|By PR Newswire||
|January 8, 2014 07:00 AM EST||
JERUSALEM and HSINCHU, Taiwan, Jan. 8, 2014 /PRNewswire/ -- BioLineRx (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, and JHL Biotech, a biopharmaceutical company that develops, manufactures, and commercializes biologic medicines, announced today that they have entered into an agreement to collaborate in the development and commercialization of BL-9020, a novel monoclonal antibody for the treatment of Type 1 diabetes.
Pursuant to the collaboration agreement, JHL Biotech will be responsible for all process development and manufacturing of BL-9020 during its pre-clinical and clinical development stages, and BioLineRx will be responsible for all pre-clinical development of BL-9020. Responsibility for clinical development of BL-9020 will be shared by the parties on a regional basis.
BL-9020 is a novel monoclonal antibody treatment designed to prevent destruction of insulin-producing beta cells in the pancreas. It was developed to treat Type 1 diabetes in early stage patients, during what is known as the "honeymoon period," where the pancreatic beta cells have not been completely destroyed and continue to secrete insulin. Pre-clinical studies in mouse models of Type 1 diabetes suggest that BL-9020 can preserve surviving cells, thus preventing full maturation of the disease. This effect could significantly delay, and potentially prevent, the need for chronic insulin use by Type 1 diabetes patients.
Under the terms of the agreement, JHL Biotech will have global manufacturing rights to BL-9020, along with development and commercialization rights in China and Southeast Asia, and BioLineRx will have development and commercialization rights in the rest of the world. In all development and manufacturing of BL-9020, JHL Biotech will adhere to FDA guidelines and regulations. Each of JHL Biotech and BioLineRx will have rights to all development and regulatory data generated under the agreement in order to commercialize BL-9020 in its respective territory. Each party will also be entitled to single-digit royalties on the sale of BL-9020 in the other party's respective territory.
"We are extremely pleased to partner with JHL Biotech, one of the rising stars of the Chinese biotech industry, with its impressive expertise in the development and manufacturing of biologic products, as well as its existing collaborations with leading global players. We view this as a strategic long-term partnership that we hope will form the basis for additional co-development projects for other biologic therapies," stated Dr. Kinneret Savitsky, CEO of BioLineRx.
"Type 1 diabetes is a highly prevalent autoimmune disease affecting millions around the world. Currently there is no cure for the disease, and patients with diabetes need to administer insulin on a daily basis throughout their lifetime. Oftentimes, when the disease is diagnosed, patients experience a "honeymoon period" that may last up to a year, during which there are still some insulin producing cells in the pancreas. Based on promising preclinical results, we have high hopes that BL-9020 may slow down or halt progression of the disease at this stage, which could be a significant step towards curing diabetes," added Dr. Savitsky.
Mr. Racho Jordanov, CEO of JHL Biotech, stated, "China is unfortunately experiencing a diabetes epidemic, with approximately 100 million people inflicted and a projection of reaching 150 million by 2035, thus making China one of the largest diabetes markets worldwide. Type 1 diabetes accounts for 5-10% percent of diabetes cases. It is diagnosed mainly during childhood and inflicts patients on a chronic basis for their entire lives. We believe that BioLineRx's novel drug for the prevention of Type 1 diabetes holds great promise for improving the health and welfare of people in China and throughout Southeast Asia."
"Israel is a global center for innovative technologies, and we hope our collaboration with BioLineRx will expand to other products, contributing to our vision of making world-class biopharmaceuticals affordable and accessible to all patients," concluded Mr. Jordanov.
BL-9020 is a first-in-class, monoclonal antibody which targets the Natural Killer (NK) receptor NKp46, which has been linked to Type 1 diabetes. Studies have shown that Natural Killer cells belonging to the innate immune system have a key role in the damage to pancreatic cells and, as a consequence, in the development of Type 1 diabetes. Professor Ofer Mandelboim from the Hebrew University of Jerusalem and Professor Angel Progador from Ben-Gurion University, the inventors of BL-9020, together with Professor Yaakov Naparstek and Dr. Chamutal Gur from Hadassah Medical Center in Jerusalem, found that the NKp46 receptor specifically recognizes pancreatic beta cells, leading to their destruction in both animal and human cells. These findings demonstrate the importance of the NKp46 receptor in diabetes development and emphasize the therapeutic potential of an anti-NKp46 monoclonal antibody as a new treatment modality for Type 1 diabetes. The inhibition of NK cells that are specifically targeted to the pancreas is a novel mechanism with potential to modify the course of the disease.
About Type 1 Diabetes
Type 1 diabetes, which usually appears in children and adolescents, results from auto-immune destruction of the pancreatic beta cells producing insulin. This leads to a pathological, high level of sugar in the blood and urine. Treatment of Type 1 diabetes is currently limited to lifetime administration of insulin by injection. The disease affects over 20 million people worldwide, and in 2012 the Type 1 diabetes market was estimated at over $3.5 billion.
About JHL Biotech
JHL Biotech is an emerging biopharmaceuticals company, founded by a group of biotech veterans and backed by a consortium of top-tier venture capital firms that includes Kleiner Perkins Caufield & Byers, Burrill & Company, China Development Investment Bank, and Sequoia Capital, with the mission to develop, manufacture, and commercialize world-class, affordable biologic medicines. JHL Biotech focuses on high-quality, cost-effective bioengineering as well as innovative product development technologies that follow current Good Manufacturing Practices (cGMP). In its first year, JHL Biotech has five biosimilar programs and one new molecular entity in development. JHL plans to submit its first clinical trial and investigational new drug applications in 2014 and expects to be cash flow positive and profitable by 2016.
JHL Biotech has built new headquarters, research, and manufacturing facilities in Taiwan to support all pre-clinical and early clinical biologic development. New facilities are also being built in Wuhan, China to support commercial manufacturing. When completed in early 2015, the Wuhan facility will be the largest single-use cell culture plant in the world.
The two cGMP facilities were designed and built in collaboration with GE Healthcare and utilize the latest in single use bioreactor technology. With this infrastructure, JHL Biotech has the advantage of strong intellectual property protection in Taiwan, the opportunity to serve the local market in China, and the capabilities to provide process development and bioengineering services to global partners.
For more information on JHL Biotech, please visit www.jhlbiotech.com.
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
BioLineRx's current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc. and is in the midst of a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions, which is expected to commence a pivotal CE-mark registration trial in early 2014; BL-8040 for treating acute myeloid leukemia (AML) and other hematological indications, which is in the midst of a Phase 2 study; and BL-7010 for celiac disease, which recently commenced a Phase 1/2 study.
For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company's SEC documents, press releases, and events. BioLineRx's IR app is available on the iTunes App Store as well as the Google Play Store.
Various statements in this release concerning BioLineRx's future expectations, including specifically those related to the development and commercialization of BL-9020, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2013. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
For JHL Biotech:
Dr. William Shen, VP, Business Development
SYS-CON Events announced today that DatacenterDynamics has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY. DatacenterDynamics is a brand of DCD Group, a global B2B media and publishing company that develops products to help senior professionals in the world's most ICT dependent organizations make risk-based infrastructure and capacity decisions.
Feb. 24, 2017 03:00 AM EST Reads: 1,799
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 24, 2017 02:15 AM EST Reads: 13,179
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, Sandy Ca...
Feb. 24, 2017 01:45 AM EST Reads: 9,518
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Feb. 24, 2017 01:00 AM EST Reads: 1,886
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, introduced the technologies required for implementing these idea...
Feb. 23, 2017 11:30 PM EST Reads: 6,289
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Feb. 23, 2017 11:00 PM EST Reads: 7,009
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
Feb. 23, 2017 10:00 PM EST Reads: 4,597
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 23, 2017 09:15 PM EST Reads: 1,516
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Feb. 23, 2017 08:45 PM EST Reads: 1,290
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Feb. 23, 2017 08:30 PM EST Reads: 1,451
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
Feb. 23, 2017 07:45 PM EST Reads: 3,386
SYS-CON Events announced today that IoT Now has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
Feb. 23, 2017 06:45 PM EST Reads: 1,454
SYS-CON Events announced today that WineSOFT will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Based in Seoul and Irvine, WineSOFT is an innovative software house focusing on internet infrastructure solutions. The venture started as a bootstrap start-up in 2010 by focusing on making the internet faster and more powerful. WineSOFT’s knowledge is based on the expertise of TCP/IP, VPN, SSL, peer-to-peer, mob...
Feb. 23, 2017 06:30 PM EST Reads: 1,722
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Feb. 23, 2017 06:30 PM EST Reads: 6,292
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Feb. 23, 2017 06:00 PM EST Reads: 1,507
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Feb. 23, 2017 06:00 PM EST Reads: 13,054
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Feb. 23, 2017 05:45 PM EST Reads: 1,223
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Feb. 23, 2017 05:30 PM EST Reads: 1,976
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
Feb. 23, 2017 04:45 PM EST Reads: 2,552
SYS-CON Events announced today that Outlyer, a monitoring service for DevOps and operations teams, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outlyer is a monitoring service for DevOps and Operations teams running Cloud, SaaS, Microservices and IoT deployments. Designed for today's dynamic environments that need beyond cloud-scale monitoring, we make monitoring effortless so you...
Feb. 23, 2017 03:45 PM EST Reads: 1,664