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SillaJen
SillaJen, Inc. is a South Korea-based biotechnology company, with offices in Busan, Yangsan and Seoul, South Korea, and San Francisco, California. Technology Pexa-Vec (JX-594) was developed using the SOLVE (Selective Oncolytic Vaccinia Engineering) platform. This platform may be used to optimize virus targeting to specific cancer types, to select transgenes to include into the viral genome, and to optimize viral infection and/or replication selectively through targeted mutations. JX-900 (VVDD): VVDD Platform: Next-gen enhanced oncolytic immunotherapy. Clinical trials Pexa-Vec (JX-594) As of June 2018, these are the clinical trials investigating Pexa-Vec. Partnerships SillaJen has partnered with Transgene, Green Cross, anLee's Pharmaceuticalsand clinical collaboration agreements with Regeneron Pharmaceuticals and the US National Cancer Institute for JX-594. History 2003. Jennerex, Inc. (San Francisco, USA) was established. 2014. SillaJen acquires Jennerex, Inc. 2015 ...
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Jennerex
Jennerex Biotherapeutics, Inc. (now owned by SillaJen) was an American private biopharmaceutical company that developed the oncolytic viruses JX-594 and JX-929 among others. By creating oncolytic viruses that can (1) kill tumor cells directly through lysis, (2) activate the immune system by delivering genes that encode immunostimulants and by overcoming tumor cell-induced immunological tolerance, and (3) reduce tumor nutrient supply through the destruction of blood vessels, Jennerex aimed to create a novel approach to treating and possibly curing cancer. Company Jennerex received its name in honor of Edward Jenner, the pioneer of the smallpox vaccine and "the father of immunology". Locations Headquarters are located in the Financial District, San Francisco. R&D and manufacturing operations are located at the UCSF Mission Bay campus in San Francisco, at the Ottawa Hospital Research Institute (OHRI) in Ottawa, Ontario, Canada, and at SillaJen, Inc. in Busan, South Korea. Company ...
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Pexastimogene Devacirepvec
JX-594 is an oncolytic virus is designed to target and destroy cancer cells. It is also known as Pexa-Vec, INN pexastimogene devacirepvec) and was constructed in Dr. Edmund Lattime's lab at Thomas Jefferson University, tested in clinical trials on melanoma patients, and licensed and further developed by SillaJen. JX-594 is a modified Copenhagen strain (or Wyeth strain) vaccinia poxvirus engineered by addition of the GM-CSF gene and deletion of the thymidine kinase gene which limits viral replication to cells with high levels of thymidine kinase, typically seen in cancer cells with a mutated RAS or p53 gene. The virus also has the ''LacZ'' gene insertion under control of the p7.5 promoter. The virus kills the infected/cancer cells by lysis and also expresses GM-CSF which may help initiate an anti-tumour immune response. It has orphan drug designation from US Food and Drug Administration and EUMA for the treatment of hepatocellular carcinoma (liver cancer). In clinical trials d ...
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Biopharmaceuticals
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological med ...
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ...
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Regeneron Pharmaceuticals
Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to its name, the company then branched out into the study of both cytokine and tyrosine kinase receptors. Company history The company was founded by CEO Leonard Schleifer and scientist George Yancopoulos in 1988. Regeneron has developed aflibercept, a VEGF inhibitor, and rilonacept, an interleukin-1 blocker. VEGF is a protein that normally stimulates the growth of blood vessels, and interleukin-1 is a protein that is normally involved in inflammation. On March 26, 2012, Bloomberg announced that Sanofi and Regeneron were in development of a new drug that would help reduce cholesterol up to 72% more than its competitors. The new drug would target the PCSK9 gene. In July 2015, the company announced a new global collaboration with Sano ...
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Green Cross (South Korea)
GC Pharma reen Cross Corporation() is a biopharmaceutical company headquartered in Yongin, South Korea South Korea, officially the Republic of Korea (ROK), is a country in East Asia, constituting the southern part of the Korea, Korean Peninsula and sharing a Korean Demilitarized Zone, land border with North Korea. Its western border is formed .... GC Pharma specializes in the development and commercialization of vaccines, protein therapies, and therapeutic antibodies for use in the fields of oncology and infectious disease. GC Pharma was established as "Sudo Microorganism Medical Supplies Co." in 1967, and changed the name to "Green Cross" in 1971. The company is engaged in research, development, manufacturing and sales of biotherapeutics, including plasma proteins, recombinant antibodies, and vaccines. Green Cross developed "Hepavax B", the world's third hepatitis B vaccine, in 1983, the world's first vaccine “Hantavax” against epidemic hemorrhagic fever in 1988, t ...
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Transgene
A transgene is a gene that has been transferred naturally, or by any of a number of genetic engineering techniques, from one organism to another. The introduction of a transgene, in a process known as transgenesis, has the potential to change the phenotype of an organism. ''Transgene'' describes a segment of DNA containing a gene sequence that has been isolated from one organism and is introduced into a different organism. This non-native segment of DNA may either retain the ability to produce RNA or protein in the transgenic organism or alter the normal function of the transgenic organism's genetic code. In general, the DNA is incorporated into the organism's germ line. For example, in higher vertebrates this can be accomplished by injecting the foreign DNA into the nucleus of a fertilized ovum. This technique is routinely used to introduce human disease genes or other genes of interest into strains of laboratory mice to study the function or pathology involved with that par ...
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Ipilimumab
Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. Cytotoxic T lymphocytes (CTLs) can recognize and destroy cancer cells. However, an inhibitory mechanism interrupts this destruction. Ipilimumab turns off this inhibitory mechanism and boosts the body's immune response against cancer cells. Ipilimumab was approved by the US Food and Drug Administration (FDA) in March 2011, for the treatment of melanoma, a type of skin cancer. It is undergoing clinical trials for the treatment of non-small cell lung carcinoma (NSCLC), small cell lung cancer (SCLC), (completed) bladder cancer (completed) and metastatic hormone-refractory prostate cancer. The concept of using anti-CTLA4 antibodies to treat cancer was first developed by James P. Allison while he was director of the Cancer Research Laboratory at the University of California, Berkele ...
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Transgene SA
Transgene S.A. is a French biotechnology company founded in 1979. It is based in Illkirch-Graffenstaden, near Strasbourg, and develops and manufactures immunotherapies for the treatment of cancer. The company has two technological platforms based on these respective approaches: myvac (therapeutic vaccines) and Invir.IO (oncolytic viruses). Transgene’s portfolio consists of four products currently in clinical development. Since January 2021, Hedi Ben Brahim has served as President and Chief Executive Officer of Transgene SA. The company is listed on the Paris Stock Exchange. History Transgene was founded in 1979, on the initiative of Pierre Chambon and Philippe Kourilsky. Jean-Pierre Lecocq was the first Scientific Director of Transgene in 1980. Technological platforms Transgene owns two technological platforms: * Invir.IO is a technology platform based on the patented oncolytic viruses that replicate only in cancer cells. The genome of these viruses has been modified to e ...
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Nivolumab
Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer. This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction (GEJ) cancer. It is used by slow injection into a vein. The most common side effects include fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, and vomiting. Use during pregnancy may harm the baby and use when breastfeeding is not recommended. Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from att ...
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Tremelimumab
Tremelimumab, sold under the brand name Imjudo, is a fully human monoclonal antibody against CTLA-4. It is an immune checkpoint blocker. Tremelimumab was approved for unresectable hepatocellular carcinoma medical use in the United States in October 2022. Medical uses Tremelimumab is indicated, in combination with durvalumab, for the treatment of adults with unresectable hepatocellular carcinoma. Mechanism of action Tremelimumab aims to stimulate an immune system attack on tumors. Cytotoxic T lymphocytes (CTLs) can recognize and destroy cancer cells. However, there is also an inhibitory mechanism (immune checkpoint) that interrupts this destruction. Tremelimumab turns off this inhibitory mechanism and allows CTLs to continue to destroy the cancer cells. Tremelimumab binds to the protein CTLA-4, which is expressed on the surface of activated T lymphocytes and inhibits the killing of cancer cells. Tremelimumab blocks the binding of the antigen-presenting cell ligands B7. ...
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CTLA4
CTLA-4 or CTLA4 (cytotoxic T-lymphocyte-associated protein 4), also known as CD152 (cluster of differentiation 152), is a protein receptor that functions as an immune checkpoint and downregulates immune responses. CTLA-4 is constitutively expressed in regulatory T cells but only upregulated in conventional T cells after activation – a phenomenon which is particularly notable in cancers. It acts as an "off" switch when bound to CD80 or CD86 on the surface of antigen-presenting cells. The CTLA-4 protein is encoded by the ''Ctla-4'' gene in mice and the ''CTLA-4'' gene in humans. History CTLA-4 was first identified in 1991 as a second receptor for the T cell costimulation ligand B7. In November 1995, the labs of Tak Wah Mak and Arlene H. Sharpe independently published their findings on the discovery of the function of CTLA-4 as a negative regulator of T-cell activation, by knocking out the gene in mice. Previous studies from several labs had used methods which could not de ...
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