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  5. THERAPYX, INC.

THERAPYX, INC.

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Company Details

Name: THERAPYX, INC.
Jurisdiction: New York
Legal type: DOMESTIC BUSINESS CORPORATION
Status: Active
Date of registration: 26 Sep 2001 (24 years ago)
Entity Number: 2683576
ZIP code: 14203
County: Erie
Place of Formation: New York
Address: B3-304, 701 Ellicott Street, BUFFALO, NY, United States, 14203
Principal Address: B3-304 CBLS, 701 Ellicott Street, buffalo, NY, United States, 14203

Shares Details

Shares issued 200

Share Par Value 0

Type NO PAR VALUE

DOS Process Agent

Name Role Address
the corporation DOS Process Agent B3-304, 701 Ellicott Street, BUFFALO, NY, United States, 14203

Chief Executive Officer

Name Role Address
NEJAT EGILMEZ Chief Executive Officer B3-304 CBLS, 701 ELLICOTT STREET, BUFFALO, NY, United States, 14203

Links between entities

Type:
Headquarter of
Company Number:
0925652
State:
KENTUCKY
KENTUCKY profile:
THERAPYX, INC. (KY)

Unique Entity ID

Unique Entity ID:
CHPPVKPN2VE1
CAGE Code:
47VT7
UEI Expiration Date:
2026-01-09

Business Information

URL:
therapyxinc.com
Division Name:
THERAPYXINC
Activation Date:
2025-01-13
Initial Registration Date:
2005-11-21

Commercial and government entity program

CAGE number:
47VT7
Status:
Obsolete
Type:
Non-Manufacturer
CAGE Update Date:
2025-01-13
SAM Expiration:
2026-01-09

Contact Information

POC:
DOMINICK AUCI
Corporate URL:
therapyxinc.com

History

Start date End date Type Value
2024-03-05 2024-03-05 Address 4786 ENSER ROAD, EDEN, NY, 14057, USA (Type of address: Chief Executive Officer)
2024-03-05 2024-03-05 Address B3-304 CBLS, 701 ELLICOTT STREET, BUFFALO, NY, 14203, USA (Type of address: Chief Executive Officer)
2024-03-05 2024-03-05 Address 41 GOLDFINCH DRIVE, NANTUCKET, MA, 02554, USA (Type of address: Chief Executive Officer)
2024-02-16 2024-02-16 Address B3-304 CBLS, 701 ELLICOTT STREET, BUFFALO, NY, 14203, USA (Type of address: Chief Executive Officer)
2024-02-16 2024-02-16 Address 41 GOLDFINCH DRIVE, NANTUCKET, MA, 02554, USA (Type of address: Chief Executive Officer)

Filings

Filing Number Date Filed Type Effective Date
240305003367 2024-03-05 AMENDMENT TO BIENNIAL STATEMENT 2024-03-05
240216002264 2024-02-16 AMENDMENT TO BIENNIAL STATEMENT 2024-02-16
240207001622 2024-02-06 CERTIFICATE OF CHANGE BY ENTITY 2024-02-06
240201037989 2024-02-01 BIENNIAL STATEMENT 2024-02-01
130920002182 2013-09-20 BIENNIAL STATEMENT 2013-09-01

USAspending Awards / Financial Assistance

Date:
2024-07-29
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
OMV VACCINE AGAINST GONORRHEA - ABSTRACT GONORRHEA IS A GENITAL TRACT INFECTION CAUSED BY NEISSERIA GONORRHOEAE, WHICH CAN BE ACQUIRED REPEATEDLY AND DOES NOT NATURALLY INDUCE A STATE OF SPECIFIC PROTECTIVE IMMUNITY AGAINST REINFECTION. DESPITE PUBLIC HEALTH MEASURES, GONORRHEA PERSISTS AT AN UNACCEPTABLY HIGH FREQUENCY, AND THERE IS NO VACCINE AGAINST IT. THE CONTINUING EMERGENCE OF ANTIBIOTIC RESISTANCE THREATENS TO RENDER GONORRHEA UNTREATABLE. OUR FINDINGS HAVE REVEALED THAT N. GONORRHOEAE SUBVERTS THE IMMUNE SYSTEM FOR ITS OWN BENEFIT BY INDUCING HIGH LEVELS OF THE IMMUNO-REGULATORY CYTOKINE, INTERLEUKIN-10 (IL-10). USING THE ESTABLISHED MURINE MODEL OF VAGINAL GONOCOCCAL INFECTION, WE PROPOSE TO INVESTIGATE A NOVEL STRATEGY OF VACCINATION AGAINST N. GONORRHOEAE, EXPLOITING NEUTRALIZING ANTIBODY AGAINST IL-10 ENCAPSULATED IN BIODEGRADABLE MICRO-PARTICLES (GNEXA10®) AS ADJUVANT. AS VACCINE ANTIGEN, OUTER MEMBRANE VESICLES (OMV) DERIVED FROM A DOUBLE- MUTANT (DM) STRAIN OF N. GONORRHOEAE, DESIGNED TO REDUCE ADVERSE RESPONSES TO ADMINISTRATION IN HUMANS, WILL BE USED. WE WILL DETERMINE THE ROLE OF SERUM AND MUCOSAL ANTIBODY AND T-CELL CYTOKINE RESPONSES TO INTRA-NASAL (I.N.) IMMUNIZATION WITH DMOMV PLUS GNEXA10®, IN RESISTANCE TO CHALLENGE INFECTION WITH BOTH HOMOLOGOUS AND HETEROLOGOUS STRAINS. PERSISTENCE OF IMMUNITY AND RECALL OF MEMORY RESPONSES AT INCREASING TIME INTERVALS AFTER IMMUNIZATION WILL BE EVALUATED. FUNCTIONAL ANTIBODIES ACTIVE AGAINST N. GONORRHOEAE WILL BE ASSESSED IN VITRO. THIS WORK WILL PROVIDE PROOF-OF-PRINCIPLE FOR A VACCINE BASED ON GONOCOCCAL DMOMVS AND GNEXA10®. FUTURE SBIR PHASE II STUDIES WILL FURTHER ELUCIDATE MECHANISMS OF CROSS-PROTECTION AGAINST DIVERSE STRAINS OF N. GONORRHOEAE, AND VALIDATE THE EXPECTED APPLICABILITY OF SCALED-UP VACCINE DEVELOPMENT, EVALUATING YIELD, BIOACTIVITY, BATCH-TO-BATCH CONSISTENCY, AND SHELF STABILITY. THIS PROPOSAL IS PART OF OUR COMPANY’S RESPONSE TO THE CDC’S AND WHO’S CALLS FOR DEVELOPMENT OF NOVEL VACCINE APPROACHES IN THE FACE OF THE PUBLIC HEALTH THREAT POSED BY ANTIBIOTIC-RESISTANT N. GONORRHOEAE.
Obligated Amount:
300000.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2024-03-25
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
IL-10NANOCAP® FOR THERAPY OF FAMILIAL ADENOMATOUS POLYPOSIS - ABSTRACT THIS SBIR PHASE IIB PROPOSAL BUILDS ON THE SUCCESS OF OUR FAST-TRACK AWARD SUPPORTING THE PRE-CLINICAL DEVELOPMENT OF FAPXIL, AN ORAL SUSTAINED-RELEASE MICRO-PARTICULATE FORMULATION OF INTERLEUKIN-10 FOR THE TREATMENT OF FAMILIAL ADENOMATOUS POLYPOSIS (FAP). THE PHASE I PORTION OF OUR FAST-TRACK PROJECT PROVIDED VALIDATION OF OUR LARGE-BATCH METHODS AND ACTIVITY IN A CLINICALLY-RELEVANT MURINE MODEL OF HUMAN FAP. THE PHASE II SEGMENT FURTHER OPTIMIZED THE TREATMENT PROTOCOL, DEFINED THE LONG-TERM THERAPEUTIC POTENTIAL AND ASSESSED POTENTIAL EFFECTS OF LONG-TERM TREATMENT ON LOCAL AND SYSTEMIC IMMUNE HOMEOSTASIS. ADDITIONAL PHASE II TASKS INCLUDED PRODUCTION OF MULTIPLE SCALE-UP BATCHES FOR VALIDATION OF BATCH-TO-BATCH CONSISTENCY, LONG-TERM STABILITY ANALYSIS, TRANSFER OF MANUFACTURING METHODS TO A CMO WITH GMP CAPABILITY, AND A TYPE C PRE-IND MEETING WITH THE FDA TO INFORM FUTURE TOXICOLOGY. AGENCY RECOMMENDATIONS AND RESPONSES TO OUR INTERROGATIVES FORM THE AIMS OF THIS PHASE IIB APPLICATION TO CONTINUE THE DEVELOPMENT OF FAPXIL® TOWARDS CLINICAL TRIALS IN FAP PATIENTS. TO THIS END, AIM 1 WILL CONTINUE PHARMACEUTICAL QUALITY AND DEVELOPMENT ACTIVITIES; AIM 2 WILL ESTABLISH SAFETY, TOLERABILITY AND PK OF FAPXIL IN NON-HUMAN PRIMATES; AIM 3 WILL COMPLETE A TYPE B PRE-IND MEETING WITH THE US FDA; AIM 4 WILL ASSESS INVESTIGATIONAL NEW DRUG (IND) READINESS AND SUBMIT AN ORPHAN-DRUG DESIGNATION REQUEST FOR FAPXIL. THE AIMS PROPOSED ABOVE WILL ENABLE THERAPYX, INC. TO CONTINUE PRE-CLINICAL WORK REQUIRED TO OBTAIN IND APPROVAL FOR THIS FIRST-IN-CLASS ORAL BIOLOGIC. SUBSEQUENT PRODUCTION OF CLINICAL GRADE DRUG PRODUCT AND IND SUBMISSION WILL BE SUPPORTED VIA NIH'S SBIR COMMERCIALIZATION READINESS PROGRAM AND COMPANY FUNDS.
Obligated Amount:
5216444.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2016-09-02
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
ORAL SUSTAINED-RELEASE IL-10 MICROSPHERES FOR THERAPY OF IBD
Obligated Amount:
295831.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2024-03-25
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
EXPERIMENTAL GONOCOCCAL VACCINE - ABSTRACT GENITAL TRACT INFECTION WITH NEISSERIA GONORRHOEAE DOES NOT INDUCE A STATE OF SPECIFIC PROTECTIVE IMMUNITY AND IT CAN BE ACQUIRED REPEATEDLY. DESPITE PUBLIC HEALTH MEASURES, THE DISEASE PERSISTS AT AN UNACCEPTABLY HIGH FREQUENCY; THERE IS NO VACCINE AGAINST IT, AND RESISTANCE EVEN TO THE LATEST GENERATIONS OF ANTIBIOTICS CONTINUES TO EMERGE. OUR SBIR PHASE I WORK ESTABLISHED PROOF-OF-PRINCIPLE THAT INTRA-VAGINAL IMMUNIZATION WITH A SUSTAINED-RELEASE INTERLEUKIN-12 MICROSPHERE FORMULATION PLUS PROPRIETARY GONOCOCCAL (GC) OUTER MEMBRANE VESICLES (NGOXIM, PREVIOUSLY GVAX12) INDUCES DURABLE TH1-DRIVEN ADAPTIVE IMMUNE RESPONSES THAT PROTECT MICE AGAINST GENITAL TRACT INFECTION WITH N. GONORRHOEAE. THOSE STUDIES DEMONSTRATED: (I) INDUCTION OF GC-SPECIFIC TH1 CELLS, (II) GENERATION OF ANTI-GC ANTIBODIES IN SERUM AND GENITAL TRACT SECRETIONS, (III) PROTECTION AGAINST DIVERSE STRAINS OF N. GONORRHOEAE, (IV) RECALL OF SPECIFIC ANTIBODIES AND REACTIVATION OF T CELLS AFTER CHALLENGE INFECTION, AND (V) DURATION OF PROTECTION AGAINST INFECTION FOR AT LEAST 6 MONTHS. PROTECTION DEPENDED UPON BOTH ANTIBODIES AND IFNΓ PRODUCTION. IN SBIR PHASE II, WE ESTABLISHED EFFICACY OF INTRANASAL (I.N.) IMMUNIZATION IN MICE AND, IMPORTANTLY, IN NON-HUMAN PRIMATES. WE CONFIRMED SIMILAR IFNΓ PRODUCTION AND GENERATION OF GC- SPECIFIC ANTIBODIES AND BY THIS ROUTE, DEMONSTRATED ACTIVITY AGAINST ADDITIONAL ANTIGENICALLY DIVERSE STRAINS OF N. GONORRHOEAE, INCLUDING CLINICAL ISOLATES, AND SHOWED FUNCTIONAL ANTIBODY ACTIVITY AGAINST GC IN BACTERICIDAL ASSAYS. FINALLY, WE CONCLUDED A TYPE C PRE-PRE-IND MEETING WITH THE FDA, GARNERING AGENCY AGREEMENT WITH OUR SINGLE SPECIES PRIMATE TOXICOLOGY PLANS. THE SPECIFIC AIMS OF THIS PHASE IIB APPLICATION ARE PARTIALLY BASED ON AGENCY RECOMMENDATIONS COMMUNICATED DURING THAT MEETING AND THE NEED TO OPTIMIZE NGOXIM FOR HUMAN APPLICATION. IN AIM 1 NGOXIM WILL BE FURTHER OPTIMIZED IN NON-HUMAN PRIMATES USING THE I.N. ROUTE IN PREPARATION FOR HUMAN TRIALS. AIM 2 STUDIES WILL CONCLUDE FDA-COMPLIANT PHARMACEUTICAL QUALITY AND DEVELOPMENT ACTIVITY FOR THE VACCINE COMPONENTS. UPON SUCCESSFUL COMPLETION OF AIMS 1 AND 2, THERAPYX WILL REQUEST A TYPE B MEETING WITH THE FDA TO CONFIRM THAT THE COMPLETED NON-CLINICAL IND-ENABLING PROGRAM, INCLUDING AN NHP TOXICOLOGY STUDY PLAN AND PRELIMINARY CLINICAL STUDY DESIGN, IS SUFFICIENT TO SUPPORT AN IND (AIM 3). IN AIM 4, FOLLOWING FDA GUIDANCE AND THE RESULTS OF OUR TYPE B MEETING, WE WILL USE VALIDATED PRODUCTS GENERATED IN AIM 2 TO EVALUATE INITIAL SERUM PHARMACOKINETICS (PK) AND TOXICITY PROFILES OF NGOXIM IN CYNOMOLGUS MONKEYS. THE OVERALL GOAL OF THIS PROJECT IS TO PRODUCE THE WORLD'S FIRST PROPHYLACTIC VACCINE AGAINST GENITAL TRACT INFECTION WITH NEISSERIA GONORRHOEAE.
Obligated Amount:
4601089.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2014-12-17
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
EXPERIMENTAL GONOCOCCAL VACCINE
Obligated Amount:
271000.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00

Trademarks Section

Serial Number:
88225340
Mark:
NGOXIM
Status:
ABANDONED - NO STATEMENT OF USE FILED
Mark Type:
TRADEMARK
Application Filing Date:
2018-12-11
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
NGOXIM
USPTO Link:
View Trademark Status and Document Retrieval (TSDR)

Goods And Services

For:
Pharmaceuticals, namely, anti-infectives; Vaccines; Drug delivery agents consisting of compounds that facilitate delivery of a wide range of pharmaceuticals; Drug delivery agents in the form of capsules that provide controlled release of the active ingredients for a wide variety of pharmaceuticals;...
International Classes:
005 - Primary Class
Class Status:
Active
Serial Number:
87854413
Mark:
EXSTAM
Status:
ABANDONED - NO STATEMENT OF USE FILED
Mark Type:
TRADEMARK
Application Filing Date:
2018-03-28
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
EXSTAM
USPTO Link:
View Trademark Status and Document Retrieval (TSDR)

Goods And Services

For:
Excipients for use in the manufacture of microencapsulated therapeutic proteins
International Classes:
001 - Primary Class
Class Status:
Active
Serial Number:
87742133
Mark:
ATRAXIM
Status:
ABANDONED - NO STATEMENT OF USE FILED
Mark Type:
TRADEMARK
Application Filing Date:
2018-01-03
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
ATRAXIM
USPTO Link:
View Trademark Status and Document Retrieval (TSDR)

Goods And Services

For:
Pharmaceutical preparations, namely, a drug delivery system comprising polymer-based oral tablets for the continuous release of a wide variety of therapeutic agents; Therapeutic pharmaceutical for the treatment of Inflammatory Bowel Diseases and Fibrosis
International Classes:
005 - Primary Class
Class Status:
Active
Serial Number:
87732226
Mark:
NGOXIL
Status:
ABANDONED - EXPRESS
Mark Type:
TRADEMARK
Application Filing Date:
2017-12-22
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
NGOXIL
USPTO Link:
View Trademark Status and Document Retrieval (TSDR)

Goods And Services

For:
Vaccines
International Classes:
005 - Primary Class
Class Status:
Active
Serial Number:
87665043
Mark:
TREXTAM
Status:
ABANDONED - NO STATEMENT OF USE FILED
Mark Type:
TRADEMARK
Application Filing Date:
2017-10-30
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
TREXTAM
USPTO Link:
View Trademark Status and Document Retrieval (TSDR)

Goods And Services

For:
Pharmaceutical preparations, namely, a drug delivery system comprising polymer-based oral tablets for the continuous release of a wide variety of therapeutic agents
International Classes:
005 - Primary Class
Class Status:
Active

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Date of last update: 30 Mar 2025

Sources: New York Secretary of State

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