WO2020093006 METHODS OF TREATING CANCER IN BIOMARKER-IDENTIFIED PATIENTS WITH NON-COVALENT INHIBITORS OF CYCLIN-DEPENDENT KINASE 7 (CDK7)

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Publication Number WO/2020/093006

Publication Date 07.05.2020

International Application No. PCT/US2019/059535

International Filing Date 01.11.2019

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Applicants

SYROS PHARMACEUTICALS, INC. [US]/[US]

Inventors

HODGSON, John Graeme
JOHANNESSEN, Liv Helena

Agents

DENHART, Derek
BUCHMAN, Joshua, J.
ARGENTIERI, Steven, R.
MICHAEL, Brodowski
SHOVON, Ashraf

Priority Data

62/754,398	01.11.2018	US
62/877,189	22.07.2019	US
62/915,983	16.10.2019	US
62/927,469	29.10.2019	US

Publication Language English (en)

Filing Language English (EN)

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Title

(EN) METHODS OF TREATING CANCER IN BIOMARKER-IDENTIFIED PATIENTS WITH NON-COVALENT INHIBITORS OF CYCLIN-DEPENDENT KINASE 7 (CDK7)

(FR) MÉTHODES DE TRAITEMENT DU CANCER CHEZ DES PATIENTS IDENTIFIÉS PAR BIOMARQUEURS AVEC DES INHIBITEURS NON COVALENTS DE LA KINASE CYCLINE-DÉPENDANTE 7 (CDK7)

Abstract

(EN) The present invention relates to methods of identifying patients suffering from various types of cancer who are more likely to respond to treatment with a CDK7 inhibitor conforming to structural Formula (I), (la), a species thereof, or a specified form thereof (as described herein), either when administered or used alone or in combination with a second therapeutic agent (e.g., another anti-cancer therapy). Patients are identified based on one or more features (e.g., gene copy number or expression level) of certain biomarkers (e.g., RB1 or another member of the E2F pathway). In addition, the present invention relates to methods of treating an identified patient with a compound conforming to structural Formula (I), (la), a species thereof, or a specified form thereof, either alone or in combination with a second therapeutic agent. In another aspect, the present invention features kits including instructions for treating a patient identified as described herein.

(FR) La présente invention concerne des procédés d'identification de patients souffrant de divers types de cancer qui sont plus susceptibles de réagir au traitement avec un inhibiteur de CDK7 conforme à la formule développée (I), (la), une espèce de celle-ci, ou une forme spécifiée de celle-ci (telle que décrite ici), soit lorsqu'elle est administrée ou utilisée seule ou en combinaison avec un second agent thérapeutique (par exemple, une autre thérapie anticancéreuse). Les patients sont identifiés sur la base d'une ou de plusieurs caractéristiques (par exemple, le nombre de copies ou le niveau d'expression de gènes) de certains biomarqueurs (par exemple, RB1 ou un autre élément de la voie biologique E2F). De plus, la présente invention concerne des méthodes de traitement d'un patient identifié avec un composé conforme à la formule développée (I), (la), une espèce de celui-ci, ou une forme spécifiée de celui-ci, soit seul, soit en combinaison avec un second agent thérapeutique. Dans un autre aspect, la présente invention concerne des kits comprenant des instructions pour traiter un patient identifié comme décrit ici.

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
33	Heterocyclic compounds
395	having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
40	having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403	condensed with carbocyclic rings, e.g. carbazole
404	Indoles, e.g. pindolol

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
33	Heterocyclic compounds
395	having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495	having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505	Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
506	not condensed and containing further heterocyclic rings

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
66	Phosphorus compounds

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
D	HETEROCYCLIC COMPOUNDS
209	Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
02	condensed with one carbocyclic ring
04	Indoles; Hydrogenated indoles
30	with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, directly attached to carbon atoms of the hetero ring

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
D	HETEROCYCLIC COMPOUNDS
247	Heterocyclic compounds containing rings having two nitrogen atoms as the only ring hetero atoms, according to more than one of groups C07D229/-C07D245/186
02	having the nitrogen atoms in positions 1 and 3

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1. WO2020093006 - METHODS OF TREATING CANCER IN BIOMARKER-IDENTIFIED PATIENTS WITH NON-COVALENT INHIBITORS OF CYCLIN-DEPENDENT KINASE 7 (CDK7)

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
P	SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35	Antineoplastic agents

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
B	GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
2200	Indexing scheme relating to specific properties of organic compounds
05	Isotopically modified compounds, e.g. labelled

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
F	ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
9	Compounds containing elements of Groups 5 or 15 of the Periodic System
02	Phosphorus compounds
547	Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom
6558	containing at least two different or differently substituted hetero rings neither condensed among themselves nor condensed with a common carbocyclic ring or ring system
65583	each of the hetero rings containing nitrogen as ring hetero atom

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47	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
06	Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
26	Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47	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
30	Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
36	Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47	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
30	Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
36	Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
38	Cellulose; Derivatives thereof

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
0012	Galenical forms characterised by the site of application
0019	Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner