POP BIOTECHNOLOGIES, LLC

7FCR8

2017-08-05

2016-08-05

2015-08-07

75N93023C00031

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AWARD

DEFINITIVE CONTRACT

599806.00

599806.00

599806.00

Department of Health and Human Services

2023-09-30

POP TECHNOLOGIES, INC., "MULTIVALENT QS-18 PROTEIN NANOPARTICLES FOR A BROADLY PROTECTIVE INFLUENZA VIRUS VACCINE".

541715: RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT NANOTECHNOLOGY AND BIOTECHNOLOGY)

AN12: HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

75N93019C00011

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AWARD

DEFINITIVE CONTRACT

599897.00

599897.00

599897.00

Department of Health and Human Services

2019-06-17

THE OBJECTIVE OF THIS CONTRACT IS TO UTILIZE A NEXT-GENERATION VACCINE ADJUVANT THAT INDUCES RAPID AND SERUM-STABLE SPONTANEOUS NANOLIPOSOME-ANTIGEN PARTICLEIZATION IN COMBINATION WITH MULTIPLE NATIVE FLEXIBLY LINKED (NFL) HIV ENVELOPE TRIMERS TO INDUCE HIGH LEVEL OF VIRUS-NEUTRALIZING ANTIBODIES FOLLOWING IMMUNIZATION.

541715: RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT NANOTECHNOLOGY AND BIOTECHNOLOGY)

AN12: R&D- MEDICAL: BIOMEDICAL (APPLIED RESEARCH/EXPLORATORY DEVELOPMENT)

2024-08-01

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Department of Health and Human Services

LIPOSOME-DISPLAYED PEPTIDE VACCINE AGAINST DISSEMINATED CANDIDIASIS BY CLINICALLY-RELEVANT CANDIDA SPECIES - PROJECT SUMMARY THE GOAL OF THIS PROPOSAL IS TO DEVELOP AN ANTI-CANDIDA PEPTIDE VACCINE THAT WORKS ALONE OR AS AN ADJUNCT TO ANTIFUNGAL DRUGS TO REDUCE FUNGAL BURDEN AND MORBIDITY DUE TO LIFE-THREATENING DISSEMINATED CANDIDIASIS, WHICH REMAINS THE MOST COMMON BLOODSTREAM INFECTION IN HOSPITALIZED PATIENTS IN THE US. DESPITE THE AVAILABILITY OF MODERN ANTIFUNGAL THERAPY, CRUDE MORTALITY IN THE LAST DECADE HAS REMAINED UNACCEPTABLY HIGH. IN PARTICULAR, C. AURIS IS A MULTIDRUG-RESISTANT (MDR), HEALTH CARE-ASSOCIATED FUNGAL PATHOGEN, AND HAS EMERGED AS THE FIRST FUNGAL PATHOGEN TO CAUSE A GLOBAL PUBLIC HEALTH THREAT. THERE ARE NO EFFECTIVE VACCINES FOR CANDIDA INFECTION OR INDEED FOR ANY FUNGI, AND SIGNIFICANT THERAPEUTIC CHALLENGES REMAIN. ADDITIONALLY, CURRENT ANTI-CANDIDA TREATMENTS ARE PLAGUED BY SIGNIFICANT TOXICITY AND POOR EFFICACY, ESPECIALLY TREATING DRUG RESISTANT CANDIDA SPECIES IN IMMUNOCOMPROMISED PATIENTS. THUS, THERE IS A PRESSING AND URGENT NEED FOR DISEASE PREVENTION THROUGH ACTIVE AND PASSIVE IMMUNIZATION STRATEGIES. WE PREVIOUSLY IDENTIFIED FBA AND MET6 (FBA, DERIVED FROM FRUCTOSE- BISPHOSPHATE ALDOLASE AND MET6, DERIVED FROM 5-METHYLTETRAHYDROPTEROYLTRIGLUTAMATE HOMOCYSTEINE METHYLTRANSFERASE) PEPTIDE IMMUNOGENS THAT INDUCE PROTECTIVE ANTIBODIES IN A MOUSE MODEL OF CANDIDIASIS. TO FURTHER ADVANCE THIS ANTIFUNGAL PEPTIDE VACCINE TOWARD HUMAN CLINICAL APPLICATION, A NOVEL PARTICLE-INDUCING LIPOSOME SYSTEM CONTAINING COBALT-PORPHYRIN-PHOSPHOLIPID (COPOP) WILL BE USED AS AN ULTRAPOTENT VACCINE ADJUVANT PLATFORM FOR FBA AND MET6 PEPTIDES. IN PRELIMINARY DATA, IMMUNIZATION OF MICE WITH LIPOSOME-DISPLAYED FBA / MET6 PEPTIDES OR TWO-PEPTIDE COMBINATION INDUCED ROBUST IGG RESPONSES AND BALANCED TH1/TH2 IMMUNITY OR TH1-BAISED WHICH WOULD PLAY A KEY ROLE CONTRIBUTED TO RESISTANCE TO INVASIVE CANDIDIASIS.

300000.00

0.00

0.00

2024-09-05

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Department of Health and Human Services

ADVANCED TESTING OF A HEXAVALENT ADJUVANTED INFLUENZA VACCINE PLATFORM FOR DOSE SPARING, MULTIPLEXING, AND RAPID DEPLOYMENT - ABSTRACT INFLUENZA IS THE CAUSE OF CONSIDERABLE MORBIDITY AND MORTALITY GLOBALLY. DESPITE IMMUNIZATION BEING THE MOST EFFECTIVE AND ECONOMICAL PROPHYLACTIC APPROACH, VACCINES OFTEN PROVIDE LESS THAN OPTIMAL DEFENSE AGAINST AN INFLUENZA VIRUS INFECTION AND ILLNESS. WHILE HEMAGGLUTININ (HA) IS THE PRIMARY TARGET OF INFLUENZA VACCINES, IT IS ALSO KNOWN THAT THE OTHER MAJOR SURFACE PROTEIN, NEURAMINIDASES (NA) INDUCES PROTECTIVE ANTIBODIES. THIS DIRECT TO PHASE 2 SBIR PROPOSAL CONTINUES OUR DEVELOPMENT AND CHARACTERIZATION OF A UNIQUE VACCINE PLATFORM THAT HAS BEEN FORMULATED BY POP BIO. THIS PLATFORM CONSISTS OF FABRICATING LIPID BILAYER NANOLIPOSOMES WITH A COBALT- PORPHYRIN MOIETY INTERCALATED INTO THE BILAYER (COPOP) ALONG WITH A MONOPHOSPHORYL LIPID A, A TLR4-BASED VACCINE ADJUVANT, AND A SAPONIN QS-21. COPOP ENABLES SPONTANEOUS NANOLIPOSOME ADJUVANT PARTICLE FORMATION (SNAP). WHEN SNAP LIPOSOMES ARE COMBINED WITH HIS-TAGGED RECOMBINANT TRIMERIC HAS AND TETRAMERIC NAS, A MOSAIC NANOPARTICLE VACCINE CANDIDATE, SNAP-FLU IS FORMED. THE HIS-TAG STABLY INSERTS INTO THE BILAYER BY ASSOCIATION WITH THE COBALT PRODUCING NANOLIPOSOMES DECORATED WITH THE IMMUNOGENIC INFLUENZA ANTIGENS. IN PRELIMINARY DATA, WE HAVE ESTABLISHED THAT HA AND NA PROTECT MICE FROM LETHAL H1N1, H3N2 AND B STRAIN INFLENZA VIRUS CHALLENGE, WHILE EVEN BETTER PROTECTION IS OBSERVED WITH THE MULTIVALENT SNAP-FLU NANOPARTICLE VACCINE. IT HAS ALSO BEEN SHOWN THAT THIS PLATFORM ALLOWS FOR THE USE OF MUCH LESS ANTIGEN IN THE VACCINE (ANTIGEN SPARING) IN ADDITION TO THE CAPACITY FOR MULTIPLEXING WITH NUMEROUS ANTIGENS FROM DIFFERENT INFLUENZA STRAINS. THIS STUDY WILL INVOLVE POP BIO PRODUCING AND CHARACTERIZING THE PHYSICAL AND CHEMICAL PROPERTIES OF SNAP-FLU. POP BIO WILL INTERACT WITH THE UNIVERSITY AT BUFFALO, BIOQUAL, AND TEXAS BIOMEDICAL RESEARCH INSTITUTE TO ASSESS THE LEVEL OF PROTECTION OF SNAP-FLU AGAINST CHALLENGE WITH MOUSE-ADAPTED STRAINS OF INFLUENZA IN MICE, HUMAN INFLUENZA STRAINS IN FERRETS, AND HUMAN INFLUENZA STRAINS IN NON-HUMAN PRIMATES. THE AMOUNT OF ANTIGEN-SPARING WILL BE DETERMINED AS WILL HEAD-TO-HEAD COMPARISON WITH OTHER COMMERCIALLY AVAILABLE INFLUENZA VACCINE FORMULATIONS. THIS DIRECT TO PHASE 2 SBIR PROPOSAL WILL EXPAND DEVELOPMENT OF THIS PLATFORM TO NOVEL INFLUENZA ANTIGEN DESIGNS IN PREPARATION FOR CLINICAL TRANSLATION.

950225.00

0.00

0.00

2024-03-27

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Department of Health and Human Services

CLINICAL TRANSLATION OF INTERSTITIAL CHEMOPHOTOTHERAPY WITH LIGHT-ACTIVATED NANOPARTICULATE DOXORUBICIN - SUMMARY POP BIO’S GOAL IS TO COMMERCIALIZE INTERSTITIAL CHEMO-PHOTOTHERAPY (I-CPT) AS A NEW THERAPEUTIC OPTION FOR LOCALLY ADVANCED LIVER CANCERS. DOXORUBICIN (DOX) CAN BE ACTIVELY LOADED INTO LONG CIRCULATING, SERUM-STABLE, PORPHYRIN- PHOSPHOLIPID (POP) LIPOSOMES AND BE RELEASED WITH 665-NM LASER LIGHT (PHOTODOX). THIS APPROACH LEADS TO VASTLY ENHANCED DRUG ACCUMULATION IN IRRADIATED TISSUES, RESULTING IN ULTRAPOTENT TUMOR ABLATION. IN THE PHASE I STTR, WE EMPLOYED THIS DOSIMETRY-TREATMENT PLANNING PLATFORM TO GUIDE LIGHT ADMINISTRATION OF I-CPT WITH PHOTODOX. WE DEMONSTRATED THAT THIS TREATMENT PLANNING WITH LIGHT DOSIMETRY IS EFFECTIVE IN ABLATING LARGE ORTHOTOPIC HEPATOCELLULAR CARCINOMA TUMORS IN RATS. THE PHASE II STTR FOCUSES ON OPTIMIZING TREATMENT PLANNING WITH LIGHT DOSIMETRY USING LARGER (~50CM3) TUMORS IN WOODCHUCKS AS WELL AS DEVELOPING A GLP TOXICOLOGY PACKAGE AS PART OF AN FDA IND SUBMISSION BASED ON OUR PRE-IND MEETING. POP BIO HAS PREVIOUSLY GENERATED NON-GLP TOXICITY DATA OF PHOTODOX IN RATS INCLUDING CURSORY ESTABLISHMENT OF THE MAXIMUM TOLERATED DOSE. IN 2019, POP BIO HELD A PRE-IND MEETING WITH THE FDA, WHO CONFIRMED THE SUITABILITY OF THE 505(B)(2) ROUTE FOR COMPONENTS OF PHOTODOX AND PROVIDED GUIDANCE ABOUT THE REQUIRED TOXICOLOGICAL STUDIES REQUIRED PRIOR TO FIRST-IN-HUMAN STUDIES. THE TOXICOLOGY PROGRAM WILL ALSO GENERATE SERA SAMPLES IN TWO ANIMAL MODELS THAT NEED TO BE ANALYZED BY LC/MS (THE REQUEST OF THIS APPLICATION). IN THIS COMMERCIAL READINESS PROGRAM APPLICATION WE PROPOSE TO FURTHER ADVANCE I-CPT WITH PHOTODOX TOWARDS AN IND FOR ENABLING FUTURE CLINICAL STUDIES BY ASSESSING THE PHARMACOKINETICS OF DOX, DOXORUBICINOL (DOX-OL), THE MAJOR METABOLITE OF DOX, AND PPA-LIPID, THE PHOTOACTIVE EXCIPIENT OF PHOTODOX, AS WELL AS THE STABILITY OF PHOTODOX UNDER ACCELERATED STORAGE CONDITIONS. THESE TASKS ARE REQUIRED BY THE FDA AS PART OF OUR IND PACKAGE. THE SERA SAMPLES TO ASSESS PHARMACOKINETICS HAVE BEEN GENERATED AS PART OF THE PARENT PHASE II STTR AWARD’S GLP TOXICOLOGY PROGRAM. UNDER GLP CONDITIONS USING LC/MS, THE SERA CONCENTRATION OF FREE DOX, LIPOSOME ENTRAPPED DOX, DOX-OL, AND PPA-LIPID WILL BE MEASURED. SUBSEQUENT PHARMACOKINETIC ANALYSIS, AS PART OF THIS APPLICATION, WILL BE PERFORMED BY ROSWELL PARK’S BIOANALYTICS, METABOLOMICS & PHARMACOKINETICS (BMPK) SHARED RESOURCE. THE RESULT OF THIS APPLICATION WILL BE THE GENERATION OF DATA DIRECTLY USED IN POP BIO’S IND PACKAGE GENERATION. IF SUCCESSFUL, I-CPT WITH PHOTODOX STANDS TO BENEFIT THE MAJORITY OF NEW LIVER CANCER PATIENTS, WHO HAVE INOPERABLE AND PROBLEMATIC PRIMARY TUMORS.

249873.00

0.00

0.00

2023-09-14

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Department of Health and Human Services

MOSAIC DISPLAY OF MULTIVALENT TAU AND A-BETA PEPTIDES ON IMMUNOGENIC SNAP LIPOSOMES - PROJECT SUMMARY/ABSTRACT ALZHEIMER’S DISEASE (AD) CURRENTLY AFFECTS ~6.2 MILLION AMERICANS, AND THIS NUMBER IS PROJECTED TO INCREASE TO 14 MILLION BY 2060 UNLESS NOVEL TREATMENTS OR INTERVENTIONS TO PREVENT OR DELAY THE ONSET OF AD ARE IDENTIFIED. HARNESSING THE IMMUNE SYSTEM TO PREVENT OR REMOVE ASS AND/OR TAU PATHOLOGIES REPRESENTS A PROMISING DISEASE- MODIFYING THERAPEUTIC APPROACH FOR THE TREATMENT OF AD. CURRENTLY, ALL THE PREVIOUS AND ONGOING IMMUNOTHERAPY STUDIES TARGET ONLY ONE EPITOPE OF EITHER ASS OR TAU PROTEIN. BECAUSE MOST AD CASES ARE MULTIFACTORIAL, AND SPORADIC AD IS CAUSED BY MULTIPLE MECHANISMS, IT IS UNLIKELY THAT A SINGLE TARGET WILL BE SUFFICIENT TO STOP OR REDUCE THE PROGRESSION OF AD. BASED ON THE ROLE OF ASS AND TAU IN THE PATHOGENESIS OF AD, IMMUNOTHERAPY SIMULTANEOUSLY TARGETING MULTIPLE EPITOPES OF BOTH ASS AND TAU MAY PRESENT A PROMISING APPROACH FOR AD DRUG DEVELOPMENT. THE LONG-TERM OBJECTIVE OF THE PROPOSED PROJECT IS TO DEVELOP A NOVEL, EFFECTIVE VACCINE FOR AD. THE SPECIFIC GOAL OF THIS PROJECT IS TO DEVELOP A MULTIVALENT "MOSAIC" VACCINE, TERMED SNAP-AD, TARGETING MULTIPLE EPITOPES OF ASS AND TAU SIMULTANEOUSLY WITH THE SPONTANEOUS NANOLIPOSOME ANTIGEN PARTICLE (SNAP) PLATFORM AND TO INVESTIGATE ITS THERAPEUTIC EFFECTS FOR TREATING AD IN A TRANSGENIC MOUSE MODEL. OUR WORKING HYPOTHESIS IS THAT IMMUNOTHERAPY SIMULTANEOUSLY TARGETING THE MULTIPLE EPITOPES OF BOTH ASS AND TAU IS A PROMISING APPROACH FOR DEVELOPING EFFECTIVE AD THERAPEUTICS. TO TEST THIS NOVEL HYPOTHESIS, WE PROPOSE THREE SPECIFIC AIMS: (1) FORMULATE AND CHARACTERIZE SNAP-AD, A MOSAIC NANOPARTICLE VACCINE COMPRISING THREE TAU AND TWO ASS PEPTIDE EPITOPES. POP BIO WILL FORMULATE AND CHARACTERIZE THE PENTAVALENT SNAP-AD VACCINE SIMULTANEOUSLY TARGETING TAU AT ONE N-TERMINAL REGION (TAU 6-18), ONE MID-REGION (TAU 184-195), AND ONE C-TERMINAL REGION (PS396/S404), AS WELL AS N-TERMINAL ASS (1-14) AND N-TERMINAL PYROGLUTAMATE ASS (PE3-14), AND DEVELOP A MANUFACTURING METHOD WITH REPRODUCIBLE BATCH-TO-BATCH CHARACTERIZATION AND THE PROTOCOLS TO QUANTIFY EACH PEPTIDE AND IMMUNOGENIC LIPID COMPONENT. (2) ASSESS SNAP-AD FOR IMMUNE INTERFERENCE, TH1-BIASED CELLULAR RESPONSE, NEUROINFLAMMATION, AND ANTIBODIES’ DURABILITY. IMMUNE INTERFERENCE WILL BE ASSESSED AMONGST THE 5-PLEX IMMUNOGENS, AND IF OBSERVED, POSSIBLE RAMIFICATION METHODS WILL BE TESTED. CELLULAR RESPONSES, TH1/TH2 BIAS OF THE ANTIBODY RESPONSE, AND THE ANTIBODIES’ DURABILITY INDUCED BY SNAP-AD WILL BE PROBED. (3) DETERMINE SNAP- AD EFFICACY USING THE 3XTG-AD MOUSE MODEL. TEN-MONTH-OLD 3XTG-AD MICE AND AGE-MATCHED WILD-TYPE MICE WILL BE IMMUNIZED WITH SNAP-AD AND BOOSTED TWICE WITH A FOUR-WEEK INTERVAL. ONE MONTH AFTER THE THIRD DOSE OF IMMUNIZATION, BEHAVIORAL TESTS, INCLUDING GENERAL BEHAVIOR, ANXIETY, LOCOMOTOR ACTIVITY, AND COGNITIVE FUNCTION, WILL BE CONDUCTED, AND ASS AND TAU PATHOLOGY WILL BE INVESTIGATED BOTH BIOCHEMICALLY/IMMUNOHISTOCHEMICALLY. THE PROPOSED STUDIES WILL REVEAL WHETHER THE MULTIVALENT IMMUNOTHERAPY APPROACH HAS PROMISING THERAPEUTIC EFFECTS ON AD PATHOLOGIES AND COGNITIVE IMPAIRMENT. A POSITIVE OUTCOME OF THIS PROJECT WOULD POTENTIALLY LEAD TO A NOVEL VACCINE FOR THE TREATMENT OF AD, WHICH WILL IMPROVE THE QUALITY OF LIFE OF INDIVIDUALS WITH AD.

496569.00

0.00

0.00

2021-07-09

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Department of Health and Human Services

DEVELOPING A THERMOSTABLE SARS-COV-2 RBD-PARTICLE VACCINE - PROJECT SUMMARY THE CORONAVIRUS DISEASE 2019 (COVID-19) GLOBAL PANDEMIC CAUSED BY SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) IS UNPRECEDENTED IN OUR LIFETIME AND HAS CAUSED MAJOR SOCIAL, ECONOMIC AND HUMAN SUFFERING. GLOBALLY, THERE HAVE BEEN 76,858,506 CONFIRMED CASES, LEADING TO 1,711,498 DEATHS AS REPORTED BY THE WHO THROUGH DECEMBER 2020. THE ROLLOUT OF FDA-AUTHORIZED PFIZER (-80 °C STORAGE) AND MODERNA (-20 °C STORAGE) VACCINES HAS HIGHLIGHTED THE CHALLENGES POSED BY LOW REQUISITE STORAGE TEMPERATURES. ELIMINATION OF COLD CHAIN REQUIREMENTS FOR EMERGING VACCINE SOLUTIONS COULD FACILITATE DISTRIBUTION AND PROVIDE CONSIDERABLE SUPPLY CHAIN COST SAVINGS. TO OVERCOME COLD CHAIN REQUIREMENTS, POP BIOTECHNOLOGIES PROPOSES TO INVESTIGATE A LYOPHILIZATION STRATEGY FOR ITS NOVEL VACCINE ADJUVANT PLATFORM THAT INDUCES SPONTANEOUS ANTIGEN PARTICLES, USING THE RECEPTOR-BINDING DOMAIN (RBD) OF THE SARS COV-2 SPIKE (S) PROTEIN. WE WERE AMONGST THE FIRST TO SHOW THAT A LIQUID FORM OF RBD PARTICLES POTENTLY INCREASES SARS-COV-2 NEUTRALIZING ANTIBODIES BY ORDERS OF MAGNITUDE COMPARED TO THE SOLUBLE ANTIGEN. OUR VACCINE PLATFORM INDUCES THE PARTICLE FORMATION OF WELL- CHARACTERIZED HIS-TAGGED ANTIGENS BY SIMPLE ADMIXING WITH LIPOSOMES THAT CONTAIN SMALL AMOUNTS OF COBALT PORPHYRIN-PHOSPHOLIPID (COPOP) AND THE CLINICAL ADJUVANTS MONOPHOSPHORYL LIPID A AND QS-21. COPOP LIPOSOMES GIVE RISE TO RAPID ANTIGEN PARTICLEIZATION THAT IS STABLE IN BIOLOGICAL MEDIA. IN THIS COLLABORATIVE PHASE I SBIR PROPOSAL, WE WILL ASSESS THE IMPACT OF LYOPHILIZATION ON THE CONFORMATIONAL AND THERMAL STABILITY OF THE RESULTING LYOPHILIZED VACCINE, EVALUATED BY BIOCHEMICAL AND BIOPHYSICAL ASSAYS, AND ITS EFFICACY WILL BE ASSESSED BY FUNCTIONAL IMMUNOGENICITY IN MICE. THIS PROJECT WILL ASSESS THE FEASIBILITY OF BREAKING THE COLD-CHAIN REQUIREMENTS FOR A NEXT-GENERATION PARTICLE VACCINE SYSTEM, WHICH COULD BE CRITICAL FOR RESOURCE-LIMITED SETTINGS. IN COLLABORATION WITH THE TEXAS BIOMEDICAL RESEARCH INSTITUTE (TBRI), A TRANSGENIC MOUSE MODEL FOR SARS-COV- 2 INFECTION WILL BE USED TO STUDY THE THERMOSTABILITY ON PROTECTION INDUCED BY THE LYOPHILIZED, RBD PARTICLE VACCINE. 1

599982.00

0.00

0.00