Nastech Pharmaceuticals announced this week that it has launched an RNAi drugs program in influenza and has acquired Galenea's RNAi-related intellectual property and technologies, which are largely focused on the flu.
The move will double Nastech's RNAi pipeline, and appears to mark the end of Galenea's short stint in the RNAi field.
The acquisition includes IP both developed by Galenea and in-licensed from the Massachusetts Institute of Technology for the development of RNAi therapeutics against viral respiratory infections including influenza, rhinovirus, and other respiratory diseases, Steven Quay, president and CEO of Nastech, said during a conference call. The purchase also includes IP related to pulmonary drug delivery, he added.
"An important aspect of this IP is their early priority dates in the antiviral RNAi field," he added. "It is our understanding that the MIT patent applications represent some of the earliest … in the area of RNAi directed against influenza and respiratory diseases."
Specific terms of the deal, including the financials, were not disclosed. However, Quay noted that Nastech will inherit "Galenea's pending grant applications from the National Institutes of Allergy and Infectious Diseases … and the Department of Defense to support the development of RNAi-based antiviral drugs" for such indications as pandemic flu, as well as Galenea's RNAi scientific advisors and certain key researchers.
"An important aspect of this IP is their early priority dates in the antiviral RNAi field. It is our understanding that the MIT patent applications represent some of the earliest … in the area of RNAi directed against influenza and respiratory diseases."
Through primarily known for its intranasal drug-delivery technology, Nastech entered the RNAi therapeutics field in early 2004 when it took a license to the fundamental Fire-Mello patent (see RNAi News, 2/6/2004). By late 2005, it had selected an siRNA targeting the inflammatory protein TNF-alpha for clinical development as a rheumatoid arthritis treatment.
Now Nastech has added flu to its RNAi lineup, which the company expects to complement its existing TNF-alpha research since "a consequence of influenza infection can be life-threatening respiratory and systemic inflammation," Quay said.
Galenea's lead RNAi drug candidate, dubbed G101, "has demonstrated efficacy in animals against multiple influenza strains, including the avian flu strain H5N1," Paul Johnson, senior vice president of research and development at Nastech, noted during the conference call. "It can be administered by inhalation … [and] has the potential to be delivered to the nasal cavity using Nastech's proprietary nasal delivery technology in order to prevent or abate early viral infections."
Nastech said that it plans to "work closely" with the National Institutes of Health, the Centers for Disease Control and Prevention, and the US Food and Drug Administration "to accelerate G00101 development given the urgent need for influenza therapeutics." Nastech officials declined to offer a timeline for development of a flu drug during the conference call.
When it was founded in 2004, Galenea had two distinct research and development focuses: an RNAi-based treatment for influenza and calcineuron-related therapeutics for cognitive disorders.
The RNAi program stemmed from the work of company co-founder and MIT researcher Jianzhu Chen, who has published a number of papers on the use of siRNAs to target flu in vivo, including two in the Proceedings of the National Academy of Sciences in March 2003 and June 2004.
Despite the promise of its flu program, Galenea's efforts in RNAi have been troubled: Last February, the company secured a collaboration and licensing deal with Japanese drug giant Otsuka Pharmaceutical reported to be worth about $50 million. However, that deal specifically applied to Galenea's CNS operations, although the company's then-CEO John Oyler told RNAi News that a portion of the Otsuka funding would be used to fund RNAi research.
Later that year, Oyler revealed to RNAi News that Galenea had been in discussions with Alnylam about collaborating on a flu therapy (see RNAi News, 6/3/2005). He said at the time that Alnylam's ultimate decision to develop its own flu drug and set itself up as a direct competitor to Galenea came as a shock, partly because his company's IP covers "any siRNA used to treat influenza, whether it's a virulent strain or a non-virulent strain."
Since that time, Galenea has been fairly quiet about its flu program, aside from giving a timeline for filing an investigational new drug application during the second half of 2007. Alnylam, meanwhile, has managed to secure $240,000 in flu funding from the US Department of Defense's Defense Advanced Research Projects Agency, and this week announced that it will collaborate with Novartis Pharmaceuticals to develop its RNAi flu therapy (see related story, this issue). Alnylam expects that it could file an IND on a flu drug by the end of the year.
During the conference call, Nastech officials also declined to comment on the company's new role as competitor to Alnylam Pharmaceuticals. However, Quay did note that "one of the key attributes [of the IP] is the early filing date and the fact that the IP is directed especially at the viral sequences [that] are conserved … which we think provides some unique advantages."
Officials from Galenea were not available for comment by press time.
• Doug Macron ([email protected])