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US Patent and Trademark Office, Benitec, Opko Health, Targeted Genetics, MDRNA, Arrowhead Research, Calando Pharmaceuticals, Harvard Medical School, High Throughput Genomics

USPTO Again Rejects Benitec’s US Patent, Company Plans Appeal
Benitec said last week that the US Patent and Trademark Office has again rejected claims within the company’s core US patent, No. 6,573,099, as part of an ongoing re-examination of the intellectual property.
According to the company, the patent office maintained its rejection of the patent’s claims in light of one example of prior art, US patent No. 5,578,716, which was granted in 1996 to McGill University researcher Moshe Szyf.
The ‘716 patent covers “tumorigenicity-inhibiting antisense oligonucleotide sequences complementary to mRNA or double-stranded DNA that encodes mammalian DNA methyl transferase,” as well as “methods for inhibiting tumorigenicity and [a] pharmaceutical composition [that] comprises the tumorigenicity-inhibiting antisense nucleotide,” according to its abstract.
Benitec said it has requested a meeting for this month with the USPTO examiner conducting the re-examination, and that it has the right to appeal the ruling to the patent office’s board of appeals.
Benitec said that it also expects to file a written response to the rejection in January and, if necessary, a notice of appeal and appeal brief later in the year.
“If the matter proceeds to an oral hearing before the board of appeal, this would be expected toward the end of 2009/early 2010 due to the backlog of appeals,” Benitec said.
Benitec’s IP woes began in 2004 when it sued three companies for infringing the ‘099 patent, which essentially claims gene-expression knockdown using DNA that transcribes double-stranded RNA (see RNAi News, 4/2/2004). One of those companies, Nucleonics, fought the case in court and, as part of its legal strategy, either opposed the patent or requested re-examinations of Benitec’s IP in several nations, including the US.
Although the patent-infringement suit was ultimately withdrawn by Benitec and Nucleonics has since shut down its operations (see RNAi News, 11/6/2008), the re-examination proceeded.

Opko Completes Enrollment in Phase III Trial of AMD Drug
Opko Health said this week that it has completed enrollment in a phase III trial of its siRNA-based treatment for wet age-related macular degeneration.
The study of the drug, called bevasiranib, enrolled more than 330 patients and is designed to assess the efficacy and safety of bevasiranib administered every 8 or 12 weeks in preventing vision loss due to wet AMD, Opko said.
“With the completion of enrollment, we are one step closer to our goal of submitting a new drug application [for bevasiranib] to regulatory agencies worldwide,” Phillip Frost, chairman and CEO of Opko, said in a statement.
Opko acquired bevasiranib, the first RNAi drug to reach phase III testing, when it merged with Acuity Pharmaceuticals in 2007 (see RNAi News, 3/29/2007).

Targeted Genetics Narrows Focus, Cuts Jobs
Targeted Genetics said this week that it has realigned its product-development focus onto it ocular and neurological disease candidates, including its expressed RNAi treatment for Huntington’s disease.
The company also said it has cut its payroll costs by 25 percent and other costs by 15 percent. This cost-cutting effort included the elimination of seven jobs, as well as salary deferrals or reductions for seven of the most senior executives. Targeted Genetics now has 56 full-time employees.
The changes come at a time when Targeted Genetics is facing a severe cash crunch. Last month, the company announced that its current resources will only fund its operations into the first quarter of 2009 (see RNAi News, 11/13/2008).

MDRNA Reports Positive Animal Data with UNA siRNAs
MDRNA this week reported that siRNAs based on its so-called unlocked nucleic acid technology were able to knock down levels of apolipoprotein B in animal models up to 90 percent.
The company also said that its lead hypercholesterolemia drug candidate continues to appear safe and effective in preclinical studies, with no increase in blood markers of liver or kidney toxicity in single and repeat dosing studies up to 9 mg/kg.
The data, according to the company, were presented at the Informa Life Sciences 9th Annual Conference, EuroTIDES, in Germany.
"UNA-containing siRNAs were highly active in the mouse ApoB model for both message inhibition and serum cholesterol reduction,” Michael Templin, vice president of discovery research and pharmaceutical development at MDRNA, said in a statement. “Further, in in vitro studies, siRNAs containing UNA moieties at strategic positions within the siRNA are highly active across diverse gene targets involved in viral infection, metabolic disease, and cancer. In these cases, UNAs were fully compatible with RNAi machinery yet they decreased the potential for cytokine induction.”
MDRNA acquired the UNA technology for use in therapeutics earlier this year from RiboTask (see RNAi News, 10/23/2008).

Arrowhead Raises $2.7M for Calando Subsidiary
Arrowhead Research this week said it has raised $2.7 million for its subsidiary, Calando Pharmaceuticals.
Specifically, Arrowhead said that Calando has signed agreements to sell $2.7 million in unsecured convertible notes. These notes have a two-year maturity, bear interest of 10 percent per year, are convertible into Calando common stock, and are redeemable at a premium under certain conditions.

Harvard Medical to Use HTG Tech to Develop RNA Assay
Harvard Medical School researchers will use High Throughput Genomics’ technology to develop an assay that can measure the expression of miRNA precursors, mature microRNAs, and regulated RNA, the company said this week.
HTG said that it will collaborate with the Harvard Catalyst Laboratory for Innovative Translational Technologies at Harvard Medical School to create the biogenesis assay.
Under the agreement, the lab will use HTG’s quantitative Nuclease Protection Assay technology, which the company said allows researchers to “test any sample, including fixed tissues, without RNA extraction or target amplification.” The qNPA technology is used to carry out quantitative, multiplexed gene-based drug programs, including target validation, HTS lead optimization, metabolism, toxicology, and clinical development.
Financial terms of the agreement were not released.

The Scan

Genes Linked to White-Tailed Jackrabbits' Winter Coat Color Change

Climate change, the researchers noted in Science, may lead to camouflage mismatch and increase predation of white-tailed jackrabbits.

Adenine Base Editor Targets SCID Mutation in New Study

Researchers from the University of California, Los Angeles, report in Cell that adenine base editing was able to produce functional T lymphocytes in a model of severe combined immune deficiency.

Researchers Find Gene Affecting Alkaline Sensitivity in Plants

Researchers from the Chinese Academy of Science have found a locus affecting alkaline-salinity sensitivity, which could aid in efforts to improve crop productivity, as they report in Science.

International Team Proposes Checklist for Returning Genomic Research Results

Researchers in the European Journal of Human Genetics present a checklist to guide the return of genomic research results to study participants.