Archive: Company News
Company News: NATURE paper describes new molecular markers for high-risk neuroblastoma
– Researchers from the University of Cologne and NEO New Oncology AG publish new findings on the importance of thorough molecular diagnosis in cancer –
Researchers from the University of Cologne and NEO New Oncology AG today jointly published in Nature the findings of an extensive genomic analysis of neuroblastoma, a malignant pediatric tumor of the sympathetic nervous system. In the most aggressive forms of this tumor, the researchers identified previously unknown genomic alterations leading to up-regulation of the telomerase reverse transcriptase gene (TERT). Overexpression of TERT is often associated with cancers and tumor formation. These findings may help to improve tumor diagnostics and prognosis, and may also lead to the development of novel therapeutic options for the most aggressive subgroup of this deadly pediatric disease.
In neuroblastoma, the most common cancer in infancy, half of the tumors either regress spontaneously or can be cured by limited therapy, while the other half is high-risk neuroblastoma, a tumor with a very unfavorable prognosis and resistance even to intensive treatment.
So far, only a limited number of molecular markers that define high-risk neuroblastoma at a genomic level have been described, among them amplifications of the MYCN oncogene and mutations of the transcriptional regulator ATRX. By genomically analyzing more than 200 tumor samples, the authors of the study discovered genomic rearrangements close to the telomerase reverse transcriptase gene (TERT) that occur in approximately one quarter of high-risk neuroblastoma patients and clinically correlate with a particularly poor outcome. Both MYCN amplification and TERT rearrangements massively increased expression of TERT as well as enzymatic telomerase activity. Additionally, it was shown that high-risk tumors, even without any genomic alterations in MYCN or TERT, were prone to exhibiting a lengthening of telomeres.
Taken together, these findings suggest that most high-risk neuroblastomas are affected by either TERT rearrangements, MYCN amplification, or ATRX mutations, all of which lead to telomere lengthening, thereby providing a molecular, mechanistic definition of this neuroblastoma subtype. By contrast, low-risk tumors are characterized by the absence of such alterations and by low TERT expression levels, which presumably renders the tumors unable to attain immortal proliferation.
Company News: NEO New Oncology AG closes financing round
NEO New Oncology AG, a Cologne based cancer diagnostics company, today announced the closing of a financing round with a total investment of app. EUR 5 Million.
“I am pleased by the strong interest that NEO New Oncology AG has received from the investment community,” commented Dr Andreas Jenne, CEO of NEO New Oncology AG. “Together with the proceeds from the first closing earlier this year, the funds will help us to make NEOliquid, a genomic diagnostics test that identifies all therapeutically actionable genome alterations from a simple blood sample, available to patients even faster.”
Company News: Curetis and Acumen to Collaborate on Unyvero Sepsis Test and ASEAN Distribution
– Curetis licenses Acumen’s proprietary sepsis biomarker panel for use with Unyvero Platform
– Diagnostics Development (DxD) Hub in Singapore to support Acumen in development and clinical validation of the panel
– Acumen to distribute Unyvero product line in ASEAN countries
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has obtained a world-wide, non-exclusive license to AcuSept, a proprietary biomarker panel from Acumen Research Laboratories Pte Ltd. (Singapore). The panel is in advanced clinical development and will be used by Curetis and Acumen for the joint development and clinical validation of a sepsis host response test on the Unyvero Platform. Acumen’s activities in Singapore will be supported by NUS Enterprise and the Diagnostics Development (DxD) Hub, a national initiative led by the Agency for Science, Technology and Research (A*STAR), which aims to accelerate diagnostics innovations into market-ready products.
Separately, Curetis and Acumen have signed an exclusive, multi-year distribution agreement for the Unyvero product line in ASEAN markets, which will initially include Singapore, Malaysia, Thailand and Indonesia. The agreement, effective immediately, comprises Unyvero Systems and P55 and i60 ITI Application Cartridges. Acumen will seek product registration in these markets. This agreement, through which Acumen will act as a commercial hub for Curetis in the ASEAN markets, will complement the recently announced Greater China distribution partnership between Curetis and Beijing Clear Biotech, giving Curetis a strong sales and marketing presence in Asia.
The AcuSept biomarker panel is designed to accurately detect changes in a patient’s immune system indicative of pathogens in the blood stream and of a systemic inflammatory response syndrome (SIRS) caused by these microorganisms. The presence of both SIRS and infections are the medical criteria for sepsis, a severe disease with poor prognosis and an often fatal outcome: approximately 50% of people with severe sepsis and 80% of people with septic shock die. With an estimated incidence of 26 million cases worldwide per year, sepsis is among the most frequent severe medical conditions and a significant economic burden to the healthcare systems. A fast and clear distinction between patients with sepsis and those who only have either infections or SIRS by appropriate tests is key to an effective therapy and survival.
Curetis expects to launch a sepsis host response test in Europe in late 2017 at the earliest. The registration process for the current Unyvero Systems and Application Cartridges in ASEAN countries is expected to take up to one year.
Company News: Curetis Enters into Distribution Agreement to Expand Commercial Activities into Greater China
– Exclusive Unyvero distribution agreement with Beijing Clear Biotech Co., Ltd. for Mainland China, Hong Kong and Taiwan
– Clinical trials for CFDA regulatory approval in preparation
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has signed an exclusive distribution agreement (the “Agreement”) for China, Hong Kong and Taiwan (collectively “Greater China”) with Beijing Clear Biotech Co. Ltd. The Agreement, effective from September 25, 2015, comprises the Unyvero Systems and P55 and i60 ITI Application Cartridges. Based in Beijing and founded in 2001, Beijing Clear Biotech is an experienced and prominent distributor of prime medical technology brands throughout Greater China. In the in vitro diagnostics market, Beijing Clear Biotech focuses on the distribution of point-of-care diagnostics, in particular European products and PCR devices.
Under the terms of the Agreement, Beijing Clear Biotech will conduct and fully fund all prospective multi-center clinical trials required for approval of the Unyvero System and its P55 and i60 ITI Application Cartridges by the China Food and Drug Administration (“CFDA”), including funding the systems and application cartridges required for the trials. Beijing Clear Biotech’s responsibilities also include leading the registration and approval process, inclusive of paying all fees, on behalf of Curetis. The anticipated CFDA license will be owned by Curetis. Curetis will pay Beijing Clear Biotech certain milestone payments upon clinical trial initiation and CFDA approval, respectively, and grant a commercial exclusivity for distribution in China, Hong Kong and Taiwan. Under the terms of the Agreement, Beijing Clear Biotech has agreed to certain minimum purchase numbers of Unyvero Systems as well as P55 and i60 ITI Application Cartridges per year.
Upon CFDA approval, Curetis will support commercialization through Chinese-language marketing materials and regular product training for the distributor’s sales force. Beijing Clear Biotech will be responsible for managing all local marketing and sales activities as well as handling storage and logistics support. Marketing in Taiwan will start earlier than in China and Hong Kong, as specific trials are not required for product registration there.
For the commercialization of the Unyvero i60 implant and tissue infection (“ITI”) Application Cartridge, Beijing Clear Biotech will partner with LandMover Medical Technologies Co. Ltd. (Beijing, China), the exclusive Chinese distributor of Heraeus Medical, one of the leading companies in the field of bone cement and biomaterials for elective orthopedic and trauma surgery. The i60 ITI Application Cartridge was co-developed by Curetis with Heraeus Medical to improve the management of patients with implant and tissue infections, including prosthetic joint and other orthopedic infections, to support an early and informed decision on the choice of antibiotic-supplemented bone cement in revision surgery.