Hook effect

Century Therapeutics Presents New Preclinical Data Highlighting iPSC-derived Cell Therapy Platform Technology at the 2024 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Monday, April 8, 2024
Computational biology, Malignancy, Canadian Aviation Regulations, Gene editing, Bone disease, Cell, Hook effect, CXCR4, Enfortumab vedotin, Synthetic biology, Patient, Neoplasm, Epitope, Differentiable function, Ink, PBMC, Protein engineering, HLA, Science, Cytotoxicity, AACR, Phenotype, Therapy, IPSC, Skin, Inflammation, Prognosis, Carcinogenesis, Rejection, CD22, VHH, Poster, NK, Century, Autoimmunity, Bone marrow, Engineering, CD19, Vaccine

PHILADELPHIA, April 08, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.

Key Points: 
  • PHILADELPHIA, April 08, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.
  • This novel CAR was engineered and tested in iPSC-derived gamma-delta T cells, showing in vitro tumor cell cytotoxicity.
  • These findings support the continued examination of a CD19xCD22 bispecific CAR for off-the-shelf allogeneic cell therapy to expand patient access beyond CD19 CAR-T cell therapies.
  • In these preclinical studies, Century identified novel single-domain antibodies (VHH) that bind to multiple epitopes on the NECTIN4 extracellular domain.

Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Hook effect, Administration, U.S. FDA, Pre-exposure prophylaxis, Risk, COVID-19, Ageing, SARS-CoV-2, Research and development, Clinical trial, Vaccination, Immunodeficiency, Food, FDA, Vaccine

“We made remarkable progress throughout 2023 and in recent months.

Key Points: 
  • “We made remarkable progress throughout 2023 and in recent months.
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • Cash Position: Cash and cash equivalents were $200.6 million as of December 31, 2023.
  • Basic and diluted net loss per share was $1.81 for the year ended December 31, 2023, compared to $2.23 for the year ended December 31, 2022.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

Retrieved on: 
Friday, March 22, 2024
Diphenhydramine, Anaphylaxis, Hook effect, Pre-exposure prophylaxis, Half-life, Risk, Bone marrow, COVID-19, Patient, Metoprolol, Adrenaline, Epitope, DSM-IV codes, SARS-CoV-2, Death, Adolescence, Bank statement, Post-exposure prophylaxis, Clinical trial, CDC, Antibody, Vaccination, Safety, Immunodeficiency, Vaccine, FDA, Food, Medicine

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • “The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
  • It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
  • The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

OSE Immunotherapeutics Reports Full Year 2023 Financial Results and Provides Business Strategy Update

Retrieved on: 
Wednesday, March 27, 2024
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, HCC, AbbVie, GPCR, Ulcerative colitis, Head, Alpha globulin, Survival, Data science, Data analysis, Drug discovery, Partnership, Hook effect, HNSCC, Boehringer Ingelheim, Inflammation, Patient, Research, RNA, Veloxis Pharmaceuticals, Cancer, Lung cancer, Bank statement, AACR, Investment, First, Therapy, ESMO, Collaboration, Hepatocellular carcinoma, RNA therapeutics, FDA, Artificial intelligence, Audit committee, Food, Pharmaceutical industry

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today reported its consolidated annual financial results for 2023 and provided an update on key proprietary clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2024 Company’s outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today reported its consolidated annual financial results for 2023 and provided an update on key proprietary clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2024 Company’s outlook.
  • Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, adds: “Our business-model is mostly based on recurrent and strategic partnerships with pharmaceutical companies.
  • A meeting of the Board of Directors of OSE Immunotherapeutics was held on March 27, 2024.
  • Following the Audit Committee opinion, the Board approved the annual and consolidated financial statements prepared under IFRS on 31 December 2023.

US Biosimilar Industry Projected to Surge With CAGR of 40% Through 2028: New Study Highlights Market Growth and Trends - ResearchAndMarkets.com

Retrieved on: 
Monday, March 18, 2024
Biotechnology, Pharmaceutical, Health, Competitive advantage, Conditional sentence, Incidence, Patient, Research, Cancer, Oncology, Ecosystem, Compound annual growth rate, FDA, Movement, Medicine, Ageing, Hook effect, Generic drug

The study delves into the complex ecosystem of the US Biosimilar market, identifying the critical factors that contribute to its projected Compound Annual Growth Rate (CAGR) of approximately 40% over the next five years.

Key Points: 
  • The study delves into the complex ecosystem of the US Biosimilar market, identifying the critical factors that contribute to its projected Compound Annual Growth Rate (CAGR) of approximately 40% over the next five years.
  • Key Insights from the Report:
    The cost-effectiveness of Biosimilar drugs is key to market growth as patients seek affordable alternatives to high-priced generic drugs.
  • The Competitive Edge in Biosimilars:
    The US Biosimilar market is characterized by a robust presence of both domestic and global pharmaceutical titans.
  • The research highlights the strategies employed by these entities to navigate the market dynamics and enhance their foothold within the industry.

Sanyou Bio: Sanyou's Intelligence-Enabled Innovative Biologics R&D Platform Leads in the New Era of Biological Drug Development

Retrieved on: 
Wednesday, March 27, 2024
Sequence, Sequence analysis, Automation, Quality control, Logic, Database, Algorithm, Communication, Intelligence, Printing, Biomedical Research, Digitalization, Sequence alignment, Acceleration, Internet, Research, ELISA, Artificial intelligence, Software, PTM, Record, Molecular biology, CDE, Thought, Hook effect, Investment, Drug development, Telephone numbers in Hungary, Literature, Digital technology, EC50, Collection, Data management, Marketing, FDA, Parallel, Map, Mobile phone

This is the driving force behind Sanyou's development of an intelligence-enabled innovative biologics R&D platform.

Key Points: 
  • This is the driving force behind Sanyou's development of an intelligence-enabled innovative biologics R&D platform.
  • This system finds extensive applications across various domains, including research and development, data management, project management, quality control, and marketing.
  • By optimizing drug development processes and supporting intelligence-enabled decision-making, it comprehensively enhances R&D efficiency and accuracy, potentially playing a critical role in drug development.
  • In drug development, the modeling and prediction of drug developability analysis aims to comprehensively enhance the efficiency of the drug development process.

Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans

Retrieved on: 
Tuesday, March 5, 2024
Tonix Pharmaceuticals, Animal, Transplant, FC, Risk, Multiple sclerosis, Protein engineering, Thrombosis, Immunoglobulin G, Autoimmunity, Haematopoietic system, Hook effect, Half-life, Sclerosis, Kidney

CHATHAM, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the results of modeling key human pharmacokinetic (PK) properties for TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* from animal studies. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplantation and for the treatment of autoimmune disorders.

Key Points: 
  • TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplantation and for the treatment of autoimmune disorders.
  • “Preclinical studies in non-human primates have shown that TNX-1500 maintains the activity of first generation mAbs, with reduced risk of thrombotic complications.3-5 Today we are announcing that modeling studies from animal PK data3, predict that a half-life of approximately three weeks for TNX-1500 in humans6,7, which supports monthly dosing.
  • or biweekly s.c. dosing regimens.2 Based on its results in multiple sclerosis, Sanofi projects that frexalimab will exceed €5B per year in peak sales1.
  • TNX-1500 was designed to reduce binding to the Fc-receptor for IgG type 2a, or FcγR2a, which has been shown to play a role in the thrombosis associated with first-generation anti-CD40L mAbs, similar to frexalimab.

Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers

Retrieved on: 
Wednesday, February 28, 2024
Tonix Pharmaceuticals, Toxicity, CD40L, Risk, Multiple sclerosis, Protein engineering, Thrombosis, Sanofi, Haematopoietic system, Hook effect, Kidney, Pharmaceutical industry

CHATHAM, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy volunteers. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and for the treatment of autoimmune disorders.

Key Points: 
  • TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and for the treatment of autoimmune disorders.
  • “Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • “Anti-CD40L modulates T cell function and has the potential to promote tolerance of transplanted organs.
  • We are excited to have completed the clinical stage of this Phase 1 trial of TNX-1500, a third-generation Fc-modified anti-CD40L mAb that has been designed by protein engineering to eliminate the risk of thrombosis associated with first-generation anti-CD40L mAbs.

NIAID-Sponsored Study Shows N-803 Combined with Neutralizing Antibodies Could Lead to Sustained HIV Viral Control After Discontinuation of Antiretroviral Therapy

Retrieved on: 
Wednesday, March 6, 2024
Pharmaceutical, AIDS, Health, Clinical Trials, Infection, Bangladesh Technical Education Board, SHIV, AD8, Research, Virology, BCG, NIAID, FDA, Safety, Animal, Hook effect, NMIBC, Rockefeller University, ART, Viremia, Patient, NK, Harvard Medical School, HIV, HIV/AIDS, Immune system, Vaccine

Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir.

Key Points: 
  • Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir.
  • Upon ART discontinuation, all animals experienced viral rebound, followed by long-term virus control for up to 10 months in approximately 70% of those treated with N-803 and bNAbs.
  • “When combined with broadly neutralizing antibodies, N-803 has the potential to provide viral control without significant reduction in the viral reservoir, which further suggests that the complete eradication of this reservoir may not be required to induce sustained remission after discontinuing antiretroviral therapy."
  • Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.

N-803 Combined with Natural Killer Cells Showed Potential to Reduce HIV Viral Load in HIV Positive Subjects; Part of HIV Cure Study

Retrieved on: 
Tuesday, March 5, 2024
AIDS, Health, Infectious Diseases, Hospitals, Research, Science, Biotechnology, Infection, BCG, Medicine, MD, FDA, Safety, Hook effect, NMIBC, Rockefeller University, University, ART, Patient, Journal, NK, Management of HIV/AIDS, HIV/AIDS, HIV, Viral load, Immune system, Vaccine

ImmunityBio ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced data from a Phase 1 pilot study showed N-803 combined with natural killer cells could have the potential to reduce viral load in people living with HIV.

Key Points: 
  • ImmunityBio ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced data from a Phase 1 pilot study showed N-803 combined with natural killer cells could have the potential to reduce viral load in people living with HIV.
  • All participants in this Phase 1 study experienced significant reduction in infection levels following treatment with N-803.
  • HIV can disable NK cells—a frontline defense against viral infections—making it difficult to clear the infection.
  • The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells.