On January 6, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, reported the signing of an agreement with Mirna Therapeutics (NASDAQ: MIRN), for a worldwide sublicense to Rosetta’s patents related to therapeutic uses of certain microRNA technologies (Filing, 6-K, Rosetta Genomics, JAN 6, 2016, View Source [SID:1234508680]). Schedule your 30 min Free 1stOncology Demo! The agreement includes an exclusive sublicense related to Mirna’s MRX34 product candidate, a mimic of naturally occurring microRNA-34 being evaluated in clinical studies for a variety of cancers.
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Under the terms of the agreement, Rosetta Genomics will receive an upfront payment of $1.6 million from Mirna, and is eligible for low single-digit royalties on product sales and potential milestone payments and sublicense fees. The sublicensed patents are jointly owned by YEDA Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science, and Rosetta Genomics. As such, YEDA is entitled to a portion of these and other proceeds Rosetta may receive under the agreement with Mirna.
"We are pleased to execute this agreement with Mirna as it underscores the value of our leading intellectual property position in microRNA technology and represents a new avenue through which we can create value by leveraging our extensive patent portfolio," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We look forward to Mirna pursuing the potential of microRNAs as new and effective cancer therapeutics and believe microRNAs can play an important role in developing treatments for different cancers."
Year: 2016
Washington University in St. Louis Initiates Clinical Study of Verastem’s VS-6063 in Combination with Merck’s Pembrolizumab and Gemcitabine in Pancreatic Cancer
On January 6, 2016 Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to treat cancer reported the initiation of a Phase 1 dose-escalation study at Washington University to evaluate Verastem’s FAK inhibitor VS-6063 in combination with Merck’s PD-1 inhibitor pembrolizumab and gemcitabine in patients with pancreatic cancer (Press release, Verastem, JAN 6, 2016, View Source [SID:1234508677]). This is the first of several combination clinical trials the Company expects to initiate this year. Schedule your 30 min Free 1stOncology Demo! This Phase 1 clinical trial is anticipated to enroll approximately 50 patients and is being conducted at the Washington University School of Medicine’s Division of Oncology under the direction of Andrea Wang-Gillam, MD, PhD, Clinical Director of the Gastrointestinal Oncology Program.
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"As recently published in Cell, preclinical studies strongly suggest that the inhibition of focal adhesion kinase combined with checkpoint inhibition may potentiate a more significant tumor immune response leading to both tumor shrinkage and durable disease control," said Dr. Wang-Gillam. "This trial is primarily designed to evaluate the safety of the combination and may also provide a greater understanding of how FAK inhibition in combination with immunotherapies could improve outcomes for patients with pancreatic cancer, one of the most deadly of all cancer types."
This clinical study is supported by a growing body of preclinical research suggesting that focal adhesion kinase (FAK) inhibition, when combined with PD-1 inhibitors, increases the anti-tumor activity of these immunotherapeutic agents. As published in the September 24th, 2015 issue of the journal Cell, and presented at the recent NCI/AACR/EORTC and SITC (Free SITC Whitepaper) conferences, FAK inhibition has been shown to increase cytotoxic (CD8+) T cells in tumors, decrease T cell exhaustion, decrease immunosuppressive cell populations, enhance T cell killing of tumor cells, and create a generally more favorable tumor microenvironment, which allows for enhanced efficacy of immuno-oncology therapeutics.
In addition to other "cold" tumors like glioblastoma and prostate, pancreatic cancer is a tumor type in which immunotherapeutics have achieved limited clinical benefit, possibly due to the dense desmoplastic stroma and the presence of high numbers of immunosuppressive cells. Pre-clinical research has demonstrated that high stromal density prevents anti-cancer agents and T cells from entering pancreatic tumors thereby limiting efficacy. In addition, FAK inhibition has been shown to reduce stromal density and allow cytotoxic T cells to better penetrate the tumor and kill the cancer cells. Collectively, these data provide strong rationale for combining Verastem’s FAK inhibitors with checkpoint inhibitors in the clinic for pancreatic cancer.
"This combination trial marks the launch of a new clinical development program at Verastem which is focused on advancing our FAK inhibition program in combination with immuno-oncology agents and other current and emerging standard of care treatments," said Robert Forrester, Verastem President and Chief Executive Officer. "We anticipate initiating additional clinical trials this year to evaluate our FAK inhibitors in combination with other treatments, and the data generated will further inform the continued development of our innovative anti-cancer therapeutics."
About Focal Adhesion Kinase
Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds designed to target cancer stem cells through the potent inhibition of FAK. Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for their ability to improve patient survival through the targeting of cancer stem cells, potentiation of an immune response against cancer cells and reduction in the stromal density encapsulating a tumor.
Peregrine Pharmaceuticals and National Comprehensive Cancer Network (NCCN) Form Clinical Collaboration to Evaluate Novel Cancer Treatment Combinations With Bavituximab
On January 06, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body’s immune system to fight cancer, reported a new research collaboration with the National Comprehensive Cancer Network (NCCN) to expand the company’s ongoing clinical research and development of bavituximab for the treatment of a range of tumors (Press release, Peregrine Pharmaceuticals, JAN 6, 2016, View Source [SID:1234508676]). Schedule your 30 min Free 1stOncology Demo! NCCN, a not-for-profit alliance of 26 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN’s Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
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Bavituximab is an investigational immunotherapy designed to assist the body’s immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine’s PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer. According to Peregrine, a broad set of preclinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.
"This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine’s internal investigator sponsored trial (IST) program," said Steven W. King, president and chief executive officer of Peregrine. "Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group’s oversight of the program will allow for the conducting of many more studies than would have been otherwise possible."
"NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab," said Robert C. Young, MD, Interim Vice President, ORP, NCCN. "We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions."
Peregrine expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments. Bavituximab is currently being evaluated in combination with docetaxel (chemotherapy) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In addition, as part of its recently formed collaboration with AstraZeneca, Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated squamous or non-squamous NSCLC. The company will also be evaluating bavituximab with chemotherapy combinations in HER2-negative breast cancer.
About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS, which is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.
OXiGENE Receives U.S. Orphan Drug Designation for CA4P to Treat Neuroendocrine Tumors
On January 06, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CA4P for the treatment of neuroendocrine tumors (Press release, OXiGENE, JAN 6, 2016, View Source [SID:1234508675]). The designation provides for seven years of marketing exclusivity following product approval. CA4P has previously received orphan drug designation from the FDA for the treatment of ovarian cancer. Schedule your 30 min Free 1stOncology Demo! "I am pleased that the FDA has provided the orphan designation to CA4P for neuroendocrine tumors," stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. "Their grant of this designation is timely, as we have recently completed enrollment in our phase 2a clinical trial of CA4P in both gastrointestinal and pancreatic neuroendocrine tumors. We expect final data from this trial to be available later in 2016." Know more, wherever you are: Orphan designation can be granted by the FDA to product candidates that are intended to treat rare diseases that generally affect fewer than 200,000 people in the United States.
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MabVax Therapeutics Files IND for a Phase I Clinical Trial with 89Zr-HuMab-5B1
On January 6, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for 89Zr-HuMab-5B1, the Company’s fully human antibody product, as a new generation PET scan cancer imaging agent (Press release, MabVax, JAN 6, 2016, View Source [SID:1234508673]). Schedule your 30 min Free 1stOncology Demo! Subject to FDA authorization to proceed, MabVax plans to initiate the Phase I clinical trial in patients with pancreatic cancer in early 2016.
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The 89Zr-HuMab-5B1 imaging agent has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of pancreatic cancer patients and an attractive companion diagnostic for the HuMab-5B1 therapeutic product. In December 2015, MabVax received the FDA’s authorization to proceed with HuMab-5B1 in a Phase I trial as a therapeutic treatment for patients with pancreatic cancer.
This second planned Phase I trial will evaluate the safety, pharmacokinetics and biodistribution of 89Zr-HuMab-5B1 in cancer patients. The trial will also determine the ideal dose and conditions for an optimal PET scan image using the new imaging agent.
David Hansen, MabVax’s President and Chief Executive Officer, said, "With the submission of this second IND in late December, we have achieved our objective of filing both INDs for our HuMab-5B1 based products during 2015. We are making preparations to begin the Phase I trial with HuMab-5B1 as a therapeutic agent and, subject to FDA authorization to proceed with this second clinical trial, will begin dosing our first patients in the 89Zr-HuMab-5B1 Phase I trial soon thereafter."
"We anticipate that the Phase I trial with 89Zr-HuMab-5B1 will produce an initial set of images by mid-year 2016. This will be an important interim milestone in our continued development of this diagnostic product and could have a positive impact on our future commercial and corporate development activities. We expect to complete patient enrollment in this trial before the end of 2016," added Mr. Hansen. "We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab-5B1, as well as with follow-on antibodies under development at MabVax."
About HuMab-5B1:
MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the HuMab-5B1 antibody demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.