上海三维生物技术有限公司

 
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ONCORINE- Recombinant Human Adenovirus Type 5 Injection

Introduction of the Sunway Biotech

Shanghai Sunway Biotech Co., Ltd is a high-tech company in Shanghaiwhich is dedicated to cancer gene therapy for improving QOL of cancer patients, and health care. The headquarter is located in Shanghai Pudong Jinqiao Biotechnology Industrial Park.

The company was established in 1995 and has developed rapidlly through two major fundings in 1999 and 2003.

The main products under developing are oncolytic viruses -H100 series for cancer therapy. Three genetic engineering adenoviruses have been developed successfully with intellectual properties,which are called H101, H102, and H103.

H101 (Recombinant Human Adenovirus Type 5 Injection; Brand name: Oncorine®) : on market since September, 2006.

H103 (Oncolytic Recombinant Adenovirus Injection): phase I clinical trial finished.

H102: preclinical Stage.

The company has filed a total of 12 patents including Chinese patents, international patents (PCT) and American patents through developing H100 series products. Among those, nine Chinese patents and one Japanese patent have been granted.

Introduction of oncorine

Oncorine (Recombinant Human Adenovirus Type 5 Injection) is the first oncolytic virus drug which was approved in the world and independent intellectual property is hold by the company. After oncorine was listed on national 863 plan and SME Innovation Foundation of Science and Technology Ministry in 2000, it had been listed on “the 10th five-year plan” of major science and technology projects for national “863” plan in 2002. It was adopted as project of Shanghai New and High-tech Achievements Transformation in 2004. Oncorine was got NDA of national calss I biological products in October, 2005. Offical formal manufacture approval was got in April, 2006. And it was successful on the market since September in the same year.

1.Construction of Oncorine

The virus is reconstructed with deleting E1B-55KD and E3 region of wild adenovirus type 5. The black parts are deleted as following.

Construction of Oncorine

2.MOA of Oncorine®

Selective theory depending on the status of P53

In normal cells, early proteins (E1A and E1B) are expressed when they are infected by adenovirus. And early proteins are related with virus replication. The cell response for expression of E1A protein is to stimulate P53 expression. P53 is an important transcription regulation factor and a product of tumor suppressor gene. P53 overexpression results three changes in the cell: 1) cell arresting 2) DNA damage-repair 3) Inducing apoptosis. Those reations are preventing replication of viruse in normal cells. E1B-55KD can degrade P53 protein , which favoring to virus replication. Comparing with wild virus, replication abilityof E1B-55KD deleted virus was reduced; meanwhile, P53 couldn’t be degraded effectively when E1B-55KD is deleted. So that oncorine® can’t replicated in normal cells. In P53 deficient cancer cells , reactions of cells’ can not be induced because of P53 deficiency, it is conducive for replication of reconstructed virus. The current view is that it is not only P53 mutation itself, but also P53 pathway deficiency are conducive for selective replication of oncorine®.

MOA of Oncorine®

 
 
 
 
 

3.Clinical studies of Oncorine®

The multi-center, open, randomized and parallel controlled clinical study with squamous cell carcinoma of head & neck and esophagus showed that curative effect of oncorine® combined with chemotherapy was superior to chemotherapy alone with good safety profile.

Oncorine® was intratumoral injection at the dose of 5.0×1011~1.5×1012vp per day, combined with 5-FU (500mg/m2) and cisplatin (20mg/m2) i.v. gtt. The schedule was continued for 5 days. The cycle was 21 days. 2-4 cycles were conducted with chemotherapy only as control. The data showed that the response rate of combination group was 78.8%; the response rate of chemotherapy only group was 39.6%. The efficacy between two groups were significantly different (p<0.01).

The major adverse events were reaction to local injection, mild to medium grade fever and influenza-like symptoms. It was common that the adverse events can be controlled and relieve itself.

Promising data was noted for oncorine® in clinical studies of lung cancer, liver cancer, pancreatic cancer and malignant effusion.

4.Optimal clinical treatment regimen recommended:

Head and neck cancer:

Case selection: patients are in advanced and refractory with relapse into cervical lymph node metastasis
Usage: local injection in cervical lymph node
Dosage: oncorine® is intratumoral injected at the dose of 1-3 vials per day, combined with 5-FU (500mg/m2) and cisplatin (20mg/m2). The schedule was continued for 5 days. The cycle was 21 days upto 2~5 cycles.

Lung cancer:

Case selection: Advanced non-small cell lung cancer, CT suggests that there has lesions suitable for injection.

Usage:

Intratumoral injection through percutaneous lung puncture with needle guided with B ultrasound or CT

Dosage:

Three vials of oncorine® at 1st and 8th day; start with chemotherapy in 4th day; The cycle is 21 days upto to 2~5 cycles.

Liver cancer:

Case selection: Primary or metastatic liver tumor with clinical or phathological diagnosis confirmed.

Usage & Dosage:

During operation: regional perfusion or intratumoral injection of residual lesions with dose of 3 vials
Intervention procedure: Hepatic artery perfusion with dose of 3 vials. The cycle is 14 days up to 2~5 cycles.
Intrahepatic injection: Intratumoral injection through percutaneous and liver puncture guided with B ultrasound and the dose are 3 vials. The cycle is 14 days up to 2~5 cycles.

Malignant pleural and peritoneal effusions:

Case selection: Advanced tumor with malignant pleural and peritoneal effusions

Usage:

Pleural and peritoneal perfusion

Dosage:

Three vials of oncorine is used at1st and 4th day, and could be combined with local chemotherapy with pleural and peritoneal perfusion. The cycle is 14 days up to 2~5 cycles.

Pancreatic cancer:

Case selection: Incurable pancreatic cancer or recurrence after surgery

Usage:

intratumoral injection is guide with EUS

Dosage:

Three vials of oncorine combined with gemcitabine(1000mg/m2)Intravenous chemotherapy. The cycle is 28 days up to 2~5 cycles.
 
 
 
 
 

沟通合作

  • 营销中心:上海市浦东新区商城路518号内外联大厦2105室
  • 邮编:200120
  • 传真:021-58783831
  • 电话:021-63523313
  • e-mail:xiaoshoubu@sunwaybio.com.cn
 
 
 
 
 
总部地址:上海市浦东新区金桥出口加工区桂桥路1150号C座    邮编:201206    传真:021-58999488    电话:021-50310270    e-mail:sunwaybio@sunwaybio.com.cn