On September 26, 2019 Flatiron Health reported 13 abstracts accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019, which will be held September 27 – October 1, 2019, in Barcelona, Spain (Press release, Flatiron Health, SEP 26, 2019, View Source [SID1234539827]). The research, spanning multiple tumor types and areas of study, utilized Flatiron’s high-quality, real-world oncology datasets. Collectively, these research presentations highlight the various applications of real-world evidence, enabling deep clinical insights to better understand the use of biomarkers, comparative effectiveness of therapies and outcomes in routine clinical care.

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Presentations include collaborator research by the U.S. Food & Drug Administration’s Oncology Center of Excellence, Huntsman Cancer Institute, Yale Cancer Center, Bayer, Bristol-Myers Squibb, Celgene, Merck, Pfizer, Roche/Genentech and Foundation Medicine.

The presentation schedule and links to abstracts can be found below.

Poster Discussion
Prevalence and prognostic effect of high tumor mutation burden (TMB-H) across multiple less common solid cancers using a real-world dataset
● First Author: Daniel Backenroth (Flatiron Health)
● Date/Time: September 29 — 08:45 – 09:45
● Presentation: #1877PD

Poster Sessions
Second-line (2L) real-world treatment (tx) patterns and outcomes in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC) treated with first-line (1L) immuno-oncology (IO) monotherapy (mono tx)
● First Author: Denis Talbot (University of Oxford)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1497P

Real-world effectiveness of nivolumab monotherapy after prior systemic therapy in advanced non-small cell lung cancer (NSCLC) in the United States
● First Author: David D. Stenehjem (University of Minnesota)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1498P

Treatment patterns and outcomes for patients (pts) with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in US clinical practice
● First Author: Matthew G. Krebs (The Christie NHS Foundation Trust)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1546P

Brain metastases, treatment patterns and outcomes in ROS1-positive NSCLC patients from US oncology community centers
● First Author: Matthew G. Krebs (The Christie NHS Foundation Trust)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1551P

Biomarker status as a mediator of age-related overall survival (OS) in advanced non-small cell lung cancer (aNSCLC)
● First Author: Aaron B. Cohen (Flatiron Health)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1558P

Comparison of real-world response rate (rwRR) to RECIST-based response rate in patients with advanced non-small cell lung cancer (aNSCLC)
● First Author: Xinran Ma (Flatiron Health)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #1581P

Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis
● First Author: Mylin Torres (Winship Cancer Institute, Emory University School of Medicine)
● Date/Time: September 28 — 12:00 – 13:00
● Presentation: #327P

Comparative effectiveness of palbociclib plus letrozole vs letrozole for metastatic breast cancer in US real-world clinical practices
● First Author: Rachel M. Layman (Pfizer)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #329P

Use of trastuzumab emtansine (T-DM1; K) after pertuzumab + trastuzumab (PH) in patients with HER2-positive metastatic breast cancer (mBC): Challenges in assessing effectiveness of treatment sequencing in the real world (RW)
● First Author: Thibaut Sanglier (Roche)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #356P

Co-occurrence of NTRK fusions with other genomic biomarkers in cancer patients
● First Author: Xiaolong Jiao (Bayer)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #102P

Association of programmed cell death 1 (PD-1) inhibitor therapy with overall survival (OS) in stage IV melanoma treated with targeted therapies
● First Author: Aracelis Z. Torres (Flatiron Health)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #1290P

Comparative-effectiveness of pembrolizumab vs nivolumab for patients with metastatic melanoma
● First Author: Justin Moser (Huntsman Cancer Institute)
● Date/Time: September 30 — 12:00 – 13:00
● Presentation: #1346P

On September 26, 2019, AbbVie Inc. ("AbbVie") reported sale of €1.4 billion aggregate principal amount of its senior notes, consisting of €750 million aggregate principal amount of 0.750% senior notes due 2027 and €650 million aggregate principal amount of 1.250% senior notes due 2031 (collectively, the "Notes") (Filing, 8-K, AbbVie, SEP 26, 2019, View Source [SID1234539811]). The offering of the Notes was made pursuant to a Prospectus Supplement, dated September 17, 2019 and filed with the Securities and Exchange Commission (the "SEC") on September 19, 2019 (the "Prospectus Supplement"), and the Prospectus dated September 13, 2018, filed as part of the shelf registration statement (File No. 333-227316) that became effective under the Securities Act of 1933, as amended, when filed with the SEC on September 13, 2018.

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The Notes are governed by an indenture, dated November 8, 2012 (the "Base Indenture"), by and between AbbVie and U.S. Bank National Association, as trustee (in such capacity, the "Trustee"), as supplemented by Supplemental Indenture No. 6, dated September 26, 2019 (the "Supplemental Indenture"), among AbbVie, the Trustee, Elavon Financial Services DAC, UK Branch, as paying agent (the "Paying Agent"), and U.S. Bank National Association, as transfer agent and registrar (in such capacity, the "Transfer Agent" and the "Registrar"). In connection with the issuance and sale of the Notes, AbbVie, the Trustee, the Paying Agent, the Transfer Agent and the Registrar also entered into an agency agreement, dated September 26, 2019 (the "Agency Agreement").

The Notes will mature on November 18 of the applicable year. The Notes are unsecured, unsubordinated obligations of AbbVie and will rank equally in right of payment with all of AbbVie’s existing and future unsecured, unsubordinated indebtedness, liabilities and other obligations.

As previously disclosed, AbbVie intends to use the net proceeds from the offering of the Notes, together with cash on hand, (i) to redeem, satisfy and discharge or repay at maturity all of its 0.375% senior notes due 2019 in an aggregate outstanding principal amount of €1.4 billion, and to pay any premium and accrued interest in respect thereof, and/or (ii) for general corporate purposes.

Please refer to the Prospectus Supplement for additional information regarding the offering of the Notes and the terms and conditions of the Notes. The foregoing summary of the Notes does not purport to be complete and is qualified in its entirety by reference to the full text of (i) the Base Indenture attached as Exhibit 4.1 hereto; (ii) the Supplemental Indenture attached as Exhibit 4.2 hereto; (iii) the Agency Agreement attached as Exhibit 4.3 hereto; and (iv) the forms of the Notes attached as Exhibits 4.4 and 4.5 hereto.

On September 26, 2019 ZielBio, Inc., an early-stage biotechnology company that identifies novel high value disease targets and develops therapeutic interventions to improve patient outcomes, reported that it has closed a $25.1 million Series A financing round (Press release, ZielBio, SEP 26, 2019, View Source [SID1234539828]). The round is led by Morningside Venture Investments and Partners Innovation Fund (PIF). ZielBio’s lead candidate ZB131 is a proprietary humanized monoclonal antibody against cell surface plectin (CSP), a target that is highly expressed on the plasma membrane of multiple types of cancer cells, including ovarian, pancreatic, lung and colorectal. The funding will enable the company to conduct further research to prioritize potential cancer applications, validate additional targets and initiate a planned phase 1 clinical trial with ZB131. "We are excited to partner with Morningside and PIF whose resources and drug development experience will greatly accelerate ZB131 development," noted Kimberly Kelly, PhD, President and Chief Science Officer at ZielBio.

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"Since its first discovery by ZielBio founder Dr. Kimberly Kelly at Massachusetts General Hospital, we have been encouraged by the unique role that cell surface plectin plays in proliferation, migration and cell survival and its potential as a drug target for a range of difficult to treat cancers," said PIF Partner Meredith Fisher, PhD. "Extensive pre-clinical laboratory and animal research has demonstrated that ZB131 has a high affinity to bind to CSP, inducing growth arrest and necrosis of targeted tumor cells."

"Despite the incredible progress being made in immuno-oncology, current therapies have limits and there remains a profound need for new targets and options for many deadly cancers," said Jason Dinges, JD, PhD, Investment Advisor at Morningside Technology Advisory. "ZB131 has shown potentially superior immune activation to current checkpoint inhibitors and greater direct tumor cell killing than EGFR inhibitors."

In connection with the financing, Drs. Dinges and Fisher have joined Dr. Kelly on the ZielBio Board of Directors.

On September 26, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported multiple data presentations at the upcoming American Academy of Ophthalmology (AAO) 2019 Annual Meeting, being held October 12-15, 2019 in San Francisco, CA (Press release, Aura Biosciences, SEP 26, 2019, View Source [SID1234539812]). Aura’s lead clinical asset, AU-011, will also be highlighted in presentations at related medical meetings taking place in San Francisco around AAO 2019, including the Ophthalmology Innovation Summit taking place October 10, 2019, and the American Association of Ophthalmic Oncologists and Pathologists (AAOOP) 2019 Annual Meeting taking place October 13, 2019.

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Two key presentations at the AAO meeting include study updates by key opinion leaders Dr. Jay S. Duker, Director New England Eye Center, Professor and Chair Tufts Medical Center and Dr. Amy C. Schefler, Weill Cornell Medical College and Retina Consultants of Houston, which will include updated clinical data from Aura’s ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the first line treatment of primary choroidal melanoma. An additional presentation will be given at AAOOP 2019 by Dr. Abdhish Bhavsar, Board Certified Ophthalmologist at The Retina Center and an investigator for Aura’s Phase 1b/2 clinical trial.

"There are no FDA approved therapies for the treatment of choroidal melanoma, the most common type of primary eye cancer," said Cadmus Rich, MD, Chief Medical Officer of Aura Biosciences. "Patients are currently treated with radiotherapy and surgery which typically results in severe vision loss, along with many other significant adverse effects and comorbidities. If approved, AU-011 will be the first targeted therapy for the treatment of choroidal melanoma, with the potential to not only provide tumor control, but also preserve vision. We are excited to have these presentations on our AU-011 program and we look forward to sharing our novel technology, clinical data and an update on new delivery methods for AU-011 with the ophthalmology community at AAO and the accompanying events this year."

The details for the AAO 2019 presentations are as follows:

Title: Aura Biosciences

Presenter: Jay S. Duker, MD, New England Eye Center, Tufts Medical Center

Session: SYM22 The Innovators Symposium

Date and time: Sunday, October 13, 2019 from 2:47 – 2:54 PM PT

Location: Moscone Center, Esplanade Room

Title: Virus-Like Particles for Uveal Melanoma

Presenter: Amy C. Schefler, MD, Weill Cornell Medical College/Retina Consultants of Houston

Session: SYM50 Delivery of Therapeutics to the Posterior Ocular Segment

Date and time: Tuesday, October 15, 2019 from 9:35 – 9:45 AM PT

Location: Moscone Center, West 2002

Additional presentations taking place at other events in San Francisco around AAO 2019 include:

Event: Ophthalmology Innovation Summit (OIS) @ AAO

Title: Update on Aura Biosciences

Presenter: Elisabet de los Pinos, PhD, Chief Executive Officer of Aura Biosciences

Session: Innovation Showcase 1

Date and time: Thursday, October 10, 2019 from 8:40-8:47 AM PT

Location: Hilton San Francisco Union Square, 333 O’Farrell Street

Event: American Association of Ophthalmic Oncologists and Pathologists (AAOOP) 2019 Annual Meeting

Title: Study Update of an Ongoing Phase 1b/2 Open-label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Presenter: Abdhish Bhavsar, MD, The Retina Center

Date and time: Sunday, October 13, 2019

Location: Grand Hyatt San Francisco, 345 Stockton Street

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On September 26, 2019 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, reported the appointment of Mona M Wahba, MD, MSM to the position of Deputy Chief Medical Officer (Press release, ITM Isotopen Technologien Munchen, SEP 26, 2019, View Source [SID1234539829]). Dr Wahba joined ITM on September 15, 2019 and will primarily be responsible for the development and implementation of ITM’s clinical strategy and presence in the United States (US), where Dr Wahba will be based. In this capacity Dr Wahba will also oversee the clinical conduct of the COMPETE phase III clinical trial in North America. This pivotal study is central to ITM’s global strategy of providing cutting edge radiotheranostic care to patients with neuroendocrine tumors.

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Prior to joining ITM, Dr Wahba has held several senior executive positions with major pharmaceutical companies including Pfizer, Bristol-Myers Squibb, Novartis, and Bayer. With more than 20 years of experience in senior management roles in the industry, she has extensive knowledge in medical affairs, drug safety and clinical development. Dr Wahba was instrumental in leading US and global medical plans and launch readiness of Xofigo, a radiopharmaceutical drug designed to treat bone metastases in patients with castration-resistant prostate cancer (CRPC). At Ipsen Bioscience Dr Wahba served as Clinical Development Lead, advancing the vision and strategy for clinical development of radiotheranostics in various tumor types.

"We are delighted to welcome Mona at ITM. Given her extensive experience in the industry and her strong medical background in oncology, radiotheranostics and immunology, she will be a key member of the developing medical team and a key asset to our US presence," said Dr Philip E Harris, CMO of ITM. "She will provide important clinical and medical input to our developing pipeline and commercial operations particularly in the United States, where our Phase III clinical trial is in an accelerated phase of actively recruiting patients."

"I am excited to join ITM at this pivotal moment in the company’s history, in which many interesting projects are underway," commented Dr Mona M Wahba, newly appointed Deputy CMO of ITM. "I am looking forward to helping patients with new treatment options as appropriate, to growing the company’s US footprint and to furthering the success of our phase III clinical trial COMPETE, which is currently investigating our lead candidate Solucin for the treatment of gastroentero-pancreatic neuroendocrine tumors. Targeted Radionuclide Therapy is an extremely precise and promising field that has the potential to improve the lives of countless cancer patients worldwide. I am looking forward to participating in developing and executing ITM’s promising pipeline to address unmet medical needs."