PRESS

Nature Technology Wins Bioscience Award

A Lincoln-based biotechnology company has been given the 2017 Governor’s Bioscience Award.

 

Nature Technology Corp., which produces gene therapy products and DNA vaccines, was given the award at a ceremony Thursday night at the Strategic Air Command and Aerospace Museum near Ashland.

 

The award recognizes individuals and companies that have made significant contributions to the Nebraska bioscience industry.

 

“Companies like Nature Technology have a great vision to apply intricate biological and genetic processes in service to some of the best companies in the world. They have done this through determination, creative energy and brilliance in their field,” Lt. Gov. Mike Foley said in a news release.

 

Nature Technology CEO Clague Hodgson said he was pleased to receive the honor.

“Our story goes to show that even a small company can achieve big things," Hodgson said. "Our technologies are very complex, as are the health challenges we focus on with our research customers."

 

Nature Technology, which has eight employees, makes biologic drugs that can be used in treating genetic disorders, cancers, disease and immunological targets in both humans and animals.

 

The company manufactures products that are used by larger pharmaceutical firms in research, development and clinical trials of vaccines, therapies and technology platforms.

 

Hodgson said a recent success was the sale of an allergy treatment program, based on the company's technology, by Immunomic Therapeutics Inc., to Astellas Pharma in Japan for over $300 million.

 

“The field of genetic medicines has taken 30 years to get to where we are today,” Hodgson added. “And we still have a way to go before the first approved products appear on the shelf. What excites us is developing platform technologies that can be used for treating a diversity of diseases.”

Immunomic Therapeutics (ITI) and Nature Technology Corporation (NTC) Jointly Announce Expanded Agreement

- ITI Secures Rights to Nature Technology Corporations’ (NTC) Vectors and Manufacturing Processes for use with Investigational LAMP-Vax™ Cancer Immunotherapy

 

- The investigational LAMP-Vax technology platform has already generated upfront payments totaling more than $315 M from Astellas Pharma, Inc. for the development of allergy therapies

 

- LAMP-Vax is being studied in Phase II clinical trials as a potential cancer immunotherapy

October 04, 2016 10:28 AM Eastern Daylight Time

 

ROCKVILLE, Md. & LINCOLN, Neb.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. (ITI) and Nature Technology Corporation (NTC) announce today that they have entered into a new license agreement. The licensing of NTC’s RNA-OUT™ and HyperGro™ technology is part of ITI’s expansion into developing nucleic acid immunotherapies for cancer.

 

 Tweet this: ITI expands relationship w/ Nature Technology to research cancer immunotherapy options #Biotech #MDBiotech

 

ITI believes that LAMP-Vax immunotherapy platform has the potential to transform nucleic acid vaccine therapy. Although additional studies are needed to confirm clinical benefit, LAMP-Vax has the potential to specifically direct the cancer antigen into a processing part of the cell for more efficient presentation to the immune system. Last year, this approach gained important commercial validation when Immunomic Therapeutics entered into significant licensing agreements with Astellas Pharma Inc., totaling over $315 million in upfront payments, as well as potential future milestones and royalty payments.

 

NTC’s technologies are designed to create a potentially higher expression vector with a preferable selection method, manufactured with a process scaled for clinical use. The scope of this new agreement expands development of LAMP-Vax, coupled with NTC’s technologies, from areas such as allergy to cancer immunotherapy.

 

“LAMP-Vax, a potentially powerful approach, now coupled with other important elements such as NTC’s technology, may be able to broaden the current use of cancer immunotherapy by complementing existing approaches to treatment,” said Bill Hearl, CEO of Immunomic Therapeutics, Inc. “Published preclinical and clinical studies with LAMP show that it can enhance activation of the CD4-positive T-cells, now thought to be a critical component of how the immune system fights cancer. We look forward to our collaboration with NTC and to further evaluating the potential of LAMP in cancer immunotherapy.”

 

LAMP is an investigational platform that has been clinically studied in allergies and some cancers. ITI is currently collaborating with academic partners to study the use of LAMP in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for LAMP-Vax therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others.

 

“Nucleic acid immunotherapies are increasingly being tested in clinical trials and pursued by biopharmaceutical companies as cancer immunotherapies,” said Clague Hodgson, CEO of Nature Technology Corporation. “While some in the industry are using technology that was developed decades ago, ITI is a step ahead of the game when it comes to designing, manufacturing and developing LAMP-Vax nucleic acid vaccines that take advantage of the latest advancements, such as those Nature Technology has to offer.”

 

About LAMP-Vax

 

ITI’s investigational LAMP-Vax platform is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put LAMP-Vax technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. LAMP is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of LAMP in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for LAMP-Vax therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

 

About Immunomic Therapeutics, Inc.

 

Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of the LAMP-based nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health. ITI has entered into a significant licensing agreement with Astellas Pharma Inc. to explore the use of LAMP-Vax, an immunotherapy platform, for use in the prevention and treatment of allergic diseases. For information about ITI and LAMP Technology, visit www.immunomix.com.

 

About Nature Technology Corporation, RNA-OUT™, and HyperGRO™

 

Nature Technology Corporation is a biotechnology company that provides world class technology platforms, including non-viral vectors (plasmids) designed to offer improved safety features and higher expression, and processes producing gene and nucleic acid-based therapies. NTC also provides cost effective outsourcing of product development services including synthetic gene design, vector construction, plasmid DNA and recombinant protein manufacturing. NTC’s plasmid backbones are smaller than conventional plasmids and designed to be more potent. NTC has also engineered them with a new selection method called RNA-OUT sucrose selection method. This new technology will potentially be more favorably viewed by regulators than standard plasmid backbones that use elements such as antibiotic selection markers. To manufacture vectors, NTC has also developed a scalable manufacturing process called HyperGRO, which aims to increase yield while decreasing costs. For information, visit www.natx.com.

 

This press release is based on current expectations, forecasts and assumptions relating to, among other things, ITI, NTC, the LAMP technology and NTC’s RNA-OUT™ and HyperGro™ technologies that may contain forward looking statements. Forward looking statements include statements about our future plans and may be indicated by words such as, “we expect,” “we plan,” “we believe,” or other similar words. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. We are not obligating ourselves to revise or publicly release the results of any revision to these forward looking statements in light of new information or future events.

 

Contacts

Immunomic Therapeutics, Inc.

Sia Anagnostou, 717-327-1822

 

Next up, Nanoplasmids™: Nature Technology Corporation issues seven US Patents
Lincoln, Nebraska: Nature Technology Corporation (NTC), a leader in the development of nucleic acids...

Lincoln, Nebraska: Nature Technology Corporation (NTC), a leader in the development of nucleic acids based vaccines and therapeutics, today announced that seven key US patents in the field of gene therapy and DNA vaccination have been issued or allowed by the US Patent and Trademark Office, and three more international patent applications have been filed regarding the company’s Nanoplasmid™ platform for superior and long lasting therapeutic gene expression in humans.

“NTC’s DNA vaccines and gene therapeutic vectors are steadily advancing through partners’ clinical trials around the world,” said Clague Hodgson, NTC President.  “In order for transferred DNA to work effectively in humans, regulatory compliant vectors with strong expression, long endurance, and economical manufacturing are required,” he said, adding that the recent inventions address these ideas directly, culminating in Nanoplasmids™.

Dr. Jim Williams, leader of the scientific team, systematically attacked several problems that were facing the industry: first,  devising the RNA-OUT antibiotic free selection marker to address regulatory agency concerns regarding the use of antibiotic selection markers in non-viral or viral vectors; second,  creating the regulatory compliant antibiotic free NTC8 series RNA-OUT vectors with improved expression level compared to canonical plasmids; third, devising designer manufacturing  strains and processes to improve vector fermentation yields during manufacturing (HyperGRO™ process); and fourth developing a downstream manufacturing process wherein bacterial cell factories (that are used to grow the DNA) are designed to release the therapeutic product from the growing cells, where it can be more easily purified (autolysis). Additionally, for DNA vaccination applications, immunostimulatory expressed RNA (eRNA) cassettes that activate innate immunity to effect improved adaptive immune responses to encoded antigens were engineered into the vector backbones. The resulting inventions facilitate the production and implementation of safe, potent and economical DNA biologics.

The clinically validated NTC8 series RNA-OUT antibiotic free non-viral vector platform, and HyperGRO™ manufacturing process, has been licensed for multiple therapy and vaccination applications. The issuance of these patents that cover key vector platform features such as RNA-OUT antibiotic free selection provides added product protection value to these licenses.

“Most importantly for our clients that are developing new drugs, has been the development of NTC’s next generation RNA-OUT antibiotic free Nanoplasmid™ vector platform for superior gene expression and duration compared to alternative technologies such as minicircle vectors and even the NTC8 series vectors,” Hodgson added.  “In addition to the Nanoplasmid™ inventions themselves, this platform is now protected broadly by the patented RNA-OUT intellectual property” he said.

The three Nanoplasmid™ patents recently filed by inventor Williams protect novel Nanoplasmid™ vector compositions that dramatically increase transgene expression level and duration compared to industry standard vectors such as plasmids or minicircles, along with methodologies for high yield Nanoplasmid™ fermentation production in E. coli cells, and simple downstream purification.

Nanoplasmid™ vectors have been tested in more than 20 laboratories worldwide, and are now licensable for production of non-viral gene therapeutics, personalized medicines and DNA vaccines.  For more details, and a complete listing of the issued patents, please visit www.natx.com.

 

About Nature Technology Corporation

Nature technology Corporation is a biotechnology company that provides industry partners with world-class technology platforms including safe and efficacious non-viral vectors (plasmids) and processes for gene therapy and DNA vaccination vector production.

 

NTC also provides fast, cost-effective and complete product development services, including synthetic gene design, vector construction, plasmid DNA manufacturing and recombinant proteins.

 

www.natx.com/press

 

Company Contacts:

Clague Hodgson, CEO

Phone: 402-323-6289

Fax: 402-323-6292

Email: hodgson@natx.com,

 

Jim Williams, CSO

Phone: 402-323-6289

Fax: 402-323-6292

Email: jim@natx.com

Contact Dr. Williams to arrange a meeting at BIO 2015 Philadelphia, PA, June 17-18: Cell: 402-323-6289

 

 

VGXI implements HyperGRO: VGXI Successfully Implements Nature Technology Corporation's (NTC) HyperGRO™ Fermentation for Large-Scale

GMP Plasmid DNA Production, read more....

VGXI announced today that it has successfully scaled-up and completed two large-scale cGMP fermentation runs using Nature Technology Corporation’s HyperGRO™ fermentation system.

FOR IMMEDIATE RELEASE:

The Woodlands, TX – October 12, 2012 – VGXI, Inc., a leading provider of DNA plasmid manufacturing and development services, announced today that it has successfully scaled-up and completed two large-scale cGMP fermentation runs using Nature Technology Corporation’s (NTC) HyperGRO™ fermentation system, including their antibiotic-free selection vector.  VGXI has been able to achieve reproducible plasmid yields of up to 1.8 g/L at the 320L scale, the largest fermentation scale yet using the HyperGRO™ technology.

VGXI entered into a manufacturing agreement with Coridon Pty Ltd earlier this year to manufacture Coridon’s Herpes Simplex Virus 2 DNA vaccine for their upcoming Phase I clinical trial.  Coridon requested VGXI use HyperGRO™ fermentation technology to satisfy their project’s unique requirements.

The data will be presented on a collaborative poster at the DNA Vaccines Conference to be held December 5-7, 2012 in San Diego, CA.

About VGXI, Inc.

VGXI Inc. is a leading provider of DNA plasmid manufacturing and development services for DNA vaccine and gene therapy research.  The Company has an outstanding track record of success in manufacturing plasmid products under GMP conditions for client clinical studies in the US and Europe, and its GMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible GMP production facility, and experienced development team. The recently announced research and pre-clinical production services extend the range of high-quality, research grade materials utilizing the same efficient service. This rapid turnaround program provides consistent materials to build a reliable pre-clinical dataset.

About Nature Technology

Nature Technology Corporation is a biotechnology company that provides industry partners with world class technology platforms, including safe and efficacious non-viral vectors (plasmids) and processes for gene therapy and DNA vaccination vector production. NTC also provides cost effective outsourcing of product development services including synthetic gene design, vector construction, plasmid DNA manufacturing and recombinant proteins. For information, visit www.natx.com

About Coridon Pty Ltd

Coridon was founded in 2000 by the founder inventor Prof Ian Frazer as a private unlisted company, to develop and commercialize patented technology for improving immune responses to DNA vaccines licensed by UniQuest Pty Ltd and developed at the University of Queensland. The company has laboratories within the research facility at the Princess Alexandra Hospital in Brisbane, working in collaboration with the University of Queensland’s Diamantina Institute. Publicly listed Allied Healthcare Group Limited (ASX:AHZ) is a major investor in Coridon. The Company’s objective is to utilize its unique optimization technology to produce prophylactic and/or therapeutic DNA vaccines for a range of infectious diseases and cancers in humans. Product development is currently focused on herpes virus vaccines.

VGXI licenses HyperGRO™ from NTC: VGXI has entered into a licensing agreement with Nature Technology Corporation (NTC) to use their HyperGRO™ Fermentation Technology following the successful scale up of two cGMP fermentation runs. read more....

The Woodlands, TX – November 16, 2012 – VGXI, Inc., a leading provider of DNA plasmid contract manufacturing and development services, announced today that it has entered into a licensing agreement with Nature Technology Corporation (NTC) for the use of their HyperGRO™ fermentation technology.

According to Dorothy Peterson, Vice President of Operations at VGXI, “We are excited about the opportunity to add NTC’s HyperGRO™ fermentation technology as a viable option for clients requiring higher plasmid yields due to trial design and/or low yielding plasmids.  We are also excited to now have the ability to offer the option of an antibiotic-free selection vector, especially to European and Asian clients where this type of vector is becoming preferred”.

The agreement is a non-exclusive, royalty bearing, non-sublicensable license to market, sell, and perform the contract research and development and product manufacturing services utilizing NTC’s HyperGRO™ fermentation technology including their antibiotic-free selection vector.

In October, VGXI successfully scaled-up and manufactured two large-scale cGMP fermentation runs using NTC’s technology.  VGXI was able to achieve plasmid yields of up to 1.8 g/L at a 320L fermentation scale, the largest scale yet using the HyperGROTM technology according to NTC.  Results of these two fermentation runs will be presented at the DNA Vaccines meeting in San Diego, California held  December 5-7, 2012.

About HyperGRO™ Fermentation Technology

NTC’s HyperGRO™ fermentation process and media are used routinely for production of gene therapy vectors and DNA vaccines.  Improvements in fed-batch fermentation resulted in plasmid DNA yields of up to 2.6g/L. This process is also compatible with NTC’s antibiotic-free sucrose plasmid selection system.

 About VGXI, Inc.

VGXI Inc. is a leading provider of DNA plasmid manufacturing and development services for DNA vaccine and gene therapy research.  The Company has an outstanding track record of success in manufacturing plasmid products under GMP conditions for client clinical studies in the US and Europe, and its GMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible GMP production facility, and experienced development team. The recently announced research and pre-clinical production services extend the range of high-quality, research grade materials utilizing the same efficient service. This rapid turnaround program provides consistent materials to build a reliable pre-clinical dataset.

About Nature Technology

Nature Technology Corporation is a biotechnology company that provides industry partners with world class technology platforms, including safe and efficacious non-viral vectors (plasmids) and processes for gene therapy and DNA vaccination vector production. NTC also provides cost effective outsourcing of product development services including synthetic gene design, vector construction, plasmid DNA manufacturing and recombinant proteins. For information, visit www.natx.com

Immunomix opens next HyperGRO facility: Immunomic Therapeutics opens it's new process development lab at Hershey Center for Applied

Research and will be deploying Nature Technology Corporation's "HyperGRO™ DNA production process at the new laboratory. read more....

HERSHEY, PA, November 02, 2012 /EIN Presswire/ -- Immunomic Therapeutics, Inc., ("ITI," Lancaster, PA) a privately-held biotechnology company with laboratories in Rockville, MD, and offices in Lancaster, PA announced that it has signed the lease for a new facility in the Hershey Center for Applied Research ("HCAR"). This facility will house a fermentation laboratory to support the development of ITI's LAMP-vax(TM) plasmid-based DNA vaccines for use in ground-breaking research & development of vaccines for allergy, infectious disease and cancer.

 

The new facility will be housed in the Hershey Center for Applied Research (HCAR), a cutting-edge research park located in Hershey, PA. ITI will occupy about 1700 sq ft of the 80,000 sq ft facility, built by Wexford Science and Technology, is one of several that will be strategically located in HCAR's new research park. HCAR has leveraged local resources and forged partnerships with Penn State University and the Penn State Milton S. Hershey Medical Center. The facility is newly-constructed and offers ITI customizable laboratory and office space.

 

ITI will be deploying Nature Technology Corporation's "HyperGRO™ DNA production process at the new laboratory. The laboratory will be under the direction of a new bio-process engineer at the facility; this yet to be hired individual will establish a plasmid process development and production laboratory with the goal of generating LAMP-vax plasmid-based vaccines for internal R&D use and to support future technical transfer of the production process of future vaccines ready for commercialization.

 

Immunomic Therapeutics is currently implementing LAMP in the clinic with an investigational allergy vaccine for the treatment of rhino-conjunctivitis to Japanese Red Cedar. ITI has begun an open label, Phase I, clinical study designed to establish the safety of the LAMP-vax platform. The primary objective of this Phase I Study is to evaluate both the safety and immunological response of therapeutic doses and the dosing regimen of JRC-LAMP-Vax(TM) vaccine as it applies to allergy patients. The study, being conducted in a clinical center based in Honolulu, HI, is expected to be complete in the winter of 2012.

 

About Immunomic Therapeutics

Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company headquartered in Lancaster, PA with lab facilities in Rockville, MD. ITI is developing next generation vaccines based on its patented LAMP Technology platform. LAMP-vax(TM) vaccine technology significantly increases the effectiveness of the immune response to nucleic acid vaccines while simplifying overall vaccine design and delivery, yielding safer, more cost-effective human and animal therapies. Our LAMP constructs have been validated in human clinical trials for cancer and have been applied to a wide breadth of targets including allergy and infectious diseases. For more information about ITI and LAMP Technology please visit www.immunomix.com or contact Dr. Bill Hearl, President / CEO at 1-717-327-1919 or email immunomix@gmail.com

Immunomix clinical trial: Immunomic Therapeutics Immunizes Patients in Its Phase I Study of JRC-LAMP- Vax Vaccine to Treat Japanese Red

Cedar (Sugi) Allergy read more....

FOR IMMEDIATE RELEASE

Lancaster, PA, & Rockville, MD November 5th, 2012 – Immunomic Therapeutics, Inc., (“ITI,” Lancaster, PA) a leader in developing novel allergy immunotherapies, announced today that it has dosed the first patient in a Phase I clinical trial of its lead candidate, JRC-LAMP-vaxTMvaccine, at its clinical site in Honolulu, Hawaii. Initial subjects include Japanese ex patriates previously exposed to Japanese red cedar, or “Sugi,” as it is known in Japan. JRC-LAMP-vax vaccine is a plasmid-based DNA vaccine that will be studied for its safety and immunological activity in the treatment of patients with rhino-conjunctivitis symptoms caused by allergic reaction to Japanese red cedar pollen. Enrollees in the study each received the first of a four (4) dosing vaccine regimen and were followed for 3 hours; no adverse events were observed in these patients.

ITI intends to complete enrollment in the study in November, the dosing of all patients early in 2013, and to follow up with a Phase II trial beginning in 2013. ITI’s CEO, Dr. William Hearl, commented, “The successful initiation of this clinical study marks a significant milestone in the history of Immunomic Therapeutics. We are both pleased and excited that we are now a clinical - stage company. We are looking forward to completing the study and advancing the development of this important vaccine and other LAMP-vaxTM vaccines.”

Dr. Bruce F. Mackler, Vice President of Regulatory and Clinical Affairs, Immunomic Therapeutics, Inc., indicated that “ITI is committed to the rapid expansion of its clinical program based on the outcome of this first Japanese red cedar vaccine. We plan to move rapidly into the clinical testing of the multivalent vaccine in naturally sensitive Japanese ex patriates as well as U.S. subjects with sensitivity to mountain cedar. This study will support our food allergy program which will treat peanut allergy in sensitive patients; that study should begin in 2013.”

In Japan, it is estimated that up to 45% of the Japanese people are allergic to Japanese red cedar pollen. In North America, especially Texas, individuals suffer from a closely related allergy to mountain cedar pollen. During this Phase I study, ITI will also be monitoring the response to mountain cedar allergens in these subjects.

Key to the success of ITI’s vaccines is the incorporation of LAMP Technology. Pre-clinical studies have documented that LAMP-based vaccines induces a protective antibody IgG immune response consistent with a preferential MHC-II immune system presentation induced by LAMP. Multiple studies applying LAMP Technology in human clinical trials have shown that incorporation of the LAMP element dramatically increases the CD4+ response to the target antigen. In addition to providing important safety data on LAMP, the studies confirm that LAMP vaccines activate the human immune system. LAMP-based vaccines hold potential for the development of potent vaccines for treatment of allergies, infectious disease and cancer.

Coridon Licenses NTC vectors: Allied Healthcare announces Coridon license to Nature Technology Corporation's, (NTC) vector technology. read more....

Coridon progressing towards Phase I study

Coridon licenses vector technology to support DNA vaccine program

Coridon contracts US facility to manufacture the Phase I vaccine

Brisbane, Australia, 17th April, 2012

 

Allied Healthcare Group (ASX: AHZ) announced today an update on the progress of Coridon, its investment company founded by Professor Ian Frazer and working on developing the next generation of vaccines. Included in these activities, Cordon has entered into a license agreement with Nature Technology Corporation (NTC) and has contracted VGXI Inc in the US for production of clinical material for the Phase I study scheduled to begin later this year.

 

Nature Technology Corporation (NTC) has specifically designed safe, minimalised and antibiotic-free selection vectors, which offer superior expression of recombinant proteins in mammalian cells. These vectors have been designed to comply with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory guidance. The use of this vector improves the overall benefit of the vaccine by driving the in vivo transcription and translation of the genetic material.

 

"Access to this technology will allow the Coridon vaccine to fully maximise its gene expression and therefore improve the performance of the vaccine" stated Allied Healthcare CEO Mr Lee Rodne "these are important steps forward to the initial Phase I study for Coridon which will provide validation of the Coridon technology".

 

Coridon's Herpes vaccine, which was recently announced to be 100% effective in protecting animals against Herpes Simplex Virus 2 infection, incorporates the NTC8485 antibiotic-free expression vector. The guidance from US and European regulatory bodies seeks to eliminate non-essential sequences and to avoid use of antibiotic resistance genes where feasible.

 

In addition to the vector technology, Coridon also receives access to use NTC's HyperGRO™ fermentation technology, which provides for high yield and cost effective DNA production. The manufacturing of the Herpes vaccine utilising the HyperGRO technology has now commenced with VXGI Inc.

 

The Phase I study for Coridon's herpes vaccine is scheduled to begin later this year.

 

Neil Finlayson, Coridon CEO said: "This is an important agreement for the company to be able to access this leading technology and cements the relationship we have built up with NTC dating back to late 2009."

 

Coridon is developing the next generation of vaccines for the prevention and treatment for a range of infectious diseases and cancers in humans. Coridon's DNA vaccine technologies differ from conventional vaccines in that they offer both preventative and therapeutic value. VGXI is a contract manufacturing organization that specializes in the production of DNA plasmids under cGMP for human clinical trials. With over 12 year's experience, VGXI has manufactured products for numerous DNA vaccine and gene therapy trials in the USA, Europe and Asia. The company manufactures an approved veterinary product in Australia called LifeTide® SW5.

 

For more information, please contact:

Dr Julian Chick, Chief Operating Officer Allied Healthcare Group Tel: +61 03 9620 5454

Media:

Paul Dekkers

Buchan Consulting

+61 2 9237 2800

pdekkers@buchanwe.com.au

 

About Allied Healthcare Group Limited

 

Allied Healthcare Group Limited (ASX: AHZ) is a diversified healthcare company focused on investing in and developing

next generation technologies with world class partners, acquiring strategic assets to grow its product and service

offerings and expanding revenues from its existing profitable medical sales and distribution business. The Company has

assets from Research & Development through Clinical Development as well as Sales, Marketing and Distribution.

Allied Healthcare Group is in the process of commercializing its innovative tissue engineering technology for

regenerative medicine and is a major investor in Brisbane based Coridon Pty Ltd, led by Professor Ian Frazer developing

next generation vaccines for global markets.

 

Further information on the Company can be found on www.alliedhealthcaregroup.com.au.

 

About Coridon

 

Coridon was founded in 2000 by the founder inventor Prof Ian Frazer as a private unlisted company, to develop and

commercialise patented technology for improving immune responses to DNA vaccines licensed by UniQuest Pty Ltd and

developed at the University of Queensland. The company has laboratories within the research facility at the Princess

Alexandra Hospital in Brisbane, working in collaboration with the University of Queensland's Diamantina Institute. The

company's overall objective is to utilise its unique optimisation technology to produce prophylactic and/or therapeutic

DNA vaccines for a range of infectious diseases and cancers in humans. Product development is currently focused on

herpesvirus vaccines.

 

About Coridon's optimised technology

 

Coridon has 6 granted US patents protecting its codon optimisation DNA technology, which enhances protein expression

in the cell or tissue targeted and results in an improved humoral response. The second component of the technology,

also patent protected, is to use a mixture of DNAs encoding ubiquitinated and non ubiquitinated proteins. This strategy

enhances the degradation of the protein and optimises T cell responses, while preserving structural epitopes necessary

for B cells responses, resulting in vaccines with prophylactic and therapeutic potential.

 

About Nature Technology Corporation

 

Nature Technology Corporation is a biotechnology company that provides industry partners with world class technology platforms, including safe and efficacious non-viral vectors (plasmids) and processes for gene therapy and DNA vaccination vector production. NTC also provides cost effective outsourcing of product development services including synthetic gene design, vector construction, plasmid DNA manufacturing and recombinant proteins. For information, visit www.natx.com.

 

About VGXI

 

VGXI is a leading provider of DNA plasmid manufacturing and development services for DNA vaccine and gene therapy research. The Company has an outstanding track record of success in manufacturing plasmid products under cGMP conditions for client companies' clinical studies in the US and Europe, and its cGMP and non-cGMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team. The recently announced research and pre-clinical production services extend the range of high-quality, research grade materials utilizing the same efficient service. This rapid turnaround program provides consistent materials to build a reliable pre-clinical dataset. For information, visit www.vgxii.com.

 

Read more: Allied Healthcare announces Coridon license to vector technology - FierceVaccines http://www.fiercevaccines.com/press-releases/allied-healthcare-announces-coridon-license-vector-technology#ixzz2Dp8rKE00

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“NTC Vectors in Action: Coridon’s Therapeutic HPV Vaccine.” Allied Healthcare announces Coridon license to Nature Technology Corporation's, (NTC) vector technology. read more....

SCIENTISTS are a step closer to releasing a vaccine to treat Human Papolliloma Virus, a common precursor to cervical cancer.

 

Led by former Australian of the Year, Professor Ian Frazer, who developed Gardasil, the Coridon vaccine aims to combat existing HPV infection and stop cancer onset.

 

Prof Frazer's blockbuster vaccine Gardasil, which is administered across the country to teenage girls, is only to prevent transmission of HPV.

 

There is hope this new therapy can assist patients who have alread contracted HPV - a sexually transmitted disease.

 

Australian biomedical company Allied Healthcare Group, today announced positive trial results of Coridon.

 

The results from the preclinical study of mice confirmed the Coridon vaccine induces an immune response that prevents the development of cancer tumours associated with HPV infection.

 

Immunised animals showed no tumours at the end of the study compared to the control animals, all of which developed large tumours.

 

"These are very promising results for this program. We are moving another step closer to developing a therapeutic treatment for HPV-associated cervical cancer,'' said Lee Rodne, Group Managing Director of Allied Healthcare Group.

 

"We are very excited by the possibility of developing a vaccine, that can not only prevent infection, but can also stop the development of disease in people that have already been infected.''

 

In the study, groups of 10 mice were vaccinated intradermally with the Coridon HPV mixed DNA vaccine and compared to vaccine-free control animals.

 

After two immunisations, three weeks apart, tumour cells were implanted and tumour formation was monitored.

 

Mice receiving no vaccine developed large tumours whereas all mice immunised with Coridons DNA vaccine or the positive control survived with no tumours to the completion of the study.

“Eurogentec and NTC partner for clinical and commercial-grade plasmid DNA production.”

March, 2012

 

Eurogentec has recently licensed NTC’s (Nature Technology Corporation) high yield fermentation process for the GMP production of clinical and commercial plasmid DNA. The combination of NTC’s HyperGRO™ upstream fermentation process with Eurogentec’s downstream plasmid purification technology provides the best possible clinical and com-mercial-grade nucleic acids for gene therapy and DNA vaccination. “The combination of the two technol-ogies provides a very high yield of production together with the lowest cost of goods, all without com-promising quality” said Ingrid Dheur, Director of Eurogentec’s Biologics division. The combined high yielding fermentation and purification technologies have already been used to produce a plasmid de-signed by NTC for a European biotech company that will soon perform clinical trials in Europe. This plas-mid was made in one of NTC’s antibiotic free plasmid backbones.

 

The advent of nucleic acids based drugs necessitates a scalable plasmid DNA production process, ac-cording to Clague Hodgson, President of Nature Technology Corporation. “Eurogentec has established itself as a leader in Europe. The FDA approved CMO has manufactured over 400 batches of highly-purified clinical-grade biologics, including nucleic acids up to 100g in a single batch,” he said, adding, “NTC is pleased to be able to offer this service worldwide in partnership with this excellent organization”.

 

Pharmaceutical grade plasmid DNA is bacterial cells grown to high density using NTC’s high yield Hyper-GRO™ fermentation process. Modern plasmids have been devised by NTC specifically for use in pharma-ceutical products, combining regulatory compliance with improved performance at expressing antigens and therapeutic proteins in living cells and tissues.

 

Over 100 clinical trials have been conducted using nucleic acids-based drugs (Ref.: http://clinicaltrials.gov/ct2/results?term=plasmid+DNA) . The first human DNA vaccine is now in Phase III clinical trials (Vical, San Diego, CA), and many more vaccines and therapeutics are in the pipeline, ne-cessitating industrial scale production to fill anticipated future use in humans and animals, according to Dheur.

 Immunomic Therapeutics (ITI) Announces Interim Data Analysis of Phase I Study to Treat Japanese Red Cedar Allergy

FOR IMMEDIATE RELEASE

 

Hershey, PA, & Rockville, MD April 11th, 2013 – Immunomic Therapeutics, Inc., (“ITI,” Hershey, PA), a leading developer of novel allergy immunotherapies, announced the preliminary results of a Phase I Study to treat individuals with allergy to Japanese red cedar (“JRC”). The Company is pleased to report that the immunotherapeutic vaccine, JRC-LAMP-vax™, appears to have met all of its primary safety end points. In addition, preliminary allergic marker results indicate a favorable trend in resolving the allergy.

 

Within the three subject sub-groups, (24 total patients) there were no reports of any Severe Adverse Events (SAE). A small number of mild adverse events were reported in about 10% of the vaccinations, generally related to soreness associated with the intra-muscular injection. The safety results are consistent with other clinical studies that have incorporated LAMP, which also showed the vaccine to be safe and well tolerated. In addition to monitoring vaccine safety, subjects were also evaluated for immunological markers of allergy including circulating IgE, immunoglobulin G (IgG) and skin test reactivity.

 

At the 2013 Bio International Convention, the CEO of Immunomic Therapeutics, Dr. William Hearl, presented the preliminary data for cedar specific IgE and for skin test reactivity. All patients had stable IgE levels including those patients who entered the study as non-allergic to JRC. This observation indicates that the vaccine does not induce a new IgE antibody response in either naïve or allergic subjects.

 

Skin testing is perhaps the oldest and most reliable form of allergy testing. Skin testing has been performed for 100 years and continues to be the test of choice for the diagnosis of allergic disease. A number of the subjects, both skin test positive and skin test negative at the start of the trial, were found to be skin test negative at the end of the study: 5 of 6 converted from positive to negative for whole JRC extract and all subjects were negative for the specific cedar allergen Cry J2. In addition, all skin test negative subjects (5) remained skin test negative at the end of the Phase I study. “Immunomic Therapeutics, Inc., is proud to present these promising results for our first in human Phase I study. While we are quite excited about the initial skin test results it is important to note that this is a very small number of subjects and we have no indication that the treatment would alleviate the subjects’ rhinitis upon exposure to cedar pollen. Nevertheless, the skin test results are extraordinary in that reversal of a positive result within 132 days of treatment is not usually observed with traditional immunotherapy which may last years and require a 100 or more shots. To have seen that result within the course of this study gives us – and everyone with an allergy – hope that a

solution may be on the horizon.”

 

Poster: Preclinical safety evaluation of an antibiotic-free LAMP-1 plasmid allergy immunotherapy

 

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