CN106963948A - A Pa is combined the application in colon cancer drug is prepared for Buddhist nun with the antibody of Anti PD 1 - Google Patents
A Pa is combined the application in colon cancer drug is prepared for Buddhist nun with the antibody of Anti PD 1 Download PDFInfo
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- CN106963948A CN106963948A CN201710332298.XA CN201710332298A CN106963948A CN 106963948 A CN106963948 A CN 106963948A CN 201710332298 A CN201710332298 A CN 201710332298A CN 106963948 A CN106963948 A CN 106963948A
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- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
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Abstract
The invention discloses a kind of Ah handkerchief the application in colon cancer drug is prepared is combined for Buddhist nun with the antibody of Anti PD 1, the present invention treats colon cancer for Buddhist nun using Ah handkerchief with the antibody combined medications of Anti PD 1, it is 53.97% with the antibody of Anti PD 1 combination tumor control rate for Buddhist nun that Ah handkerchief, which is found through experiments that, compared with alone Ah handkerchief replaces Buddhist nun's group, tumor control rate improves 40.4%（53.97%vs13.57%, P<0.05,Mann‑Whitneytest）, compared with the alone antibodyomes of Anti PD 1, tumor control rate improves 23.17% (53.97%vs13.57%, P<0.05, Mann Whitneytest) (the experimental group gross tumor volume of tumor control rate=1/control group gross tumor volume).After A Pa is combined for Buddhist nun with the antibody of Anti PD 1, the area of neoplasm necrosis can substantially be increased by comparing for more alone group.
Description
Technical field
The present invention relates to pharmaceutical field, and in particular to a kind of Ah handkerchief is combined with Anti-PD-1 antibody for Buddhist nun and applied.
Background technology
Colorectal cancer is common malignant tumor of digestive tract, and its high illness rate once turned into the main of European and American developed countries and asked
Topic, ascendant trend is notable in the world in recent years.According to the newest predictions of Cancer Statistics, U.S. man in 2017
Property, which newly sends out colorectal cancer case, will account for the 9% of all tumours, and all tumours will be accounted for by coming in the 3rd of malignant tumour, women
8%, it is only second to breast cancer and lung cancer.Equally in China, as living standards of the people are improved, dietary structure changes, colorectal cancer
The incidence of disease in ascendant trend is continued, there are 376300 people to be diagnosed as colorectal cancer within 2015, account for all making a definite diagnosis cancer patient's
8%.In the common vicious behaviour tumor mortality of China, colorectal cancer patients account for the 5th in male, and women accounts for the 6th.About 15%-
25% colorectal cancer patients as late period when making a definite diagnosis, the patient for separately having 15-25% can be expert at colorectal cancer primary tumor radical correction
After occur relapse and metastasis.At present for the treatment of advanced colorectal cancer, oxaliplatin or Yi Li are added with 5-FU or capecitabine
Combine targeted drug such as bevacizumab, Cetuximab, handkerchief for health scheme chemotherapy (XELOX, FOLFOX, FOLFIRI scheme)
Based on Buddhist nun's monoclonal antibody etc..Although the survival rate that chemotherapy combined targeted therapy makes advanced colorectal cancer patient total is improved,
The medicine that can be used for the colorectal cancer patients after multi-thread Advances in Chemotherapy is seldom, and gastrointestinal reaction, bone caused by chemotherapy
The adverse reactions such as marrow suppression, neurotoxicity often occur.
Anti-PD-1 immunotherapies are the new class anticancer immunotherapies currently got most of the attention, it is intended to by blocking PD-1/
PD-L1 signal paths, the immune system of human activin itself resists cancer, and applicable tumour includes melanoma and non-small at present
Cell lung cancer, kidney, colorectal cancer etc..But compared to melanoma, kidney, non-small cell lung cancer etc. to Anti-PD-1/PD-
L1 antibody responds preferable entity tumor, and colorectal cancer is considered as the insensitive tumour of immunization therapy always.
A Pa is a kind of new small molecule tyrosine kinase inhibitor for Buddhist nun (Apatinib), can specifically bind VEGFR-
2, then suppress migration and the propagation of the endothelial cell of VEGF inductions, reduce tumor microvessel density.A Pa is global first for Buddhist nun
It is individual to be proved after late stomach cancer standard chemotherapeutic failure safely and effectively small molecule anti-angiogenesis targeted drug, in 2014 10
The moon is used for late period sdenocarcinoma of stomach or stomach-esophageal junction gland cancer three by state food pharmaceuticals administration general bureau (CFDA) approval listing
Treatment more than line or three lines.
The content of the invention
Goal of the invention：In view of the above-mentioned deficiencies in the prior art, it is an object of the present invention to provide a kind of Ah handkerchief for Buddhist nun and Anti-
PD-1 antibody is combined the application in colon cancer drug is prepared.
Technical scheme：A kind of Ah handkerchief is combined the application in colon cancer drug is prepared for Buddhist nun with Anti-PD-1 antibody.
Ah handkerchief of the present invention is for Buddhist nun with Ah handkerchief is applied comprising but be not limited only to associated with Anti-PD-1 antibody for Buddhist nun and Anti-
PD-1 antibody.
Preferably, the A Pa is administered daily dosage for 100mg/kg for Buddhist nun.
Preferably, the weekly administration dosage of the Anti-PD-1 antibody is twice, each 5mg/kg.
Present invention also includes Ah handkerchief and is combined for Buddhist nun with Anti-PD-1 antibody in mouse junction cancer Subcutaneous transplanted model
Application.
Beneficial effect：The present invention, for the antibody combined medication treatment colon cancer of Buddhist nun and Anti-PD-1, passes through experiment using Ah handkerchief
It was found that Ah handkerchief is 53.97% with Anti-PD-1 antibody combination tumor control rate for Buddhist nun, and compared with alone Ah handkerchief replaces Buddhist nun's group, tumour
Inhibiting rate improves 40.4% (53.97%vs13.57%, P<0.05, Mann-Whitneytest), with alone Anti-PD-1
Antibodyome is compared, and tumor control rate improves 23.17% (53.97%vs13.57%, P<0.05,Mann-Whitneytest)
(tumor control rate=1- experimental groups gross tumor volume/control group gross tumor volume).After A Pa is combined for Buddhist nun with Anti-PD-1 antibody,
The area of neoplasm necrosis can substantially be increased by comparing for more alone group.
Brief description of the drawings
Fig. 1 is mice-transplanted tumor Volume Changes；
Fig. 2 is tumor weight；
The mouse transplanting tumor that Fig. 3 is divested after being terminated for administration；
Fig. 4 dyes for tumor tissues HE；HE dyeing is it can be seen that Ah handkerchief replaces Buddhist nun with that after the combination of Anti-PD-1 antibody, can increase
Plus the ratio of apoptotic cell.
Embodiment
Technical solution of the present invention is described in detail below, but protection scope of the present invention is not limited to the implementation
Example.
Embodiment：
1st, cell culture
Mouse colonic cell system CT26,37 DEG C, 5%CO are incubated at 1640 complete mediums (containing 10%FBS)2Saturation
In the incubator of humidity.
2nd, mouse junction cancer Subcutaneous transplanted model
The mouse colonic cell CT26 of exponential phase is digested with pancreatin, 250g centrifugation 5min are washed with the PBS of precooling
Twice, and it is diluted to 2 × 107/ ml concentration.6-8 week old Balb/c mouse, will scrape near the armpit of right side together with right side of body hair
Totally, it is subcutaneously injected with every μ l of mouse 100 volume.It is swollen with vernier caliper measurement every three days after tumour is grown
Knurl size.Gross tumor volume calculation formula：V=0.5 × L1 × (L2)2, wherein L1 represents length of tumor, and L2 represents tumor width.
3rd, dosage regimen
When most of mouse tumor volume reaches 100-200mm3When, mouse is randomly divided into 4 groups by tumor size：Control
Group (control), Ah handkerchief replace Buddhist nun and Anti- for Buddhist nun's group (Apatinib), Anti-PD-1 antibodyomes (Anti-PD-1), Ah handkerchief
PD-1 antibody combination groups (Apatinib+Anti-PD-1), every group 12.Wherein, control group gives 0.9%CMC, once a day；
A Pa gives Ah handkerchief for Buddhist nun 100mg/kg for Buddhist nun's group, gavage, once a day；Anti-PD-1 antibodyomes give Anti-PD-1 antibody
5mg/kg, intraperitoneal injection, twice a week.A Pa gives Ah handkerchief with Anti-PD-1 antibody combination groups for Buddhist nun and given for Buddhist nun's group
A Pa replaces Buddhist nun 100mg/kg, gavage, once a day, and combines and give Anti-PD-1 antibody 5mg/kg, intraperitoneal injection, often
Week is twice.
4th, HE is dyed
After tumour is removed, 0.5cm or so is cut, 10% buffering neutral formalin or bouin liquid are fixed 24 hours, decolourized
Dehydration, transparent, saturating wax, embedding：70% ethanol 30min, 80% ethanol 30min, 80% ethanol 30min, 85% ethanol 30min,
90% ethanol 30min, 95% ethanol 30min, 100% ethanol 30min × 2, ethanol：Dimethylbenzene (1:1)30min；Dimethylbenzene is saturating
Bright 10min；Dimethylbenzene：Paraffin (1:1) 30min, paraffin 1h (can extend to 2h).Section is general in 5 μm or so, 37 roasting piece 3h.
Dimethylbenzene dewaxing 5min × 3 time, each 2 minutes of 95%, 70%, 305 ethanol, warm water 2 minutes.Haematoxylin dye liquor is added dropwise or by glass
In piece immersion haematoxylin dye liquor, dyeing 1min or so is washed 30-60 seconds, eosin stains 30 seconds, graded ethanol and dimethylbenzene dehydration
(30%, 70%, 95%, absolute ethyl alcohol, dimethylbenzene), dry naturally, mounting microscopy.
5th, count
Data are represented with mean ± SD.Comparison between two groups of gross tumor volume, with Mann-Whitneytest, other data two
Compare with Student ' s two-tailedt-test to examine the difference between each group between group.* * represent P<0.001, * * represents P
<0.01, * represents P<0.05.
Analysis of experimental results：From Fig. 1,2,3 as can be seen that Ah handkerchief is alone to mouse Colon for Buddhist nun and Anti-PD-1 antibody
Cancer has partial inhibition, but after Ah handkerchief is for Buddhist nun and the combination of Anti-PD-1 antibody, the inhibitory action to tumour is remarkably reinforced,
When treating terminal, drug combination group tumor size is compared with alone Ah handkerchief replaces Buddhist nun's group, and tumor control rate improves 40.4%
(53.97%vs13.57%, P<0.05, Mann-Whitneytest), compared with alone Anti-PD-1 antibodyomes, tumor suppression
Rate improves 23.17% (53.97%vs13.57%, P<0.05, Mann-Whitneytest) (tumor control rate=1- experiments
Group gross tumor volume/control group gross tumor volume).The alone Ah handkerchief of average tumor weight replaces Buddhist nun's group, alone Anti-PD-1 antibodyomes, Ah
Handkerchief for Buddhist nun and Anti-PD-1 antibody combination groups be respectively (2.203 ± 1.559), (1.637 ± 0.788) and (1.185 ±
0.689), combination group have dropped 1.018g compared with Ah handkerchief for alone group of tumor weight of Buddhist nun, compared with alone group of tumour weight of Anti-PD-1 antibody
Amount have dropped 0.452g.In addition, as can be seen from Figure 4 compared with alone group, after Ah handkerchief is for Buddhist nun and the combination of Anti-PD-1 antibody,
The area of neoplasm necrosis can substantially be increased.
Claims (5)
1. Ah handkerchief is combined the application in colon cancer drug is prepared for Buddhist nun with Anti-PD-1 antibody.
2. application according to claim 1, it is characterised in that：Comprising but be not limited only to Ah handkerchief and resist for Buddhist nun and Anti-PD-1
Body.
3. application according to claim 1, it is characterised in that：The A Pa is administered daily dosage for 100mg/ for Buddhist nun's
kg。
4. application according to claim 1, it is characterised in that：The weekly administration dosage of the Anti-PD-1 antibody is two
It is secondary, each 5mg/kg.
5. Ah handkerchief according to claim 1 is combined in mouse junction cancer Subcutaneous transplanted model for Buddhist nun with Anti-PD-1 antibody
In application.
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| CN201710332298.XA CN106963948A (en) | 2017-05-12 | 2017-05-12 | A Pa is combined the application in colon cancer drug is prepared for Buddhist nun with the antibody of Anti PD 1 |
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|---|---|---|---|
| CN201710332298.XA CN106963948A (en) | 2017-05-12 | 2017-05-12 | A Pa is combined the application in colon cancer drug is prepared for Buddhist nun with the antibody of Anti PD 1 |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109893654A (en) * | 2017-12-11 | 2019-06-18 | 江苏恒瑞医药股份有限公司 | The method of VEGFR inhibitor for treating tumour |
| WO2019129168A1 (en) * | 2017-12-29 | 2019-07-04 | 江苏恒瑞医药股份有限公司 | Use of combined treatment of pd-1 antibody and apatinib for treating triple negative breast cancer |
| CN111065411A (en) * | 2017-11-16 | 2020-04-24 | 江苏恒瑞医药股份有限公司 | Use of PD-1 antibody and VEGFR inhibitor for combined treatment of small cell lung cancer |
| EP3524268A4 (en) * | 2016-10-10 | 2020-07-01 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Use of combination of anti-pd-1 antibody and vegfr inhibitor in preparation of drug for treating cancers |
| JP2021502415A (en) * | 2017-11-10 | 2021-01-28 | エレバー セラピューティクス，インク． | Combination therapy with apatinib for the treatment of cancer |
| WO2021203769A1 (en) * | 2020-04-10 | 2021-10-14 | 江苏恒瑞医药股份有限公司 | Use of anti-pd-1 antibody in preparation of drugs for treating acral lentiginous melanoma |
| WO2022052874A1 (en) | 2020-09-09 | 2022-03-17 | 深圳微芯生物科技股份有限公司 | Use of chiauranib in combination with immune checkpoint inhibitor in antitumor therapy |
| CN115845052A (en) * | 2022-12-28 | 2023-03-28 | 广州誉衡生物科技有限公司 | Pharmaceutical composition, pharmaceutical preparation and application of pharmaceutical preparation in treatment of colon cancer |
| US12116363B2 (en) | 2018-10-19 | 2024-10-15 | Senhwa Biosciences, Inc. | Combinations for immune-modulation in cancer treatment |
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| JP2021502415A (en) * | 2017-11-10 | 2021-01-28 | エレバー セラピューティクス，インク． | Combination therapy with apatinib for the treatment of cancer |
| CN111065411B (en) * | 2017-11-16 | 2023-03-10 | 江苏恒瑞医药股份有限公司 | Use of PD-1 antibody and VEGFR inhibitor for combined treatment of small cell lung cancer |
| CN111065411A (en) * | 2017-11-16 | 2020-04-24 | 江苏恒瑞医药股份有限公司 | Use of PD-1 antibody and VEGFR inhibitor for combined treatment of small cell lung cancer |
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| CN111065412A (en) * | 2017-12-29 | 2020-04-24 | 江苏恒瑞医药股份有限公司 | Use of PD-1 antibody and apatinib in combination treatment of triple negative breast cancer |
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| CN111065412B (en) * | 2017-12-29 | 2021-10-08 | 江苏恒瑞医药股份有限公司 | Use of PD-1 antibody and apatinib in combination treatment of triple negative breast cancer |
| WO2019129168A1 (en) * | 2017-12-29 | 2019-07-04 | 江苏恒瑞医药股份有限公司 | Use of combined treatment of pd-1 antibody and apatinib for treating triple negative breast cancer |
| US12116363B2 (en) | 2018-10-19 | 2024-10-15 | Senhwa Biosciences, Inc. | Combinations for immune-modulation in cancer treatment |
| WO2021203769A1 (en) * | 2020-04-10 | 2021-10-14 | 江苏恒瑞医药股份有限公司 | Use of anti-pd-1 antibody in preparation of drugs for treating acral lentiginous melanoma |
| WO2022052874A1 (en) | 2020-09-09 | 2022-03-17 | 深圳微芯生物科技股份有限公司 | Use of chiauranib in combination with immune checkpoint inhibitor in antitumor therapy |
| CN115845052A (en) * | 2022-12-28 | 2023-03-28 | 广州誉衡生物科技有限公司 | Pharmaceutical composition, pharmaceutical preparation and application of pharmaceutical preparation in treatment of colon cancer |
| CN115845052B (en) * | 2022-12-28 | 2023-12-29 | 广州誉衡生物科技有限公司 | Pharmaceutical composition and pharmaceutical preparation and application thereof in treating colon cancer |
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Application publication date: 20170721 |