Immunoglobulin G

PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid Leukemia

Retrieved on: 
Wednesday, March 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Diagnosis, Head, Survival, Massachusetts General Hospital, AML, Patient, Doctor of Philosophy, MD, PRTC, HMA, Hospital, Bone marrow, MDS, Immunoglobulin G, Food, Person, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.
  • LYT-200 is a fully human IgG4 monoclonal antibody (mAb) targeting galectin-9, a potent oncogenic driver in leukemia cells and an immunosuppressive protein.
  • “Orphan drug designation from the FDA validates our belief that targeting galectin-9 with LYT-200 is a novel, promising approach that may offer patients a better tolerated, more effective treatment,” notes Aleksandra Filipovic, MD, PhD, Head of Oncology at PureTech.
  • The FDA grants orphan drug designation to novel drug and biologic products for the treatment, diagnosis, or prevention of conditions affecting fewer than 200,000 persons in the U.S. Orphan drug designation qualifies PureTech for incentives under the Orphan Drug Act, including tax credits for some clinical trials and eligibility for seven years of market exclusivity in the U.S., if the drug is approved for AML.

Global IgG Mediated Autoimmune Diseases Biologic Drugs Research Report 2024: A Highly Competitive Market with Pharmaceutical and Biotechnology Firms Competing for the $197.75 Billion Market Share - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, Pharmaceutical, Health, Psoriasis, Warfarin necrosis, Rheumatoid arthritis, Prevalence, Growth, Porter's five forces analysis, Lupus, Incidence, Inflammation, SWOT, Multiple sclerosis, Humanized antibody, ILS, Autoimmune disease, Immune system, Cytokine, Inflammatory bowel disease, USD, Immunoglobulin G, Interleukin, Ageing, Vaccine

The Global IgG Mediated Autoimmune Diseases Biologic Drugs market showcased growth at a CAGR of 7.25% during 2019-2022.

Key Points: 
  • The Global IgG Mediated Autoimmune Diseases Biologic Drugs market showcased growth at a CAGR of 7.25% during 2019-2022.
  • The increasing incidence and prevalence of IgG mediated autoimmune diseases such as rheumatoid arthritis, lupus, and psoriasis are major drivers for the growth of biologic drugs.
  • The global market for IgG mediated autoimmune diseases biologic drugs is highly competitive, with numerous pharmaceutical companies and biotechnology firms competing for market share.
  • The report analyses the IgG Mediated Autoimmune Diseases Biologic Drugs Market By Antibody Source (Humanized, Fully Human, Chimeric, Other Antibody Sources)
    The report analyses the IgG Mediated Autoimmune Diseases Biologic Drugs Market By Indication (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Multiple Sclerosis and Other Indications).

Akston Biosciences' AKS-107 Study Published in Frontiers in Immunology, Displaying Ambifect® Platform’s Versatility

Retrieved on: 
Monday, March 11, 2024
Biotechnology, Manufacturing, Diabetes, Health, Pharmaceutical, Research, Other Manufacturing, Infectious Diseases, Science, Veterinary, Clinical Trials, MERS, NOD, Atopic dermatitis, Insulin, Immune tolerance, CGMP, Epitope, Mouse, Immunoglobulin G, Chronic pain, Protein, Infection, Vaccination, Immune system, Nerve growth factor, Notifiable disease, Dengue fever, Vaccine

The study demonstrated AKS-107's potential to target and delete insulin-specific B cells, which are implicated in the development of Type 1 Diabetes (T1D).

Key Points: 
  • The study demonstrated AKS-107's potential to target and delete insulin-specific B cells, which are implicated in the development of Type 1 Diabetes (T1D).
  • AKS-107 is a human IgG1 Fc-fusion protein engineered to retain conformational insulin epitopes that bind to B cell receptors while preventing binding to the insulin metabolic receptor.
  • Regarding its Animal Health applications, Akston is partnered with Dechra Pharmaceuticals PLC to commercialize canine and feline ultra-long insulins.
  • Akston Biosciences Corporation is dedicated to accelerating the next revolution in Animal Health by inventing, developing, and manufacturing breakthrough protein therapeutics for veterinary use.

Adcentrx Therapeutics to Present Preclinical Data for Nectin-4 ADC Program at the American Association for Cancer Research (AACR) Annual Meeting 2024

Retrieved on: 
Monday, April 1, 2024
Biotechnology, DAR, SAN, Neoplasm, Bystander effect, Immunoglobulin G, Cancer, Spacecraft, AACR, Monomethyl auristatin E, Clinical trial, Conjugation, Therapy, ADC, Antibody-drug conjugate, Pharmaceutical industry

Preclinical data support clear differentiation of Adcentrx's platform and lead program, ADRX-0706, currently being evaluated in a Phase 1a/b clinical trial

Key Points: 
  • Preclinical data support clear differentiation of Adcentrx's platform and lead program, ADRX-0706, currently being evaluated in a Phase 1a/b clinical trial
    SAN DIEGO, April 1, 2024 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, today announced that preclinical data for ADRX-0706 will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 , taking place April 5-10, 2024, in San Diego, CA.
  • The three presentations will include preclinical data for Adcentrx's lead ADC program, ADRX-0706.
  • The preclinical data presentations show improved therapeutic window of ADRX-0706, enhanced bystander effect and improved payload delivery to Nectin-4 expressing tumors while minimizing exposure to normal tissues.
  • Details of the three AACR poster presentations are below:
    Presentation Title: Advancing a novel tubulin-inhibitor ADC technology: The Adcentrx auristatin platform offers enhanced efficacy and safety profiles compared to vedotin technology

Novavax Presents Data on Updated COVID-19 Vaccine and Progress to Date on its COVID-19-Influenza Combination Vaccine Candidate at World Vaccine Congress 2024

Retrieved on: 
Monday, April 1, 2024
CIC, COVID-19, Immunoglobulin G, Research, WVC, Novavax, NVAX, Messenger, Vaccine

New data from Novavax's ongoing research on its updated XBB.1.5 COVID-19 vaccine in participants who previously received an mRNA vaccine showed robust neutralizing antibody titers for the XBB.1.5 subvariant as well as for the currently circulating JN.1 subvariant.

Key Points: 
  • New data from Novavax's ongoing research on its updated XBB.1.5 COVID-19 vaccine in participants who previously received an mRNA vaccine showed robust neutralizing antibody titers for the XBB.1.5 subvariant as well as for the currently circulating JN.1 subvariant.
  • Data also showed that the vaccine's safety and reactogenicity profile was consistent with its prototype vaccine (NVX-CoV2373).
  • Differences observed in immunoglobulin (IgG) subclass responses and Fcγ-mediated effector functions following mRNA and protein-based COVID-19 vaccinations will be shared.
  • Novavax will also discuss its influenza and CIC vaccine candidates, including a recap of data to date and the timeline for the Phase 3 trial anticipated to start during the second half of 2024.

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS

Retrieved on: 
Thursday, March 28, 2024
Agreement, Transplant, CASI Pharmaceuticals, CASI, Patient, Travel, PTCL, Immunoglobulin G, CMC, Depreciation, Bone marrow, Therapy, VCP, Marketing, Research, Cleave, Pralatrexate, MCL, Rituximab, AML, Pembrolizumab, Trial of the century, Myelodysplastic syndrome, Melphalan, MDS, Clinical trial, Follicular lymphoma, Republic, Multiple myeloma, Acute myeloid leukemia, Annual report, National Medical Products Administration, Haematopoietic system, FDA, Cayman, CD19, NMPA, COVID-19, CTA, HKIAC, NHL, Non-Hodgkin lymphoma, MICL, Pharmaceutical industry

BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.

Key Points: 
  • BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.
  • CASI reported fourth quarter 2023 revenue of $6.9 million for EVOMELA®, 33% lower than the same period in 2022.
  • 2023 marks a major milestone for CASI and our partner Juventas; Inaticabtagene Autoleucel (CNCT-19 CAR-T cell therapy) was approved by National Medical Products Administration (NMPA) in November 2023.
  • As of December 31, 2023, CASI had cash, cash equivalents and short term investment of $29.1 million compared to $48.6 million as of December 31, 2022.

Biond Biologics Announces Presentation of BND-35, a Novel Anti-ILT3 Antibody for Remodeling the Tumor Microenvironment, at the American Association for Cancer Research (AACR) 2024 Annual Meeting

Retrieved on: 
Tuesday, March 26, 2024
TME, Cancer, EGFR, Ligand, Patient, ILT3, Research, Tumor microenvironment, LILRB4, AACR, Myelocyte, Immunoglobulin G, San Diego Convention Center, NK, Pharmaceutical industry

MISGAV, Israel, March 26, 2024 /PRNewswire/ -- Biond Biologics Ltd., a pioneering clinical-stage biopharmaceutical company, developing innovative immunotherapies for cancer and a transformative platform for the intracellular delivery of biologics, is excited to announce that our BND-35 program has been selected for presentation at the esteemed American Association for Cancer Research (AACR) Annual Meeting, scheduled for April 5 - 10, 2024, in San Diego Convention Center, San Diego, CA, USA. BND-35 is distinguished as a humanized IgG4, ILT3 (LILRB4) antagonist antibody, designed to modulate the tumor microenvironment (TME) from immunosuppressive to pro-inflammatory, thereby counteracting tumor growth. BND-35 phase 1 trial includes a unique clinical design, that will be presented in the ACCR, and is based on Biond's extensive pre-clinical work and the ability of BND-35 to block interactions with the various ligands of ILT3.

Key Points: 
  • BND-35 is distinguished as a humanized IgG4, ILT3 (LILRB4) antagonist antibody, designed to modulate the tumor microenvironment (TME) from immunosuppressive to pro-inflammatory, thereby counteracting tumor growth.
  • The presentation, titled "BND-35, a novel anti-ILT3 antibody for remodulation of the tumor microenvironment", will be part of the session on "Immune Targets and Therapies."
  • Biond Biologics' pivotal research on BND-35 demonstrates its specificity in binding ILT3 with high affinity, without affecting other ILT-family receptors.
  • The presentation will underscore Biond's commitment to groundbreaking research and development, aiming to unlock new pathways for cancer treatment.

argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting

Retrieved on: 
Thursday, March 7, 2024
OCS, Neonatal Fc receptor, Autoimmune disease, Continuity, ADAPT, CIDP, Alfa Romeo, FDA, Immunoglobulin therapy, Quality of life, NXT, PDUFA, Euronext, Risk, AAN, Clinical trial, Immunoglobulin G, GMG, Abstract, Efficacy, American Academy, Pharmaceutical industry

“We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.

Key Points: 
  • “We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.
  • These positive data from the ADHERE study have been submitted to the FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.
  • Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies.
  • Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment.

Kamada Issues 2024 CEO Letter to Shareholders

Retrieved on: 
Wednesday, March 6, 2024
Acquisition, KMDA, CMV, Hospital, Division, EMA, CSL Behring, Letter, Physician, Critical care, FDA, Technology transfer, Food, Growth, FEV1, AAT, Immunoglobulin G, Safety, University, European Medicines Agency, Food and Drug Administration, Pan American Health Organization, Patient, Plasma, Research, Partnership, Pharmaceutical industry

The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.

Key Points: 
  • The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.
  • Looking ahead, we expect the momentum from 2023 to extend throughout 2024, with profitability to be further increased as compared to last year.
  • These significant catalysts are propelling our continued annual double-digit profitable growth with substantial upside potential and limited downside risk.
  • On behalf of the entire Kamada team, we look forward to continuing to support patients and clinicians with the important lifesaving products that we develop, manufacture, and commercialize.

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.