EP3365021A4 - Excipient compounds for biopolymer formulations - Google Patents

Excipient compounds for biopolymer formulations Download PDF

Info

Publication number
EP3365021A4
EP3365021A4 EP16858314.4A EP16858314A EP3365021A4 EP 3365021 A4 EP3365021 A4 EP 3365021A4 EP 16858314 A EP16858314 A EP 16858314A EP 3365021 A4 EP3365021 A4 EP 3365021A4
Authority
EP
European Patent Office
Prior art keywords
excipient compounds
biopolymer formulations
biopolymer
formulations
excipient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP16858314.4A
Other languages
German (de)
French (fr)
Other versions
EP3365021A1 (en
Inventor
David S. Soane
Philip Wuthrich
Rosa Casado Portilla
Robert P. Mahoney
Mark Moody
Daniel G. GREENE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Comera Life Sciences Inc
Original Assignee
Reform Biologics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Reform Biologics Inc filed Critical Reform Biologics Inc
Priority to EP23205025.2A priority Critical patent/EP4324482A2/en
Publication of EP3365021A1 publication Critical patent/EP3365021A1/en
Publication of EP3365021A4 publication Critical patent/EP3365021A4/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
EP16858314.4A 2015-10-23 2016-10-21 Excipient compounds for biopolymer formulations Pending EP3365021A4 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP23205025.2A EP4324482A2 (en) 2015-10-23 2016-10-21 Excipient compounds for biopolymer formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562245513P 2015-10-23 2015-10-23
PCT/US2016/058169 WO2017070501A1 (en) 2015-10-23 2016-10-21 Excipient compounds for biopolymer formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP23205025.2A Division EP4324482A2 (en) 2015-10-23 2016-10-21 Excipient compounds for biopolymer formulations

Publications (2)

Publication Number Publication Date
EP3365021A1 EP3365021A1 (en) 2018-08-29
EP3365021A4 true EP3365021A4 (en) 2019-06-05

Family

ID=58558088

Family Applications (2)

Application Number Title Priority Date Filing Date
EP23205025.2A Pending EP4324482A2 (en) 2015-10-23 2016-10-21 Excipient compounds for biopolymer formulations
EP16858314.4A Pending EP3365021A4 (en) 2015-10-23 2016-10-21 Excipient compounds for biopolymer formulations

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP23205025.2A Pending EP4324482A2 (en) 2015-10-23 2016-10-21 Excipient compounds for biopolymer formulations

Country Status (3)

Country Link
EP (2) EP4324482A2 (en)
CA (2) CA3129181C (en)
WO (1) WO2017070501A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2021108427A1 (en) * 2019-11-26 2021-06-03 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2020112855A1 (en) * 2018-11-29 2020-06-04 Reform Biologics, Llc Excipient compounds for protein processing
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
EP3624846A1 (en) 2017-05-16 2020-03-25 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
IL299671A (en) 2020-07-13 2023-03-01 Merck Patent Gmbh Viscosity reducing excipients and combinations thereof for highly concentrated protein formulations

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997027750A1 (en) * 1996-02-01 1997-08-07 Anthea Enterprises Incorporated Aqueous caffeine dosage forms
WO2004037018A1 (en) * 2002-10-23 2004-05-06 Quercegen Holdings Llc Composition for enhancing physical performance

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2230965A (en) 1940-06-14 1941-02-04 American Cyanamid Co Process of preparing guanyl taurine
WO2009065126A2 (en) * 2007-11-16 2009-05-22 Boston Protein Solutions Excipients for protein stabilization
CA2904458C (en) * 2007-11-30 2017-07-25 Wolfgang Fraunhofer Protein formulations and methods of making same
CN110559435B (en) 2013-09-11 2023-10-20 伊戈尔生物药品股份有限公司 Liquid protein formulations comprising ionic liquids
US20160074515A1 (en) * 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997027750A1 (en) * 1996-02-01 1997-08-07 Anthea Enterprises Incorporated Aqueous caffeine dosage forms
WO2004037018A1 (en) * 2002-10-23 2004-05-06 Quercegen Holdings Llc Composition for enhancing physical performance

Also Published As

Publication number Publication date
WO2017070501A1 (en) 2017-04-27
CA3002373A1 (en) 2017-04-27
EP4324482A2 (en) 2024-02-21
CA3129181A1 (en) 2017-04-27
CA3129181C (en) 2023-10-31
EP3365021A1 (en) 2018-08-29

Similar Documents

Publication Publication Date Title
EP3160484A4 (en) Viscosity-reducing excipient compounds for protein formulations
EP3302426A4 (en) D2o stabilized pharmaceutical formulations
EP3322441A4 (en) Vaccine compositions
EP3319606A4 (en) Pharmaceutical compound
EP3102190A4 (en) Novel pharmaceutical formulations
EP3129028A4 (en) Pharmaceutical compositions
EP3253382A4 (en) Pharmaceutical compositions for combination therapy
EP3280421A4 (en) Pharmaceutical compositions for combination therapy
EP3104860A4 (en) Pharmaceutical compounds
EP3193888A4 (en) Novel formulations
EP3365021A4 (en) Excipient compounds for biopolymer formulations
EP3541385A4 (en) Pharmaceutical formulations
EP3310439A4 (en) Pharmaceutical compositions for anesthesiological applications
EP3160491A4 (en) Pharmaceutical compositions
EP3349750A4 (en) Pharmaceutical compound
EP3362052A4 (en) Processes for preparing formulations for gastrointestinal-targeted therapies
EP3141243A4 (en) Pharmaceutical composition
EP3102564A4 (en) Tablet formulation for cgrp-active compounds
EP3344293A4 (en) Vlp stabilized vaccine compositions
AU2016218074B2 (en) Pharmaceutical formulation
EP3389633A4 (en) Pharmaceutical compositions comprising phenylaminopyrimidine derivative
EP3524250A4 (en) Pharmaceutical composition
EP3373928A4 (en) Novel formulations
EP3337463A4 (en) Pharmaceutical formulations
EP3189033A4 (en) Pharmaceutical compounds

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20180419

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: REFORM BIOLOGICS, LLC

A4 Supplementary search report drawn up and despatched

Effective date: 20190508

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 47/12 20060101ALI20190502BHEP

Ipc: A61K 47/22 20060101AFI20190502BHEP

Ipc: A61K 47/18 20170101ALI20190502BHEP

Ipc: A61K 38/00 20060101ALI20190502BHEP

Ipc: A61K 47/06 20060101ALI20190502BHEP

Ipc: A61K 39/395 20060101ALI20190502BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

17Q First examination report despatched

Effective date: 20210115

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

RAP3 Party data changed (applicant data changed or rights of an application transferred)

Owner name: REFORM BIOLOGICS, INC.

RAP3 Party data changed (applicant data changed or rights of an application transferred)

Owner name: COMERA LIFE SCIENCES, INC.

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: GRANT OF PATENT IS INTENDED

INTG Intention to grant announced

Effective date: 20230508

P01 Opt-out of the competence of the unified patent court (upc) registered

Effective date: 20230516

GRAJ Information related to disapproval of communication of intention to grant by the applicant or resumption of examination proceedings by the epo deleted

Free format text: ORIGINAL CODE: EPIDOSDIGR1

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

INTC Intention to grant announced (deleted)
GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: GRANT OF PATENT IS INTENDED

INTG Intention to grant announced

Effective date: 20240104