Bavarian Nordic

Bavarian Nordic initiates phase II PROSTVAC combo prostate cancer trial

Wednesday, April 19, 2017

Bavarian Nordic initiated a phase II clinical trial of its prostate cancer immunotherapy candidate, PROSTVAC (rilimogene), in combination treatment with YERVOY (ipilimumab) and/or OPDIVO (nivolumab), both of which are immune checkpoint inhibitors from Bristol-Myers Squibb, as neoadjuvant therapy in patients with localized prostate cancer.

A lead-in stage will evaluate the safety of the combination of all three drugs in 10 patients with castration-resistant prostate cancer, followed by enrollment of up to 55 patients with localized prostate cancer in three cohorts, who will receive PROSTVAC in combination with either ipilimumab or nivolumab, or a combination of all three drugs prior to undergoing radical prostatectomy. The primary endpoint of the study is to evaluate and compare changes in T cell infiltration in the tumor after neoadjuvant treatment across the three different cohorts.

The principal investigator of the study is James L. Gulley, MD, Senior Investigator, Center for Cancer Research, part of the National Cancer Institute (NCI), and the sponsor of the study.  

“There are now 11 ongoing studies of PROSTVAC across various stages of prostate cancer. In recent years, there has been a growing interest in the evaluation of the immunotherapy candidate in earlier disease stages, where the cancer has not yet spread beyond the prostate. We are excited to learn more about the potential of PROSTVAC for treating this population, and to evaluate the potential synergistic effects of combining the vaccine with checkpoint inhibitors, as we believe PROSTVAC may enhance the clinical activity of these drugs,” said Paul Chaplin, president & chief executive officer of Bavarian Nordic.

This is the second trial conducted in collaboration with Bristol-Myers Squibb. The first trial was initiated in October 2016, and is investigating the combination treatment of PROSTVAC and ipilimumab at the University of California, San Francisco (UCSF), also in a neoadjuvant setting.

Janssen completes WHO submission for EUAL for Ebola vaccine regimen

Wednesday, September 14, 2016

Bavarian Nordic has announced that Janssen Vaccines & Prevention has completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen, which includes Bavarian Nordic’s MVA-BN Filo vaccine. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options.

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J&J begins Ebola vaccine regimen in Sierra Leone

Monday, October 19, 2015

Johnson & Johnson (J&J) has begun a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies. Trial recruitment is underway, and the first volunteers have received their initial vaccine dose. It is the first study conducted of Janssen’s Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic.

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Johnson & Johnson forms Ebola vaccine development consortia

Monday, January 19, 2015

Johnson & Johnson has formed a consortia with leading global research institutions and non-government organizations to work in conjunction with Janssen Pharmaceutical to accelerate the development of its Ebola vaccine regimen. The Innovative Medicines Initiative (IMI) plans to award these consortia grants totaling more than $116 million from the Ebola+ program to support the development, manufacturing and patient education for the vaccine regimen.

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Johnson & Johnson begins phase I clinical trial of Ebola vaccine regimen

Thursday, January 8, 2015

Johnson & Johnson has begun a phase I, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Pediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January.

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U.S. immunity against legal claims given to developers of Ebola treatments

Monday, January 5, 2015

Health and Human Services Secretary Sylvia M. Burwell has announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to facilitate the development and availability of experimental Ebola vaccines. This declaration is intended to assist in the global community’s effort to help combat the current epidemic in West Africa and help prevent future outbreaks there.

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Johnson & Johnson to speed Ebola vaccine development, expand production

Thursday, October 23, 2014

Johnson & Johnson has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at Janssen Pharmaceutical Companies. The company is closely collaborating with the World Health Organization (WHO), the National Institute of Allergy and Infectious Diseases (NIAID), as well as other key stakeholders, governments and public health authorities on the clinical testing, development, production and distribution of the vaccine regimen.

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