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WO2025076424A1 - Aptamère bb-031 et ses méthodes d'utilisation - Google Patents

Aptamère bb-031 et ses méthodes d'utilisation Download PDF

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Publication number
WO2025076424A1
WO2025076424A1 PCT/US2024/050062 US2024050062W WO2025076424A1 WO 2025076424 A1 WO2025076424 A1 WO 2025076424A1 US 2024050062 W US2024050062 W US 2024050062W WO 2025076424 A1 WO2025076424 A1 WO 2025076424A1
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thrombosis
combination
subject
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administered
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Shahid Nimjee
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Ohio State Innovation Foundation
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Ohio State Innovation Foundation
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7105—Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7115—Nucleic acids or oligonucleotides having modified bases, i.e. other than adenine, guanine, cytosine, uracil or thymine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/115—Aptamers, i.e. nucleic acids binding a target molecule specifically and with high affinity without hybridising therewith ; Nucleic acids binding to non-nucleic acids, e.g. aptamers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/16—Aptamers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications

Definitions

  • venous thrombosis Patients suffer from venous thrombosis and inflammation. Every year, approximately 1 to 3 in every 1 ,000 adults in the United States develop venous thrombosis or pulmonary embolism. Up to 300,000 people die each year as a result of venous thrombosis/pulmonary embolism. It is the third most common vascular disease, behind heart attacks and strokes. It can occur at any age but is more common in those over 60 years old. There is a need to treat and prevent venous thrombosis in subjects.
  • the disclosed subject matter in one aspect, relates to aptamers and methods of using thereof.
  • a method of treating venous thrombosis in a subject in need thereof comprising administering a therapeutically effective amount of BB-031 to the subject.
  • a method of reducing risk of venous thrombosis in a subject in need thereof comprising administering a therapeutically effective amount of BB-031 to the subject.
  • Aptamer BB-031 prophylactic and thrombolytic applications were applied to decrease inflammation and venous thrombosis.
  • FIG. 1 shows MMP-9 concentration at sacrifice.MMP-9 is an inflammatory marker. Increased MMP-9 levels correlated with increased risk of intracranial hemorrhage in patients receiving rTPA. BB-031 treated dogs had decreased MMP-9 levels compared to saline control treated animals.
  • FIG. 2 shows heart rate in beats per minute.
  • FIGS. 3A-3D show data demonstrating that aged males and females have different baseline times to occlusion.
  • FIG. 3A shows data for aged males vs. young males.
  • FIG. 3B shows data for young females vs. young males.
  • FIG. 3C shows data for aged female vs. young female.
  • FIG. 3D shows data for aged female vs. aged male.
  • FIGS. 4A-4B show that BB-031 demonstrates significantly longer times to occlusion compared to other treatments.
  • FIG. 4A shows the results of female prophylactic treatment.
  • FIG. 4B shows the results of male prophylactic treatment.
  • FIGS. 5 A-5B show that BB-31 prevents clot formation and subsequent occlusion when used as a prophylactic.
  • FIG. 5A shows the data corresponding to male prophylactic treatment.
  • FIG. 5B shows the data corresponding to female prophylactic treatment.
  • FIGS. 6A-6B show that BB-031 facilitates reperfusion following occlusion comparable to rTPA and heparin in both wild-type and obese mice.
  • FIG. 6A shows the data pertaining to murine venous thrombosis.
  • FIG. 6B shows data pertaining to male murine venous thrombosis (DlO+wild- type).
  • FIGS. 7A-7B show BB-031 is especially effective in females.
  • FIG. 7A shows the data relating to male murine venous thrombosis.
  • FIG. 7B shows data relating to female murine venous thrombosis.
  • FIG. 8 shows that BB-031 is especially effective in obese mice. More specifically, the data relates to the murine venous thrombosis diet-induced obese mice.
  • FIG. 12 shows Von Willebrand factor levels at sacrifice in obese mice.
  • ratios, concentrations, amounts, and other numerical data can be expressed herein in a range format. It can be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it can be understood that the particular value forms a further aspect. For example, if the value “about 10” is disclosed, then “10” is also disclosed.
  • a further aspect includes from the one particular value and/or to the other particular value.
  • ranges excluding either or both of those included limits are also included in the disclosure, e.g., the phrase “x to y” includes the range from ‘x’ to ‘y’ as well as the range greater than ‘x’ and less than ‘y’.
  • the range can also be expressed as an upper limit, e.g., ‘about x, y, z, or less’ and should be interpreted to include the specific ranges of ‘about x’, ‘about y’, and ‘about z’ as well as the ranges of ‘less than x’, less than y’, and Tess thanz’.
  • the phrase ‘about x, y, z, or greater’ should be interpreted to include the specific ranges of ‘about x’, ‘about y’, and ‘about z’ as well as the ranges of ‘ greater than x ’ , greater than y ’ , and ‘ greater than z ’ .
  • the phrase “about ‘x’ to ‘y’”, where ‘x’ and ‘y’ are numerical values, includes “about ‘x’ to about ‘y’”.
  • a numerical range of “about 0.1% to 5%” should be interpreted to include not only the explicitly recited values of about 0.1% to about 5%, but also include individual values (e.g., about 1%, about 2%, about 3%, and about 4%) and the sub-ranges (e.g., about 0.5% to about 1.1%; about 5% to about 2.4%; about 0.5% to about 3.2%, and about 0.5% to about 4.4%, and other possible sub-ranges) within the indicated range.
  • the terms “about,” “approximate,” “at or about,” and “substantially” mean that the amount or value in question can be the exact value or a value that provides equivalent results or effects as recited in the claims or taught herein. That is, it is understood that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art such that equivalent results or effects are obtained. In some circumstances, the value that provides equivalent results or effects cannot be reasonably determined.
  • the term “substantially free,” when used in the context of a composition or component of a composition that is substantially absent, is intended to refer to an amount that is then about 1 % by weight or less, e.g., less than about 0.5 % by weight, less than about 0.1 % by weight, less than about 0.05 % by weight, or less than about 0.01 % by weight of the stated material, based on the total weight of the composition.
  • subject preferably refers to a human in need of treatment with an anti-cancer agent or treatment for any purpose, and more preferably a human in need of such a treatment to treat cancer, or a precancerous condition or lesion.
  • patient can also refer to non-human animals, preferably mammals such as dogs, cats, horses, cows, pigs, sheep, and nonhuman primates, among others, which are in need of treatment with an anti-cancer agent or treatment.
  • reduce or other forms of the word, such as “reducing” or “reduction,” is meant lowering of an event or characteristic (e.g. , tumor growth). It is understood that this is typically in relation to some standard or expected value, in other words it is relative, but that it is not always necessary for the standard or relative value to be referred to.
  • reduced tumor growth means reducing the rate of growth of a tumor relative to a standard or a control (e.g., an untreated tumor).
  • prevent or other forms of the word, such as “preventing” or “prevention,” is meant to stop a particular event or characteristic, to stabilize or delay the development or progression of a particular event or characteristic, or to minimize the chances that a particular event or characteristic will occur. Prevent does not require comparison to a control as it is typically more absolute than, for example, reduce. As used herein, something could be reduced but not prevented, but something that is reduced could also be prevented. Likewise, something could be prevented but not reduced, but something that is prevented could also be reduced. It is understood that where reduce or prevent are used, unless specifically indicated otherwise, the use of the other word is also expressly disclosed.
  • the terms “prevent” or “suppress” can refer to a treatment that forestalls or slows the onset of a disease or condition or reduced the severity of the disease or condition.
  • a treatment can treat a disease in a subject having symptoms of the disease, it can also prevent or suppress that disease in a subject who has yet to suffer some or all of the symptoms.
  • treatment refers to the medical management of a patient with the intent to cure, ameliorate, stabilize, or prevent a disease, pathological condition, or disorder.
  • This term includes active treatment, that is, treatment directed specifically toward the improvement of a disease, pathological condition, or disorder, and also includes causal treatment, that is, treatment directed toward removal of the cause of the associated disease, pathological condition, or disorder.
  • this term includes palliative treatment, that is, treatment designed for the relief of symptoms rather than the curing of the disease, pathological condition, or disorder; preventative treatment, that is, treatment directed to minimizing or partially or completely inhibiting the development of the associated disease, pathological condition, or disorder; and supportive treatment, that is, treatment employed to supplement another specific therapy directed toward the improvement of the associated disease, pathological condition, or disorder.
  • terapéuticaally effective refers to the amount of the composition used is of sufficient quantity to ameliorate one or more causes or symptoms of a disease or disorder. Such amelioration only requires a reduction or alteration, not necessarily elimination.
  • pharmaceutically acceptable refers to those compounds, materials, compositions, and/or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problems or complications commensurate with a reasonable benefit/risk ratio.
  • carrier means a compound, composition, substance, or structure that, when in combination with a compound or composition, aids or facilitates preparation, storage, administration, delivery, effectiveness, selectivity, or any other feature of the compound or composition for its intended use or purpose.
  • a carrier can be selected to minimize any degradation of the active ingredient and to minimize any adverse side effects in the subject.
  • the present disclosure in one aspect, provides for a method of treating venous thrombosis in a subject in need thereof comprising administering a therapeutically effective amount of BB- 031 to the subject.
  • BB-031 is an RNA aptamer that targets and inhibits Von Willebrand Factor, necessary for blood clot formation and attachment to blood vessel walls. It has shown efficacy in three mouse models and five canine models of vascular injury and stroke. Efficacy has been demonstrated in a venous model of vascular injury and decreased inflammation in a canine model of stroke. Herein, BB-031 is used to reduce inflammation and efficacy in venous thrombosis.
  • BB-031 comprises a sequence at least 60% (e.g., at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%) identical to SEQ ID NO. 1. In certain examples, BB-031 comprises SEQ ID NO. 1.
  • Venous thrombosis also referred to as deep vein thrombosis (DVT) occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, often in the legs.
  • the blood clots partially block blood flow through the vein.
  • the blood clots completely block blood flow through the vein.
  • venous thrombosis happens in the lower leg, thigh, pelvis, or any combination thereof.
  • venous thrombosis can occur in other parts of the body, such as, but not limited to, the arm, brain, intestines, liver, kidney, or any combination thereof.
  • venous thrombosis causes leg pain and/or swelling. In further examples, there are no noticeable symptoms.
  • Venous Thrombosis can be serious because blood clots in the veins can break loose at which point the clots can then travel through the bloodstream and get stuck in the lungs and/or block blood flow.
  • a blood clot in the legs develops in a subject if they do not move for a lengthy period of time. For example, this can occur when a subject does not move a lot when traveling a long distance, is on bed rest due to surgery, has an illness, or is in an accident.
  • symptoms of venous thrombosis include leg swelling, leg pain, cramping or soreness that can start in the calf, a change in skin color on the leg - such as a red or purple, depending on the color of the skin, a feeling of warmth on the affected leg, or any combination thereof.
  • symptoms of venous thrombosis include pooling of blood, increased pressure within the veins, leg ulcers, also known as venous stasis ulcers, or any combination thereof.
  • the venous thrombosis comprises deep vein thrombosis, portal vein thrombosis, renal vein thrombosis, jugular vein thrombosis, pulmonary embolism, femoral vein thrombosis, Paget-Schroetter Syndrome, myocardial infarction, superior vena cava thrombosis, thrombotic stroke, cerebral venous sinus thrombosis, cavernous sinus thrombosis, retinal vein occlusion, May-Thurner Syndrome, Budd-Chiari Syndrome, or any combination thereof.
  • the subject has a Von Willebrand factor (vWF) of 2 ng/mL or less (e.g., 1.8 ng/mL or less, 1.6 ng/mL or less, 1.4 ng/mL or less, 1.2 ng/mL or less, 1/0 ng/mL or less, 0.8 ng/mL or less, 0.6 ng/mL or less, 0.4 ng/mL or less, or 0.2 ng/mL or less; 1.5 ng/mL or less, 1.0 ng/mL or less, or 0.5 ng/mL or less).
  • vWF Von Willebrand factor
  • the vWF is 1.5 ng/mL or less (e.g., 1.3 ng/mL or less, 1.1 ng/mL or less, 0.9 ng/mL or less, 0.7 ng/mL or less, 0.5 ng/mL or less, 0.3 ng/mL 0.1 ng/mL or less).
  • the BB-031 is administered with an anticoagulant, surgery, endovascular treatment, a thrombolytic, a filter, or any combination thereof.
  • the anticoagulant comprises direct factor Xa inhibitors, direct thrombin inhibitors, indirect factor Xa inhibitors, low molecular weight heparin, fibrinolytics, vitamin K antagonists, or any combination thereof.
  • the direct factor Xa inhibitor comprises apixaban, edoxaban, rivaroxaban, or any combination thereof.
  • the direct thrombin inhibitor comprises dabigatran.
  • the indirect factor Xa inhibitor comprises fondaparinux.
  • the low molecular weight heparin comprises dalteparin, enoxaparin, or any combination thereof.
  • the fibrinolytics comprise alteplase, unfractionated heparin, or any combination thereof.
  • the vitamin K antagonist comprises warfarin.
  • the thrombolytic comprises streptokinase, alteplase, reteplase, Tenecteplase, urokinase, prourokinase, anistreplase, or any combination thereof.
  • the surgery comprises a thrombolysis, a thrombectomy, or any combination thereof.
  • the filter comprises an inferior vena cava (I VC) filter.
  • I VC inferior vena cava
  • the BB-031 is administered in an amount of from 1.0 mg/kg to 10 mg/kg. In some examples, the BB-031 is administered in an amount of from 1.0 mg/kg to 5.0 mg/kg, or 5.0 mg/kg to 10 mg/kg.
  • the BB-031 is administered in an amount of from 4.0 mg/kg to 4.4 mg/kg, 4.0 mg/kg to 4.6 mg/kg, 4.0 mg/kg to 4.8 mg/kg, 4.0 mg/kg to 5.0 mg/kg, 4.0 mg/kg to 5.2 mg/kg, 4.0 mg/kg to 5.4 mg/kg, 4.0 mg/kg to 5.6 mg/kg, or 4.0 mg/kg to 5.8 mg/kg.
  • 5.5 mg/kg is administered in an amount of from 4.5 mg/kg to 4.7 mg/kg, 4.5 mg/kg to 4.8 mg/kg, 4.5 mg/kg to 4.9 mg/kg, 4.5 mg/kg to 5.0 mg/kg, 4.5 mg/kg to 5.1 mg/kg, 4.5 mg/kg to 5.2 mg/kg, 4.5 mg/kg to 5.3 mg/kg, 4.5 mg/kg to 5.4 mg/kg, or 4.5 mg/kg to 5.5 mg/kg.
  • the BB-031 is administered in an amount of 5 mg/kg.
  • the mechanisms of treating and preventing venous thrombosis include those such as preventing clots, preventing clots from getting bigger, preventing clots from breaking loose and traveling to the lungs, and reducing the chance of another venous thrombosis.
  • a method of reducing risk of venous thrombosis in a subject in need thereof comprising administering a therapeutically effective amount of BB-031 to the subject.
  • the BB-031 is administered in an amount of from 0.1 mg/kg to 1.0 mg/kg. In some examples, the BB-031 is administered in an amount of from 0.1 mg/kg to 0.5 mg/kg, 0.5 mg/kg to 1.0 mg/kg, 1.0 mg/kg to 1.5 mg/kg, 1.5 mg/kg to 2.0 mg/kg, 2.0 mg/kg to 2.5 mg/kg, 2.5 mg/kg to 3.0 mg/kg, 3.0 mg/kg to 3.5 mg/kg, 3.5 mg/kg to 4.0 mg/kg, 4.0 to 4.5 mg/kg,
  • the BB-031 is administered in an amount of from 0.1 mg/kg to 1.0 mg/kg, 0.1 mg/kg to 1.5 mg/kg, 0.1 mg/kg to 2.0 mg/kg, 0.1 mg/kg to 2.5 mg/kg, 0.1 mg/kg to 3.0 mg/kg, 0.1 mg/kg to 3.5 mg/kg, 0.1 mg/kg to 4.0 mg/kg, 0.1 mg/kg to 4.5 mg/kg, 0.1 mg/kg to 5.0 mg/kg, 0.1 mg/kg to 5.5 mg/kg, 0.1 mg/kg to 6.0 mg/kg, 0.1 mg/kg to 6.5 mg/kg, 0.1 mg/kg to 7.0 mg/kg, 0.1 mg/kg to 7.5 mg/kg, 0.1 mg/kg to 8.0 mg/kg, 0.1 mg/kg to 8.5 mg/kg, 0.1 mg/kg to 9.0 mg/kg, or 0.1 mg/kg to 9.5 mg/kg.
  • the BB-031 is administered in an amount of from 0.4 mg/kg to 0.6 mg/kg. In some examples, the BB-031 is administered in an amount of from 0.4 mg/kg to 0.42 mg/kg, 0.42 mg/kg to 0.44 mg/kg, 0.44 mg/kg to 0.46 mg/kg, 0.46 mg/kg to 0.48 mg/kg, 0.48 mg/kg to 0.50 mg/kg, 0.50 mg/kg to 0.52 mg/kg, 0.52 mg/kg to 0.54 mg/kg, 0.54 mg/kg to 0.56 mg/kg, 0.56 mg/kg to 0.58 mg/kg, or 0.58 mg/kg to 0.60.
  • the BB-031 is administered in an amount of from 0.40 mg/kg to 0.44 mg/kg, 0.40 mg/kg to 0.46 mg/kg, 0.40 mg/kg to 0.48 mg/kg, 0.40 mg/kg to 0.50 mg/kg, 0.40 mg/kg to 0.52 mg/kg, 0.40 mg/kg to 0.54 mg/kg, 0.40 mg/kg to 0.56 mg/kg, or 0.40 mg/kg to 0.58 mg/kg.
  • the BB-031 is administered in an amount of from 0.45 mg/kg to 0.46 mg/kg, 0.46 mg/kg to 0.47 mg/kg, 0.48 mg/kg to 0.49 mg/kg, 0.49 mg/kg to 0.50 mg/kg, 0.50 mg/kg to 0.51 mg/kg, 0.51 mg/kg to 0.52 mg/kg, 0.52 mg/kg to 0.53 mg/kg, 0.53 mg/kg to 0.54 mg/kg, or 0.54 mg/kg to 0.55 mg/kg.

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Abstract

La présente divulgation concerne une méthode de traitement de la thrombose veineuse chez un sujet en ayant besoin qui consiste à administrer au sujet une quantité thérapeutiquement efficace de BB-031.
PCT/US2024/050062 2023-10-06 2024-10-04 Aptamère bb-031 et ses méthodes d'utilisation Pending WO2025076424A1 (fr)

Applications Claiming Priority (4)

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US202363542836P 2023-10-06 2023-10-06
US63/542,836 2023-10-06
US202463641142P 2024-05-01 2024-05-01
US63/641,142 2024-05-01

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190218553A1 (en) * 2016-09-16 2019-07-18 Duke University Von willebrand factor (vwf)-targeting agents and methods of using the same
US20230038761A1 (en) * 2020-02-04 2023-02-09 Band Therapeutics, Llc Regulation of von willebrand factor (vwf)

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190218553A1 (en) * 2016-09-16 2019-07-18 Duke University Von willebrand factor (vwf)-targeting agents and methods of using the same
US20230038761A1 (en) * 2020-02-04 2023-02-09 Band Therapeutics, Llc Regulation of von willebrand factor (vwf)

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