Key Developments: Alnylam Pharmaceuticals, Inc. (ALNY.O)
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9 Feb 2010
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Latest Key Developments
Alnylam Pharmaceuticals, Inc. Receives Notice Of Allowance From United States Patent And Trademark Office
Alnylam Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office (USPTO) has awarded a Notice of Allowance for the Soutschek and Manoharan patent (Application No. 10/916,185), which covers certain chemically modified siRNAs of any length directed to any target, including siRNAs with sterol conjugates for in vivo delivery. The new patent is based on the ground-breaking research by Alnylam scientists on systemic delivery of RNAi therapeutics as documented in Soutschek et al. (Nature 432, 173-178 (11 November 2004)).
Alnylam Pharmaceuticals, Inc.'s Kreutzer-Limmer I Patent Upheld In German Opposition Proceedings
Alnylam Pharmaceuticals, Inc. announced that the German Patent Office has upheld the Kreutzer-Limmer I `235 (DE 10066235) patent in oral proceedings held before the Opposition Board. The patent was upheld in an amended form and the opponents` request to revoke the patent was rejected. The `235 patent stems from the broader Kreutzer-Limmer I patent family, which is exclusively owned by Alnylam, and in this particular case includes broad claims covering methods of silencing disease genes with vector-expressed small interfering RNAs, or siRNAs, the molecules that mediate RNAi. The maintenance of key granted claims in the Kreutzer-Limmer `235 patent reinforces the strength of Alnylam`s overall intellectual property (IP) estate which is believed by the Alnylam to be needed for the development and commercialization of RNAi therapeutics. The `235 patent was challenged by Silence Therapeutics plc, Pfizer Inc., and sanofi-aventis, whose collective request to revoke the patent was denied.
Alnylam Pharmaceuticals, Inc. And Isis Pharmaceuticals Founded Regulus Therapeutics Present New Pre-clinical Data From Multiple Therapeutic Programs
Regulus Therapeutics Inc., founded by Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. announced that new pre-clinical data from multiple therapeutic programs were presented. Regulus and its collaborators presented data showing microRNA target regulation by anti-miRs, as well as data from therapeutic programs focused on oncology, immune disease and hepatitis C virus (HCV) infection. In a poster titled microRNA mimics as cancer therapeutics, Regulus scientists presented in vivo data demonstrating delivery of miR mimics and microRNA target repression in an orthotopic liver tumor mouse model. Using lipid nanoparticles developed by collaborators at Alnylam Pharmaceuticals, Regulus scientists demonstrated effective delivery of a miR-34a mimic to both the normal liver cells and human hepatocellular carcinoma cells growing as tumors within the liver. Microarray profiling of the livers from mice treated with the miR-34a mimic displayed a significant down-regulation of messenger RNA targets of miR-34a. Within the tumors, Regulus scientists saw a similar down-regulation of messenger RNA targets. When Regulus scientists further analyzed the down-regulated messenger RNAs for functional significance, it was discovered that several cell cycle progression and cellular division genes were over represented. This demonstrates the potential utility of a miR-34a mimic delivered by lipid nanoparticles for the treatment of liver cancer. anti-miR target regulation in immune cells.
Alnylam Pharmaceuticals, Inc. And Collaborators Discover Key Mechanism For Delivery of RNAi Therapeutics
Alnylam Pharmaceuticals, Inc. announce that it has discovered a key mechanism related to the systemic delivery of RNAi therapeutics using lipid nanoparticles (LNPs). The new pre-clinical research was presented at the Advances in Biopharmaceuticals Keystone Symposium held January 8-13, 2010 in Midway, Utah, and was performed in collaboration with scientists at the Max Planck Institute of Molecular Cell Biology and Genetics. The new data document a key mechanism for endogenous targeting of LNPs to the liver, provide alternative targeting strategies for the hepatic delivery of RNAi therapeutics, and highlight potential targeting approaches for delivery to non-hepatic tissues and cell types.
Alnylam Pharmaceuticals, Inc. And Collaborators At MIT Report New Pre Clinical Research On Systemic Delivery of RNAi Therapeutics
Alnylam Pharmaceuticals, Inc. and collaborators from the David H. Koch Institute for Integrative Research at the Massachusetts Institute of Technology (MIT) announced the publication of new data in the journal Proceedings of the National Academy of Sciences (PNAS) describing further advancements in discovery and development of lipidoid formulations for the systemic delivery of RNAi therapeutics. Lipidoids are lipid-like materials discovered for the delivery of RNAi therapeutics, and were originally described by Alnylam and MIT collaborators (Akinc et al., Nature Biotechnology, 26: 561-569, 2008). In particular, the new research findings demonstrate the discovery of new lipidoid materials that facilitate significantly improved in vivo potency for RNAi therapeutics. The new pre-clinical data describe a formulation based on a lipidoid known as C12-200 that was shown to: - enable gene silencing in vivo in rodents at doses below 0.01 mg/kg; - demonstrate complete, rapid, and durable gene silencing in rodents as soon as 24 hours with protein levels returning to baseline within 20 to 35 days; - specifically inhibit expression of as many as five target genes simultaneously after a single injection of an LNP formulation in rodents; and, - demonstrate potent and selective silencing of the clinically relevant gene transthyretin (TTR) at doses as low as 0.03 mg/kg in non-human primates.
Alnylam Pharmaceuticals, Inc. Presents New Pre Clinical Data On ALN-VSP
Alnylam Pharmaceuticals, Inc. announced new pre clinical data from its ALN-VSP program presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics International conference being held November 15 to 19, 2009 in Boston, Mass. ALN-VSP is an RNAi therapeutic currently in a Phase I clinical trial for the treatment of liver cancers, including hepatocellular carcinoma (HCC) and other solid tumors with liver involvement. The new data demonstrated robust anti-tumor activity in orthotopic liver tumor models comprised of both HCC- and colorectal cancer-derived cell lines. ALN-VSP was also shown to act on disseminated tumors outside of the liver. Further, in addition to anti-proliferative effects, studies showed that ALN-VSP exerts a potent anti-angiogenic effect on tumors. The Company Scientist presented the following data: ALN-VSP-mediated silencing of KSP in both HCC and colorectal carcinoma models, resulting in the accumulation in tumor cells of aberrant mitotic figures, also known as monoasters, a hallmark of KSP inhibition; monoaster formation in tumor cells within lymph node metastases derived from the orthotopic liver tumors, demonstrating the ability of LNPs in general, and ALN-VSP in particular, to achieve effective delivery in extra-hepatic tumor sites; marked anti-angiogenic effects resulting from ALN-VSP treatment, including reductions in both tumor microvessel density and intratumoral hemorrhage; and similar anti-angiogenic results.
Alnylam Pharmaceuticals, Inc. Announces NewPre Clinical Data On RNAi Therapeutics At Oligonucleotides Therapeutics Society (OTS) Meeting
Alnylam Pharmaceuticals, Inc. announced that it has presented new data related to its overall delivery research efforts including the rational design of Mimetic Lipoprotein Particles, or MLPs, a technology for the systemic delivery of small interfering RNAs, or siRNAs, the molecules that mediate RNAi. In addition, Alnylam scientists and collaborators presented additional new data on systemic delivery and provided an update on RNA activation (RNAa) technology. In a poster titled Lipophilic siRNA Delivery by Reconstituted Lipoprotein Particles In Vivo Tomoko Nakayama, Ph.D., Associate Director, Research at Alnylam, presented for the first time the rational design and characterization of MLPs as an RNAi delivery platform. MLPs were designed to mimic the physiologic properties of endogenous lipoprotein particles and were engineered using recombinant human apolipoprotein A1 (rh-apoA1) or recombinant human apolipoprotein E (rh-apoE), phosphatidylcholine, and a cholesterol-conjugated siRNA (chol-siRNA). The resulting MLPs had biophysical properties comparable to normal high density lipoprotein (HDL, or good cholesterol) particles including a mean diameter size of approximately 10 nm. The stoichiometry for siRNA:particle loading ratio was observed to be 1:1. The reported in vivo studies were performed in mice using MLPs with chol-siRNAs targeting apolipoprotein B (apoB), the major apolipoprotein involved in the metabolism of low-density lipoprotein (LDL, or bad) cholesterol.
Alnylam Pharmaceuticals, Inc. and Roche Holding Ltd. Advance RNAi Therapeutic Collaboration Phase Of 2007 Alliance
Alnylam Pharmaceuticals, Inc. announced that it has advanced to the RNAi therapeutic collaboration stage of its alliance with Roche Holding Ltd. formed in 2007. In this phase of the collaboration, the partners will jointly collaborate on the discovery and development of specific RNAi therapeutic products and each will contribute key delivery technologies in the new disease target-focused effort. New delivery technologies include Alnylam lipid nanoparticles and Roche Madison dynamic polyconjugate delivery technologies. Alnylam and Roche will co-develop and co-commercialize RNAi therapeutic products in the U.S. market and Alnylam is eligible to receive additional milestone and royalty payments for products developed in the rest of world.
Alnylam Pharmaceuticals, Inc. Announces New Pre Clinical Data On ALN-TTR
Alnylam Pharmaceuticals, Inc. announced that it has presented new pre-clinical research findings from its transthyretin (TTR)-mediated amyloidosis (ATTR) program at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting). Alnylam is developing ALN-TTR, a systemically delivered RNAi therapeutic targeting the TTR gene for the treatment of ATTR, including familial amyloidotic cardiomyopathy (FAC) and familial amyloidotic polyneuropathy (FAP). There are more than 100 mutations that have been identified in the TTR gene. ALN-TTR targets a region of the gene common to wild-type and all known mutant forms of TTR, and therefore, has potential as a therapeutic for all patients with FAC and FAP. The new pre-clinical research findings presented at the meeting demonstrated dose-dependent ALN-TTR reduction of liver TTR messenger (mRNA) and serum TTR protein levels by greater than 80% in transgenic mice and non-human primates, with gene silencing effects found to be durable for more than three weeks following a single dose administration.
Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. Founded Regulus Therapeutics Inc. Announces U.S. Allowance Of Fundamental microRNA Therapeutics Patent Application
Regulus Therapeutics Inc., founded by Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office (USPTO) has allowed a patent application within the 'Esau' patent family (US Application Serial No. 10/909,125). The Esau patent estate, which is owned exclusively by Regulus, represents one of the earliest filings in the microRNA intellectual property landscape, and is fundamental to the discovery, development, and commercialization of microRNA therapeutics.
Nanotech gene therapy kills ovarian cancer in mice
CHICAGO (Reuters) - Tiny synthetic particles carrying a payload of toxin worked as well as chemotherapy at killing ovarian cancer cells in mice, without the bad side effects, U.S. researchers said on Thursday.
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