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Mona M Wahba joins ITM as Deputy Chief Medical Officer

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."

ZielBio Closes $25.1 Million Series A Financing

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.

"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.

Flatiron Health Announces Research to be Presented at European Society for Medical Oncology Congress 2019

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.

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

AVEO Oncology to Present at the 2019 Cantor Fitzgerald Global Healthcare Conference

On September 26, 2019 AVEO Oncology (NASDAQ:AVEO) reported that Michael Bailey, president and chief executive officer, will present at the 2019 Cantor Fitzgerald Global Healthcare Conference in New York on Friday, October 4, 2019 at 10:05 a.m. Eastern Time (Press release, AVEO, SEP 26, 2019, View Source [SID1234539826]).

A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

Early and Effective Nutritional Therapy in GI Cancer Patients: An Opportunity to Improve Patient Outcomes & Quality of Life

On September 26, 2019 Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition reported that it will present at the ESMO (Free ESMO Whitepaper) congress to be held in Barcelona from 27 September to 1 October, organizing the symposium "Early and effective nutritional therapy in GI cancer patients: an opportunity to improve outcome (Press release, Baxter International, SEP 26, 2019, View Source [SID1234539825])."

Approximately 50% of oncology patients in Europe are affected by malnutrition. While the rate of malnutrition is even higher for patients with gastrointestinal (GI) cancers real-world evidence suggests that only 23% of GI cancer patients have malnutrition diagnosed, due to the lack of appropriate nutritional screening.1 Approximately one quarter of all cancer patients die due to consequences of malnutrition, but cancer-related malnutrition goes undiagnosed in many patients.2

Seven out of ten patients experience feeding problems during cancer treatment, chemotherapy and radiotherapy, leaving them at serious risk of malnutrition and its associated problems.3

Early initiation of clinical nutrition therapy after cancer diagnosis allows to achieve the best possible patient outcomes, improvement of cancer care and optimisation of healthcare resources use.4,5 Parenteral nutrition is a life-sustaining therapy when oral and enteral nutrition are not possible.

1 Tlemsani C et al. (2018) Malnutrition in cancer patients: is a late diagnosis a missed opportunity to improve care? Ann Oncol 29: viii603-40.
2 Hu W-H et al. (2015). Nutr J 14: 91. Lee H et al. (2013) Clin Nutr Res 2: 12-8.
3 ECPC Nutrition Booklet, 2018.
4 Tlemsani C et al. (2018) Malnutrition in cancer patients: is a late diagnosis a missed opportunity to improve care? Ann Oncol 29: viii603-4
5 Goldwasser, F et al. Challenges and Opportunities in Clinical Nutrition in Oncology: Available Evidence, Real-World Practices and the Way Forward, 2018.