This week saw two new announcements of Ebola-related deals in the pharma/biotech world: NewLink Genetics Corp. and Merck collaborating to manufacture an Ebola vaccine candidate and Tekmira Pharmaceuticals Corp. entering into a manufacturing and clinical trial agreement with the University of Oxford to provide the new TKM-Ebola-Guinea therapeutic product for clinical studies in West Africa.
In the first agreement, NewLink Genetics and Merck—known as MSD outside the United States and Canada—announced that the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services has named NewLink Genetics' wholly-owned subsidiary, BioProtection Systems, as the prime contractor in a $30-million contract to support the manufacturing and development activities of its investigational rVSV-EBOV (Ebola) vaccine candidate, including clinical development through a new 330-person Phase 1b study.
The vaccine candidate was initially developed by the Public Health Agency of Canada, and is now being developed under an exclusive licensing and collaboration agreement between NewLink Genetics and Merck.
“The current funding provided by BARDA is key to the rapid development of this Ebola vaccine candidate. These funds will support multiple facets of the accelerated Ebola vaccine program including the expansion of critical vaccine supplies and larger clinical studies,” said Dr. Charles Link, CEO and chief scientific officer of NewLink Genetics.
“Governments and industry are effectively collaborating in an unprecedented effort to accelerate the development of Ebola vaccine candidates,” added Dr. Mark Feinberg, chief public health and science officer of Merck Vaccines. “If we can bring an efficacious and well-tolerated vaccine to the outbreak countries, we will not only help protect people at risk in the current crisis, but also may help reduce the likelihood of such tragic events in the future.”
Pending the results of Phase 1 trials underway, the U.S. National Institutes of Health recently announced plans to initiate, in early 2015, a large randomized, controlled Phase 2/3 study to evaluate the safety and efficacy of this and another investigational Ebola vaccine candidate.
As for the Tekmira side of Ebola news, the company, a developer of RNA interference (RNAi) therapeutics, announced that it has entered into a manufacturing and clinical trial agreement with the University of Oxford to provide the new TKM-Ebola-Guinea therapeutic product for clinical studies in West Africa that are expected to commence early next year, subject to finalization of a suitable clinical protocol.
The University of Oxford is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). ISARIC will conduct clinical studies of TKM-Ebola-Guinea in Ebola virus infected patients, with funding provided by the Wellcome Trust. GMP manufacture of TKM-Ebola-Guinea is now complete and 100 treatment courses are available for the study.
“We are very pleased that TKM-Ebola-Guinea will be studied in patients and result in benefit to them. While the clinical protocol is still being finalized, the studies are designed to establish efficacy, so that an effective therapeutic can be available to patients,” said Dr. Mark J. Murray, Tekmira'’ President and CEO.
In early October, the genomic sequence of the Ebola-Guinea variant, which is responsible for the current outbreak in West Africa, was determined from several viral isolates and was published in the New England Journal of Medicine. Tekmira developed a modified RNAi therapeutic to specifically target the Ebola-Guinea variant. The new product, TKM-Ebola-Guinea, is designed to match the genomic sequence exactly, with two RNAi triggers.
Results of preclinical studies with TKM-Ebola-Guinea demonstrated efficacy results comparable to those obtained with TKM-Ebola, which has demonstrated up to 100-percent protection from an otherwise lethal dose of the virus.
“TKM-Ebola-Guinea underscores how RNAi-based technology allows for rapid response to emerging viral variants,” said Murray.
These two bits of Monday news in mid-December join a growing list of other Ebola-related efforts, including Integrated DNA Technologies and Ubiquitome announcing a partnership to develop the Ubiquitome Freedom4 Real-Time RT-PCR Ebola Virus Assay for easy use in the field as a mobile Ebola test; Kymab, a monoclonal antibody biopharmaceutical company, announcing that it had been awarded a grant from the Wellcome Trust to lead a consortium developing new treatments in the fight against Ebola; and the Massachusetts Life Sciences Center announcing its $1-million challenge grant to support a partnership of life-sciences companies, non-governmental organizations and academic institutions, led by Diagnostics For All, that is working to develop an improved, fast and accurate diagnostic test for Ebola.
Also on the Ebola front, the Biotechnology Industry Organization (BIO) in early December gave its full support for the U.S. House of Representatives’ unanimous decision to add Ebola into the FDA Priority Review Voucher Program Act. According to the act, companies that develop vaccines or drugs to treat Ebola will be granted an FDA priority review voucher for one of their non-Ebola related products.
Also, in mid-December, came cautionary words from the European Medicines Agency (EMA) that, at this point in time, there is not enough evidence for any of the experimental therapies for Ebola virus disease to draw conclusions on their safety or efficacy when used in Ebola patients.
“Treatments for patients infected with the Ebola virus are still in early stages of development,” noted Marco Cavaleri, head of anti-infectives and vaccines at EMA. “We encourage developers to generate more information on the use of these medicines in the treatment of Ebola patients. We will review any new information as soon as it becomes available to support the response to this ongoing public health crisis.”