Immunogenicity

DGAP-News: AFFiRiS: Positive phase 1 results with immunotherapies targeting PCSK9 to treat hypercholesterolemia published by the European Journal of Clinical Pharmacology

Retrieved on: 
Thursday, May 27, 2021
Medical specialties, Clinical medicine, PCSK9, Medicine, Low-density lipoprotein, Proprotein convertase, Immunotherapy, Immunogenicity, Familial hypercholesterolemia, Evolocumab, AFFITOPE's(R) AT04A and AT06A, AFFiRiS AG, AFFITOPE'S(R) AT04A AND AT06A, AFFIRIS AG, SAIT

A pathway to reduce these risks involves targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), a protein which downregulates the LDL receptor and therefore reduces uptake of LDLc.

Key Points: 
  • A pathway to reduce these risks involves targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), a protein which downregulates the LDL receptor and therefore reduces uptake of LDLc.
  • Neutralizing PCSK9 by induction of specific antibodies, results in reduced LDLc levels via an increased density of the LDL receptor.
  • Participants were evaluated over a period of 90 weeks to assess safety, immunogenicity, and LDLc-lowering activity of both SAIT products targeting PCSK9.
  • The Company's ultimate goal is to improve the lives of patients suffering from these diseases by providing disease-modifying specific immunotherapies.

AFFiRiS: Positive phase 1 results with immunotherapies targeting PCSK9 to treat hypercholesterolemia published by the European Journal of Clinical Pharmacology

Retrieved on: 
Thursday, May 27, 2021
Medical specialties, PCSK9, Low-density lipoprotein, Proprotein convertase, Immunogenicity, Neutralizing antibody, Evolocumab

The results of the phase 1 trial demonstrated that repeated immunization with AT04A or AT06A is well tolerated, safe and elicited a humoral immune response against the PCSK9 target epitope.

Key Points: 
  • The results of the phase 1 trial demonstrated that repeated immunization with AT04A or AT06A is well tolerated, safe and elicited a humoral immune response against the PCSK9 target epitope.
  • A pathway to reduce these risks involves targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), a protein which downregulates the LDL receptor and therefore reduces uptake of LDLc.
  • Neutralizing PCSK9 by induction of specific antibodies, results in reduced LDLc levels via an increased density of the LDL receptor.
  • Participants were evaluated over a period of 90 weeks to assess safety, immunogenicity, and LDLc-lowering activity of both SAIT products targeting PCSK9.

Target RWE Research Presented at DDW 2021 Shows High Rates of Biologic Combination Therapy and Previous Biologic Exposure in IBD Population

Retrieved on: 
Sunday, May 23, 2021
Medical specialties, Clinical medicine, Life sciences, Immunosuppressants, Monoclonal antibodies, Autoimmune diseases, Inflammatory bowel disease, Biotechnology, Vedolizumab, Ustekinumab, Biopharmaceutical, Immunogenicity

b'DURHAM, N.C., May 23, 2021 /PRNewswire/ -- Research presented today at Digestive Disease Week (DDW) 2021 evaluated the prevalence and predictors of immunomodulator use as concomitant therapy with two commonly prescribed biologics, vedolizumab (Entyvio) or ustekinumab (Stelara), in patients with inflammatory bowel disease (IBD).

Key Points: 
  • b'DURHAM, N.C., May 23, 2021 /PRNewswire/ -- Research presented today at Digestive Disease Week (DDW) 2021 evaluated the prevalence and predictors of immunomodulator use as concomitant therapy with two commonly prescribed biologics, vedolizumab (Entyvio) or ustekinumab (Stelara), in patients with inflammatory bowel disease (IBD).
  • Data from Target RWE\'s TARGET-IBD large longitudinal cohort Immunomodulators are Commonly Used as Concomitant Therapy with Vedolizumab or Ustekinumab: TARGET-IBD Real World Cohort was selected for the Poster of Distinction Award.\nGlobal IBD prevalence has risen substantially over the past 30 years.
  • The addition of an immunomodulator in combination therapy may limit this potential benefit, especially in those over age 65, without reducing immunogenicity.\n"Immunogenicity occurs when a treatment provokes an immune response against itself.
  • Target RWE\'s novel NoviSci analytics platform enables the analysis and visualization of health data using state-of-the-science epidemiological methods and scientific principles, providing a highly adaptive environment to accelerate insights and reproducible research.

Nemysis Limited Announces Grant of First Canadian Patent for E-40

Retrieved on: 
Wednesday, May 19, 2021
Immunology, Gluten, Branches of biology, Sedolisin, Subtilisin, Kexin, Immunogenicity, ImmunoGen, Gliadin, S53

The patented Endoproteases belong to the S8/S53 family of subtilisin kexin sedolisins, effective in cleaving the immunogenic epitopes of gliadin at pH between 3 and 8.

Key Points: 
  • The patented Endoproteases belong to the S8/S53 family of subtilisin kexin sedolisins, effective in cleaving the immunogenic epitopes of gliadin at pH between 3 and 8.
  • The invention also includes methods for the recombinant production of the enzymatic compositions in several cell hosts.
  • "\nMaria Cristina Comelli, Chief Scientific Officer of Nemysis Ltd added: "At Nemysis, we are working continuously to bring innovative treatments to patients with nutritional deficiencies.
  • We are excited about the possibility of making a significant impact on their health and quality of life with E40.

AC Immune Announces Expansion of Phase 1b/2a phospho-Tau Alzheimer’s Vaccine Trial and Provides a Program Update

Retrieved on: 
Monday, May 17, 2021
Medical specialties, Medicine, Clinical medicine, Immunology, Vaccines, Virology, Immunogenicity, Vaccine, ImmunoGen, Clinical trials

The trial expansion, which is based on encouraging interim safety, tolerability and immunogenicity results to date, specifically includes vaccination of additional AD patients at the second highest dose to support continued development of ACI-35.030 into Phase 2b/3.

Key Points: 
  • The trial expansion, which is based on encouraging interim safety, tolerability and immunogenicity results to date, specifically includes vaccination of additional AD patients at the second highest dose to support continued development of ACI-35.030 into Phase 2b/3.
  • ACI-35.030 is the first AD vaccine candidate designed to generate antibodies that specifically target pathological pTau proteins in the brain.
  • Andrea Pfeifer, CEO of AC Immune SA, commented: \xe2\x80\x9cExpanding the second highest dose cohort will increase the amount of immunogenicity and safety data and potentially facilitate advancement into a Phase 2b/3 trial.
  • Antibodies generated by the platform are highly specific for the pathological conformations of misfolded proteins and have shown strong safety.

Improving Cancer Survival Prediction: A New Approach with EpiVax Therapeutics' Ancer Platform

Retrieved on: 
Thursday, May 13, 2021
Branches of biology, Medical specialties, Clinical medicine, Vaccines, Cancer vaccines, Genomics, Applied genetics, Biotechnology, Immunogenicity, Mutanome, Epitope, Antigen

b'PROVIDENCE, R.I., May 13, 2021 /PRNewswire/ -- EpiVax Therapeutics, Inc. ("EVT") announces the publication "Multistep screening of neoantigens\' HLA and TCRinterfaces improves prediction of survival" in Scientific Reports.

Key Points: 
  • b'PROVIDENCE, R.I., May 13, 2021 /PRNewswire/ -- EpiVax Therapeutics, Inc. ("EVT") announces the publication "Multistep screening of neoantigens\' HLA and TCRinterfaces improves prediction of survival" in Scientific Reports.
  • This study demonstrates a superior method of survival analysis for cancer patients using EVT\'s Ancer platform.
  • EVT spun-off from EpiVax, Inc. in 2017 to apply EpiVax tools to clinical research.\nBuilt on validated in silico tools EpiMatrix and JanusMatrix , Ancer analyzesindividual cancer mutanomes to definethe presence of T cell epitopes likely to be immunogenic.
  • EVT\'s pipeline includes a COVID-19 vaccine and a personalized bladder cancer vaccine.\n'

Improving Cancer Survival Prediction: A New Approach with EpiVax Therapeutics' Ancer Platform

Retrieved on: 
Thursday, May 13, 2021
Branches of biology, Medical specialties, Clinical medicine, Vaccines, Cancer vaccines, Genomics, Applied genetics, Biotechnology, Immunogenicity, Mutanome, Antigen, Cancer vaccine

b'PROVIDENCE, R.I., May 13, 2021 /PRNewswire/ -- EpiVax Therapeutics, Inc. ("EVT") announces the publication "Multistep screening of neoantigens\' HLA and TCRinterfaces improves prediction of survival" in Scientific Reports.

Key Points: 
  • b'PROVIDENCE, R.I., May 13, 2021 /PRNewswire/ -- EpiVax Therapeutics, Inc. ("EVT") announces the publication "Multistep screening of neoantigens\' HLA and TCRinterfaces improves prediction of survival" in Scientific Reports.
  • This study demonstrates a superior method of survival analysis for cancer patients using EVT\'s Ancer platform.
  • EVT spun-off from EpiVax, Inc. in 2017 to apply EpiVax tools to clinical research.\nEpiVax Therapeutics researchers develop improved method for cancer survival prediction.\nBuilt on validated in silico tools EpiMatrix and JanusMatrix , Ancer analyzesindividual cancer mutanomes to definethe presence of T cell epitopes likely to be immunogenic.
  • EVT\'s pipeline includes a COVID-19 vaccine and a personalized bladder cancer vaccine.\nView original content to download multimedia: http://www.prnewswire.com/news-releases/improving-cancer-survival-predic...\n'

Preclinical Data of Arcellx’s Novel Synthetic CAR-T Binding Domain Presented at the 2021 ASGCT Annual Meeting and the 2021 PEGS Summit

Retrieved on: 
Thursday, May 13, 2021
Health sciences, Life sciences, Immunology, Immunogenicity, Therapy

b'GAITHERSBURG, Md., May 13, 2021 (GLOBE NEWSWIRE) -- Arcellx, a privately held clinical-stage biopharmaceutical company, today announced the presentation of preclinical data of CART-ddBCMA, Arcellx\xe2\x80\x99s BCMA-specific CAR-modified T-cell therapy, at the 2021 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting and at the 2021 Protein Engineering & Cell Therapy Summit (PEGS).

Key Points: 
  • b'GAITHERSBURG, Md., May 13, 2021 (GLOBE NEWSWIRE) -- Arcellx, a privately held clinical-stage biopharmaceutical company, today announced the presentation of preclinical data of CART-ddBCMA, Arcellx\xe2\x80\x99s BCMA-specific CAR-modified T-cell therapy, at the 2021 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting and at the 2021 Protein Engineering & Cell Therapy Summit (PEGS).
  • Arcellx announced positive initial clinical results from the first six patients in the trial at the 2020 American Society of Hematology (ASH) Annual Meeting.
  • Arcellx\xe2\x80\x99s proprietary binding domains are novel synthetic proteins engineered for reduced immunogenicity and designed to bind specific therapeutic targets.
  • CART-ddBCMA has been granted Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration.

Certara Releases New Versions of Its Preeminent Quantitative Systems Pharmacology (QSP) Simulators for Expediting Development of Biologics and Immuno-oncology Therapies

Retrieved on: 
Thursday, May 13, 2021
Life sciences, Biotechnology, Health sciences, Biopharmaceutical, Pharmaceutical industry, Pharmacy, Simulation, Immunogenicity

Immunogenicity is a key challenge for developing biologics, including novel modalities such as gene and cell therapies.

Key Points: 
  • Immunogenicity is a key challenge for developing biologics, including novel modalities such as gene and cell therapies.
  • Researchers use Certara\xe2\x80\x99s IG Simulator to simulate immunogenicity in virtual patients.
  • Certara\xe2\x80\x99s IO Simulator uses virtual patients to quickly test these different combinations to determine the optimal combination of therapies and dosing regimens.
  • Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.\n'

Affinia Therapeutics Presents New Data and Updates on AAV Platform at American Society of Gene and Cell Therapy Annual Meeting

Retrieved on: 
Thursday, May 13, 2021
Medicine, Clinical medicine, Lumbar puncture, Pediatrics, Affinia, Immunogenicity, Health care

Affinia Therapeutics presented data in a poster session on its proprietary AAV vector Anc80L65 showing superiority to AAV9 in various non-human primate (NHP) CNS regions after a single intrathecal injection.

Key Points: 
  • Affinia Therapeutics presented data in a poster session on its proprietary AAV vector Anc80L65 showing superiority to AAV9 in various non-human primate (NHP) CNS regions after a single intrathecal injection.
  • When delivered via lumbar puncture, Anc80L65 demonstrated up to 32-fold higher RNA expression versus AAV9 delivered via the more invasive intracisternal route of administration.
  • Anc80L65 led to higher expression than AAV9 in both the cortex and deep brain nuclei.
  • Our proprietary platform enables us to methodically engineer novel AAV vectors and gene therapies with potentially improved tissue tropism, cell specificity, immunogenicity, and safety.