CUREBIOTECH, LLC

7KNF5

2018-03-25

2017-03-28

2016-03-07

7KNF5

Obsolete

Non-Manufacturer

2024-03-03

2022-10-18

LOUIS SCHURE

+1 516-724-0542

2024-08-09

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Department of Health and Human Services

COMBINATION OF CB101 AND RADIATION THERAPY IN HEAD AND NECK SQUAMOUS CELL CARCINOMA - CUREBIOTECH, INC., FOA # PA-21-262 APPLICATION NUMBER 1121483 PROJECT SUMMARY HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) IS THE SEVENTH LEADING CAUSE OF CANCER-RELATED MORTALITY IN THE WORLD. RADIATION THERAPY (RT) IS ROUTINELY USED FOR PATIENTS WITH LOCOREGIONALLY ADVANCED DISEASE. THE HISTORICAL 5-YEAR OVERALL SURVIVAL RATES FOR LOCALLY ADVANCED HNSCC AFTER TREATMENT WITH SURGERY, CHEMOTHERAPY, AND RT IS ~50%. MANY OF THESE PATIENTS RELAPSE AFTER INITIAL THERAPY AND/OR DEVELOP METASTATIC DISEASE, AND THE PROGNOSIS FOR THESE PATIENTS REMAINS POOR, WITH A MEDIAN SURVIVAL BETWEEN 6 TO 12 MONTHS. IMMUNOTHERAPY WITH ANTI-PD-1 ANTIBODIES YIELDS A RESPONSE RATE LESS THAN 20%. HENCE, THERE IS A PRESSING CLINICAL NEED TO DEVELOP ALTERNATIVE APPROACHES FOR PATIENTS WITH RELAPSED AND/OR METASTATIC HNSCC. CUREBIOTECH INC. IS A PRECLINICAL STAGE BIOTECH COMPANY THAT FOCUSES ON TOLL-LIKE RECEPTOR 7/8 AGONIST, RESIQUIMOD. RESIQUIMOD IS MORE POTENT AND HAS BETTER BIOAVAILABILITY THAN IMIQUIMOD, AN FDA APPROVED IMMUNE MODULATING DRUG. CUREBIOTECH HAS DEVELOPED AN INNOVATIVE INTRATUMORAL CONTROLLED RELEASE FORMULATION OF RESIQUIMOD, CB101, WHICH SEQUESTERS THE DRUG TO A LOCAL SITE USING A POLYMER MATRIX, WITH THE AIM OF AVOIDING SYSTEMIC ADVERSE IMMUNE RESPONSE. IT SHOWED SUPERIOR TREATMENT EFFICACY OVER UNFORMULATED RESIQUIMOD IN MULTIPLE PRECLINICAL MODELS. LOCALLY ADVANCED OR RELAPSED HNSCC IS EASILY ACCESSIBLE FOR INTRATUMORAL INJECTION OF CB101. WE POSTULATE THAT CB101 WILL SIGNIFICANTLY AUGMENT THE RESPONSE OF CANCERS TO RT VIA MODULATING THE TUMOR MICROENVIRONMENT (TME). IN AIM 1, WE WILL OPTIMIZE DOSE AND TREATMENT SCHEDULE OF CB101 AND RT IN HNSCC PRE-CLINICAL MODELS. SINCE RT MAY INCREASE PD-L1 EXPRESSION ON TUMOR CELLS, IN AIM 2, WE WILL INVESTIGATE THE TREATMENT EFFICACY OF ANTI-PD-1 ANTIBODIES WITH CB101/RT COMBINATION. WE EXPECT THAT LOWER DOSES OF RT WITH CB101 MAY YIELD THE SAME OR BETTER RESULTS AS HIGHER DOSE RADIATION ALONE BUT WITH REDUCED TOXICITY, MAKING RT RESISTANT TUMORS SENSITIVE AND ENHANCING THE ABSCOPAL EFFECT OF RT. SUCCESSFUL COMPLETION OF THESE AIMS WILL HAVE A DIRECT IMPACT ON THE DESIGN OF FUTURE CLINICAL TRIALS. WE HAVE THE SCIENTIFIC AND PERSONNEL CAPABILITY TO ACHIEVE THESE AIMS QUICKLY AND METICULOUSLY. THE DATA GENERATED IN THIS PROJECT WILL BE INCLUDED IN AN IND APPLICATION OF A PHASE I CLINICAL TRIAL OF CB101/RT IN HNSCC PATIENTS TO THE FDA.

250876.00

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0.00

2017-05-12

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Department of Health and Human Services

NOVEL INJECTABLE RESIQUIMOD FORMULATION FOR TREATMENT OF METASTATIC CANCERS

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2023-12-14

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Department of Health and Human Services

INTRATUMORAL IMMUNOTHERAPY WITH FORMULATED RESIQUIMOD FOR METASTATIC MELANOMA - PROJECT SUMMARY     MALIGNANT MELANOMA IS ONE OF THE MOST AGGRESSIVE TYPES OF SKIN CANCER, CAUSING A LARGE  MAJORITY OF SKIN-­CANCER RELATED DEATHS WORLDWIDE. THE COMBINATION OF ANTI-­PD-­1 AND ANTI-­CTLA-­4  IS FDA APPROVED FOR METASTATIC MELANOMA AND SHOWS BETTER EFFICACY THAN ANY SINGLE AGENT  ALONE. UNFORTUNATELY, THE INCIDENCE OF HIGH-­GRADE IMMUNE-­RELATED ADVERSE EVENTS (IRAES) DUE TO   ANTI-­CTLA-­4 IS APPROACHING 50%. THERE IS A PRESSING CLINICAL NEED TO DEVELOP THERAPEUTIC   AGENTS THAT MAY ENHANCE THE THERAPEUTIC EFFECT OF ANTI-­PD1 THERAPY WITHOUT SIGNIFICANTLY  INCREASING TOXICITY IN CANCER PATIENTS.   CUREBIOTECH IS AIMED TO DEVELOP AN EFFICACIOUS  INTRATUMORAL IMMUNOTHERAPEUTIC DRUG THAT CAN TREAT METASTATIC MELANOMA BY ITSELF AND IN  COMBINATION WITH ANTI-­PD1 THERAPY. RESIQUIMOD IS A TOLL-­LIKE RECEPTORS (TLR) 7 AND 8 AGONIST. IT  IS A SECOND GENERATION IMIDAZOQUINOLINE THAT IS 100 TIME MORE POTENT THAN IMIQUIMOD  (ALDARA).   USING A  PHASE I SBIR GRANT, CUREBIOTECH HAS DEVELOPED TWO PROPRIETARY HYDROGEL BASED  INJECTABLE FORMULATIONS FOR RESIQUIMOD. THE FORMULATIONS WERE DESIGNED TO CONFINE RESIQUIMOD  LOCALLY IN THE TUMOR TO DECREASE SYSTEMIC CYTOKINE RELEASE SYMPTOMS;; AND TO BE PENETRATE BETTER  FIBROTIC TUMOR STROMA TO ALLOW A STRONGER HOST IMMUNE RESPONSE.  OUR PRELIMINARY DATA  DEMONSTRATES THAT RESIQUIMOD TREATMENT NOT ONLY INHIBITED MELANOMA GROWTH, BUT ALSO  SUPPRESSED LYMPH NODE METASTASIS. RESIQUIMOD INCREASES THE NUMBER OF INTRA-­TUMORAL CD45+  LEUKOCYTES AND ENHANCES THE PROLIFERATION AND FUNCTION OF TUMOR ANTIGEN RECOGNIZING CD8+  EFFECTOR T-­CELLS. RESIQUIMOD SHOWS SYNERGISTIC EFFECT IN INHIBITING MELANOMA GROWTH WHEN   COMBINED WITH ANTI-­PD1 THERAPY. THIS SBIR  PHASE II PROJECT IS AIMED TO 1) STUDY PD/PK OF THE  FORMULATED INJECTABLE RESIQUIMOD IN MELANOMA MOUSE MODELS;; 2) OPTIMIZE  DOSE/FREQUENCY/TIMING OF FORMULATED RESIQUIMOD IN COMBINATION WITH ANTI-­PD1 THERAPY FOR  MELANOMA;; 3) PERFORM NON-­CLINICAL IND ENABLING STUDIES USING FORMULATED INJECTABLE RESIQUIMOD.   THE DELIVERABLES PROPOSED IN THIS SBIR GRANT REPRESENT THE JUMPING STONE TOWARDS (I)  SUBMISSION OF FDA IND APPLICATION OF AN INJECTABLE RESIQUIMOD FORMULATION AND (II) ATTRACTING  PRIVATE EQUITY FUNDING TO SUPPORT PHASE I CLINICAL TRIAL OF INJECTABLE RESIQUIMOD IN PATIENTS WITH  METASTATIC MELANOMA. CUREBIOTECH HAS THE BUSINESS DEVELOPMENT EXPERTISE, PROPER INTELLECTUAL  PROPERTY AND SCIENTIFIC AND PERSONNEL CAPABILITY TO ACHIEVE THESE AIMS QUICKLY AND METICULOUSLY.   RESULTS FROM THIS PROPOSAL WILL LAY A SOLID FOUNDATION FOR FDA IND SUBMISSION THAT WILL ULTIMATELY  BRING A NOVEL AND EFFECTIVE THERAPY TO CLINICIANS AND PATIENTS IN THEIR FIGHT AGAINST MELANOMA.

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