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BioLineRx Announces Initiation of Phase 2a Trial of BL-8040 in Combination With KEYTRUDA® (pembrolizumab) for Treatment of Pancreatic Cancer

On September 20, 2016 BioLineRx Ltd. (NASDAQ/TASE:BLRX) reported the initiation of a Phase 2a trial investigating BL-8040 in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer (Press release, BioLineRx, SEP 20, 2016, View Source [SID:SID1234515229]).

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The Phase 2a study, named the COMBAT study, is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA in up to 30 subjects with metastatic pancreatic adenocarcinoma. The study is designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity. The study will be conducted in the US, Israel and additional territories.

In January 2016, BioLineRx entered into an immunotherapy collaboration with MSD, known as Merck in the US and Canada, to support a Phase 2a study investigating BioLineRx’s BL-8040 in combination with KEYTRUDA in patients with metastatic pancreatic cancer. BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells and to be effective at inducing direct tumor cell death. Additional findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the infiltration of anti-tumor T cells into the tumor. Therefore, when combined with KEYTRUDA, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells, BL-8040 has the potential to enable activated T cells to better reach tumor cells in the fight against pancreatic cancer.

Philip Serlin, Chief Financial and Operating Officer of BioLineRx, stated, "We are looking forward to conducting this combination study of our lead oncology product and MSD’s immune checkpoint inhibitor, which will be the first study of BL-8040 in the exciting and promising field of cancer immunotherapy. We believe that the combination of BL-8040 with KEYTRUDA has the potential to expand the benefit of immunotherapy to cancer types currently resistant to immuno-oncology treatments, such as pancreatic cancer, which represent a significant unmet medical need."

"Furthermore, we view BL-8040’s inhibition of CXCR4, which effects a change in the protective tumor micro-environment, as potentially synergistic with immune checkpoint inhibitors in additional oncological indications. To this end, as announced earlier this month, we have entered into a significant cancer immunotherapy collaboration with another global pharma company to support several Phase 1b studies investigating BL-8040 in combination with another immune check point inhibitor in multiple cancer indications. Upon completion of the expected multiple studies, under collaboration with these two world leaders in cancer immunotherapy, each of the parties will have the option to expand the collaboration to include pivotal registration studies," added Mr. Serlin.

About Pancreatic Cancer

Pancreatic cancers of all types are the seventh most common cause of cancer deaths. According to the American Cancer Society, in 2015, nearly 50,000 were diagnosed with pancreatic cancer and an estimated 40,000 will die from the disease. The most common type of pancreatic cancer is pancreatic adenocarcinoma, which accounts for about 85 percent of cases. These adenocarcinomas start within the part of the pancreas that makes digestive enzymes. There are usually no symptoms in the early stages of the disease and symptoms that are specific enough to suggest the onset of pancreatic cancer typically do not develop until the disease has reached an advanced stage. The five-year survival rate of pancreatic adenocarcinoma is around 7 percent.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About BioLineRx

Sutro ADCs Targeting CD74 Suppress Tumors in Multiple Malignant Cell Lines and Animal Models of Multiple Myeloma and Non-Hodgkin Lymphoma

On September 19, 2016 Sutro Biopharma reported that it has presented findings from two studies of investigational antibody drug conjugates, or ADCs, that it developed to target CD74, a protein highly expressed in hematologic malignancies (Press release, Sutro Biopharma, SEP 19, 2016, View Source [SID1234516951]). The ADCs demonstrated efficient cell killing in multiple malignant B-cell lines and suppressed tumor growth in six mouse tumor models of non-Hodgkin lymphoma and multiple myeloma. The findings were presented Friday, September 16 at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting on Hematologic Malignancies in Chicago.
"The findings demonstrate that CD74 is an ideal target for Sutro’s novel antibody drug conjugates and underscore how we’re accelerating ADC development using Sutro’s proprietary cell-free platform through the late preclinical phase and towards the clinic," Sutro CEO Bill Newell said.
Sutro’s novel ADCs efficiently killed multiple myeloma, mantle cell lymphoma, diffuse large B-cell lymphoma and other Non-Hodgkin lymphoma cell lines in vitro. In vivo, these ADCs significantly reduced tumor growth in ANBL-6, CAG and ARP-1 multiple myeloma models and WSU-DLCL2, OCI-Ly10, SU-DHL-6 lymphoma models.

Glenmark announces Strategic Development and Global Licensing Agreement with Particle Sciences,
Inc., a Lubrizol Company, for generic ABRAXANE®

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]).

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

CNS Oncology Publishes Tumor Treating Fields Treatment Planning and Patient Follow-up Guidelines in Glioblastoma

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.

"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.

Delcath Sponsors Ocular Melanoma Foundation Patient Retreat

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).

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."