October's top stories: First Ebola trial in Mali, Novartis' AS Phase III study

University of Maryland School of Medicine's (UM SOM) Centre for Vaccine Development (CVD) together with CVD-Mali and the Ministry of Health of Mali started a clinical trial of Ebola vaccine on Malian health care workers.


ebola mali

First clinical trial of Ebola Vaccine begins in Mali, West Africa

University of Maryland School of Medicine's (UM SOM) Centre for Vaccine Development (CVD) together with CVD-Mali and the Ministry of Health of Mali started a clinical trial of Ebola vaccine on Malian health care workers.

The vaccine was developed by the Vaccine Research Centre (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, US.

It consists of an adenovirus (cold virus) that develops a single attachment protein of Ebola virus in humans without creating any harm to the human body.

Novartis' Phase III trials of ankylosing spondylitis drug secukinumab meets primary endpoint

Swiss Pharmaceutical firm Novartis reported positive results from its Phase III MEASURE 1 and MEASURE 2 trials of AIN457 (secukinumab), an investigational medicine, in patients with ankylosing spondylitis (AS), a common type of spondyloarthropathy (SpA).

SpA is a family of long-term diseases impacting joints (inflammatory diseases), which includes other conditions such as psoriatic arthritis (PsA).

The company said that the trials met primary and key secondary endpoints, which included improvements in signs and symptoms of the disease versus a placebo and associated improvements in physical function and quality of life.

Regeneron and Sanofi initiate Phase III trial of dupilumab to treat atopic dermatitis

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Regeneron Pharmaceuticals and Sanofi started dosing patients in a Phase III clinical trial of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD).

Liberty AD Chronos is the first trial in the Phase III clinical programme for dupilumab and its primary objective is to show the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.

Approximately 700 adult patients will be enrolled in this randomised, double-blind, placebo-controlled, multi-national trial and its secondary objectives will be to evaluate the long-term safety and efficacy of dupilumab up to 52 weeks.

BMS, Pharmacyclics and Janssen partner to evaluate non-Hodgkin's lymphoma drug

Bristol-Myers Squibb (BMS), Pharmacyclics and Janssen Research & Development collaborated to start a Phase I/II clinical trial to assess the safety, tolerability and preliminary efficacy concerning the combination of OPDIVO (nivolumab) and IMBRUVICA (ibrutinib) in patients with non-Hodgkin's lymphoma (NHL).

OPDIVO is BMS's investigational PD-1 immune checkpoint inhibitor, while IMBRUVICA is an oral Bruton's tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.

The trial is designed to evaluate the safety and anti-tumour activity of the combination therapy as a potential treatment option for patients with NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL)

GSK's Stiefel begins subcutaneous ofatumumab Phase III trial for pemphigus vulgaris

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British drug maker GlaxoSmithKline's (GSK) subsidiary Stiefel commenced a Phase III trial to assess the efficacy and safety of subcutaneous ofatumumab in patients with a rare autoimmune skin disorder, pemphigus vulgaris.

Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule, and encompasses parts of the small and large extracellular loops.

The trial is said to evaluate disease remission in patients with pemphigus vulgaris treated with subcutaneous ofatumumab as add-on treatment to oral steroids.

Pfizer, Kyowa Hakko Kirin partner for Phase Ib immuno-oncology combination trial

Pfizer entered into an agreement with Japanese pharmaceutical firm Kyowa Hakko Kirin to carry out an immuno-oncology combination Phase Ib trial in patients with solid tumours.

Under the deal, Kyowa's anti-CCR4 antibody mogamulizumab will be evaluated in combination with Pfizer's investigational 4-1BB agonist PF-05082566 in this Phase Ib trial designed to evaluate the safety and tolerability of the combination in these patients.

Pfizer's PF-05082566 is an investigational, fully humanised monoclonal antibody (mAb) that stimulates signalling through 4-1BB (CD-137), a protein involved in regulation of immune cell activation, proliferation and survival.

Lilly extends collaboration with Zymeworks for new bi-specific immunotherapies

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Eli Lilly and Company extended its existing licensing and collaboration agreement with Zymeworks for bi-specific immunotherapies.

The collaboration is focused on the development of an undisclosed number of bi-specific antibody therapeutics using Zymeworks' Azymetric platform.

As part of the deal, Zymeworks is eligible to receive an unspecified up-front payment in the form of an equity investment, as well as the majority of the $375m in potential rewards, connected to development and commercial milestones.

The collaboration with Zymeworks adds to Lilly's bi-specific antibody and immunotherapy research portfolio.

Ablynx reports positive results from Phase I bioavailability trial of SC ALX-0061

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Belgium-based biopharmaceutical firm Ablynx reported positive results from the Phase I bioavailability trial of the subcutaneous (SC) formulation of its anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).

The trial evaluated the bioavailability of single doses of ALX-0061, administered SC at three dose levels 50mg, 150mg and 300mg dose, using two corresponding single intravenous (IV) dose levels 50mg and 300mg as a reference.

The trial also evaluated the pharmacodynamics, safety, tolerability and immunogenicity of single SC and IV doses of ALX-0061.