Immune Pharmaceuticals is developing first-in-class monoclonal antibody therapeutics targeting significant unmet medical needs. It has a rheumatoid arthritis drug that is more specific than anti-TNF drugs in development. It also has an anti-CD44 monoclonal antibody targeting cancer stem cells in acute myeloid leukemia entering development. Immune is building a portfolio of clinical and pre-clinical monoclonal antibodies and establishing an R&D center in Israel.
Immune Pharmaceuticals is developing monoclonal antibody therapeutics targeting significant unmet medical needs. It is building a portfolio of clinical and pre-clinical monoclonal antibodies that it believes have potential to become $1 billion drugs. Key programs include a first-in-class monoclonal antibody for rheumatoid arthritis that targets a protein expressed on pathological inflammatory cells but not healthy cells. It is also developing monoclonal antibodies to target cancer stem cells expressing CD44 in acute myeloid leukemia.
Gene Olinger, USAMRIID, Fort Detrick USA, presents at the ProImmune Antigen Characterization and Biomarker Discovery Summit, January 2011.
Protective Immune Reponses to Ebola Virus
A Guide to HIV Drug Resistance_the body.comanjanamatya
The document provides information about HIV drug resistance. It discusses how HIV mutates naturally as it reproduces, and how these mutations can sometimes enable the virus to evade antiretroviral drugs. It explains that understanding resistance is important because prolonged viral replication increases the risk of developing resistant mutations, and resistance can limit future treatment options. The document also outlines different types of resistance tests that can help clinicians determine the best treatment regimen for a patient.
The document discusses the emerging threat of carbapenemase producing enterobacteria and approaches to address it. It provides background on carbapenem antibiotics and the different classes of carbapenemases. It emphasizes that carbapenemases can hydrolyze all beta-lactam antibiotics, making detection and control critical. It recommends surveillance, enhanced infection control practices, and improved laboratory detection methods to help control the spread of these resistant bacteria.
This document discusses virologic monitoring during antiretroviral therapy (ART). It describes how ART works to decrease viral load and allow CD4 cell counts to rebound. It notes that monitoring viral load is important to detect treatment failure early, as failure can lead to immune deterioration, opportunistic infections, drug resistance, and increased transmission. The document discusses different monitoring strategies and outlines goals of achieving viral suppression and immune restoration. It emphasizes that viral load is the best measure of whether ART is controlling HIV replication. Pooled viral load testing is proposed as a way to perform monitoring more efficiently in resource-limited settings.
This document discusses oncolytic virus therapies, including their mechanisms of action, preclinical studies, experiences with patients, and future outlook. It provides an overview of deletion mutant oncolytic adenoviruses that selectively replicate in cancer cells. Clinical trials have shown safety and some efficacy of these viruses as monotherapies and in combination with other treatments like radiation or chemotherapy. Oncolytic viruses show promise as a novel cancer treatment approach.
This document describes a study examining the ability of anti-biofilm peptides (DJK-5, DJK-6, and 1018) to inhibit biofilm formation and enhance the activity of β-lactam antibiotics against carbapenemase-producing Klebsiella pneumoniae clinical isolates. The peptides were found to prevent biofilm formation at concentrations below the minimum inhibitory concentration for planktonic cells. DJK-6 in particular was able to enhance the ability of meropenem to eradicate pre-formed biofilms by at least 16-fold, representing a promising strategy for treating infections caused by these resistant isolates.
The document discusses immune monitoring in vaccine trials. It provides context on regulatory requirements and the need for standardization. A variety of assays are used to assess cellular and antibody responses, including ELISPOT, flow cytometry, and neutralizing antibody assays [PRIMARY]. Challenges include the need for improved assays to measure antiviral function and mucosal responses. New technologies like single cell analysis and viral inhibition assays provide more detailed immune profiling but require significant bioinformatics support [SECONDARY]. The goal is to define immune correlates of protection to guide vaccine design, but this remains difficult without human challenge models [THIRDARY].
Immune Pharmaceuticals is developing monoclonal antibody therapeutics targeting significant unmet medical needs. It is building a portfolio of clinical and pre-clinical monoclonal antibodies that it believes have potential to become $1 billion drugs. Key programs include a first-in-class monoclonal antibody for rheumatoid arthritis that targets a protein expressed on pathological inflammatory cells but not healthy cells. It is also developing monoclonal antibodies to target cancer stem cells expressing CD44 in acute myeloid leukemia.
Gene Olinger, USAMRIID, Fort Detrick USA, presents at the ProImmune Antigen Characterization and Biomarker Discovery Summit, January 2011.
Protective Immune Reponses to Ebola Virus
A Guide to HIV Drug Resistance_the body.comanjanamatya
The document provides information about HIV drug resistance. It discusses how HIV mutates naturally as it reproduces, and how these mutations can sometimes enable the virus to evade antiretroviral drugs. It explains that understanding resistance is important because prolonged viral replication increases the risk of developing resistant mutations, and resistance can limit future treatment options. The document also outlines different types of resistance tests that can help clinicians determine the best treatment regimen for a patient.
The document discusses the emerging threat of carbapenemase producing enterobacteria and approaches to address it. It provides background on carbapenem antibiotics and the different classes of carbapenemases. It emphasizes that carbapenemases can hydrolyze all beta-lactam antibiotics, making detection and control critical. It recommends surveillance, enhanced infection control practices, and improved laboratory detection methods to help control the spread of these resistant bacteria.
This document discusses virologic monitoring during antiretroviral therapy (ART). It describes how ART works to decrease viral load and allow CD4 cell counts to rebound. It notes that monitoring viral load is important to detect treatment failure early, as failure can lead to immune deterioration, opportunistic infections, drug resistance, and increased transmission. The document discusses different monitoring strategies and outlines goals of achieving viral suppression and immune restoration. It emphasizes that viral load is the best measure of whether ART is controlling HIV replication. Pooled viral load testing is proposed as a way to perform monitoring more efficiently in resource-limited settings.
This document discusses oncolytic virus therapies, including their mechanisms of action, preclinical studies, experiences with patients, and future outlook. It provides an overview of deletion mutant oncolytic adenoviruses that selectively replicate in cancer cells. Clinical trials have shown safety and some efficacy of these viruses as monotherapies and in combination with other treatments like radiation or chemotherapy. Oncolytic viruses show promise as a novel cancer treatment approach.
This document describes a study examining the ability of anti-biofilm peptides (DJK-5, DJK-6, and 1018) to inhibit biofilm formation and enhance the activity of β-lactam antibiotics against carbapenemase-producing Klebsiella pneumoniae clinical isolates. The peptides were found to prevent biofilm formation at concentrations below the minimum inhibitory concentration for planktonic cells. DJK-6 in particular was able to enhance the ability of meropenem to eradicate pre-formed biofilms by at least 16-fold, representing a promising strategy for treating infections caused by these resistant isolates.
The document discusses immune monitoring in vaccine trials. It provides context on regulatory requirements and the need for standardization. A variety of assays are used to assess cellular and antibody responses, including ELISPOT, flow cytometry, and neutralizing antibody assays [PRIMARY]. Challenges include the need for improved assays to measure antiviral function and mucosal responses. New technologies like single cell analysis and viral inhibition assays provide more detailed immune profiling but require significant bioinformatics support [SECONDARY]. The goal is to define immune correlates of protection to guide vaccine design, but this remains difficult without human challenge models [THIRDARY].
The document discusses MAGE genes, which code for tumor antigens recognized by cytotoxic T lymphocytes. It provides background on MAGE genes, including that they were first identified in melanoma in 1991. MAGE genes are expressed in various cancers but not most normal tissues. The expression of certain MAGE genes has been associated with prognosis in cancers like lung and prostate cancer. Immunotherapies targeting MAGE antigens show potential for cancer treatment by activating CD8+ T cells against tumor cells. However, the tumor microenvironment can also induce immune suppression, presenting a barrier to the clinical efficacy of cancer vaccines.
On March 14 I presented the history of my research activities and proposals for MS Biology thesis work for the students entering the program at National University,
This document discusses carbapenem-resistant Klebsiella pneumoniae (CRKP) strains. It finds that while the ST258 strain is the most common carrier of the bla-KPC gene responsible for carbapenem resistance, non-ST258 strains like ST514, ST11, and ST13 also play an important role in the dissemination and epidemiology of CRKP worldwide. Multilocus sequence typing (MLST) was used to characterize 70 CRKP isolates, identifying 62 as ST258 and 7 as non-ST258 strains. Rep-PCR clustering found that some non-ST258 strains carried the bla-KPC gene as well, showing the epidemiological significance of non-ST258 CRKP cannot be dismissed
This study evaluated different susceptibility testing methods for their ability to identify carbapenem resistance mediated by the Klebsiella pneumoniae carbapenemase (KPC) in Enterobacteriaceae. Broth microdilution was the most sensitive method, identifying KPC resistance in over 90% of isolates when interpreting ertapenem, meropenem, or imipenem as intermediate or resistant. The modified Hodge test, which detects carbapenemase production, had 100% sensitivity and specificity for KPC. Ertapenem susceptibility testing showed higher sensitivity than meropenem or imipenem across different test methods.
The document summarizes research on hepatitis C virus (HCV) resistance to treatments. It discusses three key points:
1. HCV can develop resistance to interferon-alpha and ribavirin treatment, as well as direct-acting antivirals (DAAs). Resistance is caused by genetic mutations in the virus.
2. Certain genetic variants of the host, particularly near the IL28B gene, influence treatment response by affecting interferon signaling and HCV kinetics.
3. New DAAs target various stages of the HCV life cycle including the NS3/4A protease, NS5B polymerase, and NS5A protein. While some DAAs have a low barrier to resistance,
Triple combination treatment failures are associated with poor interferon responsiveness in patients and the presence of pre-existing resistant variants, such as Q80K, which can influence treatment outcomes. Treatment failures typically result in the selection of drug-resistant viruses, though protease inhibitor-resistant viruses are progressively replaced by wild-type viruses over time after treatment ends. In contrast, NS5A inhibitor-resistant viruses appear to persist longer. The presence of pre-existing resistance variants has only a modest impact on success rates of interferon-free regimens. While resistance is observed in some treatment failures with these regimens, overall response rates remain very high even in the presence of variants.
A Clinical Trial of CCR5 Inhibition in Treated HIV Infection: Highlighting Mu...CTSI at UCSF
A presentation by Peter W. Hunt, M.D., Assistant Professor in Residence at the University of California, San Francisco (UCSF), conducted at the San Francisco General Hospital (SFGH) and supported by CTSI's Clinical Research Services. Learn more about the service at http://ctsi.ucsf.edu/our-work/clinical-research-services
This document discusses hepatitis C virus (HCV) resistance to treatments. It covers three main topics:
1. Resistance to interferon-alpha (IFN-α) and ribavirin treatment is common, especially for genotype 1 HCV infections. Viral factors like intrinsic properties and kinetics contribute to treatment failure and resistance.
2. HCV can develop resistance to direct-acting antivirals (DAAs) like protease inhibitors and polymerase inhibitors through amino acid substitutions. Resistance emerges from minor viral populations and affects drug efficacy.
3. Several new DAAs are in clinical trials, including protease inhibitors, nucleotide analogues, and non-nucleoside polymerase inhibitors. Their resistance profiles are being
Professor Akseli Hemminki presents on gene therapy and oncolytic virusesOncos Therapeutics
Presentation held on October 28, 2010, at Institute for Molecular Medicine for Finland (FIMM). The presentation includes information on a newest theory on immune response against the cancer tumor, mediated by oncolytic viruses
This document describes research into using the recombinant dense granule antigen GRA7 from Toxoplasma gondii for serodiagnosis of toxoplasmosis. The GRA7 gene was amplified from T. gondii genomic DNA and inserted into an expression vector. The recombinant GRA7 protein was expressed in E. coli and purified. Western blot analysis showed human sera reacted with the 29 kDa rGRA7 antigen. ELISA tests using rGRA7 showed sensitivity of 96% for IgM detection and 89% for IgG detection, with specificity of 90% for both, demonstrating its potential usefulness for toxoplasmosis diagnosis.
CIMNA, the unique center for Immune monitoring. CRO / Central Lab / Services in Cytometry, ELISpot, Luminex, Miccroarrays, biostatistics, clinical management, medical writing...
Unveiling the Potential of your AAV Gene Therapy: Orthogonal methods to under...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3pCCjPF
Ensure your Adeno-Associated Virus (AAV) is safe throughout its entire drug development journey. Learn methods that will help you speed to clinic, potentially treating diseases sooner and with greater effectiveness.
The potential of gene therapies to cure previously untreatable diseases has spurred the development of novel drugs, including those based on Adeno-Associated Virus (AAV). As with all biopharmaceuticals, it is important to identify and monitor the critical quality attributes (CQAs) of these products to ensure their safety and efficacy.
In this webinar, we will present a range of orthogonal methods to understand and define the CQAs of AAV products. These include assays for the confirmation of capsid protein identity and quantity, as well as the characterization of important product-related impurities, such as aggregates. Together these methods represent a comprehensive analytical testing package to support the characterization and lot release of AAV products.
In this webinar, you will learn:
• How to identify and monitor the critical quality attributes (CQAs) of your AAV therapy
• What assays to utilize to confirm capsid protein identity and quantity
• Why you need look to product characterization to identify and remove important product-related impurities
1) Bacteria can contribute to carcinogenesis through chronic inflammation and by producing genotoxins. Chronic inflammation and activation of NF-kB helps cancer cells overcome barriers to tumor development.
2) Epidemiological and animal studies provide evidence that bacteria like H. pylori and Salmonella that cause chronic inflammation increase cancer risk by inducing cytokines like IL-1β and TNFα. Blocking NF-kB reduces colorectal cancer progression in mouse models.
3) Bacterial toxins such as CagA from H. pylori and cytolethal distending toxin (CDT) directly cause DNA damage and genomic instability, contributing to mutations and tumor development in vitro and in vivo mouse models.
Does your cell line have a secret? Avoid surprises with characterizationMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2Y05bV4
The first step to avoiding an unpleasant and costly contamination event is characterization of your cell banks.
Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. We will describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that meets current regulatory expectations. Different levels of testing are performed for master, working, and end of production cell banks, and the differences in testing for each of these types of banks will be discussed.
In this webinar, you will learn:
• The types of tests that are needed to fully characterize your cell banks
• The best tests to use for your particular cell line
• Reasons why a viral contaminant may be missed
1. Chronic HCV infection can lead to increased mortality from both hepatic and extrahepatic diseases such as liver cancer, cardiovascular disease, and kidney disease.
2. HCV infection is associated with a variety of autoimmune manifestations and lymphoproliferative disorders, most notably mixed cryoglobulinemia vasculitis.
3. Treatment of HCV infection with direct-acting antivirals or pegylated interferon/ribavirin can result in remission of extrahepatic manifestations by achieving sustained virological response.
Cancer is caused by unusual cell growth due to genetic mutations and can form benign or malignant tumors. Oncolytic viral therapy uses viruses that specifically infect and destroy cancer cells by exploiting differences between normal and cancer cells. Various strategies are used for tumor targeting including pro-apoptotic targeting using viral genes, transcriptional targeting by placing viral genes under tumor-specific promoters, and transductional targeting based on overexpression of receptors on cancer cells. Adenoviruses and reoviruses have been studied extensively as oncolytic viruses due to their ability to selectively replicate in and lyse cancer cells.
Advances in Rheumatoid Arthritis (RA) treatment James Wei 魏正宗
1. Dr. James Wei is the Chief of the Division of Allergy, Immunology and Rheumatology at Chung Shan Medical University Hospital and is an expert in clinical trials.
2. He has extensive experience leading clinical trials for rheumatoid arthritis and ankylosing spondylitis medications and has been the top enroller for trials of several major pharmaceutical companies.
3. Biological agents targeting cytokines like TNF and IL-6 have revolutionized treatment for rheumatoid arthritis but require close monitoring due to potential serious side effects like infection.
This document discusses therapeutic antibodies that are used to treat autoimmune and inflammatory diseases. More than 25 antibodies have been approved for human therapy and over 240 are currently in clinical development. The clinical success of antibodies has led to annual sales exceeding $27 billion in 2007. While early mouse antibodies had limitations, advances like chimerization and humanization overcame many of these issues. Current antibodies provide experience to guide future development in overcoming limitations and pursuing new opportunities.
monoclonal antibodies and engineered antibodiesMunawar Ali
This document provides an overview of monoclonal antibodies and engineered antibodies. It discusses the advantages and disadvantages of monoclonal versus polyclonal antibodies. Production methods like hybridoma technology and fermentation are described. Problems associated with monoclonal antibody therapy like HAMA response are covered. Applications in diagnosis, therapy and analytical uses are mentioned. Finally, the document discusses engineering antibodies by modifying regions to reduce immunogenicity and enhance functions.
The document discusses MAGE genes, which code for tumor antigens recognized by cytotoxic T lymphocytes. It provides background on MAGE genes, including that they were first identified in melanoma in 1991. MAGE genes are expressed in various cancers but not most normal tissues. The expression of certain MAGE genes has been associated with prognosis in cancers like lung and prostate cancer. Immunotherapies targeting MAGE antigens show potential for cancer treatment by activating CD8+ T cells against tumor cells. However, the tumor microenvironment can also induce immune suppression, presenting a barrier to the clinical efficacy of cancer vaccines.
On March 14 I presented the history of my research activities and proposals for MS Biology thesis work for the students entering the program at National University,
This document discusses carbapenem-resistant Klebsiella pneumoniae (CRKP) strains. It finds that while the ST258 strain is the most common carrier of the bla-KPC gene responsible for carbapenem resistance, non-ST258 strains like ST514, ST11, and ST13 also play an important role in the dissemination and epidemiology of CRKP worldwide. Multilocus sequence typing (MLST) was used to characterize 70 CRKP isolates, identifying 62 as ST258 and 7 as non-ST258 strains. Rep-PCR clustering found that some non-ST258 strains carried the bla-KPC gene as well, showing the epidemiological significance of non-ST258 CRKP cannot be dismissed
This study evaluated different susceptibility testing methods for their ability to identify carbapenem resistance mediated by the Klebsiella pneumoniae carbapenemase (KPC) in Enterobacteriaceae. Broth microdilution was the most sensitive method, identifying KPC resistance in over 90% of isolates when interpreting ertapenem, meropenem, or imipenem as intermediate or resistant. The modified Hodge test, which detects carbapenemase production, had 100% sensitivity and specificity for KPC. Ertapenem susceptibility testing showed higher sensitivity than meropenem or imipenem across different test methods.
The document summarizes research on hepatitis C virus (HCV) resistance to treatments. It discusses three key points:
1. HCV can develop resistance to interferon-alpha and ribavirin treatment, as well as direct-acting antivirals (DAAs). Resistance is caused by genetic mutations in the virus.
2. Certain genetic variants of the host, particularly near the IL28B gene, influence treatment response by affecting interferon signaling and HCV kinetics.
3. New DAAs target various stages of the HCV life cycle including the NS3/4A protease, NS5B polymerase, and NS5A protein. While some DAAs have a low barrier to resistance,
Triple combination treatment failures are associated with poor interferon responsiveness in patients and the presence of pre-existing resistant variants, such as Q80K, which can influence treatment outcomes. Treatment failures typically result in the selection of drug-resistant viruses, though protease inhibitor-resistant viruses are progressively replaced by wild-type viruses over time after treatment ends. In contrast, NS5A inhibitor-resistant viruses appear to persist longer. The presence of pre-existing resistance variants has only a modest impact on success rates of interferon-free regimens. While resistance is observed in some treatment failures with these regimens, overall response rates remain very high even in the presence of variants.
A Clinical Trial of CCR5 Inhibition in Treated HIV Infection: Highlighting Mu...CTSI at UCSF
A presentation by Peter W. Hunt, M.D., Assistant Professor in Residence at the University of California, San Francisco (UCSF), conducted at the San Francisco General Hospital (SFGH) and supported by CTSI's Clinical Research Services. Learn more about the service at http://ctsi.ucsf.edu/our-work/clinical-research-services
This document discusses hepatitis C virus (HCV) resistance to treatments. It covers three main topics:
1. Resistance to interferon-alpha (IFN-α) and ribavirin treatment is common, especially for genotype 1 HCV infections. Viral factors like intrinsic properties and kinetics contribute to treatment failure and resistance.
2. HCV can develop resistance to direct-acting antivirals (DAAs) like protease inhibitors and polymerase inhibitors through amino acid substitutions. Resistance emerges from minor viral populations and affects drug efficacy.
3. Several new DAAs are in clinical trials, including protease inhibitors, nucleotide analogues, and non-nucleoside polymerase inhibitors. Their resistance profiles are being
Professor Akseli Hemminki presents on gene therapy and oncolytic virusesOncos Therapeutics
Presentation held on October 28, 2010, at Institute for Molecular Medicine for Finland (FIMM). The presentation includes information on a newest theory on immune response against the cancer tumor, mediated by oncolytic viruses
This document describes research into using the recombinant dense granule antigen GRA7 from Toxoplasma gondii for serodiagnosis of toxoplasmosis. The GRA7 gene was amplified from T. gondii genomic DNA and inserted into an expression vector. The recombinant GRA7 protein was expressed in E. coli and purified. Western blot analysis showed human sera reacted with the 29 kDa rGRA7 antigen. ELISA tests using rGRA7 showed sensitivity of 96% for IgM detection and 89% for IgG detection, with specificity of 90% for both, demonstrating its potential usefulness for toxoplasmosis diagnosis.
CIMNA, the unique center for Immune monitoring. CRO / Central Lab / Services in Cytometry, ELISpot, Luminex, Miccroarrays, biostatistics, clinical management, medical writing...
Unveiling the Potential of your AAV Gene Therapy: Orthogonal methods to under...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3pCCjPF
Ensure your Adeno-Associated Virus (AAV) is safe throughout its entire drug development journey. Learn methods that will help you speed to clinic, potentially treating diseases sooner and with greater effectiveness.
The potential of gene therapies to cure previously untreatable diseases has spurred the development of novel drugs, including those based on Adeno-Associated Virus (AAV). As with all biopharmaceuticals, it is important to identify and monitor the critical quality attributes (CQAs) of these products to ensure their safety and efficacy.
In this webinar, we will present a range of orthogonal methods to understand and define the CQAs of AAV products. These include assays for the confirmation of capsid protein identity and quantity, as well as the characterization of important product-related impurities, such as aggregates. Together these methods represent a comprehensive analytical testing package to support the characterization and lot release of AAV products.
In this webinar, you will learn:
• How to identify and monitor the critical quality attributes (CQAs) of your AAV therapy
• What assays to utilize to confirm capsid protein identity and quantity
• Why you need look to product characterization to identify and remove important product-related impurities
1) Bacteria can contribute to carcinogenesis through chronic inflammation and by producing genotoxins. Chronic inflammation and activation of NF-kB helps cancer cells overcome barriers to tumor development.
2) Epidemiological and animal studies provide evidence that bacteria like H. pylori and Salmonella that cause chronic inflammation increase cancer risk by inducing cytokines like IL-1β and TNFα. Blocking NF-kB reduces colorectal cancer progression in mouse models.
3) Bacterial toxins such as CagA from H. pylori and cytolethal distending toxin (CDT) directly cause DNA damage and genomic instability, contributing to mutations and tumor development in vitro and in vivo mouse models.
Does your cell line have a secret? Avoid surprises with characterizationMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2Y05bV4
The first step to avoiding an unpleasant and costly contamination event is characterization of your cell banks.
Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. We will describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that meets current regulatory expectations. Different levels of testing are performed for master, working, and end of production cell banks, and the differences in testing for each of these types of banks will be discussed.
In this webinar, you will learn:
• The types of tests that are needed to fully characterize your cell banks
• The best tests to use for your particular cell line
• Reasons why a viral contaminant may be missed
1. Chronic HCV infection can lead to increased mortality from both hepatic and extrahepatic diseases such as liver cancer, cardiovascular disease, and kidney disease.
2. HCV infection is associated with a variety of autoimmune manifestations and lymphoproliferative disorders, most notably mixed cryoglobulinemia vasculitis.
3. Treatment of HCV infection with direct-acting antivirals or pegylated interferon/ribavirin can result in remission of extrahepatic manifestations by achieving sustained virological response.
Cancer is caused by unusual cell growth due to genetic mutations and can form benign or malignant tumors. Oncolytic viral therapy uses viruses that specifically infect and destroy cancer cells by exploiting differences between normal and cancer cells. Various strategies are used for tumor targeting including pro-apoptotic targeting using viral genes, transcriptional targeting by placing viral genes under tumor-specific promoters, and transductional targeting based on overexpression of receptors on cancer cells. Adenoviruses and reoviruses have been studied extensively as oncolytic viruses due to their ability to selectively replicate in and lyse cancer cells.
Advances in Rheumatoid Arthritis (RA) treatment James Wei 魏正宗
1. Dr. James Wei is the Chief of the Division of Allergy, Immunology and Rheumatology at Chung Shan Medical University Hospital and is an expert in clinical trials.
2. He has extensive experience leading clinical trials for rheumatoid arthritis and ankylosing spondylitis medications and has been the top enroller for trials of several major pharmaceutical companies.
3. Biological agents targeting cytokines like TNF and IL-6 have revolutionized treatment for rheumatoid arthritis but require close monitoring due to potential serious side effects like infection.
This document discusses therapeutic antibodies that are used to treat autoimmune and inflammatory diseases. More than 25 antibodies have been approved for human therapy and over 240 are currently in clinical development. The clinical success of antibodies has led to annual sales exceeding $27 billion in 2007. While early mouse antibodies had limitations, advances like chimerization and humanization overcame many of these issues. Current antibodies provide experience to guide future development in overcoming limitations and pursuing new opportunities.
monoclonal antibodies and engineered antibodiesMunawar Ali
This document provides an overview of monoclonal antibodies and engineered antibodies. It discusses the advantages and disadvantages of monoclonal versus polyclonal antibodies. Production methods like hybridoma technology and fermentation are described. Problems associated with monoclonal antibody therapy like HAMA response are covered. Applications in diagnosis, therapy and analytical uses are mentioned. Finally, the document discusses engineering antibodies by modifying regions to reduce immunogenicity and enhance functions.
The document summarizes information about monoclonal antibodies (mAbs), including their definition as identical antibodies generated from a single B cell clone that target a single epitope. It describes the advantages of mAbs such as specificity and applications in treatment. The document outlines the preparation process for mAbs and different types including murine, chimeric, humanized, and fully human. It discusses uses of mAbs in diagnosis, therapy, and protein purification and some challenges and future prospects.
Monoclonal Antibodies As Therapeutic Agents In Oncology Anddrmisbah83
This document discusses monoclonal antibodies as therapeutic agents for cancer and antibody gene therapy. It describes how monoclonal antibodies work to target cancer cells, lists some common monoclonal antibody drugs approved for cancer treatment, and discusses potential side effects. It also introduces the concept of using antibody gene therapy as a new strategy for cancer treatment by delivering antibody genes directly to tumors using vectors like adenovirus or mesenchymal stem cells.
La disponibilidad de un sistema de multiplicación del virus de la hepatitis C (VHC) infeccioso en cultivos celulares está permitiendo investigar nuevos factores de respuesta a tratamientos antivíricos en condiciones controladas. Se presentará evidencia de que el fitness vírico puede ser un factor de multiresistencia a inhibidores y quese pueden obtener eficientes reducciones de carga viral empleando diseños secuenciales de administración de inhibidores que incluyan ribavirina. Se discutirán posibilidades de aplicación clínica.
This document discusses antibody-mediated rejection (ABMR) in kidney transplant recipients. It provides information on:
- The role of HLA and non-HLA antibodies in ABMR, including donor-specific antibodies (DSAs)
- Methods for detecting sensitization and antibodies pre-transplant, including complement-dependent cytotoxicity, flow cytometry, and Luminex single-antigen beads
- Studies showing an association between preformed DSA strength/level and risk of ABMR, graft survival
- Trials of desensitization protocols using IVIG, with or without plasmapheresis, to reduce DSA levels and risk of ABMR
- Monoclonal antibodies (MAbs) are identical antibodies produced from a single clone that can be produced in large quantities with high purity. Early MAbs had limited effectiveness due to immunogenicity and inefficient effector functions as they were of murine origin.
- Later generations of chimeric, humanized, and fully human MAbs have improved effectiveness by reducing immunogenicity issues. MAbs can induce tumor cell killing through mechanisms like antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.
- Examples of approved unconjugated MAbs for solid tumors include trastuzumab for HER2-positive breast cancer, cetuximab and panitumumab for colorectal and head/neck cancers,
This document provides an overview of monoclonal antibodies (MAbs), including their definition, introduction, pharmacology, adverse effects, and therapeutic potentials. Some key points include:
- MAbs are antibodies produced from a single clone that are more abundant and uniform than natural antibodies.
- They have specific mechanisms of action including blocking target antigens, inducing cytotoxicity, and inhibiting growth factors.
- Therapeutic areas include immunosuppression, autoimmune diseases, cancer, and infectious diseases. MAbs targeting tumor necrosis factor alpha have shown promise for treating rheumatoid arthritis and Crohn's disease.
This document provides an overview of monoclonal antibodies (MAbs), including their definition, development, mechanisms of action, pharmacokinetics, adverse effects, and various therapeutic applications. Some key points discussed include:
- MAbs are antibodies produced from a single clone that are more uniform and abundant than natural antibodies. They can be produced in large quantities in the laboratory.
- Therapeutic uses of MAbs include immunosuppression for transplant rejection, treatment of autoimmune diseases by inhibiting cytokines like TNF-α, and various forms of cancer therapy by targeting cell surface antigens.
- Adverse effects are usually mild and related to cytokine release during infusion, but long-term suppression of physiological functions can also occur depending on
Immune checkpoint inhibitors work by releasing brakes on the immune system called checkpoints that normally limit anti-tumor immune responses. In clinical trials, checkpoint inhibitors have demonstrated the ability to induce long-lasting responses in a subset of patients with various cancers including melanoma. Combining checkpoint inhibitors with other immunotherapies, targeted therapies, or cell-based therapies may help generate anti-tumor immune responses in patients whose tumors do not respond to checkpoint inhibitors alone. Managing cancer in the era of checkpoint inhibitors will likely involve complex combinations of different treatment approaches.
Global cancer immunotherapy market outlook 2020KuicK Research
"Global Cancer Immunotherapy Market Outlook 2020" Report Highlight:
Introduction & Classification of Cancer Immunotherapy
Global Cancer Immunotherapy Pipeline by Company, Indication & Phase
Marketed Cancer Immunotherapies Clinical Insight & Patent Analysis by Company & Indication
Global Cancer Immunotherapy Pipeline: 1834 Drugs
Marketed Cancer Immunotherapies: 113 Drugs
Cancer Monoclonal Antibodies Pipeline: 622 Cancer mAb
Cancer Vaccines Pipeline: 312 Vaccines
Marketed Cancer mAb: 36 mAb
Marketed Cancer Vaccines: 12 Vaccines
Monoclonal antibodies (mAbs) are identical antibodies produced by a single clone of immune cells that recognize a specific antigen. There are three main mechanisms by which mAbs can treat cancer: 1) directly inducing apoptosis or inhibiting growth of cancer cells by binding to antigens, 2) delivering toxins, radioisotopes or cytokines to cancer cells when modified for drug delivery, and 3) using bispecific antibodies to bind cancer antigens and effector cells to elicit an immune response. Common mAbs approved by the FDA for cancer treatment target growth factor receptors or directly elicit apoptotic signaling in cancer cells. Production of mAbs is primarily through hybridoma technology fusing antibody-producing cells with myeloma cells.
Monoclonal antibodies are identical antibodies produced by a single clone of B cells that recognize a specific epitope on an antigen. They are produced through the fusion of B cells from an immunized animal with myeloma cells to form a hybridoma. This hybridoma will continuously secrete the same monoclonal antibody. Monoclonal antibodies have various diagnostic and therapeutic applications including use in biochemical assays, diagnostic imaging, cancer treatment, and protein purification due to their high specificity for targets.
The document discusses a clinical trial comparing the monoclonal antibodies obinutuzumab and rituximab for treating diffuse large B-cell lymphoma. Obinutuzumab is a glycoengineered, humanized antibody that clusters the CD20 antigen more effectively than rituximab. In a phase III trial, obinutuzumab plus chemotherapy did not significantly improve progression-free survival over rituximab plus chemotherapy. However, obinutuzumab's glycoengineering may enhance its antibody-dependent cellular cytotoxicity and direct cell death mechanisms relative to rituximab.
Enhanced NK cell adoptive antitumor effects against breast cancer in vitroRahul Gupta
This is the research paper which i have been choosen for presentation "Enhance NK cell adoptive antitumor effects against breast cancer in vitro via blockade of the Transforming Growth Factor-Beta".
Robert Anders, MD, PhD, Julie R. Brahmer, MD, MSc, and Christopher D. Gocke, MD, prepared useful Practice Aids pertaining to immunotherapy and biomarker testing for this CME/MOC/CC activity titled "Keeping Up With Advances in Cancer Immunotherapy and Biomarker Testing: Implications for Pathologists at the Forefront of the Emerging Precision Immuno-Oncology Era." For the full presentation, monograph, complete CME/MOC/CC information, and to apply for credit, please visit us at http://bit.ly/2L7zlSy. CME/MOC/CC credit will be available until May 2, 2020.
This document discusses the selection of antimicrobial agents and includes the following key points:
1. Selection of the appropriate antimicrobial requires identifying the infecting organism, its susceptibility, the site of infection, patient factors, safety, and cost.
2. Identification of the organism is central but empiric therapy may be needed before results are available, guided by the infection site and patient history.
3. Broad-spectrum therapy may initially be indicated when the organism is unknown or multiple organisms are possible. The likely organisms in different clinical settings can also guide empiric selection.
1. Immune Pharma
Targeted Medicine
Immune Pharmaceuticals Corporation
Developing the Next Generation Monoclonal Antibody Therapeutics
New York Biotechnology Association
Corporate Showcase
April 19, 2010
2. Immune Pharma A Development Stage Monoclonal Antibody Company
Targeted Medicine
IMMUNE Pharmaceuticals is a New York based biopharmaceutical
company focused on First-in-Class Therapeutics addressing significant
unmet medical needs in Oncology, Immunology and Infectious
Diseases.
IMMUNE is building a portfolio of Clinical and Pre-Clinical MAbs with
multiple shots on goal for $ 1 billion drugs based on novel targets and
proprietary best in class antibody technologies.
IMMUNE is establishing a Research Center in Israel to capitalize on its
academic relationships with Weizmann Institute and Hebrew University.
3. Immune Pharma Investing in a MAbs company is highly attractive
Targeted Medicine
1. Large and Growing Market
Monoclonal Antibody Market $ 40 B in 2009 to reach $ 60 B by 2014
5 of top 10 drugs are MAbs and 8 have already reached $ 1 B in sales
2. Higher Development Success Rate
50% higher success rate with MAbs compared to small molecules (Tufts CSDD)
Faster clinical development and regulatory review ( IND to BLA in 6years)
3. Longer Commercial exclusivity with reduced Generic Threats
US Healthcare Law provides for at least 12 Years Marketing Exclusivity
Antibody Complexity and lack of Regulatory consensus to delay Biosimilars
4. Improved Engineering and Decreasing Manufacturing Costs
Novel Antibody Engineering delivers improved performance
Manufacturing Costs have decreased 50% in the last 10 years
5. Rich Partnering Opportunities
Partnering for innovative phase 2 MAb exceeds $ 500 M per deal value
6. Higher Market and M&A Exit Valuations
Many company valuations range from $ 500 M to $ 2+ B
4. Immune Pharma A Portfolio with multiple shots on goal for $ 1 B drugs
Targeted Medicine
.
Multiple value creating milestones in next 3 years:
1. First-in Class Highly Specific Rheumatoid Arthritis MAb to reach
phase II a ready for Corporate Partnering
2. In Licensed MAb for orphan indication to progress to phase II/ III
3. Two INDs for novel MAbs
4. Three MAbs promoted to Early Development Candidates ( pre-clinical POC)
5. Validated Fully Human and Bi-Specific Antibody technology platforms
6. Immune Pharma Significant Unmet Medical Need
Targeted Medicine for new Rheumatoid Arthritis Treatment
Only 30% of Rheumatoid Arthritis (RA) patients are treated with TNF-alpha
blockers (Enbrel $8B, Remicade $6.9B, Humira $ 5.5B)
1. Unspecific immuno-suppression is responsible for severe and
occasionally lethal infections, including Tuberculosis,
2. 2/3 of treated patients have Partial Response with TNF-alpha Blockers
and still experience daily pain, stiffness and fatigue
3. 25-40% patients do not respond to TNF-apha blockers even at the lowest
efficacy level (ACR 20)
4. 20% of patients experience diminishing response with TNF-alpha
blockers over the course of the first year
High Unmet Medical Need for a Highly Specific RA treatment
with improved efficacy and limited off target safety concerns
7. Immune Pharma First in Class CD44vRA MAb
Targeted Medicine Highly Specific for Rheumatoid Arthritis
CD44vRA MAb recognizes and targets
specific protein expressed on the
surface of pathological inflammatory
cells but not expressed on normal cells,
so healthy cells remain undamaged:
RA Specific: binds to 75% of synovial
fluid cells from RA patients,
Site of Target Selective: not active in
action
Peripheral white blood cells from
of anti
hCD44vRA
the same patients,
MAb Keratinocytes from normal donors,
Synovial fluid cells from
osteoarthritis patients
Golan, Naor & all, Journal of Autoimmunity vol 28
issue 2-3 March-May 2007, Pages 99-113
8. Immune Pharma CD44vRA MAb binds to Gal-8
Targeted Medicine and induces Apoptosis of Inflammatory Synovial Cells
The involvement of CD44 and its novel ligand Galectin-8 in the regulation of Auto-Immune Inflammation
Golan, Naor & all, J.Immunol. 2007;179;1225-1235
9. Immune Pharma CD44vRA MAb equal or better than
Targeted Medicine anti-TNFalpha in Ex Vivo and In Vivo models
Proof of Concept studies in
Collagen Induced Arthritis
standard In Vivo model
Histo-pathology shows:
– Reduction in cell inflammation
– Reduction in fibro-vascular
proliferatiion
– Reduction in cartilage
destruction and improved repair
Anti-Human CD44vRA MAb
2.9
Negative Control
F8:33 200 ug
induces resistance to Collagen
2.7
F8:33 Time 200 ug
F8:33 70 ug induces Arthritis in DBA/1 mouse
2.5
anti-TNF
model because of the homology
between mouse CD44 v4/v5 and
Paw (mm)
2.3
2.1
human CD44vRA
1.9
Confirms ex vivo apoptotic
1.7
activity of inflammatory synovial
1.5
1 2 3 4 5 6 7 cells from RA patients
Days
10. Immune Pharma Attractive Target Product Profile
Targeted Medicine for First in Class Anti-Human CD44vRA MAb
Anti-Human Anti-TNFalpha Oral
CD44vRA MAb MAb Kinase Inhibitor
Selectivity High Average Average
Non specific
immunosuppression Low Moderate to High Moderate to High
Risk of severe
infections and TB
Risk of High Blood No No Yes
Pressure
Treatment
Responders > 75% 50% 60%
(ACR 20) up to 100% in
CD44vRA positive
patients
Biomarker for Yes No No
responders
12. Immune Pharma Treatment of cancer stem cells
Targeted Medicine one step towards the cure*
1. Next paradigm in cancer treatment
2. Significant data published and
acknowledged
3. Cancer stem cells resist current
treatments
4. Cancer stem cells lead to relapsing
cancer
5. Targeted therapeutics of cancer
stem cells can lead to full cancer
cure
*According to the American Society of Clinical Oncology,
Journal of Clinical Oncology, June 2008
13. Immune Pharma First in Class Anti-CD44 MAb
Targeted Medicine targeting Cancer Stem Cells
1. IMP 111 is a novel Anti-CD44 MAb
with the following activity:
Targets specific epitope on
constant part of CD44 on AML
cells,
Survival benefit in knock out
mice grafted with human
leukemia cells
No hemagglutination
2. Antibody Dependant Cellular
Phagocytosis (ADCP) is a novel
mechanism of action demonstrated
with IMP-111
3. Follow on screening of CD44 variant
targets specific to Stem Cells in
various malignancies and
development of a library of fully
human antibodies
14. Immune Pharma IMPH Novel “Fully Human” MAbs
Targeted Medicine Initial application for anti CD44 MAbs in AML
A Cellular Engineering Approach
Human Lymphoma B Cells
+
Human Cord Blood Mouse Myeloma Cells
Sorting
CD34+ sorted cells
Transplant
Hetero-Myeloma
Selected
Antigen +
Fusion
Human Hybridomas
Spleen
extraction
Mouse with human
immune system
Splenocytes
Fully Human MAbs
14
16. Immune Pharma
Targeted Medicine
Developing three novel Bi-Specific MAbs approaches
1. Quadrivalent bi-specific antibodies
• 3 Year EC financed pan-European academic research coordinated by
IMPH co-founder
• Patent License from CNRS-France
2. Bi-Specific Immuno-NanoParticules
• Scientific collaboration between IMPH co-founder and Hebrew
University (Prof. Benita)
• One or two antibodies grafted on a NanoParticule
• Ability to co-deliver a chemotherapeutic
• Patent License from Yissum-Hebrew University
3. Dual Soluble Receptor Fusion Protein
• Developed by IMPH
17. Immune Pharma IMPH to develop bi-specific anti-ErbB/ HER2
Targeted Medicine antibodies in partnership with Weizmann Institute
Combinations of two anti-ErbB antibodies targeting different epitopes
may increase therapeutic efficacy through enhanced endocytosis
Synergistic Tumor Inhibition by anti-HER2
Antibody combinations
T. Ben-Kasus, Bilha Schechter, Yossi Yarden &
Michael Sela, Weizmann Institute ,of Science
Publication in Proceedings of National Academy
of Sciences, March 2009
18. Immune Pharma R&D Investments supported
Targeted Medicine by strong Intellectual Property
Exclusive worldwide license from Maimonidex -Yissum/ Hebrew University Patents
on CD44vRA
Patents filed by IMPH for CD44 target and antibody against Leukemia Stem Cells
Patents filed by IMPH on Fully Human Antibodies (Cellular Engineering)
Option to exclusive license from Weizmann Institute on HER2 combinations
Option to exclusive license from Feinstein Institute on CLL targets
Option to exclusive license on Quadrivalent Bi-Specific Antibodies from European
Academic Consortium
Option to license on ImmunoNanoParticules from Yissum-Hebrew University
19. Immune Pharma IMPH Academic and Industry Network
Targeted Medicine generates a Pipeline of Opportunities
IMPH Management has extensive global relationships with leading Academic
Institutions and with Bio-Pharmaceutical companies, creating opportunities for
rewarding partnerships such as:
1. In licensing or co-development opportunity of First-in-class novel anti-
angiogenic target and antibody for the treatment of Age-Related Macular
Degeneration
2. Development of Bi-Specific Antibodies against Specific targets in Chronic
Lymphocytic Leukemia ( Collaboration with Prof. Nick Chiorazzi-
Feinstein Institute-New York)
3. Development of Antibodies and Novel Delivery forms against anti-
infective targets (Collaboration with Professor Pothier- France)
4. Development of MAbs against specific novel targets for a mid-size
Biotech company
20. Immune Pharma
Targeted Medicine A Strong Management Team
Daniel Teper, PharmD, MBA, Chief Executive Officer and Co-founder
Dr Teper has been a Partner at Strategy Consulting firms, ISO Healthcare (now part of Monitor),
Bionest , and 21 West, advising leading pharma and biotech companies. He has previously held
sales, marketing, new product development and general management positions at Novartis, GSK,
Sanofi-Aventis. Daniel holds an MBA from INSEAD and a Doctor of Pharmacy (PharmD) degree.
J.E. Kadouche, PhD, Co-founder, President and Chief Scientific Officer
Dr Kadouche has 25 years experience in the development of MAbs in both Academia and Industry.
He was until recently the CEO of MAT an Antibody company where he built and partnered a clinical
and pre-clinical portfolio. He is the founder of Clonatec and was an advisor to Sangstat, Roche, Merck
AG and J&J. He holds PhD in Immunology from the Pasteur Institute and was an Assistant Professor
at St Louis Hospital.
John Mohr, CPA, Chief Financial Officer and Chief Business Officer
Mr Mohr is a seasoned Business Development executive with over 20 years industry experience. He
was until recently the SVP, Business Development at CV Therapeutics which was acquired by Gilead
for $ 1.4 billion. As President of Fournier USA, he partnered with Abbott and launched Tricor, now a
$1 billion drug. John is a CPA and started his career in Finance at Merck & Co..
Mitchell Glass, MD, Senior Vice President, Chief Medical Officer
Dr. Glass brings leadership experience in drug development at GSK and AstraZeneca as well as
emerging Biotech companies and Academia. Mitchell is strong relationships with the FDA and the
NIH. received his MD from the University of Chicago and is a member of the American Thoracic
Society and American Academy of Asthma, Allergy & Immunology.
Eli Eldan, MBA, Vice-President, General Manager, Israel Operations
21. Immune Pharma IMMUNE aims to deliver Multiple Value Creating
Targeted Medicine Milestones over the next 3 years
2011 2012 2013
First In Class RA MAb
Phase I Phase II
In Licensed Orphan MAb
Phase I Phase II
INDs Novel MAbs
Early Dev. Candidates
Antibody Technology
Platform Partnering
22. Immune Pharma
Targeted Medicine Contact Details
Daniel Teper
CEO
Email: d.teper@immunepharma.com
Jean Kadouche
President, Research
Email: j.kadouche@immunepharma.com
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