Intradigm Corporation
Wikipedia đ NONE
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2002-11-28-the-baltimore-sun-pg-c2.jpg
2002-11-28-the-baltimore-sun-pg-c2-clip-novavax-ceo.jpg
Notes on John A. Spears :
John A. Spears
JOHN A. SPEARS was named President and CEO of Novavax, Inc. in May 1999,
succeeding Mitchell J. Kelly who served as Interim President and Chief
Executive Officer since September 1998. Mr. Spears was also elected to
the companyâs Board of Directors. Prior to joining Novavax, Mr. Spears
was President and CEO of Vion Pharmaceuticals, Inc. Vion was created in
April 1995, when Mr. Spears merged two small privately held
biotechnology companies and took the company public in August 1995.
Before heading up Vion, Mr. Spears was President and CEO of MelaRx
Pharmaceuticals, Inc., one of the predecessor companies to Vion. He
established corporate operations for the company, completed several
rounds of private financing and negotiated a five-year research support
agreement with Yale University. From 1989 to 1993, Mr. Spears was Senior
Vice President of Immunex Corporation where he was responsible for sales
and marketing, new business development and professional services. At
Immunex, Mr. Spears launched their first proprietary product, which
included creating the companyâs specialized oncology sales force. While
at Vion and Immunex, Mr. Spears negotiated several major strategic
alliances with multi-national pharmaceutical companies, which included
substantial up-front licensing fees, milestones, and royalties. Mr.
Spears also held management and research positions with several large
pharmaceutical companies, including Bristol Myers, Lederle and Ayerst
Laboratories.
Related Interviews:
John Spears - Novavax Inc (nox)
May 29, 2000
2000-05-29-wall-street-journal-online-bio-john-a-spears.pdf
2005 (March) - Research article : "Highly branched HK peptides are effective carriers of siRNA"
Research Article
https://onlinelibrary.wiley.com/doi/abs/10.1002/jgm.748
Qixin Leng, Puthupparampil Scaria, Jingsong Zhu, Nicholas Ambulos, Patricia Campbell, A. James Mixson
First published: 17 March 2005 https://doi.org/10.1002/jgm.748Citations: 112
Abstract
Background
Both viral and nonviral carriers have been used to carry small interfering RNA molecules (siRNA) to their cytosolic mRNA target. To date, few peptide carriers have been developed that have proved effective for siRNA delivery. Our previous branched carriers composed of histidine and lysine were useful for transfection of plasmids. In this study, we determined if these and more highly branched HK polymers were effective carriers of siRNA.
Methods
Several branched polymers were synthesized on a Ranin Voyager synthesizer. These polymers were then screened for their ability to transfer siRNA into SVR-bag4 cells, MDA-MB-435 cells, and C6 cells. After one polymer, H3K8b, was identified as an effective carrier of siRNA, additional polymers were synthesized to determine the essential domains for siRNA transport. The size/zeta-potential of HK : siRNA complexes were measured with the N4 submicron particle size analyzer and the Delsa 440 SX zeta-potential analyzer, respectively. Toxicity of the highly branched polymers in complex with siRNA was investigated by flow cytometry.
Results
In an endothelial cell line (SVR-bag4) that stably expressed β-galactosidase (β-gal), an siRNA in complex with the H3K8b polymer inhibited β-gal expression by more than 80%. In contrast, the polymer H2K4b, which was an effective carrier of plasmids, was not an efficient carrier of siRNA. The size and surface charge did not distinguish effective from ineffective HK carriers of siRNA. By modifying H3K8b, we then determined what properties of H3K8b augmented siRNA delivery. The histidine-rich domain and the length of the terminal arms of H3K8 were important for siRNA delivery. The modestly more effective analog of H3K8b containing an integrin ligand, H3K8b(+RGD), was able to inhibit markedly intracellular β-gal expression. Furthermore, we determined that H3K8b(+RGD) in complex with a luciferase-targeting siRNA inhibited luciferase expression in MDA-MB-435 cells. At its optimal concentration for inhibiting its target, H3K8b(+RGD) : siRNA complex had minimal toxicity. In contrast, carriers of siRNA such as Oligofectamine and Lipofectamine 2000 were significantly more toxic.
Conclusions
Both the degree of complexity and the sequence specificity are important factors to be considered for developing the HK carrier of siRNA. In particular, we found that certain branched HK polymers (H3K8b, H3K8b(+RGD), and similar structural analogs) with eight terminal branches and a histidine-rich domain were effective carriers of siRNA. Copyright Š 2005 John Wiley & Sons, Ltd.
2005 (Aug 22)
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2005-08-22-the-leader-post-regina-saskatchewan-pg-a11
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2006
2006-11-21-biospace-com-intradigm-corporation-announces-significant-enhancements-of-the-company-capabilities.pdf
Intradigm Corporation Announces Significant Enhancements Of The Company Capabilities, A New Series A Financing And Important Addition To Senior Management Team
Published: Nov 21, 2006
PALO ALTO, Calif.--(BUSINESS WIRE)--Intradigm Corporation, a privately held biotechnology drug development company focused on the discovery and development of RNA interference (RNAi) therapeutics for the treatment of diseases with unmet medical needs, has achieved several significant corporate developments. These developments encompass strengthening the senior management team, completing a $16 million Series A financing, and establishing new research and drug development facilities in Palo Alto, CA.
Intradigm was formed in 2000 to develop proprietary nucleic acid delivery technology. The fundamental platform of Intradigm's technology is a ligand-targeted nanoparticle system that is capable of systemic delivery of multiple RNAi molecules targeting different genes.
"The discovery that RNAi can silence gene expression is a major scientific breakthrough, and has led to numerous developments towards the use of this technology as a treatment modality," said Dr. Mohammad Azab, CEO of Intradigm. "However, the translation of that discovery to a therapeutic drug is hampered by lack of effective delivery systems. Intradigm is developing such a system and we intend to aggressively pursue the realization of the therapeutic promise of RNAi using our technology."
New research and drug development facilities in Palo Alto, CA
In October, Intradigm opened new facilities in Palo Alto. As a result the company's headquarters is now moved to Palo Alto from Rockville, MD. The new location allows the company to draw on the large pool of skilled biotechnology research and development expertise in the Bay area to efficiently pursue proof-of-concept preclinical and clinical programs
Strengthening Management Team
In the last several months, Intradigm has extended the strength of its management team with the following additions:
Mohammad Azab, MD, MSc, MBA - President & CEO Dr. Mohammad Azab joined in July 2006 and brings with him more than 20 years of experience in pharmaceutical drug development, including leadership of oncology drug development at Sanofi Pharmaceuticals (now Sanofi-Aventis) and Zeneca Pharmaceuticals (now Astra Zeneca), Dr. Azab previous position was Chief Medical Officer, and executive VP of R&D at QLT Inc. He has a proven track record of shepherding therapies from early stage development to market. During his career, he led drug development programs that resulted in the approval and marketing of seven different new chemical entities in oncology and other therapeutic areas including ArimidexÂŽ, and VisudyneÂŽ.
Steven Chamow, PhD - Senior Vice President of Chemistry, Manufacturing and Control Dr. Chamow joined Intradigm in November 2006 after 19 years' experience in the pharmaceutical and biotechnology industry with emphasis on process development and manufacturing. Dr. Chamow's previous assignments included senior roles in Genitope Corporation, Abgenix, Inc., (now Amgen) where he built the company's process sciences department, Scios, Inc., (acquired by J&J), and Genentech, Inc, where he served for 11 years. During his tenure at Abgenix he co-led the design of their award-winning production facility in Fremont, CA.
Xiao-Dong Yang, MD, PhD - VP of Research and Preclinical Development Dr. Yang joined Intradigm in September 2006. Prior to joining Intradigm, Dr. Yang was Senior Director of Cancer Pharmacology at Abgenix (now Amgen). While at Abgenix, he was the project team leader for Vectibix(TM) (panitumumab) and played a key role in discovery, development and BLA submission of Vectibix(TM). Dr. Yang was also Senior Director of Oncology Program team responsible for setting strategy and managing Abgenix oncology project portfolio. He has published more than 40 papers in peer-reviewed scientific journals and is inventor on over 15 issued and pending patents.
Mike Riley, JD, MSc - VP of Corporate Development Mr. Riley joined Intradigm in August 2006. Mr. Riley brings over 10 years of international business experience, with an emphasis on intellectual property. Most recently he has held various positions in Europe and the US with Amgen, Abgenix, and Celltech Group PLC.
These new additions to the management team work closely with Intradigm co-founders Martin Woodle, Ph.D.(Chief Scientific Officer), Patrick Lu, Ph.D., and Puthupparampil Scaria, Ph.D.
"Intradigm's platform is the most promising technology for developing RNAi-based therapeutics we have seen. The compelling pre-clinical results combined with the additions to management team and recently completed financing, sets the appropriate framework for advancing several novel RNAi-based products toward human clinical trials," comments Jamie Topper, MD. Ph.D. Chairman of Intradigm's board and General Partner of Frazier Healthcare Ventures.
"We are excited to be working with an outstanding, proven management team that has delivered breakthrough therapeutic approaches to the market place before," said Dr. David Mack, Director of Alta Partners. "Together with a strong investor syndicate and a validated RNAi technology, Intradigm is well positioned to advance the goal of selectively modifying gene activity for a clinical benefit"
Series A - $16 million
The company's Series A $16 million financing occurred in May 2006. This financing was co-led by Alta Partners and Frazier Healthcare Ventures. Other investors in this round included existing investors Emerging Technology Partners (ETP) and Novartis' Ventures Fund plus new investors MediBic Alliance/Daiichi and Genentech. In connection with the financing, David Mack, Ph.D., a director at Alta Partners joined the board, and James Topper, MD, Ph.D., a general partner at Frazier Healthcare Ventures, joined the board as chairman.
About Intradigm
Intradigm Corporation is a privately held biotechnology drug development company focused on the discovery and development of RNA interference (RNAi) therapeutics for the treatment of human diseases with unmet medical needs through an advanced systemic delivery technology. The company's initial product development efforts will focus on oncology therapeutics. The company is headquartered in Palo Alto, California and maintains research facilities in Rockville, Maryland.
www.intradigm.com
About Alta Partners
Alta Partners is a San Francisco-based venture capital firm focused on life sciences investing. Founded in 1996, the firm currently manages $2 billion in committed capital through eight venture fund programs. Alta invests in life sciences companies across the development continuum, from company formation to later-stage opportunities, and has funded more than 110 companies in the sector to date. www.altapartners.com
About Frazier Healthcare Ventures
Founded in 1991 and with more than $1.2 billion of capital under management, Frazier Healthcare is one of the nation's leading providers of venture and growth equity capital to emerging healthcare companies. Having invested in more than 90 emerging healthcare companies, Frazier Healthcare is well known for its depth of experience and the technical expertise of its investment team. This experience encompasses product development and launch, clinical trial implementation and design, industry operating experience, academic research and clinical practice. Partnering with Frazier Healthcare provides access to capital and an unparalleled breadth of relevant healthcare industry experience.
2008 (Nov 10) - NYTimes : "The Promise and Power of RNA"
RNA turns out to be far more important than previously thought. Left, messenger RNA, active in protein production; right, silencing RNA turns off the gene that makes the purple pigment in this petunia.
Credit...
Omikron/Photo Researchers; Richard Jorgensen/U. of Arizona
Nov. 10, 2008
intradigm references / no Dynport
https://www.nytimes.com/2008/11/11/science/11rna.html?searchResultPosition=1
2008-11-10-nytimes-the-promise-and-power-of-rna.pdf
https://drive.google.com/file/d/1gLMtPiZt3GfmZDLgqFEk83lqOBgKSJ3o/view?usp=sharing
People whose bodies make an unusually active form of a certain protein tend to have dangerously high levels of cholesterol. Those with an inactive form of the protein have low cholesterol and a low risk of heart attacks.
Needless to say, pharmaceutical companies would love to find a drug that can attach itself to the protein and block its activity. That might be difficult for this protein, which is called PCSK9.
But a powerful new approach, called RNA interference, may surmount that obstacle. Instead of mopping up a protein after it has been produced, as a conventional drug would do, RNA interference turns off the faucet, halting production of a protein by silencing the gene that contains its recipe.
In monkeys, a single injection of a drug to induce RNA interference against PCSK9 lowered levels of bad cholesterol by about 60 percent, an effect that lasted up to three weeks. Alnylam Pharmaceuticals, the biotechnology company that developed the drug, hopes to begin testing it in people next year.
The drug is a practical application of scientific discoveries that are showing that RNA, once considered a mere messenger boy for DNA, actually helps to run the show. The classic, protein-making genes are still there on the double helix, but RNA seems to play a powerful role in how genes function.
âThis is potentially the biggest change in our understanding of biology since the discovery of the double helix,â said John S. Mattick, a professor of molecular biology at the University of Queensland in Australia.
And the practical impact may be enormous.
RNA interference, or RNAi, discovered only about 10 years ago, is attracting huge interest for its seeming ability to knock out disease-causing genes. There are already at least six RNAi drugs being tested in people, for illnesses including cancer and an eye disease.
And while there are still huge challenges to surmount, that number could easily double in the coming year.
âIâve never found a gene that couldnât be down-regulated by RNAi,â said Tod Woolf, president of RXi Pharmaceuticals, one of the many companies that have sprung up in the last few years to pursue RNA-based medicines.
The two scientists credited with discovering the basic mechanism of RNA interference won the Nobel Prize in Physiology or Medicine in 2006, only eight years after publishing their seminal paper. And three scientists credited with discovering the closely related micro-RNA in the 1990s won Lasker Awards for medical research this year.
RNA and DNA are strands made up of the chemical units that represent the letters of the genetic code. Each letter pairs with only one other letter, its complement. So two strands can bind to each other if their sequences are complementary.
Genes, which contain the recipes for proteins, are made of DNA. When a protein is to be made, the genetic code for that protein is transcribed from the DNA onto a single strand of RNA, called messenger RNA, which carries the recipe to the cellâs protein-making machinery. Proteins then perform most functions of a cell, including activating other genes.
But scientists are now finding that a lot of DNA is transcribed into RNA without leading to protein production. Rather, the RNA itself appears to be playing a role in determining which genes are active and which proteins are produced.
Much attention has focused on micro-RNAs, which are short stretches of RNA, about 20 to 25 letters long. They interfere with messenger RNA, reducing protein production.
More than 400 micro-RNAs have been found in the human genome, and a single micro-RNA can regulate the activity of hundreds of genes, said David P. Bartel, a biologist at the Whitehead Institute in Cambridge, Mass., and at the Massachusetts Institute of Technology.
As a result, Dr. Bartel said, the activity of more than half the genes in the human genome is affected by micro-RNA.
âItâs going to be very difficult to find a developmental process or a disease that isnât influenced by micro-RNAs,â he said.
Indeed, scientists have found that some micro-RNAs contribute to the formation of cancer and others help block it.
Other studies have found micro-RNAs important for the proper formation and functioning of the heart and blood cells.
Scientists are also finding other types of RNA, some of which may work differently from micro-RNA. By now, there are so many types of RNA that one needs a scorecard to keep track.
Besides micro-RNA (miRNA), the new ones include small interfering RNA (siRNA), piwi-interacting RNAs (piRNA), chimeric RNA, and promoter-associated and termini- associated long and short RNAs. They join an existing stable that included messenger RNA (mRNA), transfer RNA (tRNA), and small nucleolar RNA (snoRNA), which all play roles in protein production.
Scientists do not know what all the newly discovered RNA is doing. Some of it may be just a nonfunctional byproduct of other cellular processes.
And there is still uncertainty over how big a role RNA plays. Some scientists say proteins are like a light switch, turning genes on and off, while RNA usually does fine tuning, like a dimmer.
Still, the many new discoveries are ârevealing a level of regulation and complexity that I donât think the current organizational model of the genome ever envisioned,â said Thomas R. Gingeras, professor and head of functional genomics at Cold Spring Harbor Laboratory.
Despite the remaining mysteries, researchers and companies are moving rapidly to exploit the latest findings. While micro-RNAs are getting some attention, the biggest effort is on RNA interference.
RNA interference is induced when a short snippet of double-stranded RNA â called a small interfering RNA, or siRNA â enters a cell. The cell treats it much like a micro-RNA it might make on its own. That results in the silencing of a gene that corresponds to the inserted RNA.
Scientists believe that RNA interference evolved as a way to fight viruses, since double-stranded RNA is rare outside viruses.
Given that the sequences of genes are now known, it is fairly straightforward to synthesize a small interfering RNA that can serve as a drug to silence a gene. Still, there has not yet been a truly convincing demonstration that such drugs will work in people.
One risk is that the small RNA snippets might silence genes beyond the intended target. And that could mean that a drug based on these snippets would have unwanted side effects.
But the biggest challenge is getting the RNA into the cells where it is needed. Double-stranded RNA is rare outside viruses, so the cell is not likely to welcome it.
âDouble-stranded RNA basically to the body means one thing: a virus,â said Jonas Alsenas, a biotechnology analyst at the securities firm Leerink Swann who is skeptical about RNAi drugs.
Double-stranded RNA can set off an immune response. Enzymes in the blood tear RNA apart. And even if the RNA survives a trip through the bloodstream, it can have difficulty entering the target cells.
âMost of the cell membranes are negatively charged and the RNA is negatively charged, so they wonât get close to each other,â said Dr. Mohammad Azab, president of Intradigm, an RNA interference company.
Still, startups like Intradigm, Tekmira Pharmaceuticals, Calando Pharmaceuticals, MDRNA and Traversa Therapeutics are developing delivery methods.
Chemical changes can be made to RNA to make it more stable and to avoid setting off the immune system. And the RNA can be inserted into little globules of fat or attached to polymers to help it get through the bloodstream and enter cells.
RXi is developing an oral delivery method for treating certain immune diseases. In some cases, though, these packages can introduce their own toxicities.
Delivery problems tripped up an earlier gene-silencing technology called antisense, which uses single strands of RNA instead of double strands. But progress is now being made in antisense as well, so it may turn out that antisense drugs will compete with RNAi drugs.
Given the delivery challenges, the first RNAi drugs are for uses that do not require delivery through the bloodstream.
Alnylam is testing a drug that can be inhaled to treat a respiratory virus. Three other companies are testing drugs to treat age-related macular degeneration, the leading cause of blindness among the elderly. The drugs are injected directly into the eye.
The most advanced of the eye drugs, developed by the Miami-based Opko Health, is in the final stage of clinical trials, which would give it a shot at being the first RNAi drug to reach the market.
But some systemic delivery is now being tried. Quark Pharmaceuticals has started early human testing of a drug to prevent kidney damage. Since the kidney removes RNA from blood for excretion, much of the drug is expected to end up there anyway.
Similarly, lipids tend to end up in the liver. Since cholesterol is also processed in the liver, lipid particles will be used to deliver Alnylamâs PCSK9 anticholesterol drug, as well as one it plans to test against liver cancer.
âIf all we ever get to is the liver, weâll be having our hands full with human disease,â said John Maraganore, chief executive of Alnylam. But he and other industry executives say they will eventually learn to deliver RNAi drugs anywhere in the body.
One shortcoming of RNA interference is that it can only turn genes off. But to treat some diseases, like those in which the body makes too little of a protein, it might be desirable to turn genes on or to increase their activity levels.
In one of the latest surprises in this field, scientists have found that RNA can do this too. They have discovered what they call RNA activation, or RNAa. The molecules that perform it are called either small activating RNAs (saRNA) or antigene RNAs (agRNA).
âWe werenât looking for it,â said David Corey, a professor of pharmacology at the University of Texas Southwestern Medical Center in Dallas, who was one of those to discover the phenomenon about two years ago.
Scientists in his lab were attempting to silence genes using RNAi directed at the promoters of genes. A promoter is a region of DNA that helps activate a gene.
Instead of being silenced, the genes became more active and protein production increased. Dr. Corey said it appeared that the RNA enhanced the activity of proteins that bind to the gene promoters.
Whether RNA activation can be used for therapy remains to be seen. It does show, however, that the limits of RNA activity have yet to be understood. There is more to come.
2009 (Dec 16) -
Silence Therapeutics to Merge with Intradigm Corp to Create Leading RNAi Therapeutics Company
Dec 16, 2009 10:04am
Silence Therapeutics to Merge with Intradigm Corp to Create Leading RNAi Therapeutics Company
2009-12-16-fiercebiotechcom-silence-therapeutics-to-merge-intradigm-corp-to-create-leading-rnai-therapeutics-company
PALO ALTO, Calif., Dec. 16 /PRNewswire/ -- The Boards of Silence Therapeutics plc (AIM: SLN) and Intradigm Corporation are delighted to announce the merger of their businesses to form a leading company in the field of RNAi (RNA interference). The enlarged company, to be called Silence Therapeutics, will have multiple RNAi discovery, development and delivery technologies, a broad internal and partnered product pipeline and a broad portfolio of intellectual property.
The Directors believe the merger will enable Silence Therapeutics to build a competitive offering and facilitate more deals of greater value with the pharmaceutical industry. In particular, the combined business will be able to offer potential partners a choice of technologies to deliver RNAi molecules to diseased tissue, one of the main challenges in the emerging field of RNAi therapeutics. In addition, the enlarged Silence Therapeutics will have the financial strength to exploit its technology by developing its own therapeutic candidates.
Silence Therapeutics will issue 79,640,668 of its Ordinary Shares to acquire the entire share capital of Intradigm. Upon completion of the transaction, Intradigm's shareholders and management will own 36.6 percent of the enlarged group. The completion of the proposed acquisition is contingent upon approval by Silence Therapeutics' shareholders.
In parallel with the merger, Silence Therapeutics has raised 15 million pounds Sterling through a placing and subscription of shares at a price of 23 pence per share. Existing shareholders of Intradigm, including Alta Partners, Frazier Healthcare, Lilly Ventures, Roche Finance and Astellas Venture have committed over 5 million pounds of new funds by way of subscription. The placing has been underwritten by Nomura Code Securities Limited, who also advised Silence Therapeutics on the merger with Intradigm.
Iain Ross, currently chairman of Silence Therapeutics, will remain as Chairman of the enlarged company. Philip Haworth, Chief Executive of Intradigm, will become CEO of Silence Therapeutics and Klaus Giese will continue as Chief Scientific Officer of Silence Therapeutics.
The transaction will bring five strategic benefits:
A broad platform of technologies capable of addressing the discovery, development and delivery of RNAi therapeutics. The combined companies' capabilities extend to all essential areas for short interfering RNA (siRNA) product development and in particular delivery, but also structure, chemistry and a diverse library of therapeutic siRNA sequences.
An advancing pipeline of internal and partnered product candidates. Four of the nine siRNA candidates currently in clinical development globally utilize Silence's technology.
A broad intellectual property portfolio, with protection covering all essential areas of RNAi therapeutic development, including target sequences, delivery and siRNA structural features.
An expanded scientific team and an experienced group of senior executives and board of directors.
Expanded financial support and stability to facilitate new growth opportunities. International shareholder base offers broader access to capital to enable internal growth and provide additional strength for the purpose of negotiating favorable strategic transactions in the sector.
Iain Ross, Chairman of Silence Therapeutics, said: "By bringing together a comprehensive platform of siRNA delivery and development technologies, we believe Silence Therapeutics will be a partner of choice for those seeking to develop RNAi therapeutics. With a strengthened balance sheet, experienced management and extended research capability, Silence Therapeutics is well placed to strike the development deals that will deliver value for shareholders."
Philip Haworth, Chief Executive of Intradigm, said: "We are excited to join forces with Silence Therapeutics and look forward to continuing our pursuit of valuable RNAi therapeutics as part of this new team. Perhaps most exciting about the merger is the powerful range of RNAi delivery technology solutions possessed by the new company. The most significant hurdle to be overcome in realizing the vast potential of RNAi therapeutics is that of enabling safe and effective delivery of siRNA payloads. By combining the impressive expertise of both Intradigm and Silence, we now have one of the industry's most comprehensive and versatile delivery technology platforms, providing the enlarged company with an unparalleled potential to develop delivery solutions that can be tailored to address various therapeutic requirements."
The board of the enlarged company will have eight members. Five of the nominated directors currently sit on the Board of Silence Therapeutics: Iain Ross, Jerry Randall, Annette Clancy, David U'Prichard and Melvyn Davies. The remaining three Board members are directors of Intradigm: James Topper, David Mack and Philip Haworth.
Documentation describing the transaction and share placing will be posted to Shareholders later today. More information about the proposed acquisition is also available from Silence Therapeutics and from the company website: www.silence-therapeutics.com.
An Extraordinary General Meeting of shareholders to approve the transaction and share placing will be held on January 4, 2010 at 10:00am.
The suspension of trading in Silence Therapeutics shares is expected to be lifted later today.
About Silence Therapeutics plc (www.silence-therapeutics.com)
Silence Therapeutics plc (AIM: SLN) is a leading European RNAi-focused biotechnology company.
RNA interference (RNAi) is a Nobel Prize winning technology and one of the most exciting areas of drug discovery today. It represents a completely new approach to selectively 'silence' or inactivate disease relevant genes and as such it has the potential to create a new class of therapeutic products. RNAi could therefore offer a therapeutic approach to a broad range of diseases (cancer, infectious diseases, inherited diseases), many of which have been regarded as incurable and are not addressed by current therapeutics, therefore providing a large market opportunity.
Silence Therapeutics has developed a platform of novel short interfering RNA (siRNA) molecules, AtuRNAi, which provide a number of advantages over conventional siRNA molecules, including increased stability against nuclease degradation. In addition, the Company has developed a proprietary systemic delivery system, AtuPLEX. This system enables the functional delivery of siRNA molecules to targeted diseased tissues and cells, while increasing their bioavailability and intracellular uptake.
Following the granting of its patents in Europe, the USA and Australia, Silence Therapeutics is one of only two companies worldwide with a proprietary position on composition of matter for siRNA therapeutics.
Silence's lead internal product, Atu027, is a proprietary AtuRNAi molecule in clinical development for systemic cancer indications. Atu027 has successfully completed single and repeat dose toxicology and geno-toxicology studies, as well as a 28-day toxicology study using multiple dosing regimens. In June 2009, the Company started an open-label, single-centre, dose-escalation Phase I study with Atu027 in patients with advanced solid (malignant) tumors involving single as well as repeated intravenous administration. Atu027 specifically targets PKN3, a molecule involved in cancer growth and metastasis formation. Atu027 is Silence's most advanced clinical candidate for a systemically delivered siRNA using the Company's proprietary AtuPLEX delivery technology.
In March 2008 Silence Therapeutics announced a collaboration with AstraZeneca (LSE: AZN) focused on the development of a range of novel delivery approaches for siRNA molecules. Under the terms of the agreement both Silence Therapeutics and AstraZeneca will be allowed to commercialize the truly novel delivery systems that the two partners develop together.
Silence Therapeutics has granted a license to AstraZeneca to develop novel AtuRNAi therapeutics against five specific targets. This collaboration was the first industry validation of the potential application of Silence Therapeutics' proprietary AtuRNAi molecules and solidified the Company's leadership position in field of RNAi therapeutics.
The Company's AtuRNAi technology also has been sublicensed to Pfizer via Quark's license to it of the compound RTP-801i-14 for the treatment of age-related macular degeneration (AMD) and a number of other indications. This compound entered a phase II clinical study in July 2008. Silence Therapeutics also has licensed to Quark rights to the AtuRNAi structure for Quark's proprietary compound, AKIi-5 and DGFi, which are both in Phase I human clinical studies for treatment of acute kidney injury and delayed graft function in kidney transplantation respectively.
Silence Therapeutics is based in London, UK, and Berlin, Germany, and is listed on AIM.
About Intradigm
Intradigm is a private biotechnology company committed to the discovery, development and delivery of targeted, systemic RNA interference (RNAi) therapeutics for the treatment of serious diseases with an initial focus on oncology. Intradigm is unique among private companies, with its comprehensive RNAi therapeutics platform consisting of structural features for a next generation of RNAi molecules, biodegradable polycationic polymers for the delivery of RNAi therapeutics and proprietary siRNA sequences. Intradigm's proprietary delivery technology is unique in its potential to offer safe and effective systemic administration using a library of novel peptide-based biodegradable polymers.
Intradigm has established an impressive proprietary portfolio of siRNA sequences against more than 50 highly valued oncology and other disease targets. In addition, Intradigm has secured an exclusive license to the Zamore patent family from the University of Massachusetts, which covers broad structural features of siRNA design for more potent next generation siRNA sequences.
Intradigm is based in Palo Alto, California, US.
For more information on Intradigm, please visit www.intradigm.com.
Forward-Looking Statements
This press release includes forward-looking statements that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. All forward-looking statements are based on information currently available to Silence Therapeutics and Silence Therapeutics assumes no obligation to update any such forward-looking statements.