Monoclonal antibodies

argenx announces publication of Phase 3 ADAPT trial results of efgartigimod for the treatment of generalized myasthenia gravis in The Lancet Neurology

Retrieved on: 
Wednesday, June 16, 2021

16, 2021 argenx (Euronext & Nasdaq: ARGX), today announced that The Lancet Neurology has published pivotal trial results from the Phase 3 ADAPT trial of efgartigimod, an FcRn antagonist, for the treatment of adults living with generalized myasthenia gravis (gMG).

Key Points: 
  • 16, 2021 argenx (Euronext & Nasdaq: ARGX), today announced that The Lancet Neurology has published pivotal trial results from the Phase 3 ADAPT trial of efgartigimod, an FcRn antagonist, for the treatment of adults living with generalized myasthenia gravis (gMG).
  • In the ADAPT trial, we observed clinically meaningful improvements in the first two weeks of dosing in a majority of patients treated with efgartigimod.
  • The Phase 3 ADAPT trial was a randomized, double-blind, placebo-controlled, multi-center, global trial evaluating the safety and efficacy of efgartigimod in patients with gMG.
  • ADAPT was designed to enable an individualized treatment approach with an initial treatment cycle followed by a variable number of subsequent treatment cycles.

Multi-Site Contributor Headlands Research Congratulates Biogen on FDA Approval of Aducanumab for Alzheimer’s Disease

Retrieved on: 
Wednesday, June 16, 2021

SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) -- Headlands Research ( www.headlandsresearch.com ), a global next-generation clinical research site organization, is pleased to have supported Biogen with its efforts to obtain FDA accelerated approval of Aducanumab for Alzheimers disease.

Key Points: 
  • SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) -- Headlands Research ( www.headlandsresearch.com ), a global next-generation clinical research site organization, is pleased to have supported Biogen with its efforts to obtain FDA accelerated approval of Aducanumab for Alzheimers disease.
  • Headlands contributed to the development of Aducanumab at three of its clinical trial sites: Toronto Memory Program (Toronto, Ontario), JEM Research Institute (Lake Worth, Florida), and Summit Research (Portland, Oregon).
  • Alzheimers disease is the sixth-leading cause of death in the United States and obtaining FDA approval for Aducanumab ends a more than two-decade drought for additional Alzheimer disease treatment options, said Mark Blumling, CEO and Founder of Headlands Research.
  • Headlands Researchs clinical research contributions to the develop of Aducanumab spanned two countries and four different principal investigators.

Debiopharm and Ubix Therapeutics Launch Research to Develop a New Anti-Cancer Modality - Antibody Degraducer® Conjugates

Retrieved on: 
Wednesday, June 16, 2021

The two companies are aiming to develop a new drug modality known as Antibody DegraducerConjugates (ADeC), by combining one of Ubix's Degraducer molecule, with Debiopharm's antibody drug conjugate linker Multilink.

Key Points: 
  • The two companies are aiming to develop a new drug modality known as Antibody DegraducerConjugates (ADeC), by combining one of Ubix's Degraducer molecule, with Debiopharm's antibody drug conjugate linker Multilink.
  • Multilink is a new cleavable linker platform that allows the loading of multiple drug payloads on an antibody.
  • Combining these advanced biotechnology solutions offers the unique opportunity to produce new types of antibody conjugates with dual molecular targeting.
  • These antibody Degraducerconjugates could extend the range of therapeutic antibody conjugates available for the treatment of various cancers.

Zai Lab and MacroGenics Enter Into Broad Strategic Collaboration to Develop and Commercialize Preclinical Bispecific Antibodies in Oncology

Retrieved on: 
Wednesday, June 16, 2021

Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.

Key Points: 
  • Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.
  • For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.
  • We are pleased to expand our strategic collaboration, which leverages both companies unique research capabilities and gives Zai Lab access to MacroGenics proprietary technologies to expand our innovative oncology portfolio on a global basis.
  • If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Labs territories.

MacroGenics and Zai Lab Enter Into Broad Strategic Collaboration to Develop and Commercialize Preclinical Bispecific Antibodies in Oncology

Retrieved on: 
Wednesday, June 16, 2021

Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.

Key Points: 
  • Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.
  • For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.
  • We are pleased to expand our strategic collaboration, which leverages both companies unique research capabilities and gives Zai Lab access to MacroGenics proprietary technologies to expand our innovative oncology portfolio on a global basis.
  • If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Labs territories.

Alvotech Reaches Primary Completion Date in Its Switching Study for AVT02, a Proposed Interchangeable Biosimilar to AbbVie’s Humira®

Retrieved on: 
Tuesday, June 15, 2021

Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the companys proposed interchangeable biosimilar to Humira.

Key Points: 
  • Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the companys proposed interchangeable biosimilar to Humira.
  • Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira and is executing a switching study to support approval as an interchangeable product.
  • The completion of the comparative treatment phase of the switching study is a key milestone in our program for our AVT02 interchangeable biosimilar candidate.
  • In order to be considered interchangeable, a biosimilar must meet additional requirements, including the execution of an interchangeable switching study, utilizing the innovator and biosimilar product in patients.

The Journal of the American Medical Association Publishes Data on Efficacy and Safety of Preventive Migraine Treatment VYEPTI® (eptinezumab-jjmr) When Administered During an Active Migraine Attack

Retrieved on: 
Tuesday, June 15, 2021

The RELIEF study evaluated how preventive migraine candidates may benefit from a VYEPTI infusion during an active migraine attack when administered within 1 to 6 hours of a moderate to severe migraine attack.

Key Points: 
  • The RELIEF study evaluated how preventive migraine candidates may benefit from a VYEPTI infusion during an active migraine attack when administered within 1 to 6 hours of a moderate to severe migraine attack.
  • VYEPTI is the first and only intravenous (IV) infusion approved for the preventive treatment of migraine in adults.
  • Furthermore, an active migraine would not be an obstacle for initiating preventive treatment with VYEPTI.
  • The exploratory endpoint of time to next migraine was met (10 days with VYEPTI vs. 5 days with placebo).

The U.S. FDA Approved IND Application to Investigate Combination of Asieris' APL-1202 and BeiGene's Tislelizumab as Neoadjuvant Therapy for MIBC Patients

Retrieved on: 
Tuesday, June 15, 2021

APL-1202 is an orallyavailable reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment.

Key Points: 
  • APL-1202 is an orallyavailable reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment.
  • Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.
  • "We are very pleased that FDA approved the IND application for oral APL-1202 in combination with tislelizumabas a neoadjuvant therapy in MIBC patients," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris.
  • We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

Exelixis Announces Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Evaluate XL092 in Combination with Immuno-oncology Therapies in Advanced Solid Tumors

Retrieved on: 
Monday, June 14, 2021

Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
  • Exelixis is sponsoring STELLAR-002 and Bristol Myers Squibb will provide nivolumab, ipilimumab and bempegaldesleukin for use in the trial.
  • STELLAR-002 will begin with a dose-escalation phase to determine the recommend dose for each of the XL092 combination therapies: XL092 in combination with nivolumab, XL092 in combination with nivolumab and ipilimumab and XL092 in combination with nivolumab and bempegaldesleukin.
  • XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug discovery activities.

Global Overview of Cancer Monoclonal Antibody Partnering Terms and Agreements: 2014-2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, June 14, 2021

This report contains a comprehensive listing of all Cancer monoclonal antibody partnering deals announced since Jan 2014, including financial terms where available, including links to online deal records of actual Cancer monoclonal antibody partnering deals as disclosed by the deal parties.

Key Points: 
  • This report contains a comprehensive listing of all Cancer monoclonal antibody partnering deals announced since Jan 2014, including financial terms where available, including links to online deal records of actual Cancer monoclonal antibody partnering deals as disclosed by the deal parties.
  • Global Cancer Monoclonal Antibody Partnering Terms & Agreements provides the reader with the following key benefits:
    Insight into the terms included in a cancer monoclonal antibody agreement, together with real-world clause examples
    Global Cancer Monoclonal Antibody Partnering Terms & Agreements is intended to provide the reader with an in-depth understanding and access to cancer monoclonal antibody trends and structure of deals entered into by leading companies worldwide.
  • Cancer Monoclonal Antibody Partnering Terms & Agreements includes:
    In Cancer Monoclonal Antibody Partnering Terms & Agreements, the available deals are listed by:
    Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.
  • The Cancer Monoclonal Antibody Partnering Terms & Agreements report provides comprehensive access to available deals and contract documents for over 550 cancer monoclonal antibody deals.