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 28, 2016 Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported two upcoming poster presentations on tucatinib (ONT-380), the Company’s lead product candidate for the treatment of HER2+ breast cancer, at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress being held October 7 -11, 2016 in Copenhagen, Denmark (Press release, Cascadian Therapeutics, SEP 28, 2016, View Source [SID:SID1234515460]).

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Details of Poster Presentations:

Title: Cutaneous responses in Her-2+ metastatic breast cancer (MBC) on phase 1b study of ONT-380, an oral HER2-specific inhibitor in combination with capecitabine (C) and/or trastuzumab (T) in third line or later treatment
Poster Number: 278
Date: Monday, October 10, 2016
Time: 1:00pm — 2:00pm (CEST)

Title: A phase 2 randomized, double-blinded, controlled study of ONT-380 vs. placebo in combination with capecitabine (C) and trastuzumab (T) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (MBC)
Poster Number: 312 (trial in progress)
Date: Monday, October 10, 2016
Time: 1:00pm — 2:00pm (CEST)

On September 28, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported that it has strengthened its manufacturing capabilities by opening the small molecule active pharmaceutical ingredient (API) facility of its Singapore manufacturing site (Press release, AbbVie, SEP 28, 2016, View Source [SID:SID1234515496]). This facility supports the growth of AbbVie’s oncology and women’s health pipeline and reflects progress from AbbVie’s two previous announcements for manufacturing investment in Asia in 2014.

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The new 120,000 square-meter site – located in the Tuas Biomedical Park – is AbbVie’s first manufacturing facility in Asia and will also include a biologics manufacturing facility that is expected to be fully operational by the end of 2018. Combined, the API and biologics facilities represent a $320 million (more than S$400 million) investment in Singapore that will employ more than 250 new employees, the majority of whom will be hired locally in Singapore, including skilled positions across manufacturing, technical operations, administration, quality, information technology and supply chain.

"Our goal as AbbVie is to assure patients around the world have access to new and innovative medicines when they need them and where they need them," said Azita Saleki-Gerhardt, Ph.D., senior vice president, operations, AbbVie. "Today, with the opening of the first phase of our Singapore facility, we will further strengthen our manufacturing capabilities and continue to enhance our support of AbbVie’s pipeline in the therapeutic areas of oncology and women’s health for patients around the world."

Speaking at the opening ceremony, Site Director Marc O’Donoghue, Ph.D., added, "Singapore is recognized as a leader in the biopharmaceutical industry and AbbVie is excited to open its facility and begin operations. Singapore has a robust infrastructure, a highly educated and skilled workforce and provides a supportive environment for manufacturing. Our presence in Singapore establishes AbbVie’s footprint in Asia and provides geographic balance in AbbVie’s manufacturing network to ensure continuity of supply."

"AbbVie’s choice of Singapore for its first in Asia manufacturing facility is testament to our capabilities as a high-quality, global biopharmaceutical manufacturing hub. Given our track record of providing a world-class business environment and skilled talent pool to companies, we enable companies such as AbbVie to develop and manufacture innovative products to deliver value for patients worldwide," said Ms. Weng Si Ho, director, biomedical sciences, Singapore Economic Development Board (EDB). "EDB will continue to commit strong investments in talent, infrastructure and technology to support the strong growth in the biopharmaceutical industry."

AbbVie’s manufacturing network now includes 13 locations across the United States, Europe, Asia and Puerto Rico, as well as strategic partnerships with third-party manufacturers.