On November 14, 2018 Genmab reported Interim Report for the First Nine Months Ended September 30, 2018 (Press release, Genmab, NOV 14, 2018, View Source [SID1234531309]).

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Highlights

USD 1,441 million in net sales of DARZALEX (daratumumab), resulting in royalty income of DKK 1,111 million
DARZALEX approved in Europe in combination with bortezomib, melphalan and prednisone (VMP) for frontline multiple myeloma, triggering USD 13 million milestone payment from Janssen
Entered strategic collaboration with Immatics to discover and develop next-generation bispecific cancer immunotherapies
"During the third quarter, Genmab continued to push ahead towards completing our goals for 2018. This quarter’s highlights included the European approval of DARZALEX in combination with other standard therapies for the treatment of frontline multiple myeloma and the strategic collaboration we signed with Immatics to fuel the growth of Genmab’s innovative immunotherapy pipeline in the future," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2018

Revenue was DKK 1,789 million in the first nine months of 2018 compared to DKK 1,348 million in the first nine months of 2017. The increase of DKK 441 million, or 33%, was mainly driven by higher DARZALEX royalties, the payment from Novartis of USD 50 million and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by a decrease in DARZALEX milestones.
Operating expenses were DKK 1,130 million in the first nine months of 2018 compared to DKK 707 million in the first nine months of 2017. The increase of DKK 423 million, or 60%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating income was DKK 659 million in the first nine months of 2018 compared to DKK 641 million in the first nine months of 2017. The increase of DKK 18 million, or 3%, was driven by higher revenue, which was offset by increased operating expenses.
Subsequent Events

October: The Phase III CASSIOPEIA study (MMY3006) of daratumumab in combination with bortezomib, thalidomide and dexamethasone (VTD) versus VTD alone as frontline treatment for multiple myeloma patients who are candidates for autologous stem cell transplant (ASCT) met its primary endpoint of number of patients that achieved a stringent Complete Response (sCR), which was reported in 28.9% of patients treated with daratumumab in combination with VTD, compared to 20.3% of patients who received VTD alone with an odds ratio of 1.60 (95% CI: 1.21 – 2.12, p ≤ 0.001). The safety profile of daratumumab in combination with VTD is consistent with the known safety profile of the VTD regimen used in patients receiving ASCT and the known safety profile for daratumumab.
October: The Phase III MAIA study (MMY3008) of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus Rd alone as treatment for newly diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and ASCT met its primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p < 0.0001), resulting in a 45% reduction in the risk of progression or death in patients treated with DRd. The median PFS for patients treated with DRd has not been reached, compared to an estimated median PFS of 31.9 months for patients who received Rd alone. Overall, the safety profile of daratumumab in combination with Rd is consistent with both the known safety profiles of the Rd regimen and daratumumab.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2018 today, Wednesday, November 14, at 6.00 pm CET, 5.00 pm GMT or 12.00 pm EST. To join the call dial
+1 646 828 8193 (US participants) or +44 330 336 9411 (international participants) and provide conference code 4314747.

On November 14, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that data from Phase I clinical trials of ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) have been selected for oral and poster presentations at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 1-4 in San Diego (Press release, ADC Therapeutics, NOV 14, 2018, View Source [SID1234596073]).

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Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We look forward to sharing updated data from our first-in-human clinical trials of ADCT-402 and ADCT-301 in multiple subtypes of lymphoma at the 2018 ASH (Free ASH Whitepaper) Annual Meeting. Interim data show that ADCT-402, which targets CD19, has demonstrated durable single-agent anti-tumor activity in patients with diffuse large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma who have failed other therapies or have no available treatment options. In addition, new data on ADCT-301 highlight the CD25-targeting ADC’s impressive overall and complete response rates in heavily pretreated patients with classical Hodgkin lymphoma, as well as its encouraging clinical activity in T-cell lymphoma."

Oral Presentations

Title: Interim Results from the First-in-Human Clinical Trial of Adct-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Abstract Number: 398
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: New Agents
Date and Time: Sunday, December 2, 2018; 12:15 p.m. PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
Presenter: John Radford, MD, FRCP, Manchester Academic Health Centre, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK

Title: Phase 1 Study of Adct-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Classical Hodgkin Lymphoma
Abstract Number: 928
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Hodgkin Lymphoma: Chemotherapy and Response Adapted Approaches
Date and Time: Monday, December 3, 2018; 5:15 p.m. PT
Location: San Diego Convention Center, Room 6F
Presenter: Mehdi Hamadani, MD, Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI

Poster Presentations

Title: Safety and Efficacy of Adct-402 (Loncastuximab Tesirine), a Novel Antibody Drug Conjugate, in Relapsed/Refractory Follicular Lymphoma and Mantle Cell Lymphoma: Interim Results from the Phase 1 First-in-Human Study
Abstract Number: 2874
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Date and Time: Sunday, December 2, 2018; 6-8 p.m. PT
Location: San Diego Convention Center, Hall GH
Presenter: Paolo Caimi, MD, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH

Title: Adct-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based CD25-Targeting Antibody Drug Conjugate, in a Phase 1 Study of Relapsed/Refractory Non-Hodgkin Lymphoma Shows Activity in T-Cell Lymphoma
Abstract Number: 1658
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I
Date and Time: Saturday, December 1, 2018; 6:15-8:15 p.m. PT
Location: San Diego Convention Center, Hall GH
Presenter: Graham P. Collins, MB, BS, DPhil, Oxford University Hospitals, NHS Trust, Oxford, UK

ADCT-402 is currently being evaluated in three clinical trials, including a pivotal trial in patients with relapsed or refractory diffuse large B-cell lymphoma. ADCT-301 is being evaluated in three clinical trials. To learn more about the company’s ADC programs, visit ADC Therapeutics’ Booth #117 located in the Exhibit Hall of the San Diego Convention Center.

For more information about the ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (NCT03589469). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of DLBCL and mantle cell lymphoma.

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will

trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235), as well as a Phase Ib clinical trial in solid tumors (NCT03621982).

On November 14, 2018 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported financial results for the third quarter ended September 30, 2018, and provided a business update (Press release, CohBar, NOV 14, 2018, View Source [SID1234531310]).

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"As we previously discussed, we are moving forward with our plan to address the mild but persistent injection site reactions observed in our Phase 1 clinical trial of CB4211, under development for NASH and obesity," said Simon Allen, Chief Executive Officer of CohBar. "We will be sharing this plan shortly with the FDA, and look forward to the agency’s timely feedback and resuming clinical activities as expeditiously as possible."

"This first groundbreaking study of a mitochondria based therapeutic in humans will help inform us not only for the development of CB4211, but also for the development of other potential therapeutics from our large portfolio of novel peptides. We continue to believe in the potential of MBTs to treat a broad range of age-related diseases with large-population indications, including type 2 diabetes, cancer, neurodegenerative disease and cardiovascular disease," Mr. Allen concluded.

Third Quarter and Recent Business Highlights:

Clinical Study Update for CB4211. On November 5, 2018, the company announced the temporary suspension of its ongoing Phase 1 clinical study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, in order to address mild injection site reactions that have been unexpectedly persistent. The company has a plan to address the persistent reactions and is seeking feedback from the FDA before resuming the clinical study.

Partnership with LifeSci Advisors. CohBar engaged LifeSci Advisors LLC ("LifeSci"), a leading New York-based investor relations consultancy serving life science companies, to implement a comprehensive investor outreach program that will include analyst and investor targeting/outreach, non-deal roadshows, corporate communications, and Key Opinion Leader (KOL) events in the field of mitochondria based therapeutics and age-related diseases.

Investment and Scientific Community Outreach. During the third quarter, CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at the Bio Investor Forum. Additionally, company management met with investors during the H.C. Wainwright 20th Annual Global Investment Conference.
During the third quarter, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.

Dr. Cohen co-authored a number of papers published in scientific journals during the quarter including "Humanin Prevents Age-Related Cognitive Decline in Mice and is Associated with Improved Cognitive Age in Humans," in Nature Scientific Reports; "Chronic Treatment with the Mitochondrial Peptide Humanin Prevents Age-related Myocardial Fibrosis in Mice," in American Journal of Heart Circulation Physiology; "Characterizing the Protective Effects of SHLP2, a Mitochondrial-Derived Peptide, in Macular Degeneration," in Nature Scientific Reports; and "Mitochondrial biology and prostate cancer ethnic disparity," Carcinogenesis. Dr. Cohen also received a major grant from the National Institutes of Health recognizing his ground-breaking work in the field of mitochondrial science entitled, "Humanin is an AD resilience factor through its interaction with APOE4."

Dr. Barzilai delivered a keynote speech at the Aging Cell Conference in Sitges, Spain and co-authored a number of scientific papers published during the quarter including: "Aging as a Biological Target for Prevention and Therapy," in JAMA; "A framework for selection of blood-based biomarkers for geroscience-guided clinical trials: Report from the TAME Biomarkers Workgroup," in Geroscience; "Targeting Senescence," in Nature Medicine; "APOE Alleles and Extreme Human Longevity," Journals of Gerontology; "40 Years of IGF1: The Jekyll and Hyde of the Aging Brain," in Journal of Molecular Endocrinology; "Late-Life Targeting of the IGF1 Receptor Improves Healthspan and Lifespan in Female Mice," in National Communications.
Third Quarter 2018 Financial Highlights

Cash and Investments. CohBar had cash and investments of $24,223,712 on September 30, 2018, compared to $8,452,459 on December 31, 2017.

R&D Expenses. Research and development expenses were $3,435,509 in the three months ended September 30, 2018, compared to $2,316,454 in the prior year quarter. The increase was primarily due to the costs of our clinical activities and a net increase in stock-based compensation related to performance equity grants that vested within the current year quarter, offset by a decrease in costs related to the timing of IND-enabling activities incurred in the prior year period.

G&A Expenses. General and administrative expenses were $1,061,709 for the three months ended September 30, 2018, compared to $549,505 in the prior year quarter. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation related to performance equity grants that vested within the current year quarter, the costs associated with new grants made since the prior year period and an increase in directors fees in the current quarter.

Net Loss. For the three months ended September 30, 2018, net loss was $4,613,042, or $0.11 per basic and diluted share, compared to a net loss of $2,861,107, or $0.07 per basic and diluted share, for the three months ended September 30, 2017.

Details for Conference Call

Date: November 14, 2018
Time: 5:00 p.m. Eastern Time

- Dial-in U.S. and Canada: (888) 394-8218
- Dial-in International: (323) 701-0225
- Conference ID Number: 1659879

We kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 14, 2018, through 11:59 p.m. Eastern Time on December 5, 2018. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 1659879. The audio replay will also be available at www.cohbar.com from November 14 through December 5, 2018.

About CB4211
CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

On November 14, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA (ibrutinib) (Press release, Johnson & Johnson, NOV 14, 2018, View Source [SID1234531468]). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115). The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström’s macroglobulinemia (WM).

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"Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist," said Dr. Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "Ibrutinib continues to demonstrate clinical benefit over the long term for a broad
group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC1130) study which investigated ibrutinib in combination with obinutuzumab versus
chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.

1 Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in San Diego next month.1,2 A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.

2 In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.

3 Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH (Free ASH Whitepaper) 2018 (abstract
#149).

4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.

5 Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).
6,7
#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9 Ibrutinib is currently approved in Europe for the following uses:10

 Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.

 Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.

 Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemoimmunotherapy.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.10

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About CLL
CLL is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year with rates amongst men and women approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.

12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13
CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.14 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
3
About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).15 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.
16 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.17 The causes of WM are unknown, with it typically affecting older adults and being slightly more
common in men than women.15,17

On November 13, 2018 Novocure (NASDAQ: NVCR) reported more than 70 presentations on Tumor Treating Fields, including five oral presentations, reported that it will be featured at the 23rd Annual Meeting of the Society for Neuro-Oncology (SNO) on Nov. 15 through Nov. 19 in New Orleans. External authors prepared more than 50 of the presentations, pointing to a growing interest in Novocure’s proprietary Tumor Treating Fields platform. Presentations span 21 research areas with more than 5 percent of all conference abstracts at the 23rd Annual Meeting of the Society for Neuro-Oncology discussing Tumor Treating Fields.

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Novocure announces more than 70 presentations on Tumor Treating Fields at 23rd Annual Meeting of the Society for Neuro-Oncology

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"We are pleased to have a record number of presentations on Novocure’s proprietary platform featured this year at SNO’s Annual Meeting," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "Presentations cover a broad range of topics from cell biology, radiation therapy and immunology to clinical trials and patient care, which we believe point to a growing and diversifying interest in Tumor Treating Fields from clinicians and researchers around the world. We are excited to engage the oncology community at SNO and to continue collaborating to realize the full potential of Tumor Treating Fields."

New clinical data from investigator sponsored pilot trials will be shared studying Tumor Treating Fields in progressive pediatric gliomas, Tumor Treating Fields prior to and with radiation for newly diagnosed glioblastoma (GBM),Tumor Treating Fields in combination with a personalized mutation-derived tumor vaccine for newly diagnosed GBM, and targeted skull remodeling surgery to maximize Tumor Treating Fields intensity for recurrent GBM.

Post-hoc analyses of Novocure’s EF-14 phase 3 pivotal trial in newly diagnosed GBM will highlight improved patient outcomes associated with higher delivered doses of Tumor Treating Fields, the potential combination of Tumor Treating Fields with lomustine and the absence of a negative impact on health-related quality of life in the EORTC QLQ-C30 and BN20 scales when Tumor Treating Fields was added to temozolomide.

Preclinical data will highlight the potential role of Tumor Treating Fields as an activator of the immune system, supporting further investigation into the combination of Tumor Treating Fields and immunotherapy. Other abstracts will include insights on the relative response to Tumor Treating Fields across certain cell lines, the potential for novel array layouts to improve efficacy of Tumor Treating Fields, the potential effect of Tumor Treating Fields on blood brain barrier permeability and the potential synergistic effect of Tumor Treating Fields in combination with PARP inhibitors.

Health economics and outcomes research data will discuss the cost effectiveness of Tumor Treating Fields across multiple populations and assessment frameworks.

Abstracts on Tumor Treating Fields can be viewed online and include the following:

Oral presentations

(HOUT-16) The cost effectiveness of Tumor Treating Fields treatment for patients with newly diagnosed glioblastoma based on the EF-14 trial. G. Guzauskas. 5:00 to 5:04 p.m. CST Saturday, Nov. 17. (E-talks group 3: Health outcomes / neurological complications of cancer and cancer therapy / quality of life / radiotherapy / surgical therapy / CNS metastases)

(ACTR-46) Higher doses of TTFields in the tumor are associated with improved patient outcome. M. Ballo. 5:32 to 5:36 p.m. CST Saturday, Nov. 17. (E-talks group 1: Adult therapeutics / immunology)

(ACTR-43) Open-label phase 1 clinical trial testing personalized and targeted skull remodeling surgery to maximize TTFields intensity for recurrent glioblastoma – Interim analysis and safety assessment. A. Korshoej. 9:40 to 9:45 a.m. CST Sunday, Nov. 18. (Concurrent session 7A: Adult clinical trials II)

(HOUT-18) Cost effectiveness of treating glioblastoma patients age 65 years or older with Tumor Treating Fields plus temozolomide versus temozolomide alone. G. Guzauskas. 10:30 to 10:40 a.m. CST Sunday, Nov. 18. (Concurrent session 8B: Practical & applied neuro-oncology II)

(IMMU-71) Evaluating the compatibility of tumor treating electric fields with key anti-tumoral T cell functions. G. Diamant. 11:50 to 11:55 a.m. CST Sunday, Nov. 18. (Concurrent session 8C: Immunology – Preclinical and clinical II)

Poster presentations: Adult clinical trials – Non-immunologic

(ACTR-01) Safety Analyses of Tumor Treating Fields in Combination with Lomustine in the EF14 Phase 3 Clinical Study. A. Kinzel. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(ACTR-49) Pricottf: A Phase I/II Trial of Tumor Treating Fields Prior and Concomitant to Radiotherapy in Newly Diagnosed Glioblastoma. M. Glas. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Angiogenesis

(ANGI-11) Tumor Treating Fields (TTFields) Inhibit Cancer Cell Migration and Invasion by Inducing Reorganization of the Actin Cytoskeleton and Formation of Cell Adhesions. M. Giladi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Adult clinical trials – Immunologic

(ATIM-02) Tumor Treating Fields in Combination with Bevacizumab in Recurrent or Progressive Meningioma in a Phase 2 Study. P. Kumthekar. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(ATIM-03) TTFields and Pulsed Bevacizumab in Patients with Bevacizumab-refractory Recurrent Glioblastoma: A Phase 2 Study. D. Tran. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(ATIM-31) Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients with Newly Diagnosed Glioblastoma. A. Hormigo. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Cell biology and metabolism

(CBMT-03) A Novel Metabolic PET Tracer Strategy to Determine Early Effects of Tumor Treating Fields (TTFields). C. Patel. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(CBMT-29) Induction of Autophagy Following TTFields Application Serves as a Survival Mechanism Mediated by AMPK Activation. M. Giladi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Computational omics

(COMP-15) Meta-analysis of Cancer Cell Lines Based on Their Response to Tumor Treating Fields (TTFields). M. Giladi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(COMP-19) Water-content Based Electric Property Tomography (wEPT) for Modelling Delivery of Tumor Treating Fields to the Brain. Z. Bomzon. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Drug resistance

(DRES-11) A Systems Approach for Determining the Mechanism of Resistance to Tumor Treating Fields in Glioblastoma. D. Chen. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Experimental therapies

(EXTH-01) Modeling the Safety of Topical Agents for Skin Toxicity Associated with Tumor Treating Fields Therapy in Glioblastoma. M. Lacouture. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(EXTH-24) Exposure to Tumor Treating Fields Inhibits DNA Repair, Induces Replication Stress and Renders Tumor Cells Sensitive to Agents That Impinge upon These Pathways. M. Story. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-38) A New Computational Method for Comprehensive Estimation of Anti Tumor Efficacy of Tumor Treating Fields (TTFields). A. Korshoej. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-40) Optimizing Array Layouts for Glioblastoma Therapy with Tumor Treating Fields (TTFields). A. Korshoej. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-41) Effects of Tumor Treating Fields (TTFields) on Blood Brain Barrier (BBB) Permeability. A. Kessler. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(EXTH-62) The Dielectric Properties of Malignant Glioma Tissue. M. Proescholdt. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-74) Molecular Mechanisms of Anti-tumor Action of TTFields Determined by Measurements and Modeling of Electro-conductive Properties of Microtubules. J. Tuszynki. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Health outcome measures

(HOUT-06) Pattern of low field intensity recurrence in high-grade gliomas following Tumor Treatment Field therapy. R. Briggs. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-09) Using the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) Frameworks to Assess the Clinical Value of Tumor Treating Fields for Newly Diagnosed Glioblastoma Multiforme. C. Proescholdt. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-17) Elderly Patients >65 years of Age with Newly Diagnosed Glioblastoma Multiforme Gain Life Time from Treatment with Tumor Treating Fields and Temozolomide. G. Guzauskas. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-25) Adherence to Tumor Treating Fields in Patients with High-grade Glioma – A Single Center Experience. A. Kessler. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-26) Survival Outcomes in Glioblastoma Patients Using TTFields: The Baylor Scott & White Medical Center in Central Texas Experience. A. Padhye. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-27) The Challenge of Health Utility Values for Glioblastoma Patients with Long-term Survival. C. Proescholdt. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-28) Clinical Experience with Tumor Treating Fields (TTFields, Optune) in Israel – Patient Acceptance and Safety. T. Siegal. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-30) Tumor Treating Fields (TTFields) in Combination with Lomustine (CCNU) and Temozolomide (TMZ) in Patients with Newly Diagnosed Glioblastoma (GBM). M. Glas. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-31) Care patterns and treatment efficacy: A clinical series of primary glioblastoma with an emphasis on older adults. M. Hultman. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-36) Institutional Compliance with Tumor Treating Fields for Glioblastoma. R. Bonomi. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Immunology

(IMMU-42) TTFields Induces Immunogenic Cell Death and STING Pathway Activation Through Cytoplasmic Double-stranded DNA in GBM. D. Chen. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(IMMU-52) Tumor Treating Fields (TTFields) Induce Immunogenic Cell Death Resulting in Enhanced Antitumor Efficacy When Combined with anti-pd-1 Therapy. T. Voloshin. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(IMMU-53) Impact of Tumor-treating Fields (TTFields) on the Immunogenicity of Glioma Cells. M. Silginer. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Innovations in patient care

(INNV-01) PROTECT Study: PRO Phylactic Skin Toxicity Therapy with Clindamycin and Clobetasol or Skin Barrier in Glioblastoma Patients Treated with Tumor Treating Fields. M. Lacouture. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-03) Safety and Adverse Event Profile of Tumor Treating Fields Use in the EMEA Region – a Real-world Data Analysis. M. Glas. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-04) Safety and Adverse Event Profile of Tumor Treating Fields in Glioblastoma – a Global Post-market Surveillance Analysis. U. Weinberg. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(INNV-17) Tumour Treating Fields: Acceptable to a UK Population? M. Jenkinson. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-23) Safety and Adverse Event Profile of Tumor Treating Fields in Elderly Patients – a Post-market Surveillance Analysis. W. Shi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-24) Safety of Tumor Treating Fields in Glioblastoma Patients with Implanted Non-programmable and Programmable Shunts, and Pacemakers/defibrillators. Y. Kew. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(INNV-29) Experience with TTFields (Optune) in Pediatric High Grade Glioma Patients in Israel. M. Yalon. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-30) Tumor Treating Fields and Radiotherapy for Newly Diagnosed glioblastoma: Safety and Efficacy Results from a Pilot Study. R. Grossman. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(INNV-31) User Experience with New, Aesthetically Improved Transducer Arrays for Delivery of Tumor Treating Fields for Glioblastoma. A. Kinzel. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-48) Tumor Treating Fields Utilization in a Glioblastoma Patient with a Preexisting Cardiac Pacemaker: The First Reported Case. S. McClelland. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentation: Neurological complications of cancer and cancer therapy

(NCMP-21) Real-world Surveillance Data for Tumor Treating Fields Affirm the Tolerability of Tumor Treating Fields for the Treatment of Glioblastoma in the United States. D. Tran. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Neuro-cognitive outcomes

(NCOG-06) Predicting Tumor Treating Field Compliance Using Neurocognitive Testing. K. Qualls. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Neuro-imaging

(NIMG-04) Diffusion Restriction on MR Imaging in the T2 Hyperintense, but Otherwise Normal-appearing White Matter of Glioblastoma Patients Treated with TTFields Correlates with Survival. J. Vymazal. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(NIMG-34) The Impact of Tumor Treating Fields (TTFields) on Brain Anatomy Using Computational Anatomy Analysis. A. Hottinger. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(NIMG-48) Volumetric Response to TTFields in Newly Diagnosed GBM. C. Freyschlag. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(NIMG-49) Electric Field Intensities Delivered by Tumor-treating Fields (TTFields) to Glioblastoma Regions: Effect on Treatment Response Assessed by Amino Acid PET. C. Juhasz. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(NIMG-72) A Novel Array Layout for Delivering TTFields to the Whole Brain. Z. Bomzon. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentation: Molecular pathology and classification – Adult and pediatric

(PATH-27) Identifying the Genetic Signature of Response in a Phase II Study of Tumor Treating Fields in Recurrent Glioblastoma. D. Tran. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Pediatric clinical trials

(PDCT-07) Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-grade Glioma and Ependymoma: A Pediatric Brain Tumor Consortium Study. E. Hwang. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(PDCT-11) Surveillance Data Demonstrates the Tolerability of Tumor Treating Fields in Pediatric Glioma Patients. D. Hanson. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(PDCT-12) A Phase I Trial of Tumor Treating Fields with and Without Concomitant Temozolomide and Bevacizumab in Pediatric Patients with High-grade Glioma and Ependymoma. D. Hanzon. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentation: Pediatric tumors

(PDTM-19) Tumour Treating Fields (TTFields) Exhibit Efficacy on High-grade Paediatric Brain Tumour Cell Lines. J. Branter. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Quality of life and palliative care

(QOLP-01) Effects of Tumor Treating Fields on Health-related Quality of Life (HRQoL) in Newly Diagnosed Glioblastoma: An Exploratory Analysis of the EF-14 Randomized Phase III Trial. T. Walbert. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(QOLP-15) Safety and Adverse Event Profile of Tumor Treating Fields in Anaplastic Glioma – a Post-marketing Surveillance Analysis. D. Bota. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Randomized brain tumor trials in development

(RBTT-05) Tumor Treating Fields and Radiosurgery for Supra- and/or Infratentorial Brain Metastases (1-10) from NSCLC in the Phase 3 METIS Study. M. Mehta. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Radiation biology and DNA repair

(RDNA-02) Tumor Treating Fields Differentially Alter Homologous Recombination in Patient Derived Glioma Cells versus Established Lines. L. Bronk. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(RDNA-07) idh1-mutant Glioblastoma (GBM) Cells from a Patient Post-tumor Treating Fields (TTFields) Therapy Are Sensitive to TTFields in vitro. S. Mittal. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(RDNA-10) Histopathological and Genomic Characterization of Glioblastoma (GBM) Resected After Tumor Treating Fields (TTFields) Therapy. S. Michelhaugh. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(RDNA-17) Power Density Loss Can Be Used to Defined Tumor Treating Fields Dose. Z. Bomzon. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Radiation therapy

(RTHP-12) Comparative Analysis of Tumor Treating Fields Using Conventional versus Alternative Array Placement for Posterior Fossa Glioblastoma. E. Wong. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(RTHP-13) Tumor-treating Fields Therapy Is Compatible with Standard Chemoradiotherapy for Glioblastoma. L. Kleinberg. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(RTHP-14) Tumor-treating Fields for Glioblastoma: Numerical Simulation Explores Sub-cellular Mechanisms. K. Carlson. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Tumor microenvironment

(TMIC-10) Autopsy Study on the Effects of Tumor Treatment Fields in Recurrent Glioblastoma: Preliminary Results. A. Barrington. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(TMIC-38) Enhanced Efficacy of Tumor Treating Fields and Aurora B Kinase Inhibitor Combination in Glioma Cell Lines. M. Giladi. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.