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In the ever-evolving landscape of immuno-oncology, managing the side effects of advanced therapies has become just as important as enhancing their efficacy. Existing therapies, such as tocilizumab, work by blocking specific inflammatory pathways but often come with limitations.
Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinicaldevelopment, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.
Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapydeveloped by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.
One important aspect of toxicity studies is determining whether the drug produces undesired immune effects. The focus is to ensure that the drug does not have any potential to induce an excessive immuneresponse, particularly cytokine storm, which can lead to severe adverse effects and impede clinicaldevelopment.
This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinicaldevelopment, offering promising advancements in innovative cancer treatments.
We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. Generally, IO has been focused on harnessing the anti-tumour activity of certain cancer-fighting T-cells , a key cell type involved in the adaptive immune defense system.
This interaction inhibits inflammation and immune activation, and in particular prevents macrophages from phagocytosing and destroying cancer cells. By blocking CD24 with an antibody drug, our goal is to powerfully reactivate the anti-cancer immuneresponse and drive therapeutic efficacy.
[link] Immunity is complex and can be dangerous when exploited clinically, as demonstrated by the lethal administration of TNF, or anti-CD40L antibody (Biogen) or CAR-T cells expressing the CD16 Fc-receptor (Unum), among many other examples. This is the T cell type most closely associated with anti-tumor immuneresponses.
These disease signatures capture both the linear and non-linear effects of genetic and molecular interaction networks and enable the identification of associations including those that are only relevant to a subgroup of patients that influence disease risk, prognosis and/or therapyresponse.
“The T-cell and NK-cell target discovery approach complements our portfolio aimed at turning cold tumors hot and redirecting the innate immune system to elicit a sustained and durable immuneresponse against tumors. Takeda will assume responsibility for funding all development and commercialization activities.
I am currently working as Chief Scientific Officer at CatalYm, where we translate the latest scientific findings into clinical applications. Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy.
LONDON–( BUSINESS WIRE )– Ixaka Ltd , an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The new business will continue to develop Ixaka’s proprietary technologies – concentrated multi-cell therapies (MCTs) and targeted nanoparticle (TNP) therapeutics.
Strong Th1 cell-mediated immuneresponses were also observed for the vaccine candidates with either adjuvant. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinicaldevelopment for both adjuvanted vaccines.
The Israeli-based biotech is dedicated to developing innovative therapies for cancer, based on its proprietary research of newly discovered immune-checkpoints and immune-evasion mechanisms. Ben-Moshe told BioSpace that BND-22 differs from traditional immunotherapy in that it can elicit a more total immuneresponse. . “It
The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immuneresponse. The study showed this broad immuneresponse led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. link]
1. About ImmunityBio.
Coined immunotherapy, this umbrella term describes several types of treatment, including immune checkpoint inhibitors, immune system modulators, and adoptive cell therapies. Each triggers the immune system in a different way to fight cancer.
CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. About CVnCoV.
Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. CAMBRIDGE, Mass. , 14, 2020 /PRNewswire/ — Synlogic, Inc. Synlogic’s President and Chief Executive Officer.
Precigen is focused on next-generation gene and cell therapy using precision technology. The National Institutes of Health (NIH) is planning on taking over manufacturing and clinicaldevelopment. Precigen – Germantown, Md.-based based Precigen announced its pricing of its $112.5 million IPO at a price of $7.50 IPO on January 15.
“Once we’re in the clinic, we will continue to add multiple programs into the clinic with no rate abatement, or speed abatement, in the next five- to 10-year horizon.” . Former Sarepta Therapeutics executive Bo Cumbo left to launch his new gene therapy company, AavantiBio, with a $107 million Series A. AavantiBio . Sirnaomics.
We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinicaldevelopment teams. Both Jerry and Jeff have proven and successful track records in the design and execution of early and late-stage clinical trials that have evaluated novel immunetherapies.
GAITHERSBURG, Md.,
(Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that the U.S. T cell therapy expressing a chimeric antigen receptor (CAR) targeting CD20 for treatment of non-Hodgkin’s lymphoma (NHL). T cell therapy in NHL patients.
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immuneresponses in a phase 1 trial.
These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinicaldevelopment.”
Immuneresponses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.
The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is based in Suzhou and Shanghai, China.
Vertex and Ono Pharmaceutical Forge Strategic Partnership to Develop and Commercialize Povetacicept in Japan and South Korea In a move that underscores the growing international collaboration in advancing treatment for autoimmune and kidney-related diseases, Vertex Pharmaceuticals Incorporated and Ono Pharmaceutical Co.,
The acquisition complements Gilead’s existing clinicaldevelopment priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinicaldevelopment as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development. Forward-Looking Statements.
Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinicaldevelopment of deucravacitinib. Many patients have an inadequate response or do not respond at all to currently available therapies.
Learning from Past Failures to Drive Toward a More Durable ImmuneResponse Following the initial clinical successes of blocking inhibitory receptors, like CTLA4 and PD1, many in the immuno-oncology field explored the potential to further enhance anti-tumor immunity by simultaneously enhancing co-stimulatory pathways.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. ” Arnon Rosenthal, Ph.D.,
producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? billion doses by the end of 2021.
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chPD1 will be used in the Company’s proprietary chimeric antigen receptor therapy (CAR-T) platform using gamma-delta T-cells (GD-T).
Barber’s work will give Kiromic a significant acceleration in the clinicaldevelopment of its therapy platform and an even more significant advantage over its competitors.
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinicaldevelopment program.” and Roche will develop, manufacture and distribute it outside of the U.S.
This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. “The In addition to Milciclib, the Company is also developing Foralumab for liver diseases. NEW YORK and LONDON, Nov.
T cell immuneresponses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immuneresponse data from the German trial in the near future.”. “It View the full release here: [link].
Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts.
NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.
Daratumumab induced substantial clinicalresponses in the patients. The clinicalresponses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. CUE-300 Series Immuno-STATs may offer autoimmune patients therapeutic benefits without compromising their immune systems.
During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immuneresponse. Both collaborators are committed to developing these novel vaccines with preclinical and clinical data at the forefront of all their decision making.
A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S., The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immuneresponse, and efficacy data needed for regulatory review.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.
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