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 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 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that two posters will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), being held in Copenhagen, Denmark, October 7-11, 2016 (Press release, Endocyte, SEP 29, 2016, View Source [SID:SID1234515513]).

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Presentations are as follows:

Abstract #: 731P
Title: "Phase 1 Study of the PSMA-Targeted Tubulysin Small-Molecule Drug Conjugate EC1169 in Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC): Study Update"
When: Sunday, Oct. 9, 2016, from 1 – 2 PM CEST
Session ID: Poster Display
Location: Hall E
Presenter: Michael J. Morris, M.D., Memorial Sloan Kettering Cancer Center

Abstract #: 395P
Title: "Dose Escalation Phase 1, Safety and Pharmacokinetic Study of the Folate Receptor-Targeted Drug Conjugate EC1456 in Advanced Cancer Patients: Study Update"
When: Monday, Oct. 10, 2016, from 1 – 2 PM CEST
Session ID: Poster Display
Location: Hall E
Presenter: Jasgit C. Sachdev, M.D., Virginia G. Piper Cancer Center at HonorHealth/TGen

About EC1169 and 99mTc-EC0652

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a releasable linker system to a potent cytotoxic microtubule inhibitor, tubulysin B hydrazide (TubBH). The high affinity of EC1169 for PSMA allows for the active and specific delivery of TubBH to PSMA-expressing cancer cells, while minimizing exposure to normal cells. PSMA is known to be highly expressed on the majority of prostate cancers with limited expression on normal tissues. The PSMA-targeted companion imaging agent 99mTc-EC0652 is being co-developed to characterize whole body PSMA expression in real time, to identify patients most likely to benefit from EC1169 therapy. EC1169 and 99mTc-EC0652 are currently being evaluated in a phase 1 study in patients with metastatic, castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02202447).

About EC1456 and 99mTc-etarfolatide

EC1456 is an investigational therapeutic SMDC constructed of folic acid conjugated through a spacer and releasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. The high affinity of the folic acid ligand for the folate receptor (FR) allows for the active and specific targeting of EC1456 to FR-expressing cancer cells. The FR is highly expressed in several epithelial cancers (e.g. ovarian, NSCLC) but is expressed at low levels in most normal tissues. 99mTc-etarfolatide is an FR-targeted companion imaging agent being co-developed to characterize whole body FR expression in real time, to identify patients most likely to benefit from EC1456 therapy. EC1456 and 99mTc-etarfolatide are currently being evaluated in a phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).

On September 29, 2016 Boehringer Ingelheim and Sarah Cannon Research Institute, the research arm of Sarah Cannon, the global cancer institute of HCA, reported a new strategic collaboration (Press release, Boehringer Ingelheim, SEP 29, 2016, View Source [SID:SID1234515516]). This partnership brings together Boehringer Ingelheim’s extensive experience in cancer drug development and Sarah Cannon’s expertise and leadership in designing and optimizing clinical trials. The partnership will help bring innovative cancer treatments to patients with unmet medical needs.

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The joint clinical development programme will study Boehringer Ingelheim’s BI 754091(anti- PD-1) and BI 754111 (anti-LAG 3) monoclonal antibodies for the combination treatment of multiple cancers with high unmet medical needs, including non-small cell lung cancer (NSCLC). BI 754091 and BI 754111 are immune checkpoint inhibitors designed to rally the patient’s own immune system – which is often suppressed by the tumor – to fight cancer. As both compounds interact with the immune system at different points, the combination treatment approach is expected to result in better anti-tumor response, potentially leading to improved outcomes for patients. Following preliminary findings, the collaboration could be expanded beyond the initial research focus.

"Clinical research is a critical component of finding more effective therapies for patients across different cancer types," said Howard A. "Skip" Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. "We are committed to advancing treatment options through more targeted methods for patients fighting cancer. By collaborating with Boehringer Ingelheim’s oncology research teams, we can further our understanding of immunotherapies and bring these cutting-edge treatment options into the community more rapidly for patients."

"We are excited to partner with the scientific experts at Sarah Cannon to boost the development of two immune-oncology candidates from Boehringer Ingelheim’s broad oncology pipeline," said Dr. Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim. "This collaboration is an important part of our commitment to the area of immune oncology and complements our ongoing research efforts to develop therapeutic cancer vaccines or cancer-fighting viruses as well as in the development of novel targeted therapies."

Through Sarah Cannon Development Innovations, a full-service, oncology-focused contract research organization (CRO), Sarah Cannon will provide comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. The collaboration will enable rapid patient enrollment to clinical trials through Sarah Cannon’s extensive network across the U.S. and UK. Sarah Cannon is one of the world’s leading clinical research organizations, conducting more than 220 first-in-human studies to date and enrolling more than 2,000 patients each year on innovative clinical trials.

On September 28, 2016Genomic Health, Inc. (Nasdaq: GHDX) reported that the company will present results from nine studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, which will take place October 7-11 at the Bella Center in Copenhagen, Denmark (Press release, Genomic Health, SEP 28, 2016, View Source [SID:SID1234515482]). The results will include:

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Analytical validation study results for the recently launched Oncotype SEQ Liquid Select test. Oncotype SEQ is the first non-invasive liquid biopsy test that the company is delivering through its Oncotype IQ Genomic Intelligence Platform.
Two presentations highlighting updated prospective outcomes from a large population-based observational study based on the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI). The primary SEER Registry study results, published in Nature Partner Journals Breast Cancer, demonstrated that the Oncotype DX Breast Recurrence Score accurately predicted prospective patient outcomes in more than 44,500 patients, including those with node-negative and node-positive breast cancer. The updated results to be presented at ESMO (Free ESMO Whitepaper) will include an additional year of patient data and an additional year of follow-up for patients included in the original study.
New prospective outcomes data on the Oncotype DX Breast Recurrence Score from a multi-center study in node-positive disease from Clalit Health Services, the largest health maintenance organization in Israel.
Five international studies demonstrating the value of the Oncotype DX Breast Recurrence Score on treatment decisions in Canada, the Czech Republic, Italy and Spain. These studies include new prospective clinical utility evidence for node-positive disease and results on the clinical impact of Oncotype DX beyond immunohistochemistry for Ki-67.
The ESMO (Free ESMO Whitepaper) abstracts are now available at www.esmo.org. Following are details for each presentation (all times are in Central European Summer Time):

Friday, October 7

Abstract: 146 O
Proffered Paper Session: "Outcome disparities by age and 21-gene recurrence score (RS) result in hormone receptor positive (HR+) breast cancer (BC)"
Author: S. Shak, M.D.
Location: Stockholm
Time: 16:00 – 17:30
Saturday, October 8

Abstract: 147 PD
Poster Discussion Session: "First prospectively-designed outcome study in estrogen receptor (ER)+ breast cancer (BC) patients (pts) with N1mi or 1-3 positive nodes in whom treatment decisions in clinical practice incorporated the 21-gene Recurrence Score result"
Authors: S. Stemmer, M.D.
Location: Berlin
Time: 15:00 – 16:00

Abstract: 150 PD
Poster Discussion Session: "Breast cancer-specific survival in > 4,600 patients with lymph node-positive (LN+) hormone receptor-positive (HR+) invasive breast cancer (BC) and 21-gene Recurrence Score (RS) results in the SEER registries"
Authors: D.P. Miller
Location: Berlin
Time: 15:00 – 16:00
Monday, October 10

Abstract: 175 P
Poster Display: "First prospective multicenter Italian study on the impact of the 21-gene Recurrence Score (RS) in adjuvant clinical decisions for ER+/HER2- early breast cancer patients"
Author: M.V. Dieci
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 181 P
Poster Display: "Budget impact analysis of the 21-gene assay (Oncotype DX Breast Cancer) for the breast cancer treatment in the Basque country"
Author: Toribio, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 177 P
Poster Display: "The impact of the 21-gene assay in the Czech Republic on adjuvant chemotherapy (CT) recommendations and costs in estrogen receptor positive (ER+) early stage breast cancer (ESBC) patients with grade 2 tumors and risk factors"
Author: K. Petrakova, M.D., Ph.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 180 P
Poster Display: "Use of Oncotype DX Recurrence Score (RS) reduces chemotherapy (CT) beyond treatment decisions using Ki67-based determinations of luminal A and B breast cancer subtypes: A retrospective study in the Spanish population"
Author: L. Garcia-Estevez, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 183 P
Poster Display: "Prospective evaluation of the impact of the 21-gene Recurrence Score assay on adjuvant treatment decisions for women with node-positive breast cancer in Ontario, Canada"
Author: S. Torres, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 1162 P
Poster Display: "Analytical performance of a new liquid biopsy mutation panel for detection of clinically actionable variants"
Author: C. Svedman, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. With more than 600,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.