2018: The year’s biggest Drug Development Technology stories

8th January 2019 (Last Updated January 8th, 2019 00:00)

The US National Institutes of Health (NIH) has provided funding for a clinical trial to examine the effectiveness of male contraceptive skin gel NES/T, and GlaxoSmithKline (GSK) has started its Phase III trial evaluating Benlysta (belimumab) in combination with rituximab to treat adult patients with systemic lupus erythematosus (SLE). Drug Development Technology wraps up the key headlines from 2018.

2018: The year’s biggest Drug Development Technology stories

NIH to assess efficacy of male contraceptive skin gel

The US National Institutes of Health (NIH) has provided funding for a clinical trial to examine the effectiveness of male contraceptive skin gel NES/T.

Non-governmental organisation Population Council and NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) have jointly developed NES/T.

The trial will be conducted at two NICHD Contraceptive Clinical Trials Network sites in the US and researchers intend to enroll around 420 couples.


Study claims Brexit could exclude children from clinical trials

A study from the Brexit Health Alliance has suggested that children could miss out on involvement in life-saving clinical trials as a result of the UK leaving the EU.

The group claims that without the right deal the UK might not be able to fully participate in collaborative trials and research activities such as the ones that include children and adults with rare and complex diseases.

The study also suggests that the UK could also be restricted from having access to crucial EU infrastructure that carries out the legislation authorising and managing clinical trials.


GSK initiates Phase III trial of Benlysta and rituximab combination

GlaxoSmithKline (GSK) has started its Phase III trial evaluating benlysta (belimumab) in combination with rituximab to treat adult patients with systemic lupus erythematosus (SLE).

The 104-week superiority study, BLISS-BELIEVE, will enrol around 200 patients with SLE.

The trial aims to determine the efficacy and safety of belimumab administered in combination with a single cycle of rituximab.

It will also evaluate whether co-administration improves the treatment effect of belimumab and provides sustained disease control that could lead to clinical remission.


Vedanta Biosciences initiates Phase I study of VE202 to treat IBD

Vedanta Biosciences has initiated a Phase I clinical study of its live biotherapeutic product (LBP) candidate VE202 for the treatment of inflammatory bowel disease (IBD).

The study is being conducted by Janssen Research & Development and will involve healthy volunteers.

Vedanta is set to receive $12m in milestone payments from Janssen in conjunction with the initiation of the study and as part of an ongoing collaboration.


Takeda reports positive top-line outcomes from VISIBLE 1 trial

Takeda Pharmaceutical Company has reported positive top-line results from the VISIBLE 1 trial after meeting its primary endpoint.

VISIBLE 1 is a pivotal Phase III, randomised, double-dummy, double-blind, placebo-controlled trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab as maintenance therapy for the treatment of moderately to severely active ulcerative colitis (UC).

The trial enrolled 384 patients who had inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or tumour necrosis factor-alpha (TNFα)-antagonist therapy before being enrolled.


GenSight enrols first patient for GS030 trial

GenSight Biologics has enroled the first patient in the Phase I/II PIONEER clinical trial to assess the safety and tolerability of GS030 for the treatment of patients with retinitis pigmentosa.

The subject has also been treated at the Moorfields Eye Hospital in London, UK.

GenSight is expected to enrol 18 patients as part of the first-in-man, open-label, dose-escalation trial, with registration expected to close by the last quarter of next year.


Daiichi Sankyo doses first patients in Phase lll trials for breast cancer

Daiichi Sankyo has dosed the first patients in two Phase III DESTINY-Breast03 and DESTINY-Breast02 trials investigating the safety and efficacy of [fam-] trastuzumab deruxtecan (DS-8201) to treat patients with previously treated HER2 positive unresectable and/or metastatic breast cancer.

DESTINY-Breast03 will compare [fam-] trastuzumab deruxtecan with ado-trastuzumab emtansine (T-DM1), and DESTINY-Breast02 will evaluate [fam-] trastuzumab deruxtecan in patients previously treated with standard-of-care HER2 therapies, including T-DM1.

[Fam-] trastuzumab deruxtecan is being examined by Daiichi Sankyo as a HER2 targeting antibody drug conjugate (ADC).


Merck and Pfizer’s Phase III lung cancer trial of avelumab fails

Merck KGaA and Pfizer have failed to meet the intended endpoint in a Phase III trial of avelumab in comparison with docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with a platinum-containing doublet therapy.

The JAVELIN Lung 200 trial’s prespecified endpoint was to improve overall survival (OS) in patients with programmed death ligand-1-positive (PD-L1+) (1% or higher) tumours.

The proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this could have confused the outcome of the trial, noted both companies.


DrugCendR begins CEND1-001 trial for pancreatic cancer

DrugCendR has started the Phase I CEND1-001 trial to examine the safety, tolerability, and biologic activity of CEND-1 in combination with nabpaclitaxel and gemcitabine to treat patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

The open-label, multicentre, dose-escalation, safety, pharmacodynamic, and pharmacokinetic trial intends to enrol 34 PDAC patients being treated with combination therapy of nabpaclitaxel and gemcitabine.

Patients will receive the study combination weekly for three weeks followed by one week off over 28 days as part of the trial.


Immunicum receives approval for ilixadencel and CPI Phase Ib/II trial

Immunicum has received protocol approval from the US Food and Drug Administration (FDA) to begin the ILIAD Phase Ib/II trial to investigate the safety and efficacy of intratumorally administered ilixadencel in combination with checkpoint inhibitors (CPIs) for three types of cancer indications.

The indications include head and neck cancer, non-small cell lung cancer, and gastric and gastroesophageal junction adenocarcinoma.

The newly granted approval has allowed Immunicum to start the process of patient enrolment for the trial, which is expected to include the first patient in the second half of this year.