Immunogenicity

Vaxcyte Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Monday, February 27, 2023
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-- Successfully Raised Approximately $805 Million in Gross Proceeds in Two Follow-On Equity Offerings in 2022; $957.9 Million in Cash, Cash Equivalents and Investments as of December 31, 2022 --

Key Points: 
  • The FDA’s decision was based on positive topline results from the Phase 1/2 proof-of-concept study of VAX-24 in adults 18-64 years of age.
  • VAX-PG: Vaxcyte nominated a final vaccine candidate for VAX-PG, its novel therapeutic vaccine designed to treat periodontal disease, in the fourth quarter of 2022 and continues to progress the program.
  • The December 31, 2022, balance includes $651.6 million in net proceeds from the Company’s underwritten public offering completed in the fourth quarter of 2022.
  • Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2023, at 4:30 p.m.

Larimar Therapeutics Appoints Dr. Gopi Shankar as Chief Development Officer

Retrieved on: 
Tuesday, February 7, 2023
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BALA CYNWYD, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Gopi Shankar, PhD, MBA, FAAPS, to the newly created position of Chief Development Officer (CDO).

Key Points: 
  • BALA CYNWYD, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Gopi Shankar, PhD, MBA, FAAPS, to the newly created position of Chief Development Officer (CDO).
  • Dr. Shankar will report directly to Chief Executive Officer Carole Ben-Maimon, MD, and will be responsible for the strategic development of the Company’s clinical and R&D programs, including additional applications of the Company’s platform technology.
  • “We are thrilled to welcome Dr. Shankar to Larimar and look forward to benefiting from his extensive expertise in biologics development, immunology, PK/PD, and bioanalysis,” said Dr. Ben-Maimon.
  • He also previously worked as Senior Director and Head, Bioanalytical Sciences and Immunogenicity at Janssen Research & Development.

The healthcare analytical testing services market is projected to reach USD 11.1 billion by 2027 from USD 6.5 billion in 2022, at a CAGR of 11.4%

Retrieved on: 
Thursday, December 22, 2022
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View original content:https://www.prnewswire.com/news-releases/the-healthcare-analytical-testi...

Key Points: 
  • The healthcare analytical testing services market is projected to reach USD 11.1 billion by 2027 from USD 6.5 billion in 2022, at a CAGR of 11.4%.
  • • Service Development/Innovation: Detailed insights on the upcoming trend, and service launches in the global healthcare analytical testing services market.
  • • Market Diversification: Exhaustive information about new services, growing geographies, and recent developments in the global healthcare analytical testing services market.
  • • Competitive Assessment: In-depth assessment of market shares, growth strategies, revenue analysis, and services of leading players in the global healthcare analytical testing services market.

Global Analytical Laboratory Services Market Report 2022: Favorable Government Policies to Strengthen Analytical Testing Capabilities Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 1, 2022
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The Global Analytical Laboratory Services Market is segmented based on Test Type, Method Type, Sevice Type, Technology, Application, End-Users, and Geography.

Key Points: 
  • The Global Analytical Laboratory Services Market is segmented based on Test Type, Method Type, Sevice Type, Technology, Application, End-Users, and Geography.
  • By Method Type, the market is classified into Pharmacokinetic Testing, Biomarker Testing, Virology Testing, Cell-Based Assays, Immunogenicity, and Serology.
  • The report presents a detailed Ansoff matrix analysis for the Global Analytical Laboratory Services Market.
  • The analyst analyses the Global Analytical Laboratory Services Market using the Ansoff Matrix to provide the best approaches a company can take to improve its market position.

Selecta Biosciences Announces Three Presentations at the Upcoming 29th Annual European Society of Gene and Cell Therapy (ESGCT) Conference

Retrieved on: 
Tuesday, October 11, 2022
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These presentations demonstrate the therapeutic utility of Selectas immune tolerance platform, ImmTOR, to enable safe repeated vector doses and mitigate unwanted immune responses to AAV capsids.

Key Points: 
  • These presentations demonstrate the therapeutic utility of Selectas immune tolerance platform, ImmTOR, to enable safe repeated vector doses and mitigate unwanted immune responses to AAV capsids.
  • We are thrilled to present data demonstrating the power of ImmTOR combined with T-reg specific IL-2 mutein (ImmTOR-IL), said Dr.Kei Kishimoto, Ph.D., Chief Scientific Officer ofSelecta.
  • In parallel, we will continue our pioneering efforts to help gene therapy patients overcome immunogenicity.
  • The Company specifically disclaims any intention to update any forward-looking statements included in this press release except as required by law.

Horizon to Highlight Novel Insights in Gout Care During the American College of Rheumatology Convergence 2022

Retrieved on: 
Monday, September 19, 2022
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Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.

Key Points: 
  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
  • Anaphylaxis may occur with any infusion, including a first infusion and generally manifests within 2 hours of the infusion.
  • Patients should be premedicated with antihistamines and corticosteroids and closely monitored for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA.

Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of UB-313 for Preventive Treatment of Migraine

Retrieved on: 
Tuesday, September 13, 2022
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An anti-CGRP vaccine has the potential to disrupt the migraine paradigm by offering longer-lasting relief, more convenient administration, and affordable access.

Key Points: 
  • An anti-CGRP vaccine has the potential to disrupt the migraine paradigm by offering longer-lasting relief, more convenient administration, and affordable access.
  • The Phase 1 randomized, placebo-controlled, double-blind, multidose trial will enroll approximately 40 healthy volunteers at the Center for Clinical Pharmacology, UZ Leuven in Belgium.
  • UB-313 is a novel immunotherapeutic vaccine candidate targeting calcitonin gene-related peptide (CGRP) for the preventive treatment of migraine.
  • For more information about Vaxxinity, Inc., visit http://www.vaxxinity.com and follow us on social media @vaxxinity.

ILiAD Biotechnologies Announces Presentation of Additional Positive Data for its Next Generation Pertussis Vaccine at the 13th International Bordetella Symposium

Retrieved on: 
Monday, June 27, 2022
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According to U.S. Centers for Disease Control and Prevention, pertussis affects approximately 16 million people each year globally, accounting for nearly 200,000 deaths.

Key Points: 
  • According to U.S. Centers for Disease Control and Prevention, pertussis affects approximately 16 million people each year globally, accounting for nearly 200,000 deaths.
  • Pertussis is highly contagious, and an infected person can transmit B. pertussis to as many as 15 other people.
  • ILiAD Biotechnologies is utilizing its B-Tech technology to develop next generation vaccines to prevent infectious diseases and improve lives.
  • Its lead candidate, BPZE1, is the most advanced next generation vaccine for immunization against pertussis (whooping cough), a lethal disease caused by Bordetella pertussis.

Certara Announces New Versions of Biosimulation Software for Development of Novel Biologics

Retrieved on: 
Tuesday, June 21, 2022
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The latest versions of our simulators help tackle some of the toughest challenges in drug discovery and development with complex biologics, said William F. Feehery, Ph.D., CEO of Certara.

Key Points: 
  • The latest versions of our simulators help tackle some of the toughest challenges in drug discovery and development with complex biologics, said William F. Feehery, Ph.D., CEO of Certara.
  • Our Simulators incorporate the latest advancements in biosimulation to determine the best strategies for developing safe and effective novel biologic therapies to address critical unmet patient needs.
  • The latest versions of the IG and IO Simulators enable better prediction of dosing regimens for more patient populations.
  • For more information about Certaras Simulators, please visit:
    Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development.

The Age of Cell and Gene Therapies is Upon Us - What Does it Mean for Bioanalysis?

Retrieved on: 
Wednesday, June 8, 2022
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TORONTO, June 8, 2022 /PRNewswire-PRWeb/ -- Cell and gene therapies (CGTs) are types of treatment that use cellular or genetic material with the goal of treating a disease or a disorder. Often it can be a combination of cell and gene therapies, which is the case for chimeric antigen receptor T (CAR T) cells. As of March 2022, there are 20 US Food and Drug Administration (FDA) approved cell and gene therapy (CGT) licensed products from the Office of Tissues and Advanced Therapies (OTAT) and according to clinicaltrials.gov over 2,000 active CGT clinical trials.

Key Points: 
  • TORONTO, June 8, 2022 /PRNewswire-PRWeb/ -- Cell and gene therapies (CGTs) are types of treatment that use cellular or genetic material with the goal of treating a disease or a disorder.
  • Often it can be a combination of cell and gene therapies, which is the case for chimeric antigen receptor T (CAR T) cells.
  • Join this webinar to explore what the advent of cell and gene therapies mean for bioanalysis.
  • For more information, or to register for this event, visit The Age of Cell and Gene Therapies is Upon Us!