On September 29, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused biotechnology company, reported positive data from the second cohort of patients enrolled in its orphan-drug designated Phase I study of CLR 131 in patients with relapsed or refractory multiple myeloma. Following these outcomes, the study’s Data Monitoring Committee approved patient enrollment to the third cohort, which will include a 33 percent dose increase from 18.75 to 25mCi/m2 of CLR 131 from the previous cohort (Filing, 8-K, Cellectar Biosciences, SEP 29, 2016, View Source [SID:SID1234515512]).

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All evaluable study participants (n=8) have achieved stable disease and progression-free survival (PFS), which includes four evaluable patients from Cohort 1 and four evaluable patients from Cohort 2. To date, Cohort 2 subjects have attained an average increase in PFS of greater than 30 percent as compared to Cohort 1. Cellectar continues to follow patient outcomes within Cohort 2, including PFS. After these patients have fully completed the study, the company looks forward to providing additional study data, including the full extent of the increase in PFS from Cohort 2 over Cohort 1. While patients in Cohort 2 received a 50 percent increase in dose, they did not experience a proportional increase in adverse events and demonstrated a similarly favorable safety and tolerability profile as experienced by patients in Cohort 1.

"As seen in the results to date, CLR 131 has demonstrated an outstanding safety profile in heavily pretreated, relapsed or refractory multiple myeloma patients with limited treatment options," stated Natalie Callander, MD, Associate Professor of Medicine, Director, University of Wisconsin Carbone Cancer Center Myeloma Clinical Program, and the study’s lead investigator. "I am excited that Cellectar will open the next treatment cohort to offer patients access to this novel treatment’s encouraging efficacy signals."

In this multi-center, open label Phase I dose escalation study, CLR 131 is administered as a single dose, 30-minute infusion. The primary study objective is to characterize the safety and tolerability of CLR 131 in patients with relapsed or refractory multiple myeloma. Prior to enrollment, all study participants had received a minimum of three systemic regimens and up to 12 lines of therapy. Many also received a stem cell transplant. Secondary study objectives include establishment of a recommended Phase II dose, both with and without dexamethasone, as well as an assessment of therapeutic activity.

"This important clinical milestone further validates the potential of our patented PDC delivery platform as well as the clinical benefits of CLR 131 for the treatment of an extremely challenging hematologic cancer," said Jim Caruso, president and CEO of Cellectar Biosciences. "We are focused on successfully executing this Phase I Study for relapsed or refractory multiple myeloma, as well as initiating our National Cancer Institute-supported Phase II study to further explore dose, regimen and clinical utility of CLR 131 in multiple myeloma and other selected hematologic malignancies with unmet medical need."

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first half of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides patients with a novel approach to treating hematological diseases and may provide patients with an improvement in progression-free survival and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Its phospholipid ether (PLE) carrier platform was deliberately designed to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

On September 29, 2016 Transgenomic, Inc. (TBIO) (NASDAQ: TBIO), reported that it has signed agreements with two additional distributors in China and India for its ICEme Mutation Enrichment Kits for cancer genomic testing (Press release, Transgenomic, SEP 29, 2016, View Source [SID:SID1234515504]). The kits incorporate Transgenomic’s Multiplexed ICE COLD-PCR (MX-ICP) technology and are designed to enable virtually any laboratory to conduct high quality DNA mutation detection in cancer patients using plasma, blood or tissue samples and existing sequencing platforms. The new distributors, JoyingBio in China and Biotron Healthcare in India, are important suppliers of advanced life science products in their respective markets.

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"Asia represents large and growing healthcare sectors, and our ICEme Kits will allow researchers and clinicians in the rapidly expanding markets of China and India to use the sequencing platforms already in their labs to conduct sophisticated genetic analyses to accelerate cancer research and advance patient care," commented Paul Kinnon, President and Chief Executive Officer of Transgenomic. "We decided to work with these new distributors in response to the increasingly robust demand we are seeing in Asia for our ICEme Kits, which we believe reflects the exceptional accuracy, versatility and ease of use of our unique ICP technology."

ICEme technology delivers up to a 500-fold increase in mutation detection compared to most current methods, with levels of detection routinely achievable down to 0.01%. This ultra-high sensitivity enables detection of low level mutations that allow accurate patient monitoring as well as stratification of cancer sub-populations. ICEme Kits work well with most patient samples, including tissue, blood, plasma, urine and other biofluids. The kits are simple to use and work with most of the downstream genomic analytic platforms commonly available in laboratories today. They are easily customizable for use with single mutations or in combination. The current menu includes approximate 20 clinically relevant, actionable mutations that are associated with important cancers such as colorectal, lung, breast and melanoma. Additional mutations are being added on an ongoing basis.

Additional information on the ICEme kits is available at www.transgenomic.com/products/iceme-kits-overview/.

Multiplexed ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

On September 29, 2016 Tempus, a health-tech company focused on helping doctors personalize cancer care, and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University reported a partnership to pursue their shared goal of providing precision medicine to cancer patients (Press release, Tempus, SEP 29, 2016, View Source [SID:SID1234515503]). Tempus will serve as a preferred partner to handle genomic sequencing and analysis as part of Lurie Cancer Center’s new OncoSET initiative.

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"We have built a platform to modernize cancer care by merging powerful analytics with cutting edge bioinformatics to empower physicians to make data-driven decisions tailored to each patient," said Eric Lefkofsky, Co-founder and CEO of Tempus. "With thousands of clinical trials opening all the time, and with advances in targeted therapies, including the emergence of immunotherapies, it is more important than ever to understand what is happening to a patient at a molecular level."

Lurie Cancer Center launched the OncoSET (Sequence, Evaluate, Treat) Program on Northwestern Medicine’s Chicago campus to provide personalized care and customized treatments for patients with cancer. OncoSET’s precision medicine approach to cancer care combines genomic sequencing and sophisticated molecular analysis with pathology to identify new, individually tailored treatments and clinical trials for patients whose cancers are resistant to traditional therapies.

"We are pleased to partner with Tempus to achieve our shared vision of taking precision medicine to the next level," said Leonidas Platanias, MD, PhD, Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "Lurie Cancer Center launched OncoSET to deliver personalized, effective cancer treatments to patients who currently have limited options. In the rapidly evolving landscape of precision medicine, our ability to leverage Tempus’ expertise in bioinformatics and technology infrastructure will be a major asset in OncoSET’s arsenal of targeted therapies and novel clinical trials."

"Oncologists and pathologists need modern and easy-to-use tools to keep up with the ever-increasing amount of data that is being generated during the course of a patient’s treatment," said Kevin White, President of Tempus. "We have built a technology infrastructure that can gather, store and analyze large amounts of molecular data that match clinical trials and new therapeutic options. This allows physicians to make use of the most information available when making treatment decisions for their patients."

Tempus, founded in 2015, has built a technology platform that can gather large amounts of molecular data, combine it with phenotypic and therapeutic data and analyze it, looking for clinically relevant patterns. Tempus has recruited a world-class team of accomplished geneticists, computational biologists, data scientists and software engineers who have developed software and analytic tools that work within a hospital’s existing infrastructure to analyze data and provide decision support for physicians whose patients are not responding to conventional therapies.

On september 29, 2016 Elekta (EKTA-B.ST) reported that its high-field MR-linac was the focus of multiple presentations at the American Society for Radiation Oncology (ASTRO) 2016 Annual Meeting, held September 25 – 28 in Boston (Press release, Elekta
, SEP 29, 2016, View Source [SID:SID1234515500]). Additional abstracts presented by members of Elekta’s MR-linac Consortium also highlight the need for adaptation of radiation therapy to address moving tumors and nearby organs during treatment sessions. Naturally occurring physiological movements limit our ability to conform the treatment to the target and increase exposure of radiation to healthy tissues.

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Elekta’s MR-linac will integrate an advanced linear accelerator and a 1.5 Tesla magnetic resonance imaging (MRI) system. Combined, these systems will allow for simultaneous radiation therapy delivery and high-field MR tumor monitoring.

A joint session of ASTRO and the European Society for Radiation Oncology (ESTRO) highlighted the potential for adaptive imaging in radiation therapy during a session titled "In Room Adaptive Imaging with a Focus on MRI." (View Source;sp=-1) Elekta’s MR-linac was featured in two presentations during this session:

· "Linac-based MR Device"; Christopher Schultz, MD, FACR, Professor in the Department of Radiation Oncology at Froedert and Medical College of Wisconsin. This presentation discussed strategies for integrating MR-linac into current RT protocols and provided an overview of the development plan that the Elekta MR-linac Consortium is undertaking in order to generate the clinical, physics and quality control data that will be essential for developing and realizing the full clinical potential of MR-linac technology.

· "MRI Linac: Physics Perspective"; Bas Raaymakers, PhD, Professor in the Department of Radiotherapy at University Medical Center Utrecht. This presentation highlighted the potential to leverage the power of MR-linac technology to move from pre-treatment planning to online plan adaptation and, ultimately, to real-time plan adaptation. Dr. Raaymakers also discussed the need for novel quality assurance procedures for MR-linac devices, patients and workflow.

"Online treatment adaptation is the future of radiation therapy and it is essential for enabling surgical precision and accuracy," said John Christodouleas, MD, MPH, Vice President of Clinical Affairs, Elekta, and a practicing radiation oncologist at the Hospital of the University of Pennsylvania. "The Elekta MR-linac Consortium is advancing MR-linac technology toward the clinic. Data demonstrating the feasibility of MR-linac in breast, non-small cell lung cancer and other cancers also highlight required advances in the software and computer algorithms that are critical to transforming online imaging into actionable adaptive replanning."

Additional key findings related to the MR-linac Consortium’s development of MR-linac presented at the conference include:

· Abdominal organ motion is complex and can occur despite motion management strategies. Abstract #3708: "Complex Abdominal Organ Motion Assessed from MRI"; (View Source(16)32699-2/fulltext) Eenas Omari, PhD, Postdoctoral Fellow in the Department of Radiation Oncology at Medical College of Wisconsin.

· Substantially improves targeting and lowers radiation dose to normal breast tissue in patients undergoing pre-operative partial breast irradiation. Abstract #3695: "Dosimetric Feasibility of Pre-operative Partial Breast Irradiation in Prone Position Using MR-linac" (View Source(16)32685-2/fulltext); Phil Prior, PhD, Medical Physicist in the Department of Radiation Oncology at Medical College of Wisconsin.

· Clinically acceptable treatment plans for patients with locally advanced non-small cell lung cancer can be created. Abstract #3150: "Dosimetric Implications for Radical Radiotherapy on the MR-linac (MRL) in Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)"; (View Source(16)32129-0/fulltext) Dr. Hannah Bainbridge, Clinical Fellow Lung Team, The Institute of Cancer Research, Sutton, United Kingdom, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom.

· Online adaptive replanning is feasible for prostate cancer radiation therapy. Abstract #3639: "A Hybrid Adaptive Replanning Approach for Prostate SBRT"; (View Source(16)32627-X/fulltext) Ozgur Ates, PhD, Postdoctoral Fellow in the Department of Radiation Oncology at Medical College of Wisconsin.

· An automated QA tool can quickly identify contour errors from auto-segmentation and may have utility in online adaptive replanning. Abstract #3638 "Implementation of a Machine-learning Based Automatic Contour QA Tool for Online Adaptive Radiotherapy of Prostate Cancer" (View Source(16)32626-8/fulltext); Jing Qiao Zhang, PhD, Postdoctoral Fellow in the Department of Radiation Oncology at Medical College of Wisconsin.

Several additional presentations described the potential for MR-linac and adaptive therapy to enable dose painting – the precise delivery of varying doses of radiation to specific regions within a tumor in order to account for differences in cell type, location and density from one part of the tumor to another.

"The data presented at this conference support the potential of MR-linac as a key development in the future of radiation therapy and we are encouraged by the Consortium’s progress," said Kevin Brown, Elekta’s Global Vice President of Scientific Research. "The use of integrated, MR imaging to improve radiation therapy is a topic of widespread interest within the community, and Elekta’s MR-linac is poised to deliver an advanced and intuitive treatment experience with the potential to significantly improve patient outcomes and our clinical customer experience."

Elekta’s MR-linac is a work in progress and not available for sale or distribution.

On September 29, 2016 Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, reported that interim safety data from the Company’s NeuVax (nelipepimut-S) Phase 2b combination study will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen, Denmark (Press release, Galena Biopharma, SEP 29, 2016, View Source [SID:SID1234515498]). The clinical trial is a randomized, multicenter, investigator-sponsored, 300 patient Phase 2b study. It is currently enrolling HER2 1+ and 2+ node positive, and high-risk node negative patients to study NeuVax in combination with trastuzumab. Details of the poster presentation are as follows:

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Poster #: 1069P
Abstract #: 3981 – the abstract can be found on the conference website here
Title: Interim safety analysis of a phase II trial combining trastuzumab and NeuVax, a HER2-targeted peptide vaccine, to prevent breast cancer recurrence in HER2 low expression
Date: Sunday, October 9, 2016
Time: 1:00 p.m. to 2:00 p.m. local time
Location: Hall E

About NeuVax (nelipepimut-S)

NeuVax (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).

NeuVax is currently in two breast cancer studies in combination with trastuzumab (Herceptin; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). Phase 2 clinical trials with NeuVax are also planned in patients with ductal carcinoma in situ (DCIS), and in patients with gastric cancer.

About HER2 1+/2+ Breast Cancer

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.