November’s top news stories

6th December 2017 (Last Updated December 6th, 2017 00:00)

A clinical trial (OPARATIC) funded by Cancer Research UK evaluated the use of an ovarian cancer drug, olaparib to treat glioblastoma type of brain tumour, ViiV Healthcare launched Phase III combination trial for HIV. Drugdevelopment-technology.com wraps up the key headlines from November 2017.

UK scientists assess ovarian cancer drug for brain tumours

A clinical trial (OPARATIC) funded by Cancer Research UK has evaluated the use of an ovarian cancer drug, olaparib, for the treatment of the glioblastoma type of brain tumour.

Olaparib is a PARP inhibitor designed to prevent damaged cancer cells from repairing themselves following chemotherapy or radiotherapy.

The trial investigated the ability of the drug to cross the blood-brain barrier to reach the tumour.


ViiV Healthcare launches Phase III combination trial for HIV

ViiV Healthcare has launched a Phase III clinical trial (ATLAS-2M) to assess a long-acting, two-drug regimen of cabotegravir and rilpivirine for the treatment of virally suppressed adults infected with the HIV-1 virus.

ViiV’s cabotegravir is an experimental integrase strand transfer inhibitor (INSTI) and rilpivirine is Janssen Sciences Ireland’s non-nucleoside reverse transcriptase inhibitor (NNRTI).

The Phase III trial aims to establish the non-inferior antiviral activity at 48 weeks of treatment with the combination given every two months when compared to the administration of the combination for every one month.


Takeda advances Zika vaccine candidate into Phase I trial

Japan-based Takeda Pharmaceutical has started a Phase I clinical trial (ZIK-101) of its vaccine candidate, TAK-426, for the treatment of the Zika virus infection.

The move follows a contract received by the firm in September last year from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine for the infection.

TAK-426 is a purified, inactivated, alum-adjuvanted investigational vaccine candidate being developed to aid in the prevention of the spread of the virus.


University of Illinois initiates Phase Ib brain cancer trial

Researchers at the University of Illinois (U of I) in the US have initiated a Phase Ib clinical trial to assess a new experimental cancer drug PAC-1 in patients with anaplastic astrocytoma and glioblastomamultiforme, types of brain cancer.

Claimed to cross the blood-brain barrier, PAC-1 is being developed to target procaspase-3 enzyme and stimulate cancer cells to destroy themselves.

In the new trial, the investigational drug will be evaluated to determine its safety when used in combination with temozolomide, a standard chemotherapy drug for brain cancer.


ICL evaluates pembrolizumab for rare pregnancy cancer

Researchers at Imperial College London (ICL) have evaluated immunotherapy drug pembrolizumab in a small clinical trial for the treatment of cancerous forms of gestational trophoblastic disease (GTD).

GTD is characterised by abnormal cells or tumours, which begin from womb cells that usually give rise to placenta, while pembrolizumab is designed to trigger the immune system of the body to target and destroy cancer cells.

Results showed that remission was achieved following treatment in three out of four subjects aged 37-47 with multi-drug resistant cancerous GTD.


Cancer Research UK studies AstraZeneca’s oncology drug

Cancer Research UK has started a Phase I clinical trial of AstraZeneca’s investigational compound, AZD1775, to improve head and neck cancer treatment.

AZD1775 is a part of the firm’s DNA Damage Response compounds portfolio and is being developed as a potent inhibitor of the WEE1 protein that regulates cell cycles.

The trial is being conducted through Combinations Alliance, a joint initiative by Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network.


Daiichi Sankyo begins Phase II trial for gastric cancer

Daiichi Sankyo has initiated the Phase II DESTINY-Gastric01 clinical trial of its investigational antibody drug conjugate (ADC) DS-8201 in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

DS-8201 is described as smart chemotherapy with a humanised HER2 antibody connected to a new topoisomerase I inhibitor (DXd) payload by a tetrapeptide-based linker for delivering chemotherapy inside cancer cells and minimising systemic exposure.

The trial has started patient recruitment in Japan and South Korea to evaluate the safety and efficacy of DS-8201 for HER2-expressing cancer that is resistant or refractory to trastuzumab.


US’s Seattle Children’s begins immunotherapy trial for leukaemia

Seattle Children’s hospital in the US has started a Phase I chimeric antigen receptor (CAR) T-cell immunotherapy trial (PLAT-05) in children and young adults with relapsed or refractory CD19 and CD22 positive acute lymphoblastic leukaemia (ALL).

The new investigational CAR T cell therapy simultaneously targets the CD19 and CD22 proteins, and is expected to lower the relapse rate by 50%.

PLAT-05 is based on the previous CAR T-cell immunotherapy trials such as the ongoing PLAT-02 trial, when 93% of relapsed or refractory ALL subjects are reported to have experienced complete initial remission.


Bavarian Nordic starts Phase II booster study of RSV vaccine

Bavarian Nordic has started dosing patients in a Phase II extension study of its vaccine candidate MVA-BN RSV, which is being evaluated for the treatment of respiratory syncytial virus (RSV) infection.

Developed using the firm’s MVA-BN live virus vaccine platform technology, the candidate is designed to trigger an antibody and T-cell response against various respiratory syncytial virus (RSV) antigens.

The study aims to determine whether a single shot of MVA-BN RSV would be effective over multiple seasons or would be required annually.


New US trial shows safety of blood-plasma infusions for Alzheimer’s

A small clinical trial (PLASMA) by Stanford University School of Medicine in the US has demonstrated the safety of blood-plasma infusions from young donors to patients with mild to moderate Alzheimer’s disease.

The early phase trial evaluated the safety, tolerability, and feasibility of the infusions. It is reported to have indicated some evidence of improvement in the condition of patients.

PLASMA was led by Stanford University neurology and neurological sciences clinical associate professor Sharon Sha, who said that the recipients showed improvements on tests of functional ability.