VIENNA, 24-Sep-2020 — /EPR BIOTECH NEWS/ — Eveliqure Biotechnologies GmbH, an Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries.
Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non-endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor-countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world-leading vaccine organizations – the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH.
“Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” – commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”.
“Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.
Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations.
Baltimore, MD, 2019-Sep-18 — /EPR BIOTECH NEWS/ — CoapTech LLC (Baltimore, MD) and Fidmi Medical, Ltd. (Caesarea, Israel) announced today that they will be collaborating on bringing to market a set of next-generation products for the initial placement and long-term maintenance of gastrostomy tubes (G-tubes). The collaboration between CoapTech and Fidmi will focus on integrating the company’s two technologies and expanding their collective market opportunities.
Gastrostomy tubes, which help patients receive long-term nutritional support, are typically placed endoscopically and need to be replaced every 3-6 months.
CoapTech’s PUMA-G System allows initial gastrostomy tube placement by non-surgeons/ gastroenterologists, outside of the endoscopy suite, using point-of-care ultrasound at the patient bedside. This novel approach can be performed in the ICU, emergency room, and eventually outside of the hospital setting, substantially reducing costs for tube placement.
Fidmi Medical’s innovative low-profile gastrostomy system is unique in that it can be utilized for both initial placement and replacement and has several features which make it more durable and comfortable for patients. Gastrostomy tubes very often get dislodged, clogged, or infected, and need to be replaced frequently. Fidmi’s improved low-profile gastrostomy tube is placed just like any standard PEG tube but has an easily replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications with patients’ g-tubes, therefore potentially reducing healthcare costs for payers and healthcare systems; as well as providing a substantial improvement in quality of life for patients and their caregivers.
Fidmi Medical Chairman, Lloyd Fishman, commented, “We are excited to collaborate with CoapTech in development and marketing. Both companies have developed cutting-edge technologies that will improve patient care and contribute to the ease, efficiency and confidence of clinicians’ work in the gastrostomy field.”
Dr. Steven Tropello, CoapTech’s founder and CMO said, “In combination these systems will be compatible with Push or Pull methods, be implantable in a wide variety of clinical settings, and require minimal readmission to the hospital and fewer visits to the ER. The synergy will reduce both front and back-end costs for hospitals and payers, and make care safer and more patient-centered.”
FREDERICA, DE, USA, 01-Nov-2018 — /EPR BIOTECH NEWS/ — ILC Dover, a global leader in flexible containment solutions for the pharmaceutical and biopharmaceutical industry is expanding its Irish production footprint by opening a location in Blarney, County Cork, Ireland.
The building will be operational in the first quarter of 2019 and outfitted with 4,000 square feet of
ISO 7 clean room capacity and 6,500 square feet of Class 8, both dedicated to the company’s pharmaceutical and biopharmaceutical product lines. When at full production, the company expects to hire 60-70 new ILC Dover employees. The company’s original operation in County Cork will be relocated to the Blarney site as part of the expansion project.
ILC Dover President and CEO Fran DiNuzzo expressed enthusiasm about the new launch: “The expansion of our production capabilities in Ireland will allow us to better serve our global customer base and strengthen our position as the leading single-use powder handling solutions provider to the global pharmaceutical and biopharmaceutical marketplace.”
In addition to production space, the new facility will contain state-of-the-art offices, meeting rooms and a product demonstration area for client visits. Curtis Gingles, Vice President and General Manager of the company’s Pharmaceutical Division, added, “Clients of ILC Dover will be happy to see that we’re focused on providing additional capacity located in the region with expanded technical resources. The market for our products is experiencing incredible growth and this expansion will ensure we can keep up with the growing demand for the high-quality products used in manufacturing lifesaving therapies.”
LJUBLJANA, Slovenia, 21-Sep-2018 — /EPR BIOTECH NEWS/ — The latest study published in the World Journal of Urology (Comparison between erbium‑doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence – https://doi.org/10.1007/s00345-018-2445-x) provides further confirmation that Fotona SMOOTH® laser technology is a safe, effective and minimally-invasive solution for stress and mixed urinary incontinence (SUI and MUI). The article, written by Dr. Nobuo Okui, compares Fotona’s minimally invasive IncontiLase® Er:YAG laser therapy with the more conventional TVT and TOT surgical sling procedures.
Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence
In the study performed by Dr. Okui, 50 Japanese women were treated either surgically (tension-free vaginal tape – TVT or transobturator tape – TOT) or with a Fotona laser. The 1-h pad test, ICIQ-SF, and overactive bladder-symptom score were used to assess the patients before and 12 months after treatment. Laser therapy was performed by first applying a local anesthetic to the vaginal wall and then inserting a probe into the vagina. Laser irradiation was performed for 20 min with an Er:YAG wavelength of 2940 nm (Dynamis XS, Fotona) for a total of three treatments (alternating every month). Results of the 1-h pad test and ICIQ-SF showed comparable improvements in SUI in the sling and laser therapy groups, while some of the patients with MUI in the TVT and TOT groups showed exacerbation. In conclusion, the TVT and TOT procedures and the laser therapy are comparable for SUI; however, laser therapy is superior in terms of MUI and complications. The study thus once again confirms the safety and efficacy of Fotona SMOOTH® laser therapy for urinary incontinence.
Urinary Incontinence Treatment Options
Conventional treatment options for urinary incontinence are surgical, and include TVT or TOT sling procedures, which involve inserting a synthetic material. Problems often arise with artificial meshes that require new treatment methods. With the Fotona SMOOTH® Er:YAG laser thermotherapy (also known as IncontiLase®), the goal is to provide a minimally invasive therapy based on vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, which results in overall regeneration of aged or stressed vaginal tissues and subsequently greater support to the bladder.
Unique Fotona SMOOTH® Technology for Maximum Safety
Patient safety is the primary concern and, for this reason, the patented Fotona SMOOTH® technology holds a very unique position within the spectrum of gynecological treatment options. It is a non-surgical procedure (no incisions) and without implants or appliances. The Fotona SMOOTH® method of dual-tissue regeneration is completely non-ablative and therefore minimally invasive to the vaginal wall. The treatment involves an additional superficial heat-shocking mechanism of tissue regeneration, and a unique self-regulating safety feature. These dual-tissue regeneration characteristics of the Fotona SMOOTH® Er:YAG laser allow for an exceptionally high degree of safety and efficacy in thermotherapy of the vaginal wall. This is what makes Fotona SMOOTH® a significantly safer alternative to many widely used and more-invasive procedures.
Evidence-Based Laser Medicine
Over the past few years numerous (over 35) other studies on Fotona SMOOTH® laser therapy have been published by distinguished gynecologists from around the globe in some of the most trusted and renowned international scientific journals, all with favorable results (https://www.laserandhealthacademy.com/en/practitioners/recommended-reading/gynecology/). One such noteworthy clinical paper published in March 2018 by Dr. Adolf Lukanovic and Dr. Mija Blaganje is the first randomized controlled trial study (on 114 premenopausal parous women) to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative non-invasive treatment of SUI and the improvement of sexual gratification (published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018 (224): 153-158). The results from this study indicate that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo.
In another Asian study, Dr. Yi-Wen Tien et al. from the Chang-Hua Hospital in Taiwan examined the effects of laser treatment for female SUI on pad weight, urodynamics, and sexual function in 35 women (published in the International Urogynecology Journal. 2017; 28(3): 469-476). The study reveals that the effect of IncontiLase® treatment for mild SUI was moderate at the 6-month follow-up. Moreover, it improved LUTS, quality of life, and the sexual function of both partners. The authors conclude that the IntimaLase® procedure is very effective in the treatment of SUI and is not associated with any severe adverse effects.
Similarly, Dr. Yi-Hao Lin et al. from the Chang Gung Memorial Hospital in Taiwan obtained favorable results. Their study investigated the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, SUI and sexual function in 30 women with urodynamic stress incontinence (published in the Taiwanese Journal of Obstetrics & Gynecology. 2017 (56): 815-820). The results showed that IncontiLase® treatment can resolve SUI and coexistent OAB symptoms three months after therapy, while repeated laser therapy may be necessary after six months. The results also revealed that sexual gratification improved, while no major adverse effects were noticed.
The quantity and quality of the studies performed with Fotona SMOOTH® laser therapy is such that Fotona’s Dynamis has been cleared in the European Union for SUI (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause – GSM (RenovaLase®) and pelvic organ prolapse (ProlapLase®), giving women the option to choose a safer and less-invasive treatment alternative. In Asia, the Taiwan Food and Drug Administration has already cleared Fotona Dynamis for mild to moderate SUI, and the Singapore Health Sciences Authority has cleared the Dynamis for the treatment of SUI and GSM.
GERMANY, Mar-30-2017 — /EPR Biotech News/ — Ulcerative colitis and Crohn’s disease are the most common inflammatory bowel diseases (IBD). Globally, more than 4 million people suffer from recurring inflammation of the intestinal mucosa. To date, non-invasive methods have not been able to detect these forms of IBD reliably. Researchers at the University Hospital Erlangen (Germany) have now shown for the first time how Multispectral Optoacoustic Tomography (MSOT) can more reliably detect early stages of inflammation when compared with other non-invasive diagnostic methods. These results have recently been published in the New England Journal of Medicine.
Evaluating the inflammatory activity of the intestines early and accurately helps to prevent complications associated with IBD and guide an optimal therapy regime. Currently, doctors frequently rely on an invasive endoscopy procedure to assess the intestinal mucosa of patients with IBD. Additionally, non-invasive imaging methods are increasingly used in the clinic. For example, ultrasound allows clinicians to examine the structure, thickness and blood perfusion of the intestinal wall with changes in perfusion patterns indicating an onset of inflammation.
“With the MSOT procedure, we additionally use laser light, by which we can detect inflammation earlier than previously possible with ultrasound”, explains Prof. Dr. Maximilian Waldner, Professor at the University Hospital Erlangen. “The earlier we detect signs of an upcoming flare – i.e., a change in blood content – the quicker we can react and start a preventive treatment”. The MSOT technology was developed by iThera Medical in Munich, and was first used on IBD patients last year.
The researchers of the University Hospital Erlangen have recently published their results in the renowned New England Journal of Medicine. “We examined 108 patients with Crohn’s disease using the MSOT technology and compared the results to established non-invasive diagnostic procedures as well as endoscopy and histology”, says Prof. Waldner. “We were able to demonstrate that hemoglobin values in the tissue measured with MSOT indicate very accurately the inflammatory activity in the intestines. The method appears to be superior to other non-invasive procedures, as MSOT for the first time was able to detect even low levels of inflammation without having to perform endoscopy”.
Dr. Ferdinand Knieling, a physician at the University Hospital Erlangen, adds: “We are hoping that this principle can be applied to many applications and, in particular, also be used to enable safe evaluations of children and adolescents. With this new examination method, many of the currently invasive procedures might become obsolete.”
In optoacoustic imaging, the physician scans the intestines transabdominally through the skin, applying pulsed laser light in the near-infrared region. The energy of the light absorbed in tissue is converted into acoustic signals which are then acquired by an ultrasound detector. Christian Wiest, CEO of iThera Medical, comments: “MSOT is a new diagnostic imaging modality that can detect changes in tissue composition associated with a variety of diseases, without the use of contrast agents. The technology has already been applied in other clinical feasibility studies, e.g. for the detection of melanoma metastasis in sentinel lymph nodes or for the assessment of suspicious breast lesions”.
The results of the IBD study at the University Hospital Erlangen were published on March 30th 2017 in the New England Journal of Medicine (Volume 376, Issue 13, pg.1292-1294).
Seattle, WA, San Francisco, CA and Moscow, Russia, 2016-May-25 — /EPR Biotech News/ — R-Pharm and GenQual are pleased to announce a new collaboration focused on the development of novel predictive diagnostic tools in the area of Rheumatoid Arthritis and Autoimmune diseases.
The GenQual proprietary real-time PCR platform, when applied to the genes that are involved in the manifestation of several autoimmune diseases, allows us to detect and assess single nucleotide polymorphisms. Here, allelic determination is used as potential predictor of the treatment response by the novel anti-IL6 antibody, which is currently in development by R-Pharm.
GenQual Founder and CEO Jonathan Mirich said, “This partnership is exciting for GenQual as we advance in our goal to deliver predictive diagnostic tools for the treatment of autoimmune disorders. We are very excited about the possibilities in this space and are thankful to have quality partners in R-Pharm.”
R-Pharm CEO Vasily Ignatiev indicated the importance of the Autoimmune diseases as an area of the development and growth for R-Pharm, as well as the development of novel diagnostic tools aimed to increase the level of predictive response and efficiency of the upcoming treatment paradigm.
GenQual develops proprietary biomarker diagnostics for autoimmune and oncology indications. Our personalized medicine products are designed to facilitate early disease detection and diagnosis, and to improve treatment approaches at the molecular level. GenQual is a privately-held corporation based in Seattle, WA area, USA.
R-Pharm is a private Russian pharmaceutical company founded in 2001. It employs over 3,500 highly qualified specialists in 60+ branches. R-Pharm operates in Russia and CIS, USA, Germany, Japan, Turkey/MENA.
The company is involved in R&D, manufacturing (finished dosage forms, biotech and chemical APIs), marketing, sales and distribution of innovative pharmaceutical products in hospital/specialty care therapeutic areas.
R-Pharm collaborates with major international pharmaceutical companies and universities in the fields of drug discovery, development, clinical trials, manufacturing and commercialization. The company operates several GMP compliant manufacturing sites in Russia and Germany, research, BD/licensing and marketing affiliates in Japan, Germany, Turkey and US.
Marketed portfolio and pipeline features drugs used in oncology, hematology, autoimmune diseases, HIV, HCV, neurology, diabetes, cardiology, as well as antibiotics, contrast media and anesthesia agents.
SINGAPORE, January 26, 2016 — /EPR BIOTECH NEWS/ — Austrianova announced today that, having completed the set up of its new GMP facility, it is now offering clients a GMP cell banking (Master Cell Bank and Working Cell Bank) as well as a “Fill and Finish” service for cell therapy products, in addition to its encapsulation services and technology. Austrianova is able to offer the production of Master Cell and Working Cell Banks (MCB and WCB) at the size scale required for early (phase 1 and 2) stage clinical trials at highly competitive prices using its state of the art isolator based production facility, assuring that the highest quality standards are adhered to. The company can also fill bulk cell product into syringes or vials in its GMP facility. This new cell banking and filling service is called GMP4Cells. MCB’s and WCB’s are required for all cell therapy products such as stem cell therapies as well as biologics produced from cells such as vaccines, antibodies, recombinant proteins etc. Similarly, many companies, including those developing stem cell lines and products, are seeking high quality economic fill and finish for relative small lots.
“We see this as a natural add-on to our already established Cell-in-a-Box® cell encapsulation technology for which we have recently set up a GMP manufacturing facility in Thailand. This kind of MCB and WCB production as well as “Fill and Finish” services for cells are, however, stand alone services. Although these services are generally available to all customers, they should allow start up companies and academic based cell products, vaccines etc to enter clinical trials in a quality assured manner but at lower cost that other, more conventional, cell banking companies offer” stated Walter H. Gunzburg, Chairman and CTO of Austrianova.
“In addition to our state of the art facility, Austrianova offers services that comply with major international regulatory agencies using a customized German/Swiss based quality assurance system. Our team has many years experience with regulatory agencies around the world and has taken cell therapies into clinical trials” said Brian Salmons, CEO.
More information about the GMP4Cells cell banking but also the Cell-in-a-Box® and the related Bac-in-a-Box® encapsulation services can be found on our newly revamped website www.austrianova.com.
Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability for extending storage under lyophilized conditions and protection in stomach acid.
VTU Technology to offer unique combination of technologies for the high-level production of proteins with human-like glycosylation using Pichia GlycoSwitch®
Tucson, Arizona and Grambach, Austria, December 03, 2014 — /EPR BIOTECH NEWS/ — VTU Technology and Research Corporation Technologies (RCT) announced today that they have entered into a development and commercialization agreement for VTU to combine both companies´ Pichia pastoris protein production technologies. Pichia GlycoSwitch® – a new expression system for the production of glycoproteins with human-like glycosylation patterns – and VTU´s yield enhancing Pichia pastoris expression platform are now available in one package from VTU. This unique combination of technologies acting synergistically is of great benefit for customers as it leads to a high performance production platform for recombinant glycoproteins with superior product yields and uniform Man5 – or other human-like glycoforms.
Under the terms of the agreement, RCT grants VTU Technology access to RCT´s Pichia GlycoSwitch® expression system for combination with VTU´s in-house high-yielding Pichia platform featuring different proprietary technologies such as AOX1 promoter libraries suited for both methanol-induced and methanol-free production. VTU Technology is now offering the combined technology suite as part of the company´s expression strain and corresponding bioprocess development contract services portfolio.
“We are delighted to offer Pichia GlycoSwitch® engineered with our broad portfolio of Pichia tools in this partnership with RCT and I am convinced that our yield enhancing technologies will give GlycoSwitch® an exciting extra edge for the production of glycoproteins with Man5 – or other human-like glycoforms”, states Thomas Purkarthofer, Ph.D., Head of Business Development of VTU Technology.
“Our partnership with VTU Technology brings together two technologies that will enable customers to uniquely tailor the glycosylation of their target protein and explore new biological functions. We are looking forward to working with VTU Technology to expand the potential of proteins manufactured in Pichia GlycoSwitch®”, states Kurt R. Gehlsen, Ph.D., Vice President and CSO of Research Corporation Technologies, Inc.
Pichia pastoris is a yeast widely used for recombinant protein expression. As a microbial eukaryotic organism, Pichia combines the post-translational modification systems similar to those found in mammalian cells, with the ease of use/manipulation of E. coli. Decades of processes development have been focused on efficiently growing Pichia to extremely high cell densities; and multiple generations of molecular biology tools have been created to engineer strains to produce tens of grams/liters of a recombinant protein product. Pichia can secrete high levels of properly folded, functional proteins into a simple, defined medium for easy purification. There have been more than 20,000 publications on the use of Pichia for the production of more than 5,000 proteins, with more than 70 products manufactured in Pichia on the market today. Pichia products include enzymes manufactured in 200,000-liter fermenters and two FDA-approved therapeutics.
Pichia GlycoSwitch® is a recombinant protein expression system that broadens Pichia’s applications to glycoproteins where N-linked glycosylation is important for biological function. Pichia GlycoSwitch® offers researchers the ability to control the glycosylation (sugar addition) of recombinant glycoproteins and explore the role of protein glycosylation and various glycan structures on protein function. Pichia´s typical high-mannose glycan patterns can also be eliminated to reduce immunogenicity caused by the unwanted hyperglycosylation. The Pichia GlycoSwitch® system consists of patents, strains and vectors that are useful for making proteins with a number of different human-like glycoforms.
VTU Technology, a leading contract research and development company, offers the broadest toolbox and most versatile technology platform available for Pichia pastoris recombinant protein expression / production enabling highest productivities delivering up to 22 g/L of secreted protein within a few weeks development time. VTU Technology´s powerful Pichia pastoris protein expression technology is based on its optimized gene design and cloning strategies, proprietary AOX1 promoter libraries & in-house expression platform and high-throughput screening & cultivation regime, combined with excellent know-how in fermentation and downstream process development.
Headquartered in Grambach/Graz, Austria, VTU Technology is a private company and a subsidiary of VTU Holding, an Austrian enterprise that combines several technology and engineering companies in chemistry, pharma & life science as well as power and fuel industry. For additional information about VTU Technology, please visit www.vtu-technology.com.
RCT is a Tucson, Ariz.-based technology investment and management company that provides early-stage funding and development for promising biomedical companies and technologies. RCT focuses on technology investments with origins from universities and research institutions worldwide. RCT’s technology portfolio includes platforms and tools that support the discovery, development and manufacturing of therapeutics. Current platform technologies include Pichia and E.coli protein expression systems and novel protein binding scaffolds. To learn more about RCT, see www.rctech.com and www.pichia.com.
Despite the great progress made in HIV/AIDS treatment, there is still an urgent need for new drugs, particularly for people who have had to abandon existing treatments due to HIV drug resistance and side effects.
The current treatment of HIV/AIDS involves the use of three or more drugs from five main general classes, used in combination. While this antiretroviral therapy (ART) has helped to reduced morbidity and mortality from AIDS, long term toxicity and the emergence and transmission of drug resistant HIV strains limit the effectiveness. Thus, despite therapy which can render this a chronic, rather than acute fatal infection, development of new drugs to prevent infection and overcome drug resistant strains, is increasingly urgent.
ViroCarb Inc. is developing a novel technology that addresses infections by drug resistant HIV strains. Developed from the identification of a new, natural resistance factor against HIV infection by scientists at SickKids and Canadian Blood Services, ViroCarb’s inhibitor works against a previously overlooked target on the virus to block HIV from entering human cells, the very first step in the infection. It works against all HIV strains.
Funds are needed to aid in moving forward to support preclinical studies; therefore ViroCarb Inc. has started an international crown funding campaign to carry out these HIV model studies needed before conducting clinical trials.
Please support this new way to block HIV.
Contact-Details: Dr. Mario Huesca
479 Simonston Boulevard.
L3T 4M4 Canada
HD Biosciences Co., Ltd. (HDB) and E. J. Corey Institute of Biomedical Research (CIBR) announced that they have reached a risk-sharing agreement on collaborative drug discovery and development in the therapeutic areas of infectious diseases, metabolic diseases, and oncology. This joint effort will focus on both international and Chinese markets to provide innovative medicines for unmet healthcare needs. The agreement includes lead candidate selection pre-clinical development, IND filing, clinical trials, and NDA approvals. Both companies will share financial returns from any successes or products launches.
“We are delighted to enter this partnership. The collaboration will leverage HDB’s extensive capabilities in preclinical drug discovery and development, and create long term potentials for the company.” stated Xuehai Tan, Ph.D., President & CEO of HDB. “In combination of CIBR’s expertise in drug development, we are confident to deliver novel drug candidates over the next few years, and to make this partnership a success.”
“Working with HDB gives CIBR a unique opportunity to showcase its strength in innovative drug discovery and development,” said Wuyi Meng, Ph.D., President of CIBR. “This partnership further demonstrates CIBR’s commitment in the betterment of patient’s lives by bringing forward novel medicines. We will collaborate closely with HDB to accelerate the progress of our collaborative programs”
About HD Biosciences Co., Ltd.
HD Biosciences Co., Ltd. is a Shanghai-based, biology-focused preclinical drug discovery contract research organization (CRO). The company offers comprehensive service platforms around target validation, plate-based pharmacology, hit identification and lead discovery, therapeutic antibody discovery, in vivo pharmacology, as well as other research and development services. The company currently collaborates with eight of the ten largest pharmaceutical companies in the world and has established strategic partnerships on many key R&D areas with impacts to their portfolios. The strong scientific expertise, high quality and consistency in deliveries, constantly meeting or exceeding expectations, has earned the company a great reputation in the industry, and helped the company to build its widely recognized leadership in preclinical contract research services.http://www.hdbiosciences.com
About E. J. Corey Institute of Biomedical Research
Located in the Jiangyin High-tech Industry Development Zone in Jiangyin, Jiangsu, E. J. Corey Institute of Biomedical Research (CIBR) is a non-profit research organization founded by Nobel laureate Prof. E. J. Corey with the support from Jiangyin and Jiangsu government. CIBR is committed to scientific research in the broad biomedical field and to the development of novel therapeutics to meet the unmet medical needs of patients. In addition to its strong internal research and discovery capabilities in biomedical research and drug discovery, CIBR has established solid external capabilities in translational medicine and molecular toxicology to support drug development. Under the guidance of Nobel laureate Prof. Corey, CIBR is well poised to contribute to the discovery and development of novel medicines. http://www.cibrnobel.org
Ms. Jessie Yang
HD Biosciences Co., Ltd (HDB) and Anchor Therapeutics, Inc. today announced that they have formed a strategic collaboration to co-develop and co-market Anchor’s proprietary pepducin technology and provide novel drug development solutions to global pharmaceutical companies with drug discovery efforts focused on G-protein coupled receptors (GPCR).
Pepducins are proprietary lipidated peptide modulators for GPCR signaling. They may stabilize receptor conformation, promote or inhibit dimerization, and modulate interaction of GPCR with signalosome. As a strong research tool, pepducin technology enables high throughput screening (HTS) campaigns for the identification of special class of compounds and allosteric ligands, facilitates biophysical studies via stabilization of GPCRs in different activation states and functionally de-orphanizes GPCRs to provide tools for interrogation of pharmacology in vitro and in vivo.
As a key component of HDB’s plate-based pharmacology service capabilities, GPCR assays and screenings is one of the most active research and development areas that attracts global clients and partners in drug discoveries. With over 200 recombinant GPCR cell lines in house, some of which are orphan receptors, combining a variety assay formats with pepducin technology allows HDB to enhance its capabilities for supporting hit identification, lead discovery and receptor selectivity profiling. The collaboration is also designed to provide broader exposure and accessibility of pepducin technology across pharmaceutical and biotechnology industries through HDB’s global client base. HDB’s clients will gain unprecedented access to not only the pepducin screening platform but also HDB-Anchor’s joint expertise in GPCR research.
“Anchor’s pepducin technology has provided a novel approach to search very special GPCR related compounds that have potential to alter the receptor functions. We believe this technology will be very valuable in GPCR related drug discovery.” commented Dr. Xuehai Tan, President and Chief Executive Officer of HDB. “As one of the global leaders in biology focused contract research services, HDB emphasizes on innovative and scientific driven technologies in order to deliver extra value to our clients. The partnership between HDB and Anchor is a perfect example to demonstrate our commitment to grow the expertise and strengthen our leadership in GPCR R&D.” Dr. Tan continues his comments.
“Anchor Therapeutics is extremely pleased to partner its pepducin technology with HD Biosciences, one of the leading companies providing state of the art high throughput screening services to pharmaceutical and biotechnology clients,” said Thomas J. McMurry, PhD, Anchor’s Interim President. Dr. McMurry continued, “Through this collaboration, Anchor and HDB will expand the validation of pepducin high throughput screening probes in order to provide HDB’s clients with access to innovative screens designed to facilitate access to novel small molecule pharmacophores.”
LC Sciences, LLC, a leading provider of microRNA analysis services, today announced the launch of a new online searchable knowledgebase that researchers can use to locate technical information on the company’s website. This announcement comes on the heels of the launch of LC Sciences’ re-designed company website last week. The knowledgebase contains technical information in the form of application notes, technical bulletins, customer publications, presentations, reviews of seminal publications in the field, etc. This documents database contains over one thousand entries and encompasses a wide range of research fields; from plant science to neuroscience. Additionally, all entries have been carefully meta-tagged to improve search results.
“Having served the microRNA research community for the past nine years, we’ve accumulated quite a large library of reference documents such as application notes and related customer publications. This new resource offers the community a simple, user friendly search interface that makes it easier for them to locate the information they’re looking for within that library.” – Chris Hebel (Vice President of Business Development, LC Sciences)
Microtissues® Inc. announced today the signing of a Supply and Distribution Agreement with Sigma-Aldrich® Corporation (Nasdaq: SIAL) for the worldwide sales and marketing of the 3D Petri Dish®, a new technology for the culture of living cells in three dimensions (3D). Invented at Brown University, the 3D Petri Dish® maximizes cell-to-cell interactions critical for replicating the function of natural tissues and organs. Shown in numerous peer reviewed papers to work with over fifty different cell types, including cell lines, primary cells and stem cells, the 3D Petri Dish® has applications in cancer research, drug discovery, toxicity testing and regenerative medicine.
“Researchers are rapidly recognizing the importance of 3D cell culture and its ability to reliably mimic in vivo function” said Brian Morgan, Director of Business Development, Microtissues® Inc. “The 3D Petri Dish® creates a natural 3D environment without artificial scaffolds and we’re excited that this distribution agreement will bring our unique and innovative line of products to the worldwide research community.”
Unlike the conventional plastic Petri dish where cells are grown as a thin layer on the surface of the dish, the 3D Petri Dish® forms 3D aggregates of cells. Spheroid size is controlled by the number of cells seeded and hundreds of uniform sized spheroids are formed in a single pipetting step. Spheroids are formed in a well ordered array in a stable platform suitable for long term culture. All spheroids are positioned on the same optical plane making them easy to image (phase contrast, fluorescent). Spheroid size is controlled by the number of cells seeded and a mixture of cells forms mixed spheroids, suitable for investigating tumor-stroma interactions. Spheroids can be grown from single cells, applicable to the study of cancer stem cells. For histology, Western blots and RT-PCR, spheroids are harvested by simply inverting the 3D Petri Dish®. No need to dissolve or digest the gel. The 3D Petri Dish® is a new fundamental tool for the world wide industry of life sciences research.
About Sigma-Aldrich®: Sigma-Aldrich® is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich® customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich® is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich®, please visit its website at www.sigma-aldrich.com.
About Microtissues® Inc: Microtissues® Inc. is a privately held company located in Providence, RI, advancing technologies and applications of 3D cell culture. Microtissues®, Inc.’s products are designed to serve the needs of researchers in a wide range of areas including cancer research, stem cell biology, toxicity testing, developmental biology, drug discovery, regenerative medicine and tissue engineering. Microtissues®, Inc. has an exclusive worldwide license from Brown University to US and international patent applications on the 3D Petri Dish®. For more information on Microtissues®, Inc., please visit www.microtissues.com.
Sigma-Aldrich and Sigma are trademarks of Sigma-Aldrich Co. LLC registered in the US and other countries. Microtissues and 3D Petri Dish are registered trademarks of Microtissues, Inc.
On Creative Biomart website, we can read a report about the 2012 Nobel Prize in Physiology or Medicine regarding the two winners. They bring hope for organ or tissue repair for human or even for rejuvenation, i.e. for long life through induced pluripotent stem cells (iPSCs).
Since the first appearance in 2006, iPSCs became the hit and focus. But there are still lots of unknowns waiting for us before achieving the ideal status. Thus, numerous scientists, researchers and businessmen are struggling and investing for that goal. Here are some examples:
On Dec. 5, 2012, Roche (SIX: RO, ROG; OTCQX: RHHBY) and the Innovative Medicines Initiative (IMI) announced today the launch of StemBANCC, a new academic–industry partnership that unites ten pharmaceutical companies and 23 academic institutions. Initiated and coordinated by Roche and managed by Oxford University, StemBANCC aims to use human induced pluripotent stem cells as research tools for drug discovery with the goal of using this ground-breaking new technology to develop human disease models and enhance drug development.
On Oct. 29, 2012, on the PANS Journal there is an article about Cartilage tissue engineering using differentiated and purified induced pluripotent stem cells.
On Oct. 4, 2012, on Cell Stem Cell, there is a report with the title be Genome Sequencing of Mouse Induced Pluripotent Stem Cells Reveals Retroelement Stability and Infrequent DNA Rearrangement during Reprogramming.
On Jan. 30, 2012, on the PANS Journal, there is a report about modeling hepatitis C virus infection using human induced pluripotent stem cells, which make the individual and tailor therapy further.
Above are only a small part of such studies. People still wonder does it is the moment or an abuse on the iPSCs research. When someone reviewed one of the winners, Shinya Yamanaka, about his opinion on the challenge of iPSCs research, he said, “I have two research directions, the first is to establish human iPSCs bank that comply with clinical application standards. The second is to study the cell mechanism of iPSCs regenerating. And I think the current threat is still to be the safety problem as good research respects both scientific and ethical standards.”
Sprint Bioscience, a Swedish company developing oncology therapeutics targeting cancer metabolism, announced today that it has raised money to strengthen its drug discovery portfolio.
The investment by Första Entreprenörsfonden and Almi Invest will enable the company to continue to build a pipeline of drug discovery projects within cancer metabolism.
“We are investing in Sprint Bioscience because we consider their entrepreneurial drive and their particular skills in drug development to be key success factors for the changing environment of the future pharmaceutical industry. Sprint Bioscience’s business strategy involves out-licensing or collaborating at an early stage of drug discovery to ensure that projects are developed with a focus on current and relevant market needs,” says Rune Nordlander, partner at Första Entreprenörsfonden.
Sprint Bioscience is a company founded by experienced drug hunters with an ambition to improve the drug discovery process. “We believe in small organisations with effective working procedures and collaborations throughout the sector,” says the company’s CEO and co-founder, Dr. Anders Åberg.
“Sprint Bioscience has developed an efficient, fragment-based drug discovery (FBDD) platform that can take parallel projects from initial idea to active molecules tested in cell-based systems in a very short time” Anders Åberg continues. Our goal is to align the early phase in the laboratory with pharmaceutical companies’ needs.
Targeting the metabolism in tumours provides exciting opportunities to develop drug therapies with novel mechanisms of action. This could be used to overcome the resistance that many cancer cells develop to current treatments.
Advinus Therapeutics, a research-based pharmaceutical development company promoted by the TATA Group, and SignalChem Pharmaceuticals, a British Columbia-based drug discovery company, have started working on 15 programs based on SignalChem’s proprietary Kinase platform for targeted therapies in oncology. Each program is being developed with corresponding diagnostics and tracers for patient selection and biomarkers for follow up offering the right treatment to the right patient at the right time. The companies have received a very high level of interest from pharma companies to license and collaborate on the programs and therefore see a rapid progression to the clinic.
Dr. Jasbinder Sanghera, CEO of SignalChem said – “This is a path-breaking partnership that leverages SignalChem’s extensive biology and kinase expertise and Advinus’s end-to-end capabilities of medicinal chemistry, lead optimization, preclinical development and early-clinical development capabilities to rapidly and efficiently advance new anti-cancer drug candidates into human clinical trials.”Dr. Rashmi Barbhaiya, CEO and MD of Advinus said– “This collaboration is an exemplary model of polycentric and globally networked innovation for enhancing probability of success, reducing timelines, and focusing on cost-effective partnerships to bring innovative medicines to the market. This collaboration would also leverage leading edge biomedical research of British Columbia research institutions and Advinus’s capabilities and infrastructure to translate biomedical research discoveries into potential life saving drugs.”
The collaboration was announced by B.C. Premier Christy Clark during her visit to India who said – “This is what our Jobs Trade Mission is all about – helping local companies make connections that will allow them to do business in India. We have an innovative technology and life sciences sector in B.C., which has a lot to offer India to support its economic growth. The partnership between Advinus and SignalChem will benefit people around the world.”
CYTOO SA, a company that specializes in cell-based assays, is pleased to announce the closing of a series C funding round of USD 10M (EUR 7M). New investors, Sham and Entrepreneurs Fund (EF), led the round. Existing investors AURIGA Partners and Jacques Lewiner, co-founder and president of the supervisory board at CYTOO, also participated.
CYTOO will use the financing to fully exploit its fast growing business within the global market of cellbased assays and screening, and bring the company up to profitability. Having the potential to lead the next innovation wave in cell-based drug discovery and in vitro toxicology, CYTOO is already on the radar screen of several key industrial actors.
“We are very excited about joining CYTOO as it enters a new phase in its development,” says Olivier Szymkowiak, Chief Investment Officer at Sham. “There is an exceptional opportunity for CYTOO to revolutionize the cell culture for low and high throughput applications,” added Maciek Drozdz, Investment Manager at EF and future Supervisory Board member.
Leveraging its exclusive technology of adhesive micropatterning, CYTOO’s products and services bring robustness, sensitivity and powerful quantification to cell-based assays, high content analysis and cell screening for the life science research market.
CYTOO holds an exclusive worldwide license from the Institut Curie and the CNRS (The French national scientific research center) for the adhesive micropattern patent portfolio, as well as license agreements with Harvard University (USA) and CEA, the largest government-funded technological research organization in France.
“This funding represents a strong achievement in the young history of CYTOO: the company has now the financial means for turning its technological advantage into a commercial success. A shift that the company has already initiated with the commitment of existing investors and our support through the expertise of Jacques Mallet, partner at Auriga Partners” added Franck Lescure, partner at Auriga Partners and member of the supervisory board at CYTOO.
François Chatelain, CEO of CYTOO, commented: “I am excited to lead the company and thrilled to close our series C financing round with a renowned international venture capital investors syndicate. We are welcoming Entrepreneurs Fund and Sham who bring their high level experience in building up successful biotech and medtech companies, we are also pleased with the continued commitment of our historical investors. Together we are looking to move our business and technology onto the next level of growth.”
CYTOO was advised for its capital raising by Silver Ocean Ventures’ Managing Partner Dr John Tchelingerian.
GenQual is pleased to announce initial closing of its first preferred equity round. Financial terms were not disclosed. This inaugural funding round allows GenQual to pursue proof-of-principle testing for its companion diagnostic approach for IL-6 mAb and other JAK/STAT inhibitors for autoimmune diseases and oncology indications. GenQual aims to prospectively identify responders for clinical-stage therapeutics to improve drug trial response rates and improve chances for drug approval. The round remains open for further funding.
GenQual Founder and CEO Jonathan Mirich said, “This funding round allows GenQual to pursue its business development goals to deliver companion diagnostics for very expensive IL-6 monoclonal antibody treatment for autoimmune disease, chiefly rheumatoid arthritis, as well as certain oncology indications. It allows us to extend collaborative agreements for proof-of-principle testing. We are very excited about the possibilities in this space.”
GenQual develops proprietary biomarker diagnostics for autoimmune and oncology indications. Our personalized medicine products are designed to facilitate early disease detection and diagnosis, and to improve treatment approaches at the molecular level. GenQual is a privately-held corporation based in the Seattle area.
Advanced Liquid Logic announced today that it has signed a license and collaboration agreement with the French research institute CEA-Leti. The agreement provides Advanced Liquid Logic with worldwide exclusive access to CEA’s portfolio of patents related to digital microfluidics.
Advanced Liquid Logic co-founder and Dr. Michael Pollack said, “This agreement puts our company in a clearly dominant position with respect to the intellectual property surrounding digital microfluidics.” Co-founder Dr. Vamsee Pamula added, “the accompanying collaboration with a very active and highly competent group of researchers will provide us with key technical resources to help address both today’s and tomorrow’s technology challenges.” Advanced Liquid Logic has set up a subsidiary company in Grenoble, France to help manage the collaboration and to provide an initial position to address market opportunities in Europe. CEA-Leti employee Dr. Cyril Delattre will join the company and manage Advanced Liquid Logic’s French subsidiary.
“The combination of Advanced Liquid Logic’s intellectual property position and their readiness for market made them the ideal partner,” said Dr. Laurent Malier, CEO Leti. “We expect that our complementary skills, expertise and intellectual property will be very useful going forward. This partnership with Advanced Liquid Logic offers an industrial solution that will help us develop applications bases on microfluidics for many sectors”.
Advanced Liquid Logic previously acquired intellectual property from Nanolytics and Core Microsolutions. The company now owns or controls over 45 issued patents related to their proprietary, electrowetting-based digital microfluidic technology.
About Advanced Liquid Logic
Advanced Liquid Logic, headquartered in Research Triangle Park, North Carolina, is commercializing its proprietary “Digital Microfluidics” technology in a spectrum of life sciences and clinical diagnostics applications. Digital microfluidics enables precise and flexible manipulation of microdroplets using electrical fields and therefore avoids the need for pumps, valves or microchannels required by competing technologies. For more information please visit http://www.liquid-logic.com/
CEA is a French research and technology organization, with activities in four main areas: energy, information technologies, healthcare technologies and defence and security. Within CEA, the Laboratory for Electronics & Information Technology (CEA-Leti) works with companies in order to increase their competitiveness through technological innovation and transfers. CEA-Leti is focused on micro and nanotechnologies and their applications, from wireless devices and systems, to biology and healthcare or photonics. Nanoelectronics and microsystems (MEMS) are at the core of its activities. As a major player in MINATEC campus, CEA-Leti operates 8,000-m² state-of-the-art clean rooms, on 24/7 mode, on 200mm and 300mm wafer standards. With 1,400 employees, CEA-Leti trains more than 190 Ph.D. students and hosts 200 assignees from partner companies. Strongly committed to the creation of value for the industry, CEA-Leti puts a strong emphasis on intellectual property and owns more than 1,700 patent families.
MicroTissues, Inc. announced today the launch of its 3D Petri Dish™ line of products. The 3D Petri Dish™ is a new tool for the world wide industry of life sciences research and drug discovery. Invented at Brown University, the 3D Petri Dish™ grows living human cells in three dimensions (3D) where they replicate the function of natural tissues and organs. There are important applications for these human 3D microtissues in cancer and stem cell research as well as toxicity testing, drug discovery and cell therapy.
“The scientific community has recognized the need for a reliable 3D cell culture technology that accurately produces natural cell-to-cell interactions and is easy to use” said Brian Morgan, Marketing Manager of MicroTissues, Inc. “Not only does our 3D Petri Dish™ line of products create 3D microtissues without artificial scaffolds, the microtissues are uniform in size, easy to harvest and accessible to the standard biochemical and microscopy methods that cutting edge labs demand. No other 3D cell product has all these technical advantages. And, we have the only reusable product.”
MicroTissues, Inc offers eight products that are precision micro-molds used to cast 3D Petri Dishes™ that fit in standard multi-well plates. The micro-molds are autoclavable and reusable. In a single pippetting step, the 3D Petri Dish™ forms hundreds of spheroids (hepatospheres, cardiospheres, mammospheres, neurospheres, and embryoid bodies), and microtissues with more complex shapes and geometries. Over thirty different cell types, including primary human cells, have been shown to form 3D microtissues in the 3D Petri Dish™.
MicroTissues, Inc. a privately held company with an exclusive worldwide license to US and international patent applications on the 3D Petri Dish™, is advancing technologies and applications of 3D cell culture.