7/18/2012
Prokarium Acquires Key Oral Vaccine Technology
Prokarium Ltd recently announced it completed a key technology acquisition from Emergent BioSolutions Inc. The technology includes Emergent’s live Salmonella-based typhoid vaccine Typhella and its genetic technology spi-VEC. Prokarium will combine Typhella and spi-VEC with its proprietary genetic and formulation technologies to form Vaxonella, a versatile oral vaccine delivery platform.
Emergent has successfully conducted several Phase I and II clinical trials, which have shown Typhella to be safe and immunogenic as a typhoid vaccine. The combination with Prokarium’s plasmid stabilisation technology ORT-VAC, will enable the delivery of recombinant protein vaccines without needles or adjuvants. Prokarium plans to offer this Vaxonella platform to the biotech community on a licensing basis.
Prokarium will focus on the development of a dual oral vaccine against typhoid and ETEC (enterotoxigenic E. coli – a major cause of diarrhoea) for travellers and developing country markets. There are 22 million cases of typhoid every year resulting in 200,000 deaths, so an effective oral vaccine could have a significant impact. Currently there is no dedicated vaccine against ETEC, considered responsible for 300,000 to 500,000 deaths per year, mostly of young children.
“I am delighted with the acquisition of this technology from Emergent; the combination of their Salmonella vector with Prokarium’s technologies allows us to develop an advanced oral delivery platform, which gives Prokarium the potential to revolutionize vaccinations,” said Dr. Rocky Cranenburgh, Prokarium’s Chief Scientific Officer.
Live, attenuated bacteria have been used as vaccines for decades (eg, the BCG vaccine against TB). Prokarium’s Vaxonella technology advances their use as delivery systems for vaccines against a wide range of infectious diseases by modifying the bacteria to produce a foreign protein from the target pathogen, against which an immune response is directed. Vaxonella technology uses live Salmonella bacteria, which have been genetically modified to make them safe, to carry vaccines and deliver them to the immune system via the lining of the gut. The vaccines are produced from self-replicating DNA molecules called plasmids. With conventional bacteria, these plasmids are rapidly lost when the bacterial cells divide. Vaxonella strains incorporate a mechanism called ORT-VAC that prevents plasmid loss without relying on antibiotic resistance genes which otherwise could potentially transfer to pathogenic bacteria.
The advantages of this approach include the elimination of needles, the stimulation of an effective immune response via mucosal surfaces (the entry route for many pathogens) and a simple, cost-effective manufacturing process regardless of the vaccine antigen.
Prokarium has previously shown its ORT-VAC technology to be effective in preclinical models against plague, anthrax, and tuberculosis.
Prokarium is a biotechnology start-up company based in Keele and
Cobra Biologics is a leading international clinical and commercial manufacturer of biologics and pharmaceuticals with three GMP-approved facilities. Cobra offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal product.
For more information about Prokarium, contact Ted Fjällman, Development Director, on +44 7811 367 729 or email ted.fjallman@prokarium.com or visit www.prokarium.com.
EMD Millipore Expands Chemical & Reagents Portfolio
EMD Millipore, the Life Science division of Merck KGaA of Germany, recently announced a significant expansion of their chemicals and reagents product line with the introduction of 14,706 new products to North America in the next 2 years from the “M” brand portfolio. This range of products, currently available outside
The products will be launched in phases throughout 2012 and 2013. The latest group of products being introduced include MagniSolv deuterated solvents; Reflectoquant products; EMSURE Inorganic salts (mineral and organic acids); Extran products, disinfectants, and cleaners; Spectromelt X-ray fluorescence materials; high-purity ancillary reagents for AAS; and very high-purity Suprapur inorganic salts.
In addition to superior product quality, supported by industry-leading specifications, many products are supplied in environmentally friendly packaging for less waste and greater safety.
EMD Millipore is the Life Science division of Merck KGaA of
FDA Approves Cornerstone Therapeutics’ ANDA
Cornerstone Therapeutics Inc. recently announced FDA approval of its ANDA for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension.
CRTX 067 was developed through a collaboration including Cornerstone Therapeutics, Coating Place, Inc., and NEOS Therapeutics. Cornerstone will market the product through its wholly owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies the APIs, including a patent-protected version of time-released hydrocodone and chlorpheniramine polistirex drug resin complex (DRC). These active substances will be manufactured at commercial scale in the CPI facilities. NEOS developed the CRTX 067 drug product formulation using its proprietary suspension formulation technology, Dynamic Time Release Suspension (DTRS).
“We are pleased with the FDA’s decision to approve our generic antitussive/antihistamine product,” said Craig A. Collard, Cornerstone’s Chief Executive Officer. “Given ongoing industry challenges related to manufacturing prescription cough and cold medications, this is yet another opportunity for growth within the organization. We are well positioned to supply product to meet increased demand and patient needs.”
Cornerstone will begin manufacturing its generic antitussive/antihistamine product immediately. Despite competition from other generics, Cornerstone anticipates a strong market opportunity given the demand that exists within this market. Antitussives are some of the most commonly prescribed medications during cough and cold season. Net sales for Tussionex and related generics were $127 million in 2011, according to IMS Health’s NSP, a third-party provider of prescription data. Cornerstone intends to utilize its existing relationships in the respiratory field and distribution expertise to effectively gain market share for its generic product.
Cornerstone Therapeutics Inc., headquartered in
Neos Therapeutics Inc. is a specialty pharmaceutical company focused on the development, manufacture, and sale of FDA-approved drug products that utilize the company’s proprietary delivery technologies. Neos’ drug products are developed using the Dynamic Time Release Suspension (DTRS) and Rapidly Disintegrating Ionic Masking (RDIM) technologies, that deliver controlled-release (CR) small molecule APIs in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are FDA-approved and known to be safe and effective, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s 505(b)(2) NDA approval process. For more information, visit www.neostx.com.
Coating Place is an established niche pharmaceutical company specializing in Wurster fluid bed technology focused on drug delivery system development and contract manufacturing. It provides customers with modified- and extended-release bulk active products through innovative development, unique manufacturing capabilities, and integrated quality philosophy. CPI’s extended-release drug-resin APIs were developed using its patented DRC Technology combined with its trade secret linear scale-able Wurster manufacturing process. For more information, visit www.coatingplace.com.
ImmunoGen Initiates Trial for Ovarian Cancer & Other Solid Tumors
ImmunoGen, Inc. recently announced the start of clinical testing with its IMGN853 product candidate.The Phase I trial initiated evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and anticancer activity of this TAP compound in patients with ovarian cancer or other solid tumors that over-express FOLR1 (also known as folate receptor alpha), including non-small cell lung cancer (NSCLC). Once the maximum tolerated dose (MTD) of IMGN853 is established, the activity of the compound will be evaluated in disease-specific patient cohorts.
“This trial is expected to provide key information needed to define the registration path for IMGN853,” said James O’Leary, MD, Vice President and Chief Medical Officer. “The study protocol allows for the use of single-patient cohorts for evaluation of the lower dose levels, which should accelerate the pace of advancement to higher doses and to the trial’s expansion phase. In the expansion phase, IMGN853 will be evaluated as a treatment for specific types of FOLR1-overexpressing tumors. These findings should enable us to make decisions needed to advance IMGN853 into later-stage clinical testing.”
This multi-center, first-in-human US Phase I trial is designed to enroll approximately 64 patients with previously treated ovarian cancer, NSCLC, or other epithelial malignancies that over-express FOLR1. Once the MTD is defined in the dose-escalation part of the trial, three expansion cohorts will be opened to evaluate the pharmacodynamics and antitumor activity of IMGN853 at this MTD in patients with specific types of cancers: epithelial ovarian cancer (EOC) that is refractory/resistant to platinum; EOC that is relapsed/refractory to conventional treatments; and adenocarcinoma NSCLC that is relapsed/refractory to conventional treatments.
More patients die from lung cancer in the US than from any other type of cancer, each year, approximately 226,000 patients in the US are diagnosed with lung cancer and approximately 160,000 die from the disease. About 40% of lung cancers are the adenocarcinoma subtype of NSCLC. Each year, there are approximately 22,000 new cases of ovarian cancer diagnosed in the
The novel agent IMGN853, a TAP compound, contains an ImmunoGen FOLR1-targeting antibody attached to the company’s potent cell-killing agent, DM4. The antibody enables the compound to bind specifically to cancer cells expressing FOLR1, and the DM4 serves to kill these cells. The DM4 is attached to the antibody using one of ImmunoGen’s engineered linkers. The linker in IMGN853 serves not only to keep the DM4 stably attached to the antibody while the compound is in the bloodstream, but also – once at the tumor site – to counteract the multi-drug resistance that can make previously treated tumors more difficult to kill.
ImmunoGen, Inc. develops targeted anticancer therapeutics using the company’s expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agents, and engineered linkers. The company’s TAP technology uses monoclonal antibodies to deliver one of ImmunoGen’s proprietary cancer-cell killing agents specifically to tumor cells. There are now numerous TAP compounds in clinical development with a wealth of clinical data reported. ImmunoGen’s collaborative partners include Amgen, Bayer HealthCare Pharmaceuticals, Biotest, Lilly, Novartis, Roche, and Sanofi. The most advanced compound using ImmunoGen’s TAP technology, trastuzumab emtansine (T-DM1), is in Phase III testing through the company’s collaboration with Genentech, a member of the Roche Group. More information about ImmunoGen can be found at www.immunogen.com.
Intellect Neurosciences in Dispute With Licensee Over Significant Milestone Payment
Intellect Neurosciences, Inc. recently announced an update to previously disclosed patent news. On May 8, 2012, the USPTO granted to Intellect a patent covering the company’s ANTISENILIN monoclonal antibody platform technology for the treatment and prevention of Alzheimer’s disease. This patent is at the heart of one of the company’s license agreements with a global pharmaceutical company, and Intellect believes that under the terms of the license agreement, its issuance triggers a milestone payment.
This licensee has recently informed Intellect that it does not believe the milestone payment requested is due under the license agreement. Intellect has responded that there is no legitimate basis for refusing to make the milestone payment, and the company intends to vigorously pursue its rights under the license agreement.
“We are extremely disappointed by our licensee’s response for which we are seeking further clarification,” said Dr. Daniel G. Chain, Chairman and CEO of Intellect Neurosciences. “Unless this matter can be resolved promptly, Intellect will have no choice but to pursue this matter through legal channels.”
The patent discloses therapeutic antibodies to treat Alzheimer’s disease. The antibodies specifically bind to the ends of the beta amyloid protein without binding to the amyloid precursor protein (APP), which has important safety advantages compared to antibodies that do not have this feature. The granted patent claims are directed to treatment methods that use antibodies that recognize the free C-terminus of beta amyloid 1-40. Intellect has additional patent applications pending in the
The best-known example of a therapeutic antibody that binds to the free C-terminus of beta amyloid 1-40 is ponezumab (aka PF-04360365). A Phase I study to determine effect of PF-04360365 on clearance of beta amyloid from cerebrospinal fluid in patients with Alzheimer’s disease and healthy volunteers is being conducted according to www.ClinicalTrials.gov (identifier NCT01005862) last updated July 3, 2012. This trial, which is scheduled to complete in August 2012, follows other completed Phase I and II trials.
Intellect Neurosciences, Inc., develops innovative approaches aimed at arresting or preventing Alzheimer’s disease and other neurodegenerative diseases especially focused on proteinopathies. Intellect’s pipeline includes therapeutic vaccines, antibodies, and neuroprotective antibody drug conjugates. For more information, visit www.intellectns.com.
Sophion & Creacell Announced Successful Demonstration
Sophion and CreaCell recently announced the two companies successfully demonstrated the performances of HEK-hKir2.1 cells on QPatch HT. Inward rectifier potassium channels of the Kir2 subfamily are important determinants of the electrical activity of cardiac cells, and mutations of the Kir2.1 channels are associated with familial atrial fibrillation, Andersen-Tawil syndrome, and short-QT syndrome.
Because human Kir2.1 is a relevant target in preclinical cardiac safety testing of drug compounds, Sophion and CreaCell demonstrate the functionality of the CreaCell’s HEK-hKir2.1 recombinant cell line on Sophion’s automated patch-clamp system QPatch HT. Current amplitudes, IV curves, Ba2+ currents, and chloroethylclonidine dose-response curves were analyzed.
“Several of our customers have asked us for a QPatch-optimized cell line expressing clinically relevant hKir2.1 ion channels,” said Dr. Morten Sunesen, VP of Customer Relations at Sophion. “We are pleased to announce the first result of this fruitful collaboration with CreaCell and our customers will benefit.”
“The synergy between our two companies is natural and allows us to satisfy client demands” said Dr. Pierre-Yves Perche, CEO at CreaCell. “At the same time, through this partnership with Sophion and its extensive network of customers, CreaCell confirms its intentions of developing its position in the worldwide market.”
To access the Application Report, please click on the following link: http://www.sophion.com/uploads/public/images/media/31412/hek-hkir2.1.pdf.
Sophion Bioscience, a leader in the automated patch clamp field, helps the pharmaceutical industry develop more and better drugs, faster. Sophion’s focus is to provide advanced products and integrated solutions for automated patch clamping. Sophion’s QPatch family of products provides high-quality patch clamp data on a truly industrial basis on all types of ion channels. Recently Sophion became part of Biolin Scientific, a Swedish materials science company providing high-tech precision instruments for research within surface, material, and bioscience, drug discovery and diagnostic applications. For more information, visit www.sophion.com.
CreaCell is a Products and Services company that provides innovative cell-based solutions to the pharmaceutical industry for drug discovery and drug safety. CreaCell’s expertise is exploited in two main areas: i-CreaCell offers Licence agreement for its Ion Channel Cell Lines, ii-Through its Cell Culture Services, CreaCell offers solutions for custom development, production and characterization of recombinant cell lines. The company has established several partnerships and license agreements with world leaders in these sectors. For more information, visit www.creacell.com.
Total Page Views: 1367
