On September 20, 2016 The TeraMedica Division of FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics solutions, reported a significant business milestone in serving cancer center customers (Press release, Fujifilm, SEP 20, 2016, View Source [SID:SID1234515254]). The company’s Synapse VNA, an enterprise-wide medical information and image management solution, is now installed at more than 300 oncology facilities worldwide for the management of cancer treatment data.

"Fujifilm truly dominates the oncology VNA space both for our innovative technology and also our knowledge of what it takes to deliver better cancer care," said Greg Strowig, Vice President, TeraMedica Division of FUJIFILM Medical Systems, U.S.A., Inc. "Cancer centers across the globe have turned to us because of our unparalleled experience with the management of cancer treatment data."

The over 300 oncology facilities worldwide that use Synapse VNA technology interface with a total of over 800 linear accelerators. Synapse VNA manages all clinical oncology department data, both DICOM and non-DICOM, including radiology diagnostic images, radiation treatment plans, and various other clinical data used in the treatment of cancer patients— using the most scalable single storage solution available.

Many of the world’s most reputable oncology facilities rely on Synapse VNA for the ability to quickly access and share diagnosis and treatment plan information, as well as keep data secure, backed up, and readily accessible for audit in a disaster recovery/business continuance environment.

Johns Hopkins—one of only 45 cancer centers in the U.S. designated by the National Cancer Institute (NCI) as a Comprehensive Cancer Center— implemented Synapse VNA 7 years ago. Moffitt Cancer Center—ranked the number 6 cancer center in the nation in U.S. News & World Report’s 2016 annual report of top cancer hospitals— is in the process of installation.

Fujifilm will showcase Synapse VNA at the American Society for Therapeutic Radiation and Oncology (ASTRO) 2016 Annual Meeting to be held September 25-28, 2016, at the Boston Convention and Exhibition Center in Boston, MA.

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On September 20, 2016 Bristol-Myers Squibb Company (NYSE:BMY) and LabCentral, an innovative, shared laboratory space designed as a launch pad for life-sciences and biotech startups, reported that PanTher and Suono Bio are the winners of Bristol-Myers Squibb’s Golden Tickets for LabCentral (Press release, Bristol-Myers Squibb, SEP 20, 2016, View Source [SID:SID1234515233]). As a platinum sponsor of LabCentral, Bristol-Myers Squibb can select up to two innovative life-sciences and biotech startup companies per year of active sponsorship for "Golden Tickets," which underwrite the cost of one lab bench for one year in LabCentral’s Kendall Square facility.

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"PanTher and Suono Bio are working to deliver innovative technologies that have the potential to impact patients with serious diseases, and we’re pleased that the Golden Tickets will enable them to advance their research," said Carl Decicco, Ph.D., Head of Discovery at Bristol-Myers Squibb. "Our sponsorship of LabCentral, and the awarding of Golden Tickets to these two companies, align with our strategy to encourage scientific innovations in our disease areas of focus, from academia through early development."

"Bristol-Myers Squibb has made an excellent selection of its first two Golden Ticket winners – we know them both well," commented LabCentral Co-Founder and President Johannes Fruehauf, M.D., Ph.D. "Both have the potential to make major inroads against devastating diseases using novel approaches to drug delivery. We are excited to have them join in the vibrant ecosystem of the LabCentral community and look forward to watching as these companies move down the path toward success."

A pre-clinical-stage company, PanTher Therapeutics is working to revolutionize the treatment of inoperable, locally advanced solid tumors − studying the direct delivery of existing, already proven chemotherapy agents directly onto the tumor for consistent, slow release over time. The company designed its novel delivery method to potentially eliminate the toxicity and debilitating side effects that chemo agents can produce when delivered systemically through traditional IV or oral administration. Its first potential indication is pancreatic cancer, a particularly lethal disease that affects more than 53,000 Americans annually, where excruciating symptoms arise from the primary mass invading nearby vital organs. By changing the route of administration to target just the tumor, PanTher is designed to increase the amount of drug reaching the intended destination with the aim to enhance therapeutic efficacy. Eliminating adverse outcomes may also help to lower healthcare costs. Pancreatic cancer accounts for about three percent of all cancers in the U.S. and about seven percent of cancer deaths. A privately held company, PanTher is completing pre-clinical studies prior to initiating human trials and exploring opportunities for partnerships to expand its product pipeline.

Suono Bio, a preclinical stage company, has developed breakthrough technology − the "SuonoCalmTM" system − designed to potentially enable ultra-rapid delivery of therapeutics across tissues, including the gastrointestinal (GI) tract. Preclinical studies have demonstrated that the ultrasound-based technology can deliver small molecules, proteins, and nucleic acids locally and systemically, validating further study of the SuonoCalm system. Designed as an easy-to-use device to enable patients to self-administer medication at home, the SuonoCalm technology may also be applicable to a broad set of conditions outside of the GI tract.

On September 20, 2016 Cantargia AB reported that the board has taken a decision on an enhanced development strategy for the company and its product candidate CAN04, and is initiating a project around a new antibody for the treatment of autoimmune and inflammatory diseases (Press release, Cantargia, SEP 20, 2016, View Source [SID:SID1234515265]). To accomplish this, the company plans to conduct a capital raising of approximately MSEK 80, in addition to the capitalization of up to MSEK 25 through the conversion of warrants in October 2016. The decision is planned to be taken at an extraordinary general meeting estimated to be held Q4 2016 / Q1 2017.

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Inclusion of combination therapies in the initial clinical study of CAN04

"Cantargia’s decision to increase the level of ambition in the CAN04 project is among the most important and the most intensified in the company’s history. This marks a major step to enhance the value of the CAN04 project and take greater advantage of the potential around the target IL1RAP (Interleukin 1 Receptor Associated Protein). I feel enthusiastic about the opportunities that open up with our intensified development strategy", says Göran Forsberg, CEO of Cantargia.

The decision has been taken in consultation with international key opinion leaders in the field of solid tumors, and it represents a significantly increased level of ambition in the initial stage of the clinical studies of Cantargia’s product candidate CAN04 against non-small cell lung cancer (NSCLC) and pancreatic cancer. By expanding the study to include combination therapies – where CAN04 is combined with existing standard treatment – Cantargia will receive significantly more data, which allows the company to accelerate the overall development of CAN04. This improves the conditions for a partnership of CAN04. Cancer treatment today is often some form of combination treatment, and in view of the good safety and unique mechanism, CAN04 can potentially be a good substance to combine with other treatments.

The clinical study protocol is still under development. It will be based on an adaptive design which means increased flexibility during the trial. The protocol will provide relevant data on combination therapy and significantly more information than initially planned. During 2017 Cantargia plans to start preclinical studies with different types of combination therapies to support the clinical development.

The clinical study of CAN04 is now planned to start during the first half of 2017, and a presentation of the phase I data is planned about a year after the start of the study. More data will be generated continuously, but based on the first data set, the foundation is laid for Cantargia’s ambition to find a partner who can take responsibility for the latter stages of clinical development. When phase I data are reported, in addition to the current study, the company also intends to finalize a protocol and start a clinical phase IIa trial for leukemia.

The next step in the production development of CAN04

In June 2016, Cantargia decided to invest in the further optimization of its production processes, which has resulted in a production process that can be used to produce material for initial clinical trials. Because of the company’s development strategy, the production process needs, however, to be carried out in a larger scale and at a higher cost than initially planned. Therefore, as part of the more aggressive clinical development of CAN04, Cantargia plans to invest in further process development of a production method that meets the requirements in subsequent clinical studies. Like other antibody production processes, substantial development activity and process optimization are needed between early and late clinical phase in order to increase yields and ensure a robust production. Through the investment in the production process, a better opportunity to take advantage of the time savings made in the overall clinical development is created.

Start of a new project against autoimmunity and inflammation

Cantargia intends to initiate the development of a new antibody against IL1RAP with properties optimized for the treatment of autoimmune and inflammatory diseases. IL1RAP mediates signals of both the cytokines IL-1 and IL-33, which have a role in several severe autoimmune and inflammatory diseases. The project is planned to start in 2017, and the goal is to select a clinical candidate that can enter development at the end of 2018 or the beginning of 2019.

By starting a new project against a disease segment that complements CAN04 in cancer treatment, the company gets a risk spreading that according to the board of directors is considered very attractive. In addition, the knowledge and tools developed within the CAN04 project gives a pronounced synergy between the two projects.

"The goal is that within our existing or new antibody libraries identify and optimize antibodies that inhibit both IL-1 and IL-33 activity to treat autoimmune and inflammatory diseases", says Göran Forsberg.

Planned future capitalization process

In order to carry out the activities presented above, Cantargia’s board assess that the company has an additional need of capital of about MSEK 80 until mid 2018, in addition to what has been previously announced. Further information on the planned capitalization is planned to be published in Q4 2016 or Q1 2017. In addition, the capitalization also includes the conversion of warrants of series TO 2 and TO 4 in October 2016. If fully exercised, these warrants add a total of about MSEK 25 before issue costs to Cantargia.

Cantargia’s board is expected to evaluate the opportunities and strategic options available for the company’s next development stage during mid 2018.

Certified Adviser: Sedermera Fondkommission

This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on 20 September 2016, at 8:00 am.

On September 20, 2016 Abilita Bio, Inc. reported that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to develop therapeutic antibodies targeting G Protein-Coupled Receptors (GPCRs) involved in the metastasis of breast cancer, including prostaglandin E2 receptor 2 (EP2), prostaglandin E2 receptor 4 (EP4), and C-C chemokine receptor 7 (CCR7) (Press release, Abilita Bio, SEP 20, 2016, View Source [SID:SID1234515259]). With an estimated 1.7 million new cases each year, breast cancer is the most common cancer among women worldwide. It is also the leading cause of cancer death among women, taking the lives of over 450,000 annually. In addition to the patients who are diagnosed with metastatic disease at initial diagnosis, nearly 30 percent of women diagnosed with early breast cancer will eventually develop metastatic disease.

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The chemokine receptor CCR7 is highly expressed in human breast cancer cells, malignant breast tumors and metastases, and overexpression correlates with larger primary tumors, deeper lymphatic invasion and poor prognosis. EP2 and EP4 receptors are positively correlated with increased breast cancer metastasis and have been implicated in suppression of the antitumor activity of natural killer cells. Given the body of evidence that implicates CCR7, EP2 and EP4 in cancer metastasis and immunosuppression, targeted inhibitory antibody therapeutics may address unmet needs in breast cancer therapy.

GPCRs have been proven to be challenging targets for antibody discovery due to low cell surface expression, lack of immunogenicity and marginal conformational stability when removed from the membrane. To address these limitations, Abilita Bio will leverage its directed evolution technology to rapidly generate enhanced GPCR antigens called EMPs (Enabled Membrane Proteins) that can be used for discovery and development of therapeutic antibodies targeting CCR7, EP2 and EP4 for the prevention or treatment of metastatic breast cancer.

"Antibody therapeutics against GPCRs have tremendous potential in treating cancer due to their exquisite specificity, high affinity and low toxicity relative to small molecules. However, despite intense efforts to develop them, only one GPCR targeted therapeutic antibody has gained approval in the world," said Mauro Mileni, Ph.D., Abilita Bio’s CEO and principal investigator on this grant. "We expect the use of EMPs as antigens to dramatically increase the probability of discovering new therapeutic antibodies to treat serious diseases, while reducing costs and development timelines."

About GPCRs
G Protein-Coupled Receptors (GPCRs) represent the largest class of membrane proteins in humans, and bind almost all of the known neurotransmitters and hormones that are released synaptically or secreted into the circulatory system. GPCRs are expressed in all tissue types and organs, and are associated with many diseases. The GPCR super-family includes approximately 400 medically relevant targets. To date more than 110 receptors have been exploited as drug targets, while most of the remaining receptors are orphan (130) or under-characterized.