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  5. CYTODEL, INC.

CYTODEL, INC.

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Company Details

Name: CYTODEL, INC.
Jurisdiction: New York
Legal type: FOREIGN BUSINESS CORPORATION
Status: Active
Date of registration: 02 Feb 2018 (7 years ago)
Entity Number: 5278983
ZIP code: 10027
County: New York
Place of Formation: Delaware
Address: ATTN: PHILIP A. BAND, 423 WEST 127TH STREET, NEW YORK, NY, United States, 10027

DOS Process Agent

Name Role Address
THE CORPORATION DOS Process Agent ATTN: PHILIP A. BAND, 423 WEST 127TH STREET, NEW YORK, NY, United States, 10027

U.S. Small Business Administration Profile

Website:
www.cytodel.com
Phone Number:
973-342-4899
E-mail Address:
pband@cytodel.com
Contact Person:
PHILLIP BAND
Ownership and Self-Certifications:
Self-Certified Small Disadvantaged Business
User ID:
P2862327

Commercial and government entity program

CAGE number:
6VDS7
Status:
Active
Type:
Non-Manufacturer
CAGE Update Date:
2025-05-30
CAGE Expiration:
2030-05-30
SAM Expiration:
2026-05-29

Contact Information

POC:
PHILLIP BAND
Corporate URL:
www.cytodel.com

Filings

Filing Number Date Filed Type Effective Date
180202000056 2018-02-02 APPLICATION OF AUTHORITY 2018-02-02

USAspending Awards / Contracts

Procurement Instrument Identifier:
140D6318C0114
Link:
View Award on USAspending website
Award Or Idv Flag:
AWARD
Award Type:
DEFINITIVE CONTRACT
Action Obligation:
1429034.00
Base And Exercised Options Value:
1429034.00
Base And All Options Value:
1429034.00
Awarding Agency Name:
Department of the Interior
Performance Start Date:
2018-08-28
Description:
POST-SYMPTOMATIC ANTIDOTES TO BOTULINUM NEUROTOXIN(PSABS)
Naics Code:
541715: RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT NANOTECHNOLOGY AND BIOTECHNOLOGY)
Product Or Service Code:
AZ12: R&D- OTHER RESEARCH AND DEVELOPMENT (APPLIED RESEARCH/EXPLORATORY DEVELOPMENT)

USAspending Awards / Financial Assistance

Date:
2022-12-23
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
DEVELOPMENT OF B8C1AD AS AN ORPHAN DRUG FOR IATROGENIC BOTULISM - ABSTRACT BOTULINUM NEUROTOXIN SEROTYPE A1 (BONT/A1) HAS BECOME AN IMPORTANT THERAPEUTIC TOOL FOR MULTIPLE INDICATIONS, DESPITE BEING THE MOST TOXIC PROTEIN KNOWN TO SCIENCE. ALTHOUGH SERIOUS ADVERSE EVENTS (AES) ARE RARE, THEIR IMPORTANCE IS RECOGNIZED BY THE BLACK BOX WARNING INCLUDED IN THE LABELING FOR ALL FDA-APPROVED BONT/A1 PRODUCTS. DURING A RECENT 3-YEAR PERIOD FDA RECEIVED 13,087 AE REPORTS SPECIFICALLY DESCRIBED AS “OVERDOSE”, PRIMARILY ASSOCIATED WITH THERAPEUTIC INDICATIONS. INVOLVING THE TREATMENT OF LARGE MUSCLE GROUPS (EG POST-STROKE SPASTICITY, CEREBRAL PALSY AND CERVICAL DYSTONIA). NO TREATMENT IS AVAILABLE FOR BONT/A1-ASSOCIATED IATROGENIC AES OTHER THAN SUPPORTIVE CARE. THE ONLY AVAILABLE BOTULISM THERAPEUTIC IS AN EQUINE-DERIVED ANTITOXIN (BAT, EMERGENT BIOSOLUTIONS) THAT CANNOT ACCESS THE INTRANEURONAL TOXIN PROTEASE RESPONSIBLE FOR IATROGENIC SYMPTOMS, AND IS THEREFORE OF LITTLE USE IN TREATING AES ASSOCIATED WITH BONT/A1 OVERDOSE AND OFF-TARGET ACTIONS. WE HAVE DEVELOPED A POST-SYMPTOMATIC ANTIDOTE TO BONT/A1 INTOXICATION WITH AN INTRANEURONAL MECHANISM OF ACTION, DESIGNATED B8C1AD. B8C1AD IS PRODUCED BY GENETICALLY FUSING A SINGLE DOMAIN ANTIBODY (SDAB, B8) TO A RECOMBINANT ATOXIC DERIVATIVE OF BONT/C1 (C1AD FOR ATOXIC DERIVATIVE) THAT ACTS AS A MOLECULAR VEHICLE TO DELIVER THE B8 ANTIBODY TO THE NEURONAL CYTOPLASM WHERE THE BONT/A1 TOXIC PROTEASE RESIDES. THE B8 ANTIBODY WAS SELECTED FROM A CAMELID VHH LIBRARY FOR ITS POTENT INHIBITION OF THE BONT/A1 PROTEASE. B8C1AD HAS BEEN DEMONSTRATED TO EFFECTIVELY RESCUE ANIMALS WITH SYSTEMIC BONT/A1 INTOXICATION AT TIMES POST-INTOXICATION WHEN CONVENTIONAL ANTIBODIES ARE INEFFECTIVE, BECAUSE THEY CANNOT ACCESS THE INTRA-NEURONAL BONT/A1 LC PROTEASE. THE SAFETY AND EFFECTIVENESS OF B8C1AD TO REVERSE BONT/A1 INTOXICATION SYMPTOMS AND RESCUE ANIMALS HAS BEEN PUBLISHED IN THREE SPECIES, INCLUDING NON-HUMAN PRIMATES. WE HERE PROPOSE ESTABLISHING A MODEL FOR BONT/A1 OVERDOSE VIA INTRAMUSCULAR ADMINISTRATION OF SUPRATHERAPEUTIC DOSES, AND DEVELOPING B8C1AD AS AN ORPHAN DRUG TO TREAT OFF-TARGET IATROGENIC AES ASSOCIATED WITH THE CLINICAL USE OF BONT/A1 PHARMACEUTICAL PRODUCTS. SUCCESSFUL COMPLETION OF THE PROPOSED STUDIES WILL SUPPORT ASSEMBLY OF A TARGET PRODUCT PROFILE FOR B8C1AD, WHICH WILL BE SHARED WITH FDA TO REQUEST A TYPE C MEETING FOR GUIDANCE ON THE REGULATORY PATHWAY FOR B8C1AD APPROVAL AS AN ORPHAN DRUG TO TREAT IATROGENIC OVERDOSE ASSOCIATED WITH BONT/A1 PHARMACEUTICALS.
Obligated Amount:
295365.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2022-03-01
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
RECOMBINANT BOTULINUM TOXIN WITH IMPROVED SAFETY AND EFFECTIVENESS FOR TREATMENT OF DYSTONIA - ABSTRACT BOTULINUM NEUROTOXIN (BONT) IS THE MOST TOXIC PROTEIN KNOWN TO SCIENCE. IT IS ALSO THE ACTIVE INGREDIENT IN ® PHARMACEUTICAL PRODUCTS LIKE BOTOX (ALLERGAN), WHICH HAVE PROVEN SAFE AND EFFECTIVE FOR MULTIPLE NEUROMUSCULAR INDICATIONS. ALL CURRENT BONT PRODUCTS ARE MANUFACTURED FROM CLOSTRIDIUM BOTULINUM CULTURES AND HAVE SIMILAR SAFETY CHARACTERISTICS, WHICH INCLUDE LIMITATIONS ON DOSING AND A BLACK BOX WARNING IN LABELING. BECAUSE OF ITS INHERENT TOXICITY AND NARROW THERAPEUTIC WINDOW, OPTIMAL CLINICAL OUTCOMES ARE DIFFICULT TO ACHIEVE IN INDICATIONS INVOLVING LARGE MUSCLE GROUPS, SUCH AS CERVICAL DYSTONIA, POST-STROKE SPASTICITY AND PEDIATRIC CEREBRAL PALSY. THOUGH IMPROVED MUSCLE TONE CAN CLEARLY BE ACHIEVED, CLINICIANS TEND TO DOSE ON THE SIDE OF CAUTION, AND OVERALL CLINICAL OUTCOMES LEAVE SIGNIFICANT ROOM FOR IMPROVEMENT. WE HERE PROPOSE BUILDING ON DATA GENERATED WITH A PREVIOUS CANDIDATE FOR A “SAFER BONT” PHARMACEUTICAL (SBIR PHASE 1 1R41NS086115-01A1) WHICH FOUND THAT SPECIFIC AMINO ACID SUBSTITUTIONS TO BONT/A1 CAN PRODUCE A RECOMBINANT BONT/A1 WITH AN IMPROVED SAFETY MARGIN COMPARED TO WT BONT/A1, (US 8,865,186). THE INITIAL LEAD CANDIDATE DESIGNED AND TESTED, CYTO-012, HAD AN IMPROVED SAFETY MARGIN, BUT ITS ABSOLUTE POTENCY WAS SUCH THAT DOSES REQUIRED FOR EFFICACY WERE ALSO IMMUNOGENIC. HERE, WE PROPOSE TESTING A NEW RECOMBINANT BONT/A1 DERIVATIVE TERMED CYTO-014, DESIGNED TO HAVE POTENCY AND IMMUNOGENICITY SIMILAR TO WT BONT/A1, WHILE RETAINING THE DESIRED IMPROVEMENT IN SAFETY SUGGESTED BY OUR PRELIMINARY STUDIES. THIS PROPOSAL IS INTENDED TO COMPARE THE DOSE-RESPONSE BEHAVIOR, SAFETY MARGIN AND MAXIMUM TOLERATED DOSE OF CYTO-014 RELATIVE TO WT BONT/A1 IN APPROPRIATELY POWERED STUDIES, AND TO EVALUATE ITS IMMUNOGENICITY AND EFFECTIVENESS FOR REPEAT TREATMENT. SUCCESSFUL COMPLETION OF THE PROPOSED STUDIES WILL SUPPORT A PHASE II STUDY TO FOCUS ON PRE-CLINICAL DEVELOPMENT ACTIVITIES AIMED AT FILING AN IND.
Obligated Amount:
414924.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2021-03-23
Link:
View on USAspending
Awarding Agency Name:
Small Business Administration
Transaction Description:
TO AID SMALL BUSINESSES IN MAINTAINING WORK FORCE DURING COVID-19 PANDEMIC.
Obligated Amount:
0.00
Face Value Of Loan:
75268.00
Total Face Value Of Loan:
75268.00
Date:
2020-05-03
Link:
View on USAspending
Awarding Agency Name:
Small Business Administration
Transaction Description:
TO AID SMALL BUSINESSES IN MAINTAINING WORK FORCE DURING COVID-19 PANDEMIC.
Obligated Amount:
0.00
Face Value Of Loan:
53465.00
Total Face Value Of Loan:
53465.00
Date:
2014-08-29
Link:
View on USAspending
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
RECOMBINANT BOTULINUM NEUROTOXIN FOR TREATMENT OF SPASTIC DISORDERS
Obligated Amount:
223940.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00

Trademarks Section

Serial Number:
86531852
Mark:
CYTODEL
Status:
SECTION 8 & 15-ACCEPTED AND ACKNOWLEDGED
Mark Type:
SERVICE MARK
Application Filing Date:
2015-02-11
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
CYTODEL
USPTO Link:
View Trademark Status and Document Retrieval (TSDR)

Goods And Services

For:
Pharmaceutical research and development
First Use:
2011-10-11
International Classes:
042 - Primary Class
Class Status:
Active

Paycheck Protection Program

Jobs Reported:
4
Initial Approval Amount:
$53,465
Date Approved:
2020-05-01
Loan Status:
Paid in Full
SBA Guaranty Percentage:
100
Current Approval Amount:
$53,465
Race:
Unanswered
Ethnicity:
Unknown/NotStated
Gender:
Unanswered
Veteran:
Unanswered
Forgiveness Amount:
$53,854.64
Servicing Lender:
Bank of America, National Association
Use of Proceeds:
Payroll: $53,465
Jobs Reported:
5
Initial Approval Amount:
$75,268
Date Approved:
2021-03-23
Loan Status:
Paid in Full
SBA Guaranty Percentage:
100
Current Approval Amount:
$75,268
Race:
Unanswered
Ethnicity:
Unknown/NotStated
Gender:
Unanswered
Veteran:
Unanswered
Forgiveness Amount:
$75,593.82
Servicing Lender:
Bank of America, National Association
Use of Proceeds:
Payroll: $75,263
Utilities: $1

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Date of last update: 24 Mar 2025

Sources: New York Secretary of State

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