Stone Hall Dr

DEVELOPMENT OF A PEANUT ALLERGY TREATMENT FOR ADULTS USING MICRONEEDLES

SAFETY AND TOLERABILITY OF TASIS-PEANUT (TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY WITHIN THE SKIN) PATCH FOR THE TREATMENT OF PEANUT ALLERGY - THE FOLLOWING CONTAINS PROPRIETARY/PRIVILEGED INFORMATION THAT MOONLIGHT THERAPEUTICS REQUESTS NOT BE RELEASED TO PERSONS OUTSIDE THE GOVERNMENT, EXCEPT FOR PURPOSES OF REVIEW AND EVALUATION SAFETY AND TOLERABILITY OF TASIS-PEANUT (TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY WITHIN THE SKIN) PATCH FOR THE TREATMENT OF PEANUT ALLERGY FOOD ALLERGIES AFFECT 30 MILLION PEOPLE IN THE USA AND 17 MILLION IN EUROPE. SIX MILLION CHILDREN, ROUGHLY 1 IN 13, IN THE USA HAVE AT LEAST ONE FOOD ALLERGY; THIS EQUATES TO AT LEAST 1 IN EVERY CLASSROOM. CURRENTLY, THERE IS ONLY ONE FDA APPROVED THERAPY IN THE USA FOR FOOD ALLERGIES. FOOD ALLERGIES ARE EXPECTED TO GROW 10% ANNUALLY UNTIL AT LEAST 2022. IT IS ALSO COMMON FOR SOMEONE TO HAVE MORE THAN ONE ALLERGY. THIS IS A GROWING, UNDERSERVED GLOBAL MARKET THAT HAS FEW TREATMENT OPTIONS. A MEANINGFUL INITIAL THERAPY WOULD BE ONE THAT REDUCES THE CHANCE FOR ANAPHYLACTIC REACTION AFTER ACCIDENTAL EXPOSURE. SUCH A THERAPY WILL HELP BRING PEACE OF MIND TO FAMILIES, ALLOW FOR CHILDREN AFFECTED BY FOOD ALLERGIES TO HAVE BETTER QUALITY OF LIFE, FEEL LESS SOCIALLY OUT CASTED AND MOST IMPORTANTLY REDUCE THE POTENTIAL FOR DEATH FROM ACCIDENTAL PROCEDURE. MOONLIGHT THERAPEUTICS IS DEVELOPING A TARGETED WAY TO ADMINISTER ALLERGENS INTO THE TOP SKIN LAYERS TO DESENSITIZE AN ALLERGIC PATIENT, CALLED TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY IN THE SKIN (TASIS). DELIVERY IS ACHIEVED USING MICRONEEDLES APPLIED TO THE SKIN FOR A FEW MINUTES, WHICH ARE MINIMALLY INVASIVE AND PAINLESS. IMPORTANTLY MICRONEEDLES CAN DELIVER INTO TOPMOST SKIN LAYERS WITH HIGH PRECISION AND REPRODUCIBILITY. BECAUSE TASIS DELIVERS SMALL DOSES IN THE TOP AND SUPERFICIAL SKIN LAYERS, THE APPROACH IS EXPECTED TO PRODUCE LITTLE TO NO SYSTEMIC ADVERSE REACTIONS. THE COMPANY'S FIRST TREATMENT IS FOCUSED ON PEANUT ALLERGY AND IS CALLED TASIS-PEANUT. WE HAVE DEMONSTRATED EFFICACY OF OUR APPROACH IN A PRE-CLINICAL MOUSE MODEL OF PEANUT SENSITIZATION. THIS FAST-TRACK (PHASE1/PHASE2) SBIR GRANT (U44) APPLICATION IS FOR A PHASE 1 SAFETY AND TOLERABILITY STUDY TO BE CONDUCTED IN PARTNERSHIP BETWEEN THE COMPANY AND COLLABORATING CLINICAL RESEARCH SITES. THE OBJECTIVE OF THE U44 FAST- TRACK GRANT IS TO PREPARE DOCUMENTS FOR (GRANT PHASE 1) AND CONDUCT (GRANT PHASE 2) A PHASE 1 CLINICAL TRIAL TO ASSESS THE SAFETY AND TOLERABILITY OF TASIS-PEANUT IN PEANUT ALLERGIC CHILDREN AND ADULTS. THE PHASE 2 PORTION OF THE GRANT ALSO INCLUDES AIMS GEARED TOWARDS PRODUCTION OF TASIS-PEANUT FOR THE CLINICAL TRIAL. THE COMPANY CURRENTLY HAS A R42 FAST-TRACK GRANT FOR THE PRE-CLINICAL DEVELOPMENT OF TASIS-PEANUT. OVERALL THIS GRANT WILL ENABLE EVALUATION OF THE SAFETY AND TOLERABILITY OF TASIS-PEANUT IN A FIRST-IN-HUMAN CLINICAL TRIAL. IT WILL SET THE STAGE FOR EVALUATION OF EFFICACY IN A PHASE 2 CLINICAL TRIAL.

SCALE-UP MANUFACTURING OF MICRONEEDLE STAMP FOR PEANUT ALLERGEN IMMUNOTHERAPY - THE FOLLOWING CONTAINS PROPRIETARY/PRIVILEGED INFORMATION THAT MOONLIGHT THERAPEUTICS REQUESTS NOT BE RELEASED TO PERSONS OUTSIDE THE GOVERNMENT, EXCEPT FOR PURPOSES OF REVIEW AND EVALUATION SCALE-UP MANUFACTURING OF MICRONEEDLE STAMP FOR PEANUT ALLERGEN IMMUNOTHERAPY FOOD ALLERGIES AFFECT 30 MILLION PEOPLE IN THE USA AND 17 MILLION IN EUROPE. SIX MILLION CHILDREN, ROUGHLY 1 IN 13, IN THE USA HAVE AT LEAST ONE FOOD ALLERGY; THIS EQUATES TO AT LEAST 1 IN EVERY CLASSROOM. CURRENTLY, THERE IS ONLY ONE FDA APPROVED THERAPY IN THE USA FOR FOOD ALLERGIES. FOOD ALLERGIES ARE EXPECTED TO GROW 10% ANNUALLY UNTIL AT LEAST 2022. IT IS ALSO COMMON FOR SOMEONE TO HAVE MORE THAN ONE ALLERGY. THIS IS A GROWING, UNDERSERVED GLOBAL MARKET THAT HAS FEW TREATMENT OPTIONS. A MEANINGFUL INITIAL THERAPY WOULD BE ONE THAT REDUCES THE CHANCE FOR ANAPHYLACTIC REACTION AFTER ACCIDENTAL EXPOSURE. SUCH A THERAPY WILL HELP BRING PEACE OF MIND TO FAMILIES, ALLOW FOR CHILDREN AFFECTED BY FOOD ALLERGIES TO HAVE BETTER QUALITY OF LIFE, FEEL LESS SOCIALLY OUT CASTED AND MOST IMPORTANTLY REDUCE THE POTENTIAL FOR DEATH FROM ACCIDENTAL PROCEDURE. MOONLIGHT THERAPEUTICS IS DEVELOPING A TARGETED WAY TO ADMINISTER ALLERGENS INTO THE TOP SKIN LAYERS TO DESENSITIZE AN ALLERGIC PATIENT, USING MICRONEEDLES APPLIED TO THE SKIN FOR ONLY A FEW MINUTES. MICRONEEDLES CAN DELIVER INTO TOPMOST SKIN LAYERS, NEAR IMMUNE CELLS, WITH HIGH PRECISION AND REPRODUCIBILITY. THE COMPANY’S FIRST TREATMENT IS FOCUSED ON PEANUT ALLERGY AND IS CALLED MOON101. WE HAVE DEMONSTRATED EFFICACY OF OUR APPROACH IN A PRE-CLINICAL MOUSE MODEL OF PEANUT SENSITIZATION, COMPLETED A PRE-IND MEETING WITH THE FDA AND RECEIVED A U44 CLINICAL TRIAL GRANT TO CONDUCT THE FIRST EVER CLINICAL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF MOON101 IN PEANUT ALLERGIC SUBJECTS. THE OBJECTIVE OF THE CRP GRANT IS TO IMPROVE THE CURRENT MICRONEEDLE COATING METHOD SO THAT LARGE-SCALE CLINICAL TRIALS FOR SAFETY AND EFFICACY CAN BE CONDUCTED. THERE ARE 2 MAIN IMPROVEMENTS THAT WILL BE THE FOCUS OF THE NEW DROP-ON-DEMAND COATING SYSTEM: (1) AN AUTOMATED COATING METHOD FOR MICRONEEDLES TO ALLOW FOR INCREASED PRODUCTION RATE AND (2) THE ABILITY TO CONCURRENTLY COAT DIFFERENT ALLERGENS ONTO A SINGLE MICRONEEDLE ARRAY. WE HAVE IDENTIFIED A PARTICULAR PIECE OF EQUIPMENT THAT CAN BE CUSTOMIZED TO SUIT OUR NEEDS. OUR APPROACH WILL BE TO PURCHASE THIS EQUIPMENT, SET IT UP AND DEMONSTRATE THAT IT CAN BE USED FOR CLINICAL PRODUCTION OF MOON101. WE WILL FIRST EVALUATE IT FOR COATING OF PEANUT ALLERGENS, AND THEN DETERMINE IF WE CAN COAT MULTIPLE ALLERGENS SIMULTANEOUSLY. THIS WILL ADDRESS FUTURE NEEDS OF TREATING MULTIPLE ALLERGIES CONCURRENTLY. OVERALL, THIS GRANT WILL ENABLE MOONLIGHT THERAPEUTICS TO ADVANCE THE PRODUCTION CAPABILITIES OF THEIR PLATFORM. IT WILL SET THE STAGE TO EVALUATE THE EFFICACY OF MOON101 TO TREAT PEANUT ALLERGY IN A PHASE 2 CLINICAL TRIAL AND BEGIN TO ADDRESS TREATMENT OF MULTIPLE FOOD ALLERGIES.

SCALE-UP MANUFACTURING OF MICRONEEDLE STAMP FOR PEANUT ALLERGEN IMMUNOTHERAPY - THE FOLLOWING CONTAINS PROPRIETARY/PRIVILEGED INFORMATION THAT MOONLIGHT THERAPEUTICS REQUESTS NOT BE RELEASED TO PERSONS OUTSIDE THE GOVERNMENT, EXCEPT FOR PURPOSES OF REVIEW AND EVALUATION SCALE-UP MANUFACTURING OF MICRONEEDLE STAMP FOR PEANUT ALLERGEN IMMUNOTHERAPY FOOD ALLERGIES AFFECT 30 MILLION PEOPLE IN THE USA AND 17 MILLION IN EUROPE. SIX MILLION CHILDREN, ROUGHLY 1 IN 13, IN THE USA HAVE AT LEAST ONE FOOD ALLERGY; THIS EQUATES TO AT LEAST 1 IN EVERY CLASSROOM. CURRENTLY, THERE IS ONLY ONE FDA APPROVED THERAPY IN THE USA FOR FOOD ALLERGIES. FOOD ALLERGIES ARE EXPECTED TO GROW 10% ANNUALLY UNTIL AT LEAST 2022. IT IS ALSO COMMON FOR SOMEONE TO HAVE MORE THAN ONE ALLERGY. THIS IS A GROWING, UNDERSERVED GLOBAL MARKET THAT HAS FEW TREATMENT OPTIONS. A MEANINGFUL INITIAL THERAPY WOULD BE ONE THAT REDUCES THE CHANCE FOR ANAPHYLACTIC REACTION AFTER ACCIDENTAL EXPOSURE. SUCH A THERAPY WILL HELP BRING PEACE OF MIND TO FAMILIES, ALLOW FOR CHILDREN AFFECTED BY FOOD ALLERGIES TO HAVE BETTER QUALITY OF LIFE, FEEL LESS SOCIALLY OUT CASTED AND MOST IMPORTANTLY REDUCE THE POTENTIAL FOR DEATH FROM ACCIDENTAL PROCEDURE. MOONLIGHT THERAPEUTICS IS DEVELOPING A TARGETED WAY TO ADMINISTER ALLERGENS INTO THE TOP SKIN LAYERS TO DESENSITIZE AN ALLERGIC PATIENT, USING MICRONEEDLES APPLIED TO THE SKIN FOR ONLY A FEW MINUTES. MICRONEEDLES CAN DELIVER INTO TOPMOST SKIN LAYERS, NEAR IMMUNE CELLS, WITH HIGH PRECISION AND REPRODUCIBILITY. THE COMPANY’S FIRST TREATMENT IS FOCUSED ON PEANUT ALLERGY AND IS CALLED MOON101. WE HAVE DEMONSTRATED EFFICACY OF OUR APPROACH IN A PRE-CLINICAL MOUSE MODEL OF PEANUT SENSITIZATION, COMPLETED A PRE-IND MEETING WITH THE FDA AND RECEIVED A U44 CLINICAL TRIAL GRANT TO CONDUCT THE FIRST EVER CLINICAL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF MOON101 IN PEANUT ALLERGIC SUBJECTS. THE OBJECTIVE OF THE CRP GRANT IS TO IMPROVE THE CURRENT MICRONEEDLE COATING METHOD SO THAT LARGE-SCALE CLINICAL TRIALS FOR SAFETY AND EFFICACY CAN BE CONDUCTED. THERE ARE 2 MAIN IMPROVEMENTS THAT WILL BE THE FOCUS OF THE NEW DROP-ON-DEMAND COATING SYSTEM: (1) AN AUTOMATED COATING METHOD FOR MICRONEEDLES TO ALLOW FOR INCREASED PRODUCTION RATE AND (2) THE ABILITY TO CONCURRENTLY COAT DIFFERENT ALLERGENS ONTO A SINGLE MICRONEEDLE ARRAY. WE HAVE IDENTIFIED A PARTICULAR PIECE OF EQUIPMENT THAT CAN BE CUSTOMIZED TO SUIT OUR NEEDS. OUR APPROACH WILL BE TO PURCHASE THIS EQUIPMENT, SET IT UP AND DEMONSTRATE THAT IT CAN BE USED FOR CLINICAL PRODUCTION OF MOON101. WE WILL FIRST EVALUATE IT FOR COATING OF PEANUT ALLERGENS, AND THEN DETERMINE IF WE CAN COAT MULTIPLE ALLERGENS SIMULTANEOUSLY. THIS WILL ADDRESS FUTURE NEEDS OF TREATING MULTIPLE ALLERGIES CONCURRENTLY. OVERALL, THIS GRANT WILL ENABLE MOONLIGHT THERAPEUTICS TO ADVANCE THE PRODUCTION CAPABILITIES OF THEIR PLATFORM. IT WILL SET THE STAGE TO EVALUATE THE EFFICACY OF MOON101 TO TREAT PEANUT ALLERGY IN A PHASE 2 CLINICAL TRIAL AND BEGIN TO ADDRESS TREATMENT OF MULTIPLE FOOD ALLERGIES.

SAFETY AND TOLERABILITY OF TASIS-PEANUT (TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY WITHIN THE SKIN) PATCH FOR THE TREATMENT OF PEANUT ALLERGY - THE FOLLOWING CONTAINS PROPRIETARY/PRIVILEGED INFORMATION THAT MOONLIGHT THERAPEUTICS REQUESTS NOT BE RELEASED TO PERSONS OUTSIDE THE GOVERNMENT, EXCEPT FOR PURPOSES OF REVIEW AND EVALUATION SAFETY AND TOLERABILITY OF TASIS-PEANUT (TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY WITHIN THE SKIN) PATCH FOR THE TREATMENT OF PEANUT ALLERGY FOOD ALLERGIES AFFECT 30 MILLION PEOPLE IN THE USA AND 17 MILLION IN EUROPE. SIX MILLION CHILDREN, ROUGHLY 1 IN 13, IN THE USA HAVE AT LEAST ONE FOOD ALLERGY; THIS EQUATES TO AT LEAST 1 IN EVERY CLASSROOM. CURRENTLY, THERE IS ONLY ONE FDA APPROVED THERAPY IN THE USA FOR FOOD ALLERGIES. FOOD ALLERGIES ARE EXPECTED TO GROW 10% ANNUALLY UNTIL AT LEAST 2022. IT IS ALSO COMMON FOR SOMEONE TO HAVE MORE THAN ONE ALLERGY. THIS IS A GROWING, UNDERSERVED GLOBAL MARKET THAT HAS FEW TREATMENT OPTIONS. A MEANINGFUL INITIAL THERAPY WOULD BE ONE THAT REDUCES THE CHANCE FOR ANAPHYLACTIC REACTION AFTER ACCIDENTAL EXPOSURE. SUCH A THERAPY WILL HELP BRING PEACE OF MIND TO FAMILIES, ALLOW FOR CHILDREN AFFECTED BY FOOD ALLERGIES TO HAVE BETTER QUALITY OF LIFE, FEEL LESS SOCIALLY OUT CASTED AND MOST IMPORTANTLY REDUCE THE POTENTIAL FOR DEATH FROM ACCIDENTAL PROCEDURE. MOONLIGHT THERAPEUTICS IS DEVELOPING A TARGETED WAY TO ADMINISTER ALLERGENS INTO THE TOP SKIN LAYERS TO DESENSITIZE AN ALLERGIC PATIENT, CALLED TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY IN THE SKIN (TASIS). DELIVERY IS ACHIEVED USING MICRONEEDLES APPLIED TO THE SKIN FOR A FEW MINUTES, WHICH ARE MINIMALLY INVASIVE AND PAINLESS. IMPORTANTLY MICRONEEDLES CAN DELIVER INTO TOPMOST SKIN LAYERS WITH HIGH PRECISION AND REPRODUCIBILITY. BECAUSE TASIS DELIVERS SMALL DOSES IN THE TOP AND SUPERFICIAL SKIN LAYERS, THE APPROACH IS EXPECTED TO PRODUCE LITTLE TO NO SYSTEMIC ADVERSE REACTIONS. THE COMPANY'S FIRST TREATMENT IS FOCUSED ON PEANUT ALLERGY AND IS CALLED TASIS-PEANUT. WE HAVE DEMONSTRATED EFFICACY OF OUR APPROACH IN A PRE-CLINICAL MOUSE MODEL OF PEANUT SENSITIZATION. THIS FAST-TRACK (PHASE1/PHASE2) SBIR GRANT (U44) APPLICATION IS FOR A PHASE 1 SAFETY AND TOLERABILITY STUDY TO BE CONDUCTED IN PARTNERSHIP BETWEEN THE COMPANY AND COLLABORATING CLINICAL RESEARCH SITES. THE OBJECTIVE OF THE U44 FAST- TRACK GRANT IS TO PREPARE DOCUMENTS FOR (GRANT PHASE 1) AND CONDUCT (GRANT PHASE 2) A PHASE 1 CLINICAL TRIAL TO ASSESS THE SAFETY AND TOLERABILITY OF TASIS-PEANUT IN PEANUT ALLERGIC CHILDREN AND ADULTS. THE PHASE 2 PORTION OF THE GRANT ALSO INCLUDES AIMS GEARED TOWARDS PRODUCTION OF TASIS-PEANUT FOR THE CLINICAL TRIAL. THE COMPANY CURRENTLY HAS A R42 FAST-TRACK GRANT FOR THE PRE-CLINICAL DEVELOPMENT OF TASIS-PEANUT. OVERALL THIS GRANT WILL ENABLE EVALUATION OF THE SAFETY AND TOLERABILITY OF TASIS-PEANUT IN A FIRST-IN-HUMAN CLINICAL TRIAL. IT WILL SET THE STAGE FOR EVALUATION OF EFFICACY IN A PHASE 2 CLINICAL TRIAL.

MICRONEEDLE BASED TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY FOR TREATMENT OF PEANUT ALLERGIES - MICRONEEDLE BASED TARGETED ALLERGEN SPECIFIC IMMUNOTHERAPY FOR TREATMENT OF PEANUT ALLERGIES FOOD ALLERGIES AFFECT 15 MILLION PEOPLE IN THE USA AND 17 MILLION IN EUROPE. SIX MILLION CHILDREN, ROUGHLY 1 IN 13, IN THE USA HAVE AT LEAST ONE FOOD ALLERGY; THIS EQUATES TO AT LEAST 1 IN EVERY CLASSROOM. CURRENTLY, THERE ARE NO APPROVED THERAPIES FOR FOOD ALLERGIES ANYWHERE IN THE WORLD. FOOD ALLERGIES ARE EXPECTED TO GROW 10% ANNUALLY UNTIL 2022. IT IS ALSO COMMON FOR SOMEONE TO HAVE MORE THAN ONE ALLERGY. THIS IS A GROWING, UNDERSERVED GLOBAL MARKET THAT HAS FEW TREATMENT OPTIONS. A MEANINGFUL INITIAL THERAPY WOULD BE ONE THAT REDUCES THE CHANCE FOR ANAPHYLACTIC REACTION AFTER ACCIDENTAL EXPOSURE. BASED ON SURVEYS, ALLERGISTS AND PATIENTS BELIEVE A THERAPY THAT REDUCES THE CHANCE FOR ANAPHYLACTIC REACTION FROM ACCIDENTAL EXPOSURE IS MEANINGFUL AND WORTHWHILE. SUCH A THERAPY WILL HELP BRING PEACE OF MIND TO FAMILIES, ALLOW FOR CHILDREN AFFECTED BY FOOD ALLERGIES TO HAVE BETTER QUALITY OF LIFE, FEEL LESS SOCIALLY OUT CASTED AND MOST IMPORTANTLY REDUCE THE POTENTIAL FOR DEATH FROM ACCIDENTAL PROCEDURE. THE APPROXIMATE HEALTHCARE BURDEN PER PATIENT IS $3,000-4,000 PER YEAR. MOONLIGHT THERAPEUTICS IS DEVELOPING A TARGETED WAY TO ADMINISTER PEANUT ALLERGENS INTO THE TOP SKIN LAYERS TO DESENSITIZE AN ALLERGIC PATIENT. DELIVERY IS ACHIEVED USING MICRONEEDLES, WHICH ARE MINIMALLY INVASIVE AND PAINLESS. IMPORTANTLY MICRONEEDLES CAN DELIVER INTO TOPMOST SKIN LAYERS WITH HIGH PRECISION AND REPRODUCIBILITY. BECAUSE THE DELIVERY IS IN TOP AND SUPERFICIAL SKIN LAYERS, THE APPROACH IS EXPECTED TO PRODUCE LITTLE TO NO SYSTEMIC ADVERSE REACTIONS. WE HAVE DEMONSTRATED EFFICACY OF OUR APPROACH IN A PRE-CLINICAL MOUSE MODEL OF PEANUT SENSITIZATION. IN THIS STTR FAST-TRACK GRANT APPLICATION MOONLIGHT THERAPEUTICS HAS PROPOSED AIMS THAT WILL ALLOW IT TO FILE AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION WITH THE FDA FOR FIRST-IN-HUMAN TRIALS. IN PHASE 1, FOUR AIMS ARE PROPOSED TO DEVELOP PROCESSES FOR PRODUCING PEANUT ALLERGEN PROTEINS AND COATED MNS WITH STRICT QUALITY ASSURANCE AND OPERATING PROCEDURES THAT CAN BE TRANSFERRED TO CGMP PRODUCTION. AN EFFICACY STUDY IN ANIMALS IS ALSO PROPOSED IN PHASE 1. APPROPRIATE MILESTONES AND SUCCESS CRITERIA HAVE BEEN ESTABLISHED FOR PHASE-1. IN PHASE-2, FOUR AIMS ARE PROPOSED SO AS TO PERFORM NON-GLP (GOOD LABORATORY PRACTICES) AND GLP TOXICITY STUDIES, AND ESTABLISH PRODUCTION UNDER CGMP. IN ADDITION, ANIMAL STUDIES WILL BE DONE TO COMPARE MICRONEEDLES TO A CONVENTIONAL SKIN PATCH. AT THE CONCLUSION OF PHASE-2 AN IND APPLICATION WILL BE SUBMITTED TO THE FDA. OVERALL, THESE STUDIES WILL PROVIDE THE FOUNDATION TO SUPPORT THE DEVELOPMENT OF A NOVEL AND SAFER PEANUT ALLERGY IMMUNOTHERAPY TREATMENT.