Monoclonal antibodies

Peer-Reviewed Scientific Publication Demonstrates Central Role of Neurotoxic Soluble Amyloid Oligomers in Driving Alzheimer’s Pathogenesis

Retrieved on: 
Wednesday, June 23, 2021
Research, Mental health, Genetics, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Other Science, Branches of biology, Amyloidosis, Biology, Alzheimer's disease, Neuroscience, Monoclonal antibodies, Anticonvulsants, Homotaurine, Amyloid, Alzheon, Bapineuzumab, ALZ-801, Alzheon, ALZ-801, ALZHEON

This positions ALZ-801 to potentially become the first oral disease-modifying agent for patients and healthy people at high risk for Alzheimers disease.

Key Points: 
  • This positions ALZ-801 to potentially become the first oral disease-modifying agent for patients and healthy people at high risk for Alzheimers disease.
  • The publication provides an up-to-date summary of longitudinal clinical data elucidating the chronology of amyloid and tau biomarkers in AD, and review of non-clinical studies and clinical trials supporting the upstream pathogenic role of amyloid oligomers in AD.
  • Analyze data on clearance of amyloid plaques in amyloid antibody trials showing that even complete plaque removal does not correlate with clinical efficacy.
  • ALZ-801is an oral small molecule prodrug of tramiprosate that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain.

DGAP-News: Abivax reports excellent phase 2a clinical safety and efficacy results with 50mg ABX464 in rheumatoid arthritis

Retrieved on: 
Wednesday, June 23, 2021
Medical specialties, Clinical medicine, Medicine, Autoimmune diseases, Rheumatology, Immunosuppressants, Monoclonal antibodies, Abivax, Ulcerative colitis, Arthritis, Rheumatoid arthritis, Filgotinib, ABX464[8][9], Abivax (www.abivax.com), ABX464[8][9], ABIVAX (WWW.ABIVAX.COM)

The ACR20 is the key primary efficacy endpoint required by the FDA for licensure of new drugs in rheumatoid arthritis.

Key Points: 
  • The ACR20 is the key primary efficacy endpoint required by the FDA for licensure of new drugs in rheumatoid arthritis.
  • Based on these results, Abivax is preparing to start a clinical phase 2b program in RA in early 2022.
  • ABX464 was already shown to be efficacious and safe in phase 2a and phase 2b clinical studies for the treatment of ulcerative colitis (UC).
  • Therefore, the 100mg dose will not be considered for future clinical development of ABX464 in rheumatoid arthritis.

Tiziana Enters a Collaboration Agreement with FHI Clinical to Conduct a Phase 2 Clinical Trial for Treating Hospitalized Severe COVID-19 Patients with Intranasal Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody

Retrieved on: 
Wednesday, June 23, 2021
Medical specialties, Monoclonal antibodies, Medicine, Clinical medicine, Immunology, Foralumab, Anti-CD3 monoclonal antibody, FHI 360, Dose

A subsidiary of FHI 360, FHI Clinical specializes in the clinical development of drugs for infectious diseases ( https://www.fhiclinical.com ).

Key Points: 
  • A subsidiary of FHI 360, FHI Clinical specializes in the clinical development of drugs for infectious diseases ( https://www.fhiclinical.com ).
  • In this clinical trial, Foralumab will be delivered intranasally through a metered-dose nasal atomization device.
  • Nasal administration of Foralumab is a highly innovative approach to treat patients with autoimmune diseases where the immune system may be dysregulated.
  • Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world.

LEO Pharma announces European Commission approval of Adtralza® (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis

Retrieved on: 
Tuesday, June 22, 2021
Pharmaceutical, Health, Clinical trials, Type I hypersensitivity, Monoclonal antibodies, Immunology, Medical specialties, Tralokinumab, Atopic dermatitis, Clinical medicine, Dermatitis, Atopy, Adtralza (tralokinumab), the pivotal ECZTRA 1, 2, and ECZTRA 3 Trials, atopic dermatitis, LEO Pharma, ADTRALZA (TRALOKINUMAB), THE PIVOTAL ECZTRA 1, 2, AND ECZTRA 3 TRIALS, ATOPIC DERMATITIS, LEO PHARMA

By specifically targeting IL-13 with high affinity, Adtralza has demonstrated that it can reduce atopic dermatitis signs and symptoms and sustain improvements over time.

Key Points: 
  • By specifically targeting IL-13 with high affinity, Adtralza has demonstrated that it can reduce atopic dermatitis signs and symptoms and sustain improvements over time.
  • The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.
  • Adtralza (tralokinumab) is a fully human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms.
  • Tralokinumab plus topical corticosteroids for the treatment of moderatetosevere atopic dermatitis: results from the doubleblind, randomized, multicentre, placebocontrolled phase III ECZTRA 3 trial.

Target RWE Study Shows Significant Differences in Medication Use Among Older Patients with IBD Compared to Younger Patients

Retrieved on: 
Tuesday, June 22, 2021
Medical specialties, Clinical medicine, Medicine, Immune system, Monoclonal antibodies, Biotechnology, Immunology, TNF inhibitor, Tumor necrosis factor, Inflammatory bowel disease

The study was conducted by Target RWE , a leading real-world evidence (RWE) solutions company for the healthcare industry.

Key Points: 
  • The study was conducted by Target RWE , a leading real-world evidence (RWE) solutions company for the healthcare industry.
  • The TARGET-IBD study analyzed 2,900+ patients with IBD across 34 academic/community sites from July 2017 to Feb. 2020.
  • Younger patients with this diagnosis were significantly more likely to use anti-tumor necrosis alpha (anti-TNF) monotherapy compared to older patients with IBD.
  • In one retrospective study, 94% of patients age 65 or older with IBD were taking three or more medications.

Eisai, Bristol Myers Squibb Enter Into Global Strategic Collaboration for Eisai's MORAb-202 Antibody Drug Conjugate

Retrieved on: 
Friday, June 18, 2021
Life sciences, Monoclonal antibodies, Bristol-Myers Squibb, Bristol Myers Squibb, Companies, Biotechnology, Squib, Lulizumab pegol

Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories.

Key Points: 
  • Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories.
  • The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories.
  • Bristol Myers Squibb is expected to book sales of MORAb-202 in the United States and Canada.
  • Our collaboration with Bristol Myers Squibb will accelerate the development of MORAb-202 with the goal of bringing a potentially impactful treatment option to patients globally."

Eisai and Bristol Myers Squibb Enter Into Global Strategic Collaboration for Eisai’s MORAb-202 Antibody Drug Conjugate

Retrieved on: 
Thursday, June 17, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Life sciences, Drugs, Monoclonal antibodies, Orphan drugs, Health care, Antineoplastic drugs, Bristol Myers Squibb, Eribulin, Eisai, Squib, Bristol-Myers Squibb, Eisai Co., Ltd., Bristol Myers Squibb, MORAb-202, EISAI CO., LTD., BRISTOL MYERS SQUIBB, MORAB-202

Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).

Key Points: 
  • Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).
  • MORAb-202 is Eisais first ADC and combines Eisais in house developed anti-folate receptor alpha (FR) antibody, and Eisais anticancer agent eribulin, using an enzyme cleavable linker.
  • Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories.
  • The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories.

Bristol Myers Squibb Announces Dividend

Retrieved on: 
Thursday, June 17, 2021
Biotechnology, Pharmaceutical, Health, Bristol Myers Squibb, Life sciences, Industry economics), Squib, Companies, Dividend, Bristol-Myers Squibb, Monoclonal antibodies

Bristol Myers Squibb (NYSE: BMY) today announced that its Board of Directors has declared a quarterly dividend of forty-nine cents ($0.49) per share on the $.10 par value common stock of the company.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that its Board of Directors has declared a quarterly dividend of forty-nine cents ($0.49) per share on the $.10 par value common stock of the company.
  • The dividend is payable on August 2, 2021 to stockholders of record at the close of business on July 2, 2021.
  • Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
  • For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook , and Instagram .

Biogen Announces First Patient Dosed in Phase 3 Systemic Lupus Erythematosus Study

Retrieved on: 
Thursday, June 17, 2021
Medical specialties, Autoimmune diseases, Branches of biology, Clinical medicine, Cutaneous lupus erythematosus, Monoclonal antibodies, Antibodies, Lupus, William Osler, Anti-SSA/Ro autoantibodies, Immunoglobulin E, Tolerx

Based on the positive results observed in the Phase 2 LILAC study, we are excited to continue to evaluate the potential of BIIB059 in TOPAZ-1.

Key Points: 
  • Based on the positive results observed in the Phase 2 LILAC study, we are excited to continue to evaluate the potential of BIIB059 in TOPAZ-1.
  • TOPAZ-1 is a 52-week, multicenter, randomized double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of BIIB059 compared with placebo.
  • The initiation of the TOPAZ-1 study is based on the results from the Phase 2 LILAC study.
  • BIIB059, discovered and developed exclusively by Biogen, is a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) and is being investigated for the potential treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

BeiGene Announces First Patient Dosed in Global Phase 3 Trial of Anti-TIGIT Antibody Ociperlimab in Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, June 17, 2021
Oncology, Health, Other Science, Research, Science, Pharmaceutical, Biotechnology, Drugs, Cancer treatments, Clinical medicine, Orphan drugs, Monoclonal antibodies, Cancer immunotherapy, Breakthrough therapy, Pembrolizumab, Tislelizumab, Humanized antibody, PD-1 and PD-L1 inhibitors, Ociperlimab (BGB-A1217), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, OCIPERLIMAB (BGB-A1217), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.

Key Points: 
  • This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.
  • Ociperlimab is a potent anti-TIGIT antibody with intact Fc function, which we believe to be critical for the anti-tumor activities of TIGIT antibodies.
  • Patients will be randomized to receive ociperlimab and tislelizumab combination treatment, pembrolizumab, or tislelizumab alone.
  • Ociperlimab (BGB-A1217) is an investigational humanized IgG 1 monoclonal antibody discovered and being developed globally by BeiGene.