Boehringer Ingelheim returns development and commercial rights of olmutinib to Hanmi Pharmaceutical

On September 30, 2016 Boehringer Ingelheim reported that development and global commercialization rights of olmutinib, a third-generation EGFR targeted therapy, will be returned to Hanmi Pharmaceutical Co. Ltd (Press release, Boehringer Ingelheim, SEP 30, 2016, http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2016/9-30-2016-boehringer-ingelheim-returns-development-commercial-rights-olmutinib-hanmi-pharmaceutical.html [SID:SID1234515686]).

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The decision is based on a re-evaluation of all available clinical data on olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer. Boehringer Ingelheim will not initiate new clinical trials for this compound and will work closely with Hanmi Pharmaceutical to ensure a seamless transition of the responsibilities of the current olmutinib clinical development program back to Hanmi Pharmaceutical.

Dr. Jörg Barth, Corporate Senior Vice President, Therapeutic Area Head Oncology, Boehringer Ingelheim said, "We would like to thank Hanmi Pharmaceutical for their collaboration and commitment during our joint development of olmutinib. Partnering is a key pillar of our oncology strategy at all stages of research and development, in order to offer cancer treatments that fit the needs of patients, caregivers and healthcare professionals. Boehringer Ingelheim’s oncology pipeline is robust and transformative, with several compounds currently in clinical development and we strive for best-in-class, breakthrough cancer medications."

Boehringer Ingelheim has successfully launched two products for the treatment of non-small cell lung cancer (NSCLC), which have been widely adopted and established as important additions to current clinical practice. The company continues to increase its investment in research and development and a third of Boehringer Ingelheim’s human pharmaceutical pipeline, that is planned to enter phase I clinical trials in the next 12 months, is in oncology.

Boehringer Ingelheim’s oncology pipeline is built on in-house scientific innovation as well as strong academic and industry collaborations. Two recent examples include a partnership with ViraTherapeutics to develop novel cancer treatments based on oncolytic viruses, with an option to acquire the company at a later time point. The other strategic collaboration is with Sarah Cannon Research Institute (SCRI) that brings together Boehringer Ingelheim’s extensive experience in cancer drug development and SCRI’s expertise in designing and executing clinical trials of investigational oncology drugs.

LabCorp Subsidiary Sequenom, Inc. Announces Early Tender Results for Tender Offers and Successful Completion of Consent Solicitations for 5% Convertible Senior Notes Due 2017 and 5% Convertible Senior Exchange Notes Due 2018

On September 30, 2016 Sequenom, Inc. ("Sequenom"), a wholly-owned subsidiary of Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH), reported the results, as of 5:00 p.m., New York City time, on September 29, 2016 (the "Early Tender and Consent Payment Deadline"), of (A) the cash tender offers (the "Tender Offers") for any and all of the outstanding 5% Convertible Senior Notes Due 2017 (CUSIP No. 817337 AB4, the "2017 Notes") and 5% Convertible Senior Exchange Notes Due 2018 (CUSIP No. 817337 AC2, the "2018 Notes" and, together with the 2017 Notes, the "Notes") issued by Sequenom, and (B) the solicitations (the "Consent Solicitations") of consents of the holders of Notes (the "Consents") to enact certain proposed amendments (the "Proposed Amendments") to the indentures governing the Notes to eliminate various reporting obligations and restrictive provisions related to the incurrence of indebtedness, as well as make certain other changes in the indentures (Press release, LabCorp, SEP 30, 2016, View Source;p=RssLanding&cat=news&id=2207126 [SID:SID1234515520]). The Tender Offers will expire at 5:00 p.m., Eastern Time, on Monday, October 17, 2016, unless extended or terminated (the "Expiration Date").

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As of the Early Tender and Consent Payment Deadline, (i) a total of $44,841,000 aggregate principal amount of the outstanding 2017 Notes, representing approximately 99.647% of the outstanding 2017 Notes, were validly tendered (and not validly withdrawn) and (ii) a total of $85,000,000 aggregate principal amount of the outstanding 2018 Notes, representing 100.00% of the outstanding 2018 Notes, were validly tendered (and not validly withdrawn) in the Tender Offers. All tendered Notes were accompanied by Consents to the Proposed Amendments.

As a result, as of the Early Tender and Consent Payment Deadline, Sequenom received the requisite Consents from holders of at least a majority of the outstanding principal amount of both series of Notes to meet the Consent Condition and to adopt the Proposed Amendments. On September 29, 2016, Sequenom and the trustee for the Notes entered into a supplemental indenture to each of the indentures governing the 2017 Notes and the 2018 Notes (the "Supplemental Indentures"), giving effect to the Proposed Amendments. The Supplemental Indentures are binding as of their execution and will become operative on the settlement date of the Tender Offers (the "Settlement Date"), which is expected to occur on October 20, 2016.

Sequenom will accept for purchase such amount of 2017 Notes and 2018 Notes properly tendered and not validly withdrawn in the Tender Offers as of the Early Tender and Consent Payment Deadline. Holders whose 2017 Notes were validly tendered and accompanied by a Consent on or before the Early Tender and Consent Payment Deadline, and not withdrawn, will receive, in respect of each $1,000 principal amount of 2017 Notes, the "2017 Total Consideration" of $1,037.50 plus Accrued Interest (such price being rounded to the nearest $0.01 per $1,000 principal outstanding amount of Notes) on the Settlement Date. Holders whose 2018 Notes were validly tendered and accompanied by a Consent on or before the Early Tender and Consent Payment Deadline, and not withdrawn, will receive, in respect of each $1,000 principal amount of 2018 Notes, the "2018 Total Consideration" of $1,046.25 plus Accrued Interest (such price being rounded to the nearest $0.01 per $1,000 principal outstanding amount of Notes) on the Settlement Date.

Holders who validly tender their 2017 Notes after the Early Tender and Consent Payment Deadline but on or prior to the Expiration Date and do not withdraw their tender will not receive the respective Total Consideration but will be eligible to receive, in respect of each $1,000 principal amount of 2017 Notes tendered, the "Purchase Price" of $1,000.00, plus accrued interest to but excluding the Settlement Date. No tenders of Notes will be valid if submitted after the Expiration Date.

The Tender Offers and Consent Solicitations are being made pursuant to an Offer to Purchase and Consent Solicitation Statement, dated September 16, 2016 (as supplemented on September 22, 2016, and as amended or further supplemented from time to time, the "Offer to Purchase") and the accompanying Consent and Letter of Transmittal.

Barclays is the Dealer Manager and Solicitation Agent for the Tender Offers and Consent Solicitations and may be contacted at 1-888-610-5877 (toll free) or 212-526-7255. Requests for documents may be directed to Morrow Sodali Global, LLC, the Information Agent, at 1-203-658-9400 for banks and brokers or 1-800-662-5200 (toll free) for Holders and all others.

This announcement is not an offer to purchase or the solicitation of an offer to sell the Notes or a solicitation of Consents. The Tender Offers for the Notes and the related Consent Solicitations are only being made pursuant to the Offer to Purchase and the related Consent and Letter of Transmittal. Holders of the Notes should read the Offer to Purchase and the Consent and Letter of Transmittal carefully prior to making any decision with respect to the Tender Offers and Consent Solicitations because they contain important information.

This announcement has been issued by and is the sole responsibility of Sequenom, Inc. In accordance with normal practice, Barclays expresses no opinion on the merits of the Tender Offers or the Consent Solicitations, nor does it accept any responsibility for the accuracy or completeness of this announcement or any other document prepared in connection with the Tender Offers or the Consent Solicitations.

OncoMed to Present Clinical Data for Wnt Inhibitors at the ESMO 2016 Congress

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

Galena Biopharma to Present NeuVax™ (nelipepimut-S) Interim Safety Data at the European Society for Medical Oncology (ESMO) 2016 Congress

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.

Data presented at ASTRO underscore the promise of Elekta’s high-field MR-adaptive linear accelerator as a transformative advance in radiation therapy

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.