELOPMENT-GRADE HUMAN BM-MSCS WAS CHARACTERIZED AS TYPICAL EXOSOMES. THE EXOSOME IDENTITY OF ALTENEX WAS CONFIRMED BY ITS EXOSOMAL PROTEIN MARKERS. EXCITINGLY, WE FOUND INTRA-TENDINOUS INJECTION OF ALTENEX, INTO RAT ACHILLES TENDONS WITH TENDINOPATHY MITIGATED HISTOLOGIC FEATURES OF TENDINOPATHY. THESE ENCOURAGING DATA SUPPORT THE FEASIBILITY OF DEVELOPING ALTENEX AS A BIOLOGIC DRUG FOR TENDINOPATHY CONSISTING OF ALLOGENEIC EXOSOMES AND LED US TO HYPOTHESIZE THAT ALTENEX EXERTS A THERAPEUTIC EFFECT ON MITIGATING TENDINOPATHY WITH MINIMAL, IF ANY, ADVERSE EFFECTS. TO TEST THE HYPOTHESIS, TWO SPECIFIC AIMS ARE PROPOSED. IN AIM 1, WE WILL DETERMINE THE EFFICACIES, SAFETY AND PHARMACOKINETICS OF ALTENEX USING A COLLAGENASE-INDUCED RAT MODEL OF TENDINOPATHY. SPECIFICALLY, WE WILL FIRST IDENTIFY THE OPTIMAL DOSE AND DOSE SCHEDULE FOR ALTENEX BASED ON HISTOLOGIC SCORING. THEN, USING THE OPTIMAL DOSE AND DOSE SCHEDULE, WE WILL DETERMINE THE THERAPEUTIC EFFECT OF ALTENEX ON MITIGATING TENDINOPATHY PATHOLOGY, IMPROVING TENDON MECHANICAL PROPERTIES, AND RELIEVING PAIN BEHAVIORS. FURTHERMORE, WE WILL EVALUATE THE SAFETY AND PHARMACOKINETICS OF ALTENEX. IN AIM 2, WE WILL DETERMINE THE EFFICACY AND SAFETY OF ALTENEX ON TENDINOPATHY IN RABBITS. RABBITS WITH A SEVERE STAGE OF COLLAGENASE-INDUCED ACHILLES TENDINOPATHY WILL BE TREATED WITH ALTENEX AND COMPARED AGAINST CONTROLS. THE EFFICACY MEASUREMENTS WILL FOCUS ON THE PATHOLOGY AND MECHANICAL PROPERTIES OF THE DISEASED TENDON, THE PARAMETERS THAT HAVE BEEN WELL-ESTABLISHED IN THIS RABBIT MODEL. FURTHERMORE, THE SAFETY OF ALTENEX TREATMENT WILL BE EVALUATED BY CLINICAL OBSERVATIONS AND CLINICAL PATHOLOGY, WITH PARTICULAR ATTENTION TO LOCAL TOXICITIES DUE TO INTERACTIONS ALTENEX WITH THE TISSUE AT THE SITE OF ADMINISTRATION. THIS PRECLINICAL STUDY IS A CRITICAL STEP THAT ADVANCES THE TRANSLATION OF ALTENEX TOWARD THE CLINICAL PHASE AND ULTIMATELY AN FDA-APPROVED DRUG FOR TENDINOPATHY.

766269.00

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2022-09-23

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Department of Health and Human Services

MIRNA DRUG FOR TENDINOPATHY - PROJECT SUMMARY TENDINOPATHY IS A TENDON DISORDER THAT IS HIGHLY PREVALENT IN THE AGED POPULATION. IT IS CHARACTERIZED BY TENDON DETERIORATION THAT OFTEN LEADS TO TENDON RUPTURE, AND IS ASSOCIATED WITH PAIN, SWELLING AND IMPAIRED PERFORMANCE. THERE IS CURRENTLY NO CURE FOR TENDINOPATHY AND AN URGENT NEED FOR EFFECTIVE TREATMENTS FOR TENDINOPATHY. THE TECHNOLOGY TO BE DEVELOPED IS MICRORNA (MIR)-221-5P FOR THE TREATMENT OF TENDINOPATHY. OUR PRELIMINARY STUDIES IDENTIFIED THAT MIR-221-5P EXHIBITED A THERAPEUTIC EFFECT IN A RODENT MODEL OF TENDINOPATHY AND MAY EXERT ITS THERAPEUTIC EFFECT, AT LEAST IN PART, BY SUPPRESSING EXPRESSION OF PRO-INFLAMMATORY MEDIATORS THAT CONTRIBUTE TO THE PATHOGENESIS OF TENDINOPATHY. THIS PROJECT WILL TEST THE HYPOTHESIS THAT CHEMICALLY MODIFIED MIR-221-5P EXERTS AN ENHANCED EFFECT ON MITIGATING TENDINOPATHY. THE PHASE II STUDY WILL FOCUS ON PROVIDING CRITICAL EVIDENCE TOWARDS DEVELOPING MIR-221-5P AS AN FDA-APPROVED PRODUCT FOR THE TREATMENT OF TENDINOPATHY. IN AIM 1, WE WILL DETERMINE THE CHEMICAL FORMULATION AND TREATMENT CONDITION OF MIR-221-5P USING A COLLAGENASE- INDUCED MODEL OF TENDINOPATHY. IN AIM 2, WE WILL DETERMINE THE EFFICACY AND SAFETY OF MIR-221-5P ON TENDINOPATHY IN RABBITS. SUCCESSFUL COMPLETION OF THE PROPOSED STUDIES WILL IDENTIFY MIR-221-5P AS A NEW DRUG FOR THE TREATMENT OF TENDINOPATHY AND OTHER CHRONIC INFLAMMATORY DISEASES.

1866402.00

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2024-05-21

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Department of Defense

A NOVEL MICRORNA-BASED STRATEGY FOR THE REPAIR OF INJURED TENDONS EXTEND THE PERIOD OF PERFORMANCE 1. PER SECTION 711 OF THE NATIONAL DEFENSE AUTHORIZATION ACT (NDAA) 2019, THE US ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY (USAMRAA), US ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (USAMRDC) TRANSFERRED TO THE DEFENSE HEALTH AGENCY (DHA) FROM THE U.S. ARMY EFFECTIVE 01 OCTOBER 2022. THIS MODIFICATION REFLECTS CHANGES CONSISTENT WITH THE TRANSFER TO DHA

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2022-05-09

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Department of Defense

A NOVEL MICRORNA-BASED STRATEGY FOR THE REPAIR OF INJURED TENDONS

725000.00

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