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Strands: Dec 11, 2008

Alnylam, UCSF to Collaborate on RNAi Rx for Uveal Melanoma
Alnylam Pharmaceuticals this week said that it has formed an exclusive collaboration with the University of California, San Francisco, to evaluate an RNAi therapeutic targeting a heterotrimeric G protein alpha-subunit called G-alpha q for the treatment of metastatic uveal melanoma.
The announcement comes on the heels of a publication in the advance online version of Nature linking GNAQ and the cancer.
“The emerging data on cancer genomes and the molecular basis for malignant-cell transformation form a very compelling opportunity for the advancement of RNAi therapeutics targeting genes derived from somatic mutations,” Jared Gollob, senior director of clinical research at Alnylam, said in a statement. "The new data published in Nature greatly increases our understanding of the biology of this disease, and given our clear success in achieving systemic delivery we believe that an RNAi therapeutic targeting GNAQ in uveal melanoma that has spread to the liver may represent an ideal treatment option for this devastating disease.”
Terms of the collaboration were not disclosed.

Alnylam’s Kreutzer-Limmer Patent Invalidated by European Patent Office
Alnylam Pharmaceuticals this week announced that the European Patent Office has ruled invalid the company’s European patent EP 1144623, one part of its so-called Kreutzer-Limmer intellectual property estate, in oral proceedings before the agency’s board of appeals.
Alnylam obtained the patent when it acquired German RNAi shop Ribopharma, which later became Alnylam Europe and was ultimately sold to Roche. The patent claims "a medicament containing at least one double-stranded oligonucleotide designed to inhibit the expression of a target gene."
In 2003, eight parties — Sirna Therapeutics, Atugen, Aventis Pharma, Janssen Pharmaceutica, AstraZeneca, Isis Pharmaceuticals, Novartis, and Munich-based patent attorney Martin Grund — filed to have the patent invalidated, claiming that the IP does not provide sufficient supporting data. Certain of the parties later withdrew their opposition — including Isis and Novartis, both of which are now Alnylam partners.
Alnylam said that the EPO ruling on the ‘623 patent “does not affect other granted claims of the Kreutzer-Limmer patent series, nor does it affect the ongoing examination of other applications, which the company expects will result in new granted patents.”
The company also said that the EPO intends to grant the company a new patent from the Kreutzer-Limmer family, EP 1550719, which covers siRNAs comprising 15-21 nucleotides in length stabilized by chemical linkages.

SCRI to Use DxTerity Reagents in miRNA Cardiac Test
DxTerity Diagnostics said this week that the Scottsdale Clinical Research Institute in Arizona will use the firm’s Quenched Auto Ligating reagents for development of a microRNA-based cardiac test.
The test will measure the expression of an miRNA biomarker in heart biopsy tissue samples, which has been shown to correlate with post-operative heart arrhythmia. DxTerity said that SCRI will use its QUAL reagents to validate the biomarker’s ability to reveal at-risk patients before an arrhythmia strikes.
“SCRI and DxTerity have established an alliance to develop bioassay platforms supporting the vision of personalized medicine,” Mark Slater, VP of research at SCRI, said in a statement. “Our shared goal is to accelerate the development and use of novel predictive biomarkers by physicians, and to improve patient outcomes.”
DxTerity noted that the project is being partially funded by the Ibis Foundation of Arizona.

Alnylam Buys IP Assets of Defunct Expressed RNAi Shop Nucleonics
Alnylam Pharmaceuticals this week said that it has acquired the intellectual property assets of defunct expressed RNAi shop Nucleonics.
Included in that IP portfolio are over 100 active patent filings, including 16 that have granted worldwide and six that have been granted in the US, Europe, or Japan, Alnylam said.
As reported by RNAi News, Nucleonics began selling off its assets earlier this year after the company ran into trouble obtaining new financing (see RNAi News, 6/19/2008). Court documents later revealed that the funding woes were tied to a legal dispute between the company’s co-founders and its top executives that included charges of scientific misconduct and alleged falsification of data used in an investigational new drug application (see RNAi News, 11/6/2008).
"Nucleonics was one of the first companies in the RNAi therapeutics space focused primarily on gene therapy applications of RNAi,” Alnylam President and COO Barry Greene said in a statement. “As they built their company, they acquired a number of early and broad patent families that are relevant for development and commercialization of all RNAi therapeutics, including synthetic small interfering RNAs … the molecules that mediate RNAi, which remain Alnylam's sole focus.
"When added to our existing IP estate … the Nucleonics IP estate provides further strengthening of a portfolio that is buttressed across all possible dimensions,” he added.
Terms of the deal between Alnylam and Nucleonics were not disclosed.

Calando Reports Preclinical Data on siRNA Treatment for Sepsis
Calando Pharmaceuticals, a subsidiary of Arrowhead Research, announced this week the publication of animal data showing that the company’s Rondel nucleic acid-delivery technology can be used to deliver siRNAs as a treatment for sepsis.
According to the company, siRNAs formulated with the technology and delivered to the lymphocytes of septic mice were able to reverse the depletion of immune cells that characterizes the condition.
The data appeared last month in Shock.

The Scan

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.

Study Reveals Potential Sex-Specific Role for Noncoding RNA in Depression

A long, noncoding RNA called FEDORA appears to be a sex-specific regulator of major depressive disorder, affecting more women, researchers report in Science Advances.

New mRNA Vaccines Offer Hope for Fighting Malaria

A George Washington University-led team has developed mRNA vaccines for malaria that appear to provide protection in mice, as they report in NPJ Vaccines.

Unique Germline Variants Found Among Black Prostate Cancer Patients

Through an exome sequencing study appearing in JCO Precision Oncology, researchers have found unique pathogenic or likely pathogenic variants within a cohort of Black prostate cancer patients.