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 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 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported it will present interim data from Phase 1b clinical trials of the company’s Wnt inhibitors, vantictumab and ipafricept, at the upcoming ESMO (Free ESMO Whitepaper) 2016 Congress being held October 7-11 in Copenhagen, Denmark (Press release, OncoMed, SEP 29, 2016, View Source [SID:SID1234515491]).

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Vantictumab (anti-Fzd7, OMP-18R5) and ipafricept (FZD8-Fc, OMP-54F28) are each being tested in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. Dr. Colin Weekes of the University of Colorado, an investigator for both Phase 1b clinical trials, will present.

Data from the vantictumab Phase 1b clinical trial will be presented in a poster session on Saturday, October 8 at 1:00 pm CEST:

Abstract #3412; Phase 1b study of WNT inhibitor vantictumab (VAN, human monoclonal antibody) with nab-paclitaxel (Nab-P) and gemcitabine (G) in patients (pts) with previously untreated stage IV pancreatic cancer (PC)
Session: Gastrointestinal Tumors

A poster discussion of data from the ipafricept Phase 1b clinical trial will be presented on Sunday, October 9, 2016 at 3:00 pm CEST:

Abstract #3410 Phase 1b study of WNT inhibitor ipafricept (IPA, decoy receptor for WNT ligands) with nab-paclitaxel (Nab-P) and gemcitabine (G) in patients (pts) with previously untreated stage IV pancreatic cancer (PC)
Session: Developmental Therapeutics

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.

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.