On September 29, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported the appointment of Christine Cassiano as Senior Vice President of Corporate Communications and Investor Relations (Press release, Kite Pharma, SEP 29, 2016, View Source [SID:SID1234515519]). She will also sit on the company’s Executive Committee. In this new position, Cassiano will be responsible for transforming Kite’s communications function to keep pace with the company’s expanding pipeline of chimeric antigen receptor (CAR) and T-cell receptor (TCR) product candidates to treat both hematological (blood-based) and solid cancers.

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"Christine arrives at a key inflection point for Kite as we advance our CAR-T and TCR pipeline toward key company milestones, including our BLA submission for KTE-C19 with the FDA, and evolve Kite into a commercial organization," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "Christine’s progressive communications approach and vast experience will allow us to enhance our education of key audiences on the changing cancer treatment paradigm, the value of CAR-T therapy, and our role in its innovation."

With a dual background in investor and public relations, Christine has an extensive history developing innovative approaches that advance communications in corporate positioning, issues management, employee engagement, commercialization and investor relations.

"My enthusiasm for Kite’s groundbreaking research goes beyond my professional drive to innovate healthcare communications – it is also deeply personal," said Cassiano. "Like many who have lost a loved one to cancer, I understand first-hand the optimism and promise scientific progress offers to patients whose lives depend on significant breakthroughs in care. I am eager to further the understanding of Kite’s role in advancing breakthrough therapies for cancer."

Cassiano was most recently Head of Healthcare for the W2O Group, an integrated healthcare marketing and communications consulting firm. She previously co-founded ARC2 Communications & Media, a boutique agency that developed groundbreaking platforms for some of the largest companies in healthcare. Her more than 20-year career includes multiple product launches across various therapeutic areas such as Botox/Botox Cosmetic (onabotulinumtoxinA), Prolia (denosumab), Abraxane (paclitaxel) and Lumigan (bimatoprost ophthalmic solution) as well as leading global efforts as Senior Vice President & Co-Director, Healthcare at Hill + Knowlton Strategies. Cassiano has held senior communications roles at biotechnology and pharmaceutical companies such as Amgen, Allergan and Abraxis BioScience. Some of Cassiano’s career achievements include a SABRE Silver Anvil award for the launch of Botox Cosmetic (Allergan), an In2 SABRE Award for the Most Innovative Brand/Agency Collaboration (Pfizer/ARC2), and PR Week’s 40 Under 40.

On September 29, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the completion of a strategic review of its operations (Press release, ImmunoGen, SEP 29, 2016, View Source [SID:SID1234515518]). As a result of this initiative, the Company will reduce its workforce by 17% and seek to partner its non-core B-cell lymphoma programs, creating a stronger organization focused on delivering innovative ADC therapies that meaningfully improve the lives of cancer patients.

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"I am grateful for the contributions that the employees affected by this plan have made to ImmunoGen, and we will be supporting them through this transition," stated Mark Enyedy, President and CEO of ImmunoGen. "We have taken this necessary step to build a leaner and more agile organization, better positioned to execute on our strategic objectives. As part of this effort, we restructured our Technical Operations, substantially reduced G&A, and revised our approach to managing clinical trials. By adapting how we work and aligning our portfolio priorities, we will improve operating performance, extend our cash position, and enable the Company to create value on a sustainable basis. I am confident this plan will allow ImmunoGen to achieve its tremendous potential."

Through this plan, ImmunoGen will realize significant cost savings over the next two years in headcount, program, and support activities. These savings will include approximately $11 million per year relating to the elimination of 65 positions, primarily in Technical Operations and G&A functions. Going forward, the Company expects to focus investment principally on strategic growth initiatives, including conducting the mirvetuximab soravtansine Phase 3 pivotal trial and accelerating the development of its IGN programs, IMGN779 and IMGN632.

Based on its strong cash position and the savings generated from this strategic review, ImmunoGen expects to achieve its previously-stated goal of funding operations through the interim analysis of the mirvetuximab soravtansine pivotal trial and into mid-2018. This cash runway excludes any revenue generated from potential new product partnering deals. As a result of the workforce reduction, ImmunoGen will record a one-time charge totaling approximately $3.5 million related to termination benefits and other related expenses. The majority of this charge is expected to be recorded in the quarter ending September 30, 2016.

In addition, the Company has prioritized its portfolio and aligned its resources to deliver on key development milestones and drive innovation in oncology, including:

Executing a speed-to-market strategy to obtain full marketing approval for lead program mirvetuximab soravtansine, which will enter Phase 3 development next quarter;
Accelerating its earlier-stage portfolio of highly innovative IGN programs – IMGN779, IMGN632; and
Maintaining critical scale in Research to support continued innovation in ADCs as well as existing and new partnerships.
As part of this effort and the prioritization of its IGN programs, ImmunoGen will seek to monetize its non-core B-cell assets – IMGN529 and coltuximab ravtansine – through partnering with interested parties.

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 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 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.