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Israeli startup HIL Applied Medical Ltd. acquires US-Based Nanolabz Inc. – en route to developing advanced cancer radiotherapy systems

On May 26, 2016 HIL Applied Medical Ltd. a Jerusalem, Israel medical technology startup reported the acquisition of Nanolabz Inc. – a Reno, Nevada company born out of University of Nevada research and focused on developing and fabricating smart targets for laser-based proton acceleration (Press release, HIL Applied Medical, MAY 25, 2016, View Source [SID:1234512815]). HIL Applied Medical is developing a new class of ultra-compact, high-performance Proton Beam Therapy systems, based on high-intensity lasers and nano-engineered smart targetry.

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"Today’s announcement is important on several levels," Mr. Sagi Brink-Danan, Chief Executive Officer of HIL, said, "The acquisition immediately doubles HIL’s patent portfolio, thus further fortifying our already-strong IP position in our field. It also adds strong, complimentary talent to our team, and provides a strong base for HIL’s US operations. We are looking forward to working together with the NanoLabz and UNR teams towards our joint goal of building the world’s first laser-based cancer proton therapy system."
NanoLabz co-founders Dr. Jesse Adams and Mr. Steven Malekos said they are thrilled to have found a great partner for NanoLabz’ technology with HIL, adding that "we are looking forward to working with HIL’s world-class, committed and capable team on translating cutting-edge technology into products that will benefit cancer patients worldwide."

Co-founder and president of Nanolabz, Mr. Grant Korgan, added: "It’s a joy to see us reach this milestone. It is a testament to hard work and the power of positivity." Mr. Korgan suffered a major spinal cord injury in 2010, and has since become a local and global inspiration, TED-lecturer and sought-after public speaker.

UNR president Dr. Marc Johnson stated that he was pleased to see this milestone, which highlights the institution’s role as an internationally respected, high-impact research university.

What is Proton Therapy: A proton beam is a form of focused radiation used to treat solid tumors. It is superior to traditional radiation therapy (X-Ray, or Photons) in that it reduces damage to surrounding healthy tissue by 2X-6X, thereby reducing toxicities and improving patient survival and quality of life. Proton therapy is used routinely for treating many types of cancer; it is FDA-cleared (510k) and reimbursed by both Federal and private insurers.

Proton Therapy’s Unmet Need: Proton beam therapy can help an estimated 300,000 cancer patients every year in the US – yet last year only 10,000 received it (that’s less than 4%). Protons are arguably the most advanced form of radiation therapy – yet there are only 19 active proton-therapy centers in the US today; compare with over 2,700 traditional (X-Ray) radiation therapy centers. The main barrier to widespread adoption is the large size (football stadium) and high cost ($150-250M) of building and operating a proton therapy center. Single-room solutions are slowly being introduced by some vendors for $30-50M. The key to making protons available to every patient in every midsize hospital is a scalable, add-on, single-room solution for half the current price tag or less. HIL’s technological breakthrough promises to bring about this revolution.

Sunesis Pharmaceuticals Announces Support of First-Ever Acute Myeloid Leukemia Awareness Month in June

On May 25, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported its support for the first-ever Acute Myeloid Leukemia Awareness Month to be held in June. The goal of the campaign, which is being sponsored by CancerCare, is to put a spotlight on the disease, a rare and difficult-to-treat blood cancer that typically affects older adults (Press release, Sunesis, MAY 25, 2016, View Source;p=RssLanding&cat=news&id=2172293 [SID:1234512773]).

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and can worsen quickly if left untreated. According to the National Institutes of Health, it is estimated that there will be 19,950 new cases of acute myeloid leukemia in 2016 and an estimated 10,430 people will die from the disease. AML is more common in older adults, who are also the most difficult to treat, with 67 as the median age of diagnosis. While progress in treating leukemia has been made, there has been only one AML treatment approved by the U.S. Food and Drug Administration in the past 30 years (and that drug was subsequently withdrawn from the market).

Patricia J. Goldsmith, CEO of CancerCare, said, "AML Awareness Month will feature in-depth information about AML on the organization’s website, including a video that features NBA broadcaster Craig Sager who is battling the disease, as well as his son, Craig, Jr., who donated his bone marrow twice in an effort to save his father. The website will also offer people living with AML and their caregivers easy-to-use, informative resources to understand their condition. We thank Sunesis Pharmaceuticals for their unrestricted educational grant which has helped to support the development of these resources."

"We are delighted to be supporting CancerCare’s efforts to raise awareness of acute myeloid leukemia," said Daniel Swisher, Chief Executive Officer of Sunesis. "Because it is a rare disease with an older patient population, there has been little attention focused on AML. As a company that is determined to deliver a new treatment option for this disease, we want to support the AML community by helping to provide more education and information for patients and caregivers."

Goldsmith added, "The AML community’s voice has not always been heard because the disease itself is so rare and the mortality rate is so high. We hope to put a spotlight on AML in June and help focus attention on the urgent need these patients and their families have for hope."

Patients and caregivers can find educational resources on AML online at www.cancercare.org; an unrestricted educational grant from Sunesis has helped to support the development of the informational resources on AML which also includes a patient and caregiver workshop webinar to be held on June 17.

About CancerCare

Founded in 1944, CancerCare is the leading national organization providing free, professional support services and information to help people manage the emotional, practical and financial challenges of cancer. Our comprehensive services include counseling and support groups over the phone, online and in-person, educational workshops, publications and financial and co-payment assistance. All CancerCare services are provided by oncology social workers and world-leading cancer experts. Headquartered in New York, NY, CancerCare maintains three additional locations in Norwalk, CT, Ridgewood, NJ and Syosset, NY.

Iceni Pharmaceuticals launches as new company focusing on repurposing therapies in the field of oncology

On May 25, 2016 Iceni Pharmaceuticals reported its launch as a new company, focusing on developing repurposed and reformulated cancer therapies (Press release, iceni, MAY 25, 2016, View Source [SID:1234512803]).

The company’s lead product Cilcane (generic name cilengitide) is being repurposed by Iceni as a first-in-class treatment for multiple myeloma. Iceni has demonstrated in pre-clinical studies that Cilcane is effective as a combination therapy when given with proteasome inhibitors such as bortezomib, and that this approach may also be applicable to breast and other cancers. Iceni has a broad intellectual property portfolio covering the formulation and methods of use of Cilcane. Cilengitide was formerly in late-stage clinical trials in glioblastoma with Merck Serono.

Iceni Pharmaceuticals is planning a Phase II safety/efficacy trial of Cilcane starting in 2017 aimed at relapsed refractory patients who have already received one prior therapy of proteasome inhibitor. The Company has appointed several leading authorities on cilengitide and multiple myeloma to its scientific advisory board, including:

Annalisa Jenkins, previously Head of Global Research & Development at Merck Serono, during the time cilengitide was in development.
Dr Bruno Osterwalder, previously Senior VP (Oncology) at Merck Serono.
Gareth Morgan, MD, PhD, FRCP, FRCPath, professor of medicine and pathology and director of the Myeloma Institute for Research and Therapy at the University of Arkansas for Medical Sciences (UAMS), one of the world’s foremost myeloma treatment centres.
Dr Horst Kessler, Munich Technical University, and a named inventor of cilengitide.
Dr John March, CEO at Iceni Pharmaceuticals, commented: "We are excited by the prospect of repurposing cilengitide as a novel combination therapy for the treatment of multiple myeloma and building on its established safety profile to improve the clinical outcome and quality of life of patients. Our prestigious team of world renowned scientific advisors are testament to the belief in the product and its potential."

The company’s new corporate website is available at www.icenipharma.com

GlycoMimetics Announces Publication of New Preclinical Data with GMI-1271 in Science Translational Medicine

On May 25, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that the peer-reviewed journal, Science Translational Medicine, has published preclinical research in its May 25 issue pointing to a potential clinical application for GMI-1271 in the treatment of breast cancer (Press release, GlycoMimetics, MAY 25, 2016, View Source [SID:1234512787]). The published study details research in an in vivo model that showed the company’s drug candidate, GMI-1271, a novel E-selectin antagonist, inhibits breast cancer metastasis.

The study provides important new detail on how metastasis from breast cancer can lead to relapse, even if the primary cancer is in remission. The research highlights a possible new application of GMI-1271, currently in a Phase 1/2 clinical trial in AML, as a potential treatment for solid tumors. Data from the study also suggest a possible therapeutic avenue to test GMI-1359, a GlycoMimetics drug candidate that targets both E-selectin and CXCR4, for use as a potential treatment for certain cancers.

"The preclinical data published in an important peer-reviewed journal demonstrate key roles for both E-selectin and CXCR4 in progression of metastatic breast cancer," said John Magnani, Ph.D., Vice President and Chief Scientific Officer of GlycoMimetics and co-author of the study. "The data also provide further evidence of the in vivo activity of GMI-1271 and suggest possible uses of GMI-1271 and GMI-1359 in solid tumors. This is an encouraging development as we progress through preclinical and clinical research of our drug candidates, and provides further rational for developing antagonists against both E-selectin and CXCR4."

The researchers found that breast cancer cells accumulate in regions of the protective bone marrow, an environment rich in E-selectin and SDF-1 (which binds to CXCR4, another molecule associated with cancer cell adhesion and proliferation). GMI-1271, by inhibiting E-selectin, blocks trafficking of breast cancer cells into bone marrow regions where metastasis can become dormant and protected from chemotherapy treatment. At the same time, researchers found that inhibition of CXCR4 as well as of E-selectin could mobilize and excise dormant metastasis from these protective niches and block their reentry, thereby potentially eliminating a common site for metastases and source of relapsed disease. These effects indicate a potential role in treatment of breast cancer not only for GMI-1271, but also for GMI-1359, which inhibits the actions of both E-selectin and CXCR4.

GlycoMimetics plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration in the third quarter of this year for its combined E-selectin-CXCR4 antagonist GMI-1359, initially for treatment of hematologic malignancies.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with AML cells as a targeted approach to disrupting well-established mechanisms of leukemic cell drug resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.

About GMI-1359

GMI-1359 is a compound that targets both E-selectin and CXCR4, which aid in cancer cell resistance to chemotherapy. The compound is in preclinical evaluation. GMI-1359 is a potent dual antagonist of both E-selectin and CXCR4, demonstrating anti-tumor activity in preclinical models of pancreatic cancer, FLT-3+ acute myeloid leukemia (AML), and prostate cancer. GlycoMimetics plans to file an IND for GMI-1359 in the third quarter of 2016.

8-K – Current report

On May 24, 2016 a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc. ("Spectrum"), Allos Therapeutics Inc. (the "Company"), and Teva Pharmaceuticals USA, Inc. ("Teva"), reported that it has entered into a settlement agreement to resolve their patent litigation relating to Folotyn (pralatrexate injection) (Filing, 8-K, Spectrum Pharmaceuticals, MAY 25, 2016, View Source [SID:1234512774]).

As a result of the settlement, Teva will be permitted to market a generic version of Folotyn in the United States on December 1, 2022 or earlier under certain circumstances. Details of the settlement are confidential, and the parties will submit the agreement to the Federal Trade Commission and the Department of Justice. The parties will request that the court enter an order, in which it will dismiss the Company’s litigation against Teva. The Company’s litigation against other generic filers continues. This litigation is described in further detail in Part II, Item 1 of Spectrum’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the U.S. Securities and Exchange Commission on May 6, 2016.