July's top stories: Novavax Ebola trial, Nestlé pregnancy nutrients study

Novavax presented positive data from a Phase I clinical trial of its Ebola GP vaccine, Pfizer commenced the Phase IIb trial of its S. aureus multi-antigen vaccine (PF-06290510), and Nestlé’s to assess the effects of nutrients before and during pregnancy on the health of mother and their babies. Drugdevelopment-technology.com wraps up key headlines from July.


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Novavax reports results of Phase I Ebola GP Vaccine trial

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Clinical-stage vaccine firm Novavax presented positive top-line data from a Phase I clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M.

The company presented the results at the World Health Organisation's (WHO) fifth teleconference on Ebola vaccine clinical trials.

According to the firm, the study showed that the Ebola GP Vaccine was extremely immunogenic, well-tolerated, and conjunction with company's Matrix-M adjuvant resulted in significant antigen dose-sparing.

Pfizer enrols first patient in STRIVE study for elective spinal surgery

US-based drugmaker Pfizer commenced the Phase IIb clinical trial of its investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) in adults undergoing elective spinal fusion surgery.

The company has enrolled the first patient in the Saphylococcus aureus surgical inpatient vaccine efficacy (STRIVE) trial to study the safety and efficacy of the vaccine to find out if it prevents postoperative invasive S. aureus infections in patients undergoing elective spinal surgery.

The vaccine is designed to prevent a wide-range of clinical disease manifestations, caused by S. aureus, by facilitating killing of the bacteria at the early stages of invasive infection by targeting multiple virulence mechanisms.

Nestlé and EpiGen to assess impact of nutrients before and during pregnancy

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Nestlé Research Centre collaborated with EpiGen Global Research Consortium and National University Hospital Singapore to conduct a study to evaluate the effects of nutrients before and during pregnancy on the health of mother and their babies.

The study titled "Nutritional Intervention Preconception and during Pregnancy to maintain healthy glucosE levels and offspRing health" (NiPPeR), will enrol approximately 1,800 women before pregnancy across three centres in Southampton of the UK, Singapore, and Auckland of New Zealand.

University of Southampton epidemiology and human development professor and chief investigator Keith Godfrey said: "The pre-conception phase is very important to ensure women are getting the best nutrition in preparation for their pregnancy."

Amgen presents Blincyto's Phase II trial results for Ph+ B-cell precursor ALL

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Amgen presented Blincyto's (blinatumomab) top-line results of Phase II trial in adults with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukaemia (ALL).

According to the firm, the investigational, open-label, single-arm, and multi-centre study demonstrated blinatumomab monotherapy induced a complete remission or complete remission with partial haematological recovery within two cycles of treatment in a clinically meaningful number of patients.

Blincyto is claimed to be the first bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct product and first single-agent immunotherapy that was approved by the US Food and Drug Administration (FDA) to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.

Roche presents trial results of its UBC drug atezolizumab

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Roche presented results of the IMvigor 210 study, which is designed to assess the safety and efficacy of its investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) in people with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment (second-line or late).

Atezolizumab is an investigational monoclonal antibody that is being developed to interfere with a protein known as PD-L1. It will target PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells.

According to the firm, atezolizumab shrank tumours in people with UBC in the study, which is the objective response rate (ORR) and the primary end point of this trial.

Eli Lilly presents data of Florbetapir F 18 Injection imaging for cognitive decline

Eli Lilly and Company presented the new data demonstrating that knowledge of amyloid status as specified by Florbetapir F 18 Injection imaging, altered diagnosis and management in the majority of patients being studied.

The multicentre trial was designed to assess the impact of amyloid positron emission tomography (PET) on patient management and outcomes in a randomised and controlled setting.

Presented along with its subsidiary Avid Radiopharmaceuticals, the results also demonstrated that knowledge of amyloid status as determined by florbetapir imaging changed patient management in the majority of study patients, specifically Alzheimer's disease medications, in a direction consistent with amyloid status.

Alnylam begins ALN-AAT's Phase I / II trial for alpha-1 liver disease

Alnylam Pharmaceuticals started the Phase I / II clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin (AAT) to treat AAT deficiency-associated liver disease (alpha-1 liver disease).

ALN-AAT is a subcutaneously administered investigational RNAi, which uses the firm's ESC-GalNAc-siRNA conjugate delivery technology.

Initially, the study will be carried out in normal healthy volunteers and then in patients with alpha-1 liver disease. The trial is being conducted based on pre-clinical data presented during Digestive Disease Week (DDW).

Bavarian Nordic begins Prostvac Phase II trial for localised prostate cancer

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Biopharmaceutical firm Bavarian Nordic began the new Phase II clinical study of its active prostate cancer immunotherapy candidate, Prostvac.

Prostvac is a ready-to-use immuno-oncology agent, which stimulates an immune response that attacks prostate cancer cells.

The National Cancer Institute (NCI) has sponsored the study under the collaborative research and development agreement (CRADA) and clinical supply agreement.