Monoclonal antibodies

2020 Insights on the Global Idiopathic Pulmonary Fibrosis Industry - Market and Competitive Landscape - ResearchAndMarkets.com

Friday, July 10, 2020 - 4:42pm

The "Global Idiopathic Pulmonary Fibrosis Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Idiopathic Pulmonary Fibrosis Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights into the Idiopathic Pulmonary Fibrosis pipeline, epidemiology, market valuations, drug sales, market forecast, drug forecasts, and market shares.
  • This research covers the following: Idiopathic Pulmonary Fibrosis treatment options, Idiopathic Pulmonary Fibrosis late stage clinical trials pipeline, Idiopathic Pulmonary Fibrosis prevalence by countries, Idiopathic Pulmonary Fibrosis market size and forecast by countries, key market events and trends, drug sales and forecast by countries, and market shares by countries.
  • Idiopathic Pulmonary Fibrosis pipeline: Find out drugs in clinical trials for the treatment of Idiopathic Pulmonary Fibrosis by development phase 3, phase 2, and phase 1, by pharmacological class and company
    Idiopathic Pulmonary Fibrosis drugs: Identify key drugs marketed and prescribed for Idiopathic Pulmonary Fibrosis in the US, including trade name, molecule name, and company
    Idiopathic Pulmonary Fibrosis drugs sales: Find out the sales value for Idiopathic Pulmonary Fibrosis drugs by countries
    Idiopathic Pulmonary Fibrosis market valuations: Find out the market size for Idiopathic Pulmonary Fibrosis drugs in 2019 by countries.

Indapta Therapeutics Provides Corporate Update

Thursday, July 9, 2020 - 5:31pm

Indapta Therapeutics, Inc., a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic FcR-deficient natural killer (G-NK) cell therapy to treat multiple cancers, today provided an update on its progress in advancing the development of its programs.

Key Points: 
  • Indapta Therapeutics, Inc., a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic FcR-deficient natural killer (G-NK) cell therapy to treat multiple cancers, today provided an update on its progress in advancing the development of its programs.
  • Submitted a pre-Investigational New Drug (IND) briefing package to the U.S. Food and Drug Administration (FDA) for its G-NK cells.
  • Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody therapy in multiple cancers.
  • Indapta Therapeutics, Inc. is a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf allogeneic cell therapy to treat multiple types of difficult-to-treat hematologic cancers and solid tumors.

LEO Pharma announces U.S. Food and Drug Administration (FDA) acceptance of Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis

Thursday, July 9, 2020 - 1:00pm

The acceptance of the BLA is the beginning of the formal review procedure for this potential new treatment by the FDA.

Key Points: 
  • The acceptance of the BLA is the beginning of the formal review procedure for this potential new treatment by the FDA.
  • There is a significant unmet medical need for people whose moderate-to-severe atopic dermatitis remains uncontrolled, said Kim Kjller, M.D., Executive Vice President, Global Research and Development, LEO Pharma.
  • LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.
  • Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 (ECZema TRAlokinumab Trial no.

Kitov Announces Initiation of Phase 1/2 Clinical Trial of NT219 in Advanced Cancer Patients

Thursday, July 9, 2020 - 12:30pm

The initiation of this Phase 1/2 clinical trial is a key advancement in our NT219 development program, said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov.

Key Points: 
  • The initiation of this Phase 1/2 clinical trial is a key advancement in our NT219 development program, said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov.
  • I look forward to dosing of the first patients in this trial shortly.
  • The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the recommended dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219.
  • Kitov plans to advance CM-24 as a combination therapy with anti-PD1 checkpoint inhibitors in selected cancer indications in a phase 1 study followed by a phase 2 for the treatment of non-small cell lung cancer NSCLC and pancreatic cancer.

Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer's Disease

Thursday, July 9, 2020 - 4:20am

TOKYO, July 9, 2020 - (JCN Newswire) - Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimer's disease.

Key Points: 
  • TOKYO, July 9, 2020 - (JCN Newswire) - Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimer's disease.
  • "The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease.
  • We are committed to driving progress for the Alzheimer's disease community and look forward to the FDA's review of our filing."
  • Aducanumab represents a potential breakthrough that we hope will provide a treatment foothold in the fight against Alzheimer's disease."

AbbVie 2020: Company Background, Recent Earnings Review, Company Forecast, Company Profile and Clinical Trial Overview

Tuesday, July 7, 2020 - 12:00pm

DUBLIN, July 7, 2020 /PRNewswire/ -- The "AbbVie" company profile has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, July 7, 2020 /PRNewswire/ -- The "AbbVie" company profile has been added to ResearchAndMarkets.com's offering.
  • This report explores AbbVie's prescription pharmaceutical performance and outlook over 2019-2029.
  • Declines in AbbVie's flagship product Humira due to biosimilar competition will be offset by the company's robust portfolio of launch drugs.
  • [1] Biosimilar launches in Europe and other international markets have negatively impacted Humira's growth, but the brand could grow in 2020 and should have revenue stability until US biosimilar launches in 2023
    [2] AbbVie will see tremendous growth from Imbruvica, Skyrizi, Rinvoq, and Venclexta
    [3] Acquisition of Allergan, poised to close in 2020, will further diversify AbbVie's revenues
    Skyrizi forecast adjusted higher due to robust launch in the US; international forecast adjusted lower due to slower launch in the five major EU markets and Rest of World
    Imbruvica forecast adjusted higher globally due to recent inflection in market share in first-line CLL.

Atreca and Xencor Enter Strategic Collaboration to Discover, Develop and Commercialize Novel T Cell Engaging Bispecific Antibodies

Wednesday, July 8, 2020 - 1:01pm

Atreca will provide antibodies against novel tumor targets from which Xencor will engineer XmAb bispecific antibodies that also bind to the CD3 receptor on T cells.

Key Points: 
  • Atreca will provide antibodies against novel tumor targets from which Xencor will engineer XmAb bispecific antibodies that also bind to the CD3 receptor on T cells.
  • Atreca and Xencor began working together in 2019 under a material transfer agreement to accelerate this new collaboration agreement.
  • Atrecas unique discovery platform complements our protein engineering capabilities and bispecific platform by providing novel, tumor-selective antibodies and targets to engage with cytotoxic T cell killing.
  • This collaboration offers both Xencor and Atreca with several opportunities to advance novel first-in-class CD3 bispecific antibodies for the potential treatment of patients with cancer.

Kitov Pharma Receives Notice of Intention to Grant a European Patent Covering CM24, its anti-CEACAM1 Antibody

Wednesday, July 8, 2020 - 12:30pm

The trial will be conducted under a clinical collaboration agreement with Bristol-Myers Squibb (BMS) Company, and is expected to begin in the second half of 2020.

Key Points: 
  • The trial will be conducted under a clinical collaboration agreement with Bristol-Myers Squibb (BMS) Company, and is expected to begin in the second half of 2020.
  • We look forward to the anticipated initiation of our planned Phase 1/2 clinical trial with BMS later this year, said Isaac Israel, Kitovs Chief Executive Officer.
  • Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage company focusing on advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, to create successful long-lasting treatments for people with cancer.
  • CM-24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways.

Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease

Wednesday, July 8, 2020 - 12:30pm

and TOKYO, July 08, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimers disease.

Key Points: 
  • and TOKYO, July 08, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimers disease.
  • We are committed to driving progress for the Alzheimers disease community and look forward to the FDAs review of our filing.
  • Aducanumab represents a potential breakthrough that we hope will provide a treatment foothold in the fight against Alzheimers disease.
  • If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimers.

Corvus Pharmaceuticals Initiates Clinical Trial of Novel Immunotherapy for Patients with COVID-19

Tuesday, July 7, 2020 - 12:00pm

ET / 5:30 a.m. PT

Key Points: 
  • ET / 5:30 a.m. PT
    BURLINGAME, Calif., July 07, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19.
  • Corvus is studying an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer.
  • To date, over 90 cancer patients have been treated with CPI-006 in the Corvus Phase 1/1b study, with dosing as high as 24 mg/kg every three weeks.
  • Corvus study showed that CPI-006 is associated with increases in memory B cells, the emergence of new B cell clones and, in some patients, the production of novel anti-tumor antibodies.