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 19, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported that it will present preclinical data, and preliminary biomarker data from its ongoing Phase 1/1b study of CPI-444 as a single agent, and in combination with Genentech’s TECENTRIQ (atezolizumab)‎, in both oral and poster presentations at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival, which is taking place from September 25-28 in New York (Press release, Corvus Pharmaceuticals, SEP 19, 2016, View Source;p=RssLanding&cat=news&id=2204373 [SID:SID1234515202]).

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Following are details of the oral and poster presentations.

ABSTRACT TITLE: CPI-444: A potent and selective inhibitor of A2AR induces antitumor responses alone and in combination with anti-PD-L1 in preclinical and clinical studies
PRESENTER: Stephen Willingham, Ph.D., senior scientist, Corvus
ORAL SESSION: Plenary Session 2: New Checkpoints
ORAL SESSION DATE, TIME AND LOCATION: Sunday, September 25, 1:30-4:40 p.m. ET, Sheraton Metropolitan Ballroom, Sheraton New York Times Square Hotel
POSTER SESSION: Poster Session A: New Checkpoints
POSTER NUMBER: A048
POSTER PRESENTATION DATE, TIME AND LOCATION: Sunday, September 25, 5:00-7:30 p.m. ET, Americas Hall I, New York Hilton Midtown

On September 19, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on treatments for primary and metastatic liver cancers, reported that the company provided a grant to the Ocular Melanoma Foundation (OMF) in support of the organization’s 6th Annual Eye Am Not Alone (EANA) patient education retreat, held in Miami, Florida at the Bascom Palmer Eye Institute on September 9-11, 2016 (Press release, Delcath Systems, SEP 19, 2016, View Source;p=RssLanding&cat=news&id=2204432 [SID:SID1234515223]). Delcath supported a lecture by Jonathan Zager, M.D., FACS, Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments and a Senior Member at Moffitt Cancer Center, and principal investigator for the Company’s FOCUS Phase 3 Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS Trial).

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The EANA is an annual conference and patient education seminar organized by the OMF and hosted by some of the leading research institutions working on treatments for ocular melanoma. The EANA retreat offers patients and caregivers opportunities to learn about treatment options, clinical trials and other resources available to them as they contend with this difficult to treat cancer.

"Patient advocacy organizations like the OMF are vital sources of support for patients facing an ocular melanoma diagnosis," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We were pleased to sponsor this important conference, and look forward to supporting the mission of the OMF and other patient advocacy organizations working on ocular melanoma in the future."

On September 19, 2016 Glenmark Pharmaceuticals, Inc., USA (Glenmark) reported that it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene’s ABRAXANE product – paclitaxel protein (albumin)-bound particles for injectable suspension (Press release, Glenmark, SEP 19, 2016, View Source [SID:SID1234515301]).

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As per the terms of the agreement, Glenmark has obtained Global Exclusive Marketing and Distribution rights of the product upon commercialization. Particle Sciences will develop this product exclusively for Glenmark, and shall receive certain milestone payments during various stages of the product’s development from Glenmark, including royalties on sales. Development of the product has been initiated for the USA market and Glenmark intends to file the ANDA in FY19. The product will be subsequently filed in other key markets across the globe.

"The partnership is a significant development in Glenmark’s complex generics strategy and we are pleased to collaborate with Particle Sciences given their strong technical capabilities and understanding of particulate injection products. This is a challenging product to develop and we expect it to remain a limited competition opportunity." said Robert Matsuk, President – North America and Global API, Glenmark Pharmaceuticals Limited.

ABRAXANE marketed globally by Celgene has reported sales of USD 967 million world-wide and USD 654 million in the USA in the calendar year 2015. As per IMS MAT December 2015, ABRAXANE has registered sales of USD 990 million world-wide and USD 669 million in the USA.

ABRAXANE is paclitaxel protein (albumin)-bound particles for injectable suspension indicated for the treatment of:
Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated

Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy

Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine

On September 19, 2016 Novocure (NASDAQ:NVCR) reported that CNS Oncology published Tumor Treating Fields (TTFields) treatment planning and patient follow-up guidelines, providing a standardized resource for the use of the NovoTAL System to optimize TTFields intensity in Optune patients with newly diagnosed and recurrent glioblastoma (GBM) (Press release, NovoCure, SEP 19, 2016, View Source [SID:SID1234515225]). Treatment planning with the NovoTAL System is an essential component of treatment with TTFields. The guidelines present a framework for utilizing the NovoTAL treatment planning software to start patients, monitor patient response and evaluate when TTFields treatment should be re-planned.

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"Transducer array placement and TTFields intensity are important factors in the success of treatment with Optune," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "We are pleased that CNS Oncology published treatment planning guidelines and believe the guidelines will advance Optune as a standard treatment option in GBM."

All glioblastoma patients starting Optune should receive treatment planning with the NovoTAL System. In simulation studies, personalized treatment planning with the NovoTAL system resulted in near doubling of TTFields intensity delivered to the tumor compared with TTFields delivered using a default symmetric array layout.

The guidelines explain that there may be a benefit to certified physicians conducting TTFields treatment planning because they have comprehensive information regarding the patients’ medical history, current medical status and knowledge of sequential imaging changes.

"The publication of TTFields treatment planning guidelines in CNS Oncology will increase physicians’ confidence when planning patients’ therapy with TTFields," said Dr. John Trusheim, lead author of the guidelines, Assistant Clinical Professor at the University of Minnesota Medical School and Medical Director of Neuro-oncology at the Virginia Piper Cancer Institute in Minneapolis. "This tool will help inform physicians on how to incorporate Optune into glioblastoma patients’ treatment, potentially resulting in better treatment outcomes."

Novocure’s EF-14 phase 3 pivotal trial data published in The Journal of the American Medical Association in December 2015 demonstrated that adding TTFields to maintenance temozolomide significantly extended progression free and overall survival in newly diagnosed GBM patients versus maintenance temozolomide alone.

About Glioblastoma Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. This means that GBM tumors begin in the brain, rather than traveling to the brain from other parts of the body, such as the lungs or breasts. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in adults than children and to affect men than women.

Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.