On October 15, 2015 SuviCa Inc. of Boulder, a University of Colorado Boulder biotech start-up company reported that it has been awarded roughly $1.5 million in federal funding to develop novel treatments for head and neck cancer (Press release, suvica, OCT 15, 2015, View Source [SID1234517395]).

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The award to SuviCa is a Phase II Small Business Innovation Research (SBIR) contract from the National Cancer Institute, part of National Institutes of Health and the Department of Health and Human Services. SuviCa was founded in 2010 based on a novel drug-screening technology developed by CU-Boulder Professor Tin Tin Su, SuviCa co-founder and chief scientific officer.

The funding will allow SuviCa to continue development of the drug SVC112, a compound shown to enhance the anti-tumor effects of radiation in animal models of human head and neck cancer, said SuviCa CEO Judy Hemberger. While radiation is a regular therapy used to treat such cancers, it also is associated with potentially devastating side effects and tumor recurrence, she said.

New treatments under development by Su and her colleagues involve small molecules that work together with currently used cancer therapeutics to destroy cancerous tumors, said Hemberger. The lead candidate for treatment currently is a "radiation enhancer" molecule that inhibits a specific process that cancer cells rely on to recover from radiation damage.

The project is being directed by Su and Bert Pronk, SuviCa’s vice president of preclinical development. The team also includes clinicians and scientists at CU-Boulder, the University of Colorado Cancer Center and Colorado State University.

CU’s Technology Transfer Office (TTO) exclusively licensed SVC112, along with related technology, to SuviCa in 2011 and 2012.

"We have very talented researchers at each of these institutions that together are tackling the challenges involved with successfully developing novel treatment options for head and neck cancer," said Su, a professor in CU-Boulder’s Department of Molecular, Cellular and Developmental Biology.

"We are excited to receive continued support from the National Cancer Institute," said Hemberger. "Our goal as a company is to generate innovative ways to improve how we treat cancer patients, and we are pleased that the scientific and business communities recognize that we are working with an important technology."

The small molecules developed by SuviCa target ribosomes, which synthesize proteins inside of cells, said Hemberger. Ribosomes are becoming increasingly recognized as a potential therapeutic target in cancer treatment.

TTO pursues, protects, packages and licenses intellectual property generated from research at the university. Tech Transfer provides assistance to faculty, staff and students, as well as to businesses looking to license or invest in CU technology.

On October 15, 2015 ARMO BioSciences, Inc. (ARMO), a leading developer of immuno-oncology therapeutics and Open Monoclonal Technology, Inc. (OMT ) reported a licensing agreement providing ARMO with exclusive rights to OMT’s Programmed Cell Death Protein 1 (PD-1) assets as well as unlimited access to OMT’s proprietary OmniRat, OmniMouse and OmniFlic human antibody generation platforms (Press release, ARMO BioSciences, 15 15, 2015, View Source [SID:1234513063]).

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"This is an important transaction for ARMO as we transition to our next stage of corporate growth. In particular, securing a PD-1 targeting agent provides us with a complete, efficient and cost- effective combination therapy solution for our next generation cytokine therapies," commented Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences.

The addition of an anti-PD-1 program to ARMO’s pipeline of cytokine immunotherapies reinforces the company’s commitment to the development of safe and effective treatments for cancer. ARMO’s clinical stage PEGylated form of recombinant human IL-10, known as AM0010, and anti- PD-1 antibodies work through complementary but distinct mechanisms on CD8+ T cells so the combination maximizes the activation, proliferation and survival of intratumoral, tumor-reactive, cytotoxic CD8+ T cells, which are considered to be central to clinical response. In ongoing clinical studies, AM0010 has already shown activity as a monotherapy and in combination with anti-PD-1 agents in immune-sensitive tumors such as melanoma, RCC, NSCLC and others not previously thought to be sensitive to immunotherapy such as colorectal and pancreatic cancers. Early results from these trials are suggestive of AM0010’s role in augmenting activated tumor infiltrating T cells and PD-1 expression, thereby bestowing anti-PD-1 sensitivity on tumors, including those that had been refractory to anti-PD-1 treatment.

Dr. Roland Buelow, OMT founder and CEO, said, "ARMO’s focus on discovery and development of novel therapies based on proprietary insights of dysregulated immune responses in cancer and atherosclerotic, fibrotic and inflammatory diseases are particularly amenable to human therapeutic antibodies. We are pleased to enable ARMO to access both OMT’s anti-PD1 antibodies and mono- and bi-specific antibody platforms to further the company’s therapeutic objectives."

On October 15, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that data from the company’s VALOR trial evaluating vosaroxin in older patients with acute myeloid leukemia (AML) will be presented at the AML Clinical Trial Oral Session of the 77th Annual Meeting of the Japanese Society of Hematology (JSH), taking place in Kanazawa, Japan (Press release, Sunesis, OCT 15, 2015, View Source;p=RssLanding&cat=news&id=2097654 [SID:1234507723]). The results are being presented Friday, October 16th at 8:30 a.m. Japanese Standard Time by Robert Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina.
The presentation (Abstract OS-1-82), titled "Patients Age ≥60 Yrs With First Relapsed/Refractory AML Treated With Vosaroxin/Cytarabine vs Placebo/Cytarabine," will be the first presentation in the session, which will take place in Session Room 15 (Emerald A) in Hotel Kanazawa 4F. Detailed results of the VALOR trial were presented in the "Late Breaking Abstracts" session of the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2014. The data presented today at the JSH Annual Meeting were first presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2015.

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"Globally, patients with relapsed or refractory AML are highly underserved, particularly older patients whose prognoses are far poorer," said Shuichi Miyawaki, MD, PhD., Division of Hematology, Tokyo Metropolitan Ohtsuka Hospital, and former vice-president of the Japan Adult Leukemia Study Group. "As in the U.S. and Europe, treatment standards in Japan have not changed significantly in the past several decades. The data from VALOR in patients age 60 years and older show a compelling survival benefit, durable responses and tolerability profile that strongly support the potential for the vosaroxin/cytarabine combination as an important new treatment option for this highly underserved population."

Sunesis recently announced that the company intends to submit a Marketing Authorization Application (MAA) for vosaroxin as a treatment for patients age 60 years and older with relapsed/refractory AML with the European Medicine Agency (EMA) by the end of 2015.

About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that there will be approximately 20,830 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2015. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.

On October 15, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that the first treatment with the Delcath Hepatic CHEMOSAT Delivery System for Melphalan (CHEMOSAT) has been performed in the intrahepatic cholangiocarcinoma (ICC) cohort of the Company’s global Phase 2 clinical trial program for treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer or HCC) and ICC (Press release, Delcath Systems, OCT 15, 2015, View Source;p=RssLanding&cat=news&id=2097545 [SID:1234507719]). A team led by Prof. Thomas J. Vogl, M.D., Director of the Institute for Diagnostic and Interventional Radiology of Johannes Wolfgang Goethe University Hospital, Frankfurt, Germany, treated its first patient on October 13, 2015.

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ICC is a tumor in the bile duct that arises within the liver. It is the second most common primary liver tumor and represents approximately 15% of new HCC cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.

The ICC cohort of the Phase 2 program is designed to investigate the efficacy and safety of CHEMOSAT treatment in patients with unresectable ICC confined to the liver. The study is being conducted at the same hospitals in Europe participating in the Company’s Phase 2 HCC trial. The global Phase 2 HCC/ICC program is evaluating tumor response (objective response rate) as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), and will assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by CHEMOSAT, as well as to assess patient-reported clinical outcomes, or quality-of-life.

"Our team has been involved with CHEMOSAT since February 2012," said Prof. Vogl. "The results we’ve seen in a non-clinical setting certainly warrant formal investigation of this therapy’s potential in cancers like HCC and ICC, and we’re pleased to be working with our colleagues at major European cancer centers on the Delcath global Phase 2 HCC/ICC program."

"ICC patients currently face limited treatment options," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "We believe that a positive efficacy signal in this tumor type and good safety profile may support a regulatory path to a U.S. registration trial, and that consolidated safety data from the HCC and ICC cohorts of this global Phase 2 trial will be valuable information for us to provide to the FDA."