April's top stories: NIAID's Phase II/IIb Zika vaccine trial, Boehringer's nintedanib in Phase III trial
The National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) began the Phase II/IIb clinical trial of a Zika vaccine, and Boehringer Ingelheim began patient enrolment in the Phase III PF-ILD trial of nintedanib to treat various progressive fibrosing lung diseases. Drug development-technology.com wraps up the key headlines from April.
The National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) began the Phase II/IIb clinical trial of a Zika vaccine for protection against disease related to the Zika infection.
Developed by government scientists at the NIAID’s Vaccine Research Center (VRC), the NIAID Zika virus investigational DNA vaccine is comprised of a plasmid integrated with genes that encode two proteins found on the surface of the Zika virus.
The vaccine induces the body’s immune response by assembling the encoded proteins into particles that imitate the Zika virus.
US-based Boehringer Ingelheim Pharmaceuticals began patient enrolment in its Phase III progressive fibrosing interstitial lung disease (PF-ILD) clinical trial of nintedanib to treat various progressive fibrosing lung diseases, excluding idiopathic pulmonary fibrosis (IPF).
Marketed as Ofev, nintedanib is a kinase inhibitor currently approved for the treatment of IPF.
The randomised, double-blind, placebo-controlled Phase III trial will enrol a total of 600 patients at approximately 60 sites in the country.
A new Phase II clinical trial began in West Africa to evaluate three vaccination strategies for the prevention of Ebola virus.
The French National Institute of Health and Medical Research (Inserm), the US National Institutes of Health (NIH) and the London School of Hygiene and Tropical Medicine (LSHTM) are conducting the trial under the Partnership for Research on Ebola Vaccination (PREVAC) international consortium.
The vaccine candidates for the PREVAC trial are being supplied by pharmaceutical firms Janssen Vaccines & Prevention, Bavarian Nordic and Merck Sharp & Dohme.
US-based Ra Pharmaceuticals began dosing patients in its Phase II clinical programme of its RA101495 for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).
RA101495 is being developed as a subcutaneous complement component 5 (C5) inhibitor to control complement-induced hemolysis.
The Phase II programme is currently being conducted to assess the safety, tolerability, preliminary efficacy, pharmacokinetics and pharmacodynamics of RA101495, and includes two open-label Phase II trials.
French biotechnology company Abivax began patient enrolment in the ABX464-005 clinical trial of ABX464 for the treatment of HIV.
Part of the firm's anti-viral platform, ABX464 is an oral, first-in-class, small molecule drug candidate expected to be a functional cure for HIV patients.
The ABX464-005 trial is designed to evaluate the effect and pharmacokinetics of ABX464 in HIV cellular reservoirs of 24 patients and 12 healthy subjects.
Japanese pharmaceutical firm Daiichi Sankyo's division American Regent began patient enrolment in the Phase III HEART-FID clinical trial of Injectafer (ferric carboxymaltose) for the treatment of heart failure with iron deficiency.
Injectafer is an intravenous (IV) form of iron being developed for the treatment of iron deficiency anaemia (IDA) in adults with an intolerance to oral iron or unsatisfactory response to oral iron or non-dialysis dependent chronic kidney disease.
The double-blind, multi-centre, prospective, randomised, placebo-controlled Phase III trial is expected to enrol more than 3,000 adult patients across North America.
AbbVie reported top-line results from two Phase III clinical trials of its veliparib in combination with chemotherapy regimen to treat squamous non-small-cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
The results indicated that veliparib in combination with carboplatin and paclitaxel failed to meet the primary endpoints of the trials.
Veliparib is an investigational, oral inhibitor of a naturally occurring enzyme known as poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP).
Canadian-based biopharmaceutical company Immunovaccine started dosing patients in a Phase Ib/II trial of its vaccine DPX-E7 for the treatment of incurable human papillomavirus (HPV) related oropharyngeal, cervical and anal cancers.
Stand Up To Cancer and the Farrah Fawcett Foundation granted $1.5m to Dana-Farber Cancer Institute to carry out the trial as part of its collaborative translational research on HPV-related cancers.
DPX-E7 is an investigational vaccine candidate that employs patented DepoVax platform and targets an HPV viral protein called E7.
French-based biotechnology firm Transgene started dosing patients in the Phase II stage of the METROmaJX clinical trial of Pexa-Vec and metronomic cyclophosphamide combination for the treatment of advanced solid tumours such as breast cancer and soft tissue sarcoma (STS).
Developed by Transgene in collaboration with SillaJen, Pexa-Vec is a GM-CSF-expressing vaccinia-derived oncolytic virus.
Pexa-Vec is being developed to kill cancer cells, decrease the blood supply to tumours and trigger body's immune response against the tumour cells, while cyclophosphamide is a chemotherapy that will be administered in metronomic low doses at a higher frequency.
Immuno-oncology company Alexo Therapeutics started dosing patients in its Phase I clinical trial of a fusion protein ALX148 for the treatment of solid tumours and lymphoma.
ALX148 contains a high-affinity, CD47 binding domain of SIRPα linked to human immunoglobulin's inactive Fc region.
By selectively binding to CD47, ALX148 blocks its interaction with SIRPα, resulting in the inhibition of an immune checkpoint mechanism used by tumour cells.