Monoclonal antibodies

Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021

Retrieved on: 
Thursday, July 29, 2021
Branches of biology, Alzheimer's disease, Amyloidosis, Biology, Neuroscience, Monoclonal antibodies, Aducanumab, Amyloid beta, Amyloid-beta precursor protein

ICARE AD-US, a prospective study of ADUHELM (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM.

Key Points: 
  • ICARE AD-US, a prospective study of ADUHELM (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM.
  • This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.
  • The study intends to enroll patients with Alzheimers disease over four years from approximately 200 sites in the U.S.
  • The ICARE AD-US study, designed in collaboration with Alzheimers disease experts, underscores both of these commitments.

MacroGenics Provides Update on Corporate Progress and Second Quarter 2021 Financial Results

Retrieved on: 
Thursday, July 29, 2021
Life sciences, Biotechnology, Biopharmaceutical, Pharmaceutical industry, Pharmacy, Monoclonal antibodies

ROCKVILLE, Md., July 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc.(NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021.

Key Points: 
  • ROCKVILLE, Md., July 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc.(NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021.
  • Recent progress and anticipated events in 2021 related to MacroGenics approved product, MARGENZA, and its investigational product candidates in clinical development are highlighted below.
  • R&D Expenses: Research and development expenses were$55.8 millionfor the quarter endedJune 30, 2021, compared to$57.4 millionfor the quarter endedJune 30, 2020.
  • MacroGenicswill host a conference call today at4:30 pm (ET)to discuss financial results for the quarter endedJune 30, 2021and provide a corporate update.

NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19

Retrieved on: 
Friday, July 30, 2021
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Clinical research, Monoclonal antibodies, Health, Medicine, Lenzilumab, Placebo, National Institutes of Health, Activ, Chevrolet Spin, ACTIV-5/BET-B, Lenzilumab, Humanigen, ACTIV-5/BET-B, LENZILUMAB, HUMANIGEN

We appreciate the close collaboration with NIH on this important study, said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen.

Key Points: 
  • We appreciate the close collaboration with NIH on this important study, said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen.
  • The ACTIV-5/BET-B study design has been adapted to align with the design of LIVE-AIR and may help support a future BLA for lenzilumab.
  • ACTIV-5/BET-B may provide prospective validation for lenzilumab in the treatment of COVID-19, said Cameron Durrant, MD, Chief Executive Officer, Humanigen.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through 28 days following treatment.

HUMIRA (Adalimumab) Biosimilars Report 2021: Focus on Approved & Launched, Investigational & Research Use, Inactive/Terminated/Withdrawn, Industry/Non-Industry Partnerships - ResearchAndMarkets.com

Retrieved on: 
Friday, July 30, 2021
Biotechnology, Pharmaceutical, Health, Drugs, Life sciences, Articles, Biotechnology, Immunosuppressants, TNF inhibitors, Biosimilar, Monoclonal antibodies, Adalimumab

The "HUMIRA (Adalimumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "HUMIRA (Adalimumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report has been added to ResearchAndMarkets.com's offering.
  • The "Adalimumab Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report features an extensive study of the current developer landscape and clinical research scenario related to all the follow-on products of the blockbuster biologic drug, HUMIRA, which are either available or under development.
  • An analysis of the various partnerships related to adalimumab biosimilars, based on parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities.
  • A detailed assessment of the various marketing and distribution agreements inked in relation to HUMIRA biosimilars, highlighting the key players involved.

China's Infliximab Market Investigation Report 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021
Biotechnology, Genetics, Health, Oncology, Drugs, Monoclonal antibodies, Immunosuppressants, TNF inhibitors, Janssen Pharmaceutica, Infliximab, Janssen Biotech, Economy of China, China

The "Investigation Report on China's Infliximab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Infliximab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • By 2020, Janssen Biologics BV is the only manufacturer in the Chinese Infliximab market.
  • According to the market research, since Infliximab entered the Chinese market in 2007, its sales have had an increasing trend.
  • 2 Sales of Infliximab in China, 2016-2020
    2.3 Sales of Infliximab by Dosage Form in China, 2016-2020
    3 Analysis of Major Infliximab Manufacturers in China, 2016-2020
    4 Prices of Infliximab for Different Manufacturers in China, 2020-2021
    5 Prospect of Chinese Infliximab drug Market, 2021-2025
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210729005802/en/

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Retrieved on: 
Friday, July 30, 2021
Branches of biology, Amyloidosis, Monoclonal antibodies, Biology, Health sciences, Alzheimer's disease, Lecanemab, Clinical trial, Amyloid beta, Amyloid, Crenezumab, Gantenerumab

The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.

Key Points: 
  • The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
  • In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer's disease, were presented.
  • For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented.
  • "It's very encouraging to see that Eisai's broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes.

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Retrieved on: 
Friday, July 30, 2021
Branches of biology, Amyloidosis, Monoclonal antibodies, Biology, Health sciences, Alzheimer's disease, Lecanemab, Clinical trial, Amyloid beta, Amyloid, Crenezumab, Gantenerumab

The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.

Key Points: 
  • The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
  • In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer's disease, were presented.
  • For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented.
  • "It's very encouraging to see that Eisai's broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes.

Transcenta Announces Orphan Drug Designation Granted to TST001 for Treatment of Gastric and Gastroesophageal Junction

Retrieved on: 
Thursday, July 29, 2021
Drugs, Cancer treatments, Clinical medicine, Monoclonal antibodies, Orphan drugs, Antineoplastic drugs, Breakthrough therapy, Bristol-Myers Squibb, Pembrolizumab, SeaGen

SUZHOU, China, July 28, 2021 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TST001, its anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

Key Points: 
  • SUZHOU, China, July 28, 2021 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TST001, its anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).
  • According to preclinical and clinical data, TST001 displayed potent anti-tumor activities in tumor model of gastric cancer or patient of gastric cancer expressing Claudin18.2.
  • At present, the treatment options of gastric cancer expressing Claudin18.2 are very limited other than surgical resection, chemotherapy and most recently immunotherapy.
  • Orphan Drug Designation (ODD) is granted by the FDA to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S.

DGAP-News: MorphoSys AG Reports Second Quarter and First Half 2021 Results

Retrieved on: 
Wednesday, July 28, 2021
Monoclonal antibodies, MorphoSys, Tafasitamab, Incyte, Life sciences, Biotechnology, Health care

*Value as of December 31, 2020

Key Points: 
  • *Value as of December 31, 2020
    MorphoSys will hold its conference call and webcast tomorrow, July 29, 2021, to present the results for the second quarter and first half year of 2021 and the further outlook for 2021.
  • The statement for the second quarter/first 6 months of 2021 (IFRS) is available online:
    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.
  • In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally.
  • Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees.

Infinity Pharmaceuticals Presents Updated Data from Phase 2 MARIO-275 Trial in Urothelial Cancer (UC) and Phase 2 MARIO-3 Trial in Triple Negative Breast Cancer (TNBC)

Retrieved on: 
Tuesday, July 27, 2021
Oncology, Health, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Clinical medicine, Cancer treatments, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Monoclonal antibodies, Carcinoma, Transitional cell carcinoma, Nivolumab, PD-L1, Pembrolizumab

These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.

Key Points: 
  • These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.
  • These results are consistent with the results from MARIO-275, which show the similar translation of disease control into a meaningful survival benefit for patients.
  • For patients with TNBC, the potential to extend progression free survival, regardless of PD-L1 status, would be a transformational breakthrough.
  • MARIO-275 is a global, randomized, controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.