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City of Hope Scientists Showcase New Findings at the 2019 AACR Meeting

On March 21, 2019 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it will showcase ongoing studies and data on chimeric antigen receptor (CAR) T cell therapy, immunotherapy against solid tumors and more at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting from March 29 through April 3 in Atlanta (Press release, City of Hope, MAR 21, 2019, View Source [SID1234534536]).

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"We hope to move enhanced T cell therapy forward in solid tumors, especially in lung cancers."

More than 22,500 scientists, advocates and clinicians from around the globe are expected to attend the 2019 AACR (Free AACR Whitepaper) meeting at the Georgia World Congress Center to discuss the latest advances in immunotherapy, artificial intelligence, targeted therapy, liquid biopsy, science policy and cancer health disparities.

"City of Hope’s physicians and scientists will share their discoveries and leading-edge expertise with colleagues in the cancer field," said Michael Caligiuri, Deana and Steve Campbell Physician-in-Chief Distinguished Chair, president of City of Hope National Medical Center and former AACR (Free AACR Whitepaper) president.

Highlights of City of Hope’s significant contribution to discovering breakthroughs in cancer diagnosis, prevention and treatment include the following:

The immunotherapy arsenal: Ecology of the tumor microenvironment in breast cancer

Monday, April 1, from 3 to 5 p.m. in Room A311

To destroy a tumor, physicians shouldn’t just target the cancer cells, said Peter P. Lee, M.D., Billy and Audrey L. Wilder Professor in Cancer Immunotherapeutics at City of Hope. Doctors should also develop treatments that target or alter the tumor microenvironment. "Think of the tumor microenvironment as an ecosystem or a game of Jenga," Lee said. "The building blocks of a tumor comprise not just cancer cells, but also support (stromal) cells, immune cells, as well as an extracellular matrix. If you target any of the critical building blocks that support the cancer cells, you would still be able to get the tumor ecosystem to collapse."

For the past three years, Lee has led a convergent science team to study the Ecology of the Tumor Microenvironment in Breast Cancer through the support of Stand Up to Cancer. His team of biomedical scientists, physician-scientists, physicists, mathematicians and computer scientists has generated petabytes of data about the impact of the spatial interplay between components of the tumor microenvironment on disease progression. They have published papers in Nature Communications and the Proceedings of the National Academy of Sciences (PNAS); they are currently working on several additional manuscripts.

How population differences and environmental exposures affect tumor biology

Tuesday, April 2, from 10:30 a.m. to 12:30 p.m. in Room B206

Scientists are beginning to learn how environmental exposures like culture and individual life choices influence the biology of tumors and specific cell mechanisms. Research shows that more aggressive tumors with worse prognoses are sometimes the result of population differences and increased exposure to disease risk factors. Rick A. Kittles, Ph.D., associate director of Health Equities at City of Hope’s comprehensive cancer center, will discuss an ongoing study that looks at the role of vitamin D in prostate cancer. He will elaborate on how vitamin D intake can serve as a biomarker for prostate cancer risk. Victoria L. Seewaldt, M.D., Ruth Ziegler Chair in Population Sciences at City of Hope, will discuss breast cancer and how health disparities can result in obesity and inflammation, both of which improve the chance of incurring aggressive tumors in the breast.

How global health research advances cancer health equity in the U.S.

Friday, March 29, from 3 to 6 p.m. at Morehouse School of Medicine

Rick A. Kittles, Ph.D., director of the Division of Health Equities at City of Hope, and other scientists will discuss how global efforts to eliminate cancer contributes to the advancement of cancer health equity in the United States. Kittles will explore the impact different environments have on genes. In particular, he will talk about the African diaspora, which moved millions of people from western and central Africa to the Americas and the Caribbean. Genetically, these individuals are not very different, but different environmental and social experiences across the lifespan resulted in varied disease susceptibility and health outcomes.

Natural killer cells

Wednesday, April 3, from 7 to 8 a.m. in Room A311

Michael Caligiuri, M.D., president of City of Hope National Medical Center and former AACR (Free AACR Whitepaper) president, will detail natural killer cells and the findings his scientific teams have made in the past 25-plus years in this field. His research in natural killer cells and other topics led the AACR (Free AACR Whitepaper) Academy to induct Caligiuri as a fellow last year to recognize his significant scientific contributions that have propelled consequential innovation and progress against cancer.

The protein CD27+ may mark just how effective CAR T cell products are

Monday, April 1, from 1 to 5 p.m.

City of Hope researchers continue to make headway in developing more efficient CAR T cell treatments and are using a new preclinical study finding to try to refine its ongoing clinical trial of CAR T cell therapy against glioblastomas. Dongrui Wang, a Ph.D. candidate at the institution, Christine Brown, Ph.D., Heritage Provider Network in Immunotheraphy and associate director of the T Cell Therapeutics Research Laboratory at City of Hope, and others found that the immune T cell surface protein CD27 makes CAR T cells better tumor killers through interaction within its signaling molecule CD70. Specifically, CAR T cells enriched for CD27+ cells exhibited enhanced memory function and were able to perform their antitumor activity longer both in vitro and in vivo. "This study is a big step toward refining our CAR T cell manufacturing processes: We should preserve the CD27+ population to magnify the immunotherapy’s therapeutic applications," Wang said. "Our study also suggests that CD27+ can be used as a biomarker to predict how effective and potent an immunotherapy will be in specific patients in City of Hope’s clinical trials."

The glioblastoma clinical trial Wang referenced earlier opened in 2015 and is a part of the California Institute for Regenerative Medicine-sponsored Alpha Stem Cell Clinic at City of Hope.

Poster session title: 2321 / 20: Dual-function of CD27-CD70 costimulatory signal in CAR T cell therapy

Combining engineered autologous T cells with enhanced T cell receptors in combination with a monoclonal antibody to treat solid tumors in advanced lung cancer

Tuesday, April 2, from 1 to 5 p.m.

Leading the path into the next stage of immunotherapy, City of Hope is enrolling patients in an autologous T cell clinical trial that aims to re-engineer and use a patient’s own immune T cells to attack solid tumors in their body. Enhanced T cell therapy has been successful in treating hematologic (blood) cancers and is in early development for solid tumors.

The randomized 1a/2b study will investigate the safety and efficacy of enhancing a patient’s own T cells with NY-ESO-1/LAGE-1a antigens so that their immune system will better attack advanced nonsmall cell lung cancer. The therapy, of course, can be used only in people whose tumors express the NY-ESO-1 and/or LAGE-1a receptors.

Today’s standard of care for advanced non-small cell lung cancer leads to long-term benefits for about 10 percent of patients, said Karen Reckamp, M.D., M.S., co-director of the Lung Cancer and Thoracic Oncology Program at City of Hope and principal investigator of the ongoing clinical trial. The majority of patients with this disease have few treatment options. "T cell therapy is a high priority for City of Hope," Reckamp said. "We hope to move enhanced T cell therapy forward in solid tumors, especially in lung cancers."

In the ongoing clinical trial, the patient’s engineered T cells, called GSK3377794, will be used alone and in combination with pembrolizumab, a monocolonal antibody that blocks PD-1/PD-L1 interaction and increases the antitumor function of T cells. The synergistic treatment potentially can help certain patients with Stage 3 or Stage 4 nonsmall cell lung cancer – people who have tried other treatments but have not been able to find their way back to health.

The study is a part of the California Institute for Regenerative Medicine-sponsored Alpha Stem Cell Clinic at City of Hope. It is supported by GlaxoSmithKline and is a collaboration with Merck & Co., Inc.

Poster session title: CT225 / 19: A Phase 1b/2a randomized pilot study to investigate the safety and tolerability of autologous T cells with enhanced T cell receptors specific to NY-ESO-1L/LAGE-1a (GSK3388894) alone, or in combination with pembrolizumab, in advanced non-small cell lung cancer

Moving diagnostic technology into today’s world using artificial intelligence and 3D imaging

Monday, April 1, from 8 a.m. to noon

City of Hope and its affiliate Translational Genomics Research Institute (TGen) is collaborating with others to create the future of oncologic radiology – what City of Hope’s Syed Rahmanuddin, M.B.B.S., calls "the mammogram of pancreatic cancers." His team is using top-of-the-line technology to create artificial intelligence algorithms that compile a detailed 3D image of pancreatic cancer. The purpose is to enable physicians to identify the volume of blood flow (perfusion kinetics) of tumors and learn how effective a treatment is, facilitating adjustments to regimens to allow for improved targeted cancer therapy. Right now, the standard of care is flat, black-and-white multiphase computed tomography (CT) imaging. "Our new, patient-centered 3D imaging approach is like the transition from thinking the world is flat to understanding that the world is a globe: It opens up a whole world of possibility," Rahmanuddin said. "Our pilot study suggests that change in 3D volume and perfusion (blood flow) are important imaging markers that correlate with tumor progression, regression and aggression, which could be very helpful for the early detection of pancreatic cancer."

Daniel Von Hoff, M.D., physician-in-chief and distinguished professor of TGen, and Ronald Korn, M.D., Ph.D., of Imaging Endpoints were key contributors to this research.

Poster session title: 1622 / 20: Role of 3d volumetric and perfusion imaging for detecting early changes in pancreatic adenocarcinoma

Molecule found in orange peel slows down breast cancer tumor growth in mouse models

Wednesday, April 3, from 8 a.m. to noon

A molecule found on the skin of citrus fruits appears to inhibit the growth of breast cancer tumors in a mouse model. Compared to control mice with xenografted breast cancer cells, those who received 2’-Hydroxyflavanone (2HF) experienced reduced viability and proliferation of breast cancer cells. In addition, 2HF inhibited the expression of RLIP, a protein that is overexpressed in breast cancer cells. "While more research is needed to see if what we found in our mouse models can be translated to human subjects, it is important to note that natural compounds extracted from, say, orange peels is not toxic and has been shown to be beneficial, including lowering glucose triglycerides and cholesterol levels," said Sharad Singhal, Ph.D., lead author of the study and research professor in medical oncology at City of Hope. "In the distant future, it’s possible that 2HF supplements can be taken by breast cancer patients to enhance the effectiveness of medical treatment."

Poster session title: 4801 / 15: 2’-Hydroxyflavanone, a diet-derived citrus bioflavonoid, inhibits in vitro and in vivo growth of breast cancer cells by targeting RLIP.

Cofactor Genomics to Present on Predictive Immune Modeling at 2019 American Association for Cancer Research Annual Meeting

On March 21, 2019 Cofactor Genomics reported that Natalie LaFranzo, the company’s Director of Scientific Projects and Market Development, reported that it will present at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held at the Georgia World Congress Center in Atlanta, GA (Press release, Cofactor Genomics, MAR 21, 2019, View Source [SID1234534535]). The presentation is scheduled to take place on Sunday, March 31, 2019, at in Session PO.TB06.04 – Gene Expression in the Tumor Microenvironment. The presentation features Predictive Immune Modeling and multidimensional biomarker data generated in collaboration with TriStar Technology Group, a leading provider of archived human bio specimens and related research services offering highly-characterized and well-curated donor samples with extensive clinical follow-up data.

Executives from the company including CEO, Jarret Glasscock, will be attending the meeting to engage with current and future collaborators, clients, and investors. Visit View Source to arrange a time to meet with executives from Cofactor. The company also continues to solicit applications for their ImmunoPrism Grant Program, closing April 15. The grant program offers researchers the first opportunity to access Cofactor’s Predictive Immune Modeling platform. More information on the grant program may be found here: View Source

Novocure Announces 48 Presentations and a Symposium Session on Tumor Treating Fields at the American Association for Cancer Research Annual Meeting 2019

On March 21, 2019 Novocure (NASDAQ: NVCR) reported 48 presentations on Tumor Treating Fields at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, March 29 through April 3, in Atlanta (Press release, NovoCure, MAR 21, 2019, View Source [SID1234534534]). For the first time at this conference, a symposium session on Tumor Treating Fields also will be held.

The symposium session titled, "Tumor Treating Fields: A Fourth Modality in Cancer Treatment," will be chaired by Dr. Roger Stupp, Director of Strategic Initiatives at Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago. Presentation topics include "Identification of a new mechanism for how Tumor Treating Fields affect tumor cells" and "TTFields: From bench to bedside." Presentation topics will be followed by multiple discussion sessions.

The volume of Tumor Treating Fields presentations marks a record number of abstracts for Novocure at this conference. Highlights include an oral presentation on using transducer array layouts to optimize the treatment of multiple brain metastases with Tumor Treating Fields and results from a pilot study of Tumor Treating Fields combined with radiotherapy for newly diagnosed glioblastoma.

"The presence of Tumor Treating Fields at the AACR (Free AACR Whitepaper) Annual Meeting has grown substantially over the last five years," said Dr. Uri Weinberg, Novocure’s Vice President of Clinical Development. "The AACR (Free AACR Whitepaper) Annual Meeting is one of the most important gatherings of cancer researchers and clinicians throughout the world. We are honored to be a part of this invaluable exchange of scientific information and proud of the increasing focus on Tumor Treating Fields at this meeting."

Symposium Session

Tumor Treating Fields: A Fourth Modality in Cancer Treatment

1 to 2:45 p.m. EDT April 2

Oral presentation

(Abstract #: 4450) Novel transducer array layouts to optimize the treatment of multiple brain metastases with tumor treating fields. O. Yesharim. 3 to 5 p.m. EDT April 2.

Poster presentations

(Abstract #: 688) Safety and efficacy of TTFields delivery to the lungs: A computational study. H. Hershkovich. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #: 21)

(Abstract #: 691) Simulating TTFields-induced temperature changes within a patient’s brain – a proof of concept study. A. Naveh. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #: 24)

(Abstract #: 692) Treating spinal cord metastases with tumor treating fields. O. Yesharim. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #:25)

(Abstract #: 689) Heating of head tissues during TTFields therapy: a computational study. N. Gentilal. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #: 22)

(Abstract #: 4430) Simulating delivery of TTFields to the infratentorium in patients with brainstem gliomas. 1 to 5 p.m. EDT March 31. (Session: Molecular and Cellular Biology / Genetics; Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets; poster board #: 24)

(Abstract #: 4430) Numerical simulation of tumor treating fields effects on cell structures: Mechanism and signaling pathway candidates. 1 to 5 p.m. EDT April 2. (Session: Tumor Biology; Radiation Tissue Tolerance, Immunity, and in Vivo Effects of Radiation; poster board #: 2)

(Abstract #: 3724) Molecular mechanisms of TTField action determined by measurements and modelling of electro-conductive properties of microtubules. A. Kalra. 1 to 5 p.m. EDT April 2. (Session: Tumor Biology; Radiation Tissue Tolerance, Immunity, and in Vivo Effects of Radiation; poster board #: 1)

(Abstract #:4871) Comparative analysis of tumor treating fields using conventional versus alternative array placement for posterior fossa Glioblastoma. E. Lok. 8 a.m. to 12 p.m. EDT April 3. (Session: Clinical Research; Advances in Radiation Therapy / Surgical Oncology; poster board #: 15)

(Abstract #: 252) Tumor treating fields (TTFields) affect blood brain barrier (BBB) integrity in vitro and in vivo. A. Kessler. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #: 15)

(Abstract #: 250) Tumor treating fields increases membrane permeability in glioblastoma cells. E. Chang. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #: 13)

(Abstract #: 239) Aurora kinase inhibition to enhance Tumor Treating Fields efficacy in glioblastoma treatment. P. Bartmann. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #: 2)

(Abstract #: 307) The combined treatment of 150 kHz Tumor Treating Fields (TTFields) and cisplatin or pemetrexed inhibit mesothelioma cells in vitro. M. Munster. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #28)

(Abstract #: 306) The efficacy of the combined treatment of 150 KHz tumor treating fields (TTFields) and Sorafenib in hepatocellular carcinoma in vitro and in vivo. T. Voloshin. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #27)

(Abstract #: 303) The efficacy of the combined treatment of 150 kHz Tumor Treating Fields (TTFields) and FOLFOX in gastric cancer in vitro. 1 to 5 p.m. EDT March 31. (Session: Combination Approaches to Novel Therapies; poster board #: 24)

(Abstract #: 1258) Pooled-analysis of response markers in cancer cell lines treated with tumor treating fields. G. Shahaf. 8 a.m. to 12 p.m. April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 19)

(Abstract #: 2168) Testing the electrical properties of different cell lines using 3DEP reader and compare to TTFields response. M. Giladi. 1 to 5 p.m. April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 19)

(Abstract #: 2191) Reduced clonogenic potential of patient-derived lung adenocarcinoma brain metastasis cells after in vitro application of Tumor Treating Fields (TTFields). S. Michelhaugh. 1 to 5 p.m. EDT April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 13)

(Abstract #: 2192) Concurrent Tumor Treating Fields (TTFields) and dexamethasone decrease proliferation and clonogenicity of patient-derived glioblastoma cells in vitro. S. Michelhaugh. 1 to 5 p.m. EDT April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 14)

(Abstract #: 2094) Prostaglandin E receptor 3 mediates resistance to tumor treating fields in glioblastoma cells. D. Chen. 1 to 5 p.m. EDT April 1. (Session: Experimental and Molecular Therapeutics; Drug Resistance 3; poster board #: 1)

(Abstract #: 3280) TTFields induces immunogenic cell death and STING pathway activation through cytoplasmic double-stranded DNA in glioblastoma cells. D. Chen. 8 a.m. to 12 p.m. EDT April 2. (Session: Immunology; Novel Immunomodulatory Agents 1; poster board #: 30)

(Abstract #: 3493) Tumor treating fields (TTFields) significantly alters how tumor cells repair double stranded breaks using homeologous Alu sequences. M. Morales. 8 a.m. to 12 p.m. EDT April 2. (Session: DNA Damage and Repair 3; Molecular and Cellular Biology / Genetics; poster board #: 4)

(Abstract #: 3939) Exploiting tumor treating fields induced downregulation of BRCA1 pathway for novel combination therapies. N. Karanam. 1 to 5 p.m. EDT April 2. (Session: Experimental and Molecular Therapeutics; Preclinical Radiotherapeutics; poster board #: 20)

(Abstract #: 3954) Evaluating the compatibility of tumor treating electric fields with key anti-tumoral immune functions. G. Diamant. 1 to 5 p.m. EDT April 2. (Session: Clinical Research; Immunomodulation by Chemotherapy and Targeted Agents; poster board #: 10)

(Abstract #: 3961) Alternating electric fields (TTFields) induce immunogenic cell death resulting in enhanced antitumor efficacy when combined with anti-PD-1 therapy. T. Voloshin. (Session: Clinical Research; Immunomodulation by Chemotherapy and Targeted Agents; poster board #: 17)

(Abstract #: 4031) The dielectric properties of brain tumor tissue. M. Proescholdt. 1 to 5 p.m. EDT April 2. (Session: Clinical Research; Tumor Markers to Assess the Biology and Clinical Course of Cancer 2; poster board #: 24)

(Abstract #: 4419) Cell cycle analysis during TTF to exploit novel targets for increasing treatment efficacy. P. Slangen. 1 to 5 p.m. EDT April 2. (Session: Molecular and Cellular Biology / Genetics; Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets; poster board #: 13)

(Abstract #: 3942) Animal studies evaluating the safety of Tumor Treating Fields (TTFields) in the torso. S. Davidi. 1 to 5 p.m. EDT April 2. (Session: Experimental and Molecular Therapeutics; Preclinical Radiotherapeutics; poster board #: 23)

(Abstract #: 5271) Molecular imaging of pyruvate kinase M2 (PKM2) with [18F]DASA-23 detects temozolomide- and tumor treating fields (TTFields)-induced changes in glycolysis in glioblastoma. C. Patel. 8 a.m. to 12 p.m. EDT April 3. (Session: Molecular and Cellular Biology / Genetics; Tracking Metabolic Profiles and Subtype-specific Metabolic Interventions; poster board #: 14)

(Abstract #: 5156) In vitro application of tumor-treating fields to suppress tunneling nanotubes in mesothelioma. A. Sarkari. 8 a.m. to 12 p.m. EDT April 3. (Session: Molecular and Cellular Biology / Genetics; Cellular and Stromal Interactions of Tumor Cells; poster board #: 8)

(Abstract #: CT008) Tumor Treating Fields combined with radiotherapy and temozolomide for newly diagnosed glioblastoma: Final results from a pilot study. A. Hormigo. 8 a.m. to 12 p.m. EDT April 1. (Session: Phase I Clinical Trials: Part 1; poster board #: 3)

(Abstract #: CT062) A Phase I study of the safety and immunogenicity of personalized mutation-derived tumor vaccine and treatment fields in patients with newly diagnosed glioblastoma. A. Hormigo. 8 a.m. to 12 p.m. EDT April 1. (Session: Phase I Clinical Trials: Part 2; poster board #: 19)

(Abstract #: 1413) Using conventional imaging to predict water content and electrical properties at 200 kHz in brain and GBM tumor tissues: a feasibility study in three TTFields patients. C. Wenger. 8 a.m. to 12 p.m. April 1. (Session: Deep Learning; Clinical Research; poster board #: 22)

(Abstract #: CT172) Phase III METIS study: Tumor Treating Fields (150 kHz) and radiosurgery for supra- and/or infratentorial brain metastases (1-10) from non-small cell lung cancer (NSCLC). M. Mehta. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 16)

(Abstract #: CT175) HEPANOVA Phase 2 study design for advanced hepatocellular carcinoma: tumor treating fields concomitant with sorafenib. A. Grosu. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 19)

(Abstract #: CT174) Phase III INNOVATE study of tumor treating fields (200 kHz) concomitant with weekly paclitaxel for platinum-resistant ovarian cancer (ENGOT-ov50/BGOG study groups). I. Vergote. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 18)

(Abstract #: CT173) Tumor Treating Fields (150 kHz) concurrent with standard of care treatment for stage 4 non-small cell lung cancer (NSCLC) following platinum failure: The Phase III LUNAR study. U. Weinberg. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 17)

(Abstract #: CT176) Phase III PANOVA study of tumor treating fields (150 kHz) in combination with nab-paclitaxel and gemcitabine for front-line treatment of locally-advanced pancreatic adenocarcinoma (LAPC). U. Weinberg. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 20)

(Abstract #: CT202) Safety of Tumor Treating Fields delivery to the torso: Pooled analysis from TTFields clinical trials. G. Ceresoli. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 16)

(Abstract #: CT204) Increasing Tumor Treating Fields dose at the tumor bed improves survival: Setting a framework for TTFields dosimetry based on analysis of the EF-14 Phase III trial in newly diagnosed glioblastoma. M. Ballo. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 18)

(Abstract #: CT201) Final results of Phase II STELLAR trial: TTFields with chemotherapy in unresectable malignant pleural mesothelioma. G. Ceresoli. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 15)

(Abstract #: CT203) Randomized Phase II trial of Tumor Treating Fields plus radiation therapy plus temozolamide compared to radiation therapy plus temozolomide in patients with newly diagnosed glioblastoma. R. Grossman. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 17)

(Abstract #: CT205) Tumor Treating Fields alters progression patterns in glioblastoma: An imaging analysis of the EF-14 Phase III trial. S. Jeyapalan. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 19)

(Abstract #: LB-155) Adherence to tumor treating fields (TTFields) in high-grade glioma patients – a single center experience. C. Hagemann. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 13)

(Abstract #: LB-160) Glioblastoma and mesothelioma: Do estimates of health state utilities compare in rare cancers treatable with tumor treating fields? C. Proescholdt. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #:18)

(Abstract #: LB-162) Treating elderly glioblastoma patients > 65 years with TTFields – a cost-effectiveness perspective. G. Guzauskas. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 20)

(Abstract #: LB-163 ) Comparing clinical value scores (NCCN, ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper)) for TTFields treatment in glioblastoma. J. Kelly. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 21)

(Abstract #: LB-161): Application of the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) frameworks to TTFields treatment of mesothelioma. J. Kelly. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 18)

FORMA Therapeutics Announces Frank D. Lee as Chief Executive Officer

On March 21, 2019 FORMA Therapeutics reported the appointment of Frank D. Lee as Chief Executive Officer, starting on March 27, 2019 (Press release, Forma Therapeutics, MAR 21, 2019, View Source [SID1234534533]). Frank succeeds Steve Tregay, Ph.D., who after more than a decade as Founder and CEO, will transition to the role of Senior Advisor to the CEO. Frank, an industry veteran and champion for patients, joins FORMA with over 25 years of global experience in product development and commercial leadership across a wide range of therapeutic areas within the biotech and pharmaceutical industry. Most recently, Frank served as Senior Vice President, Global Product Strategy and Therapeutic Area Head for the Immunology, Ophthalmology and Infectious Diseases at Genentech, a member of the Roche Group.

"Steve and the Board collaborated to execute a thoughtful succession plan and I’m pleased to welcome Frank as FORMA’s next CEO. Frank’s passion for understanding the patient perspective, focused commitment to offer profoundly meaningful therapeutic solutions, and proven commercial leadership in building innovative product strategies will undoubtedly provide FORMA with the critical expertise to advance our pipeline toward commercialization," said Peter Wirth, Chairman, Board of Directors, FORMA Therapeutics. "Throughout his career, Frank has proven to be an accomplished leader significantly impacting human health through building highly productive teams, fostering a patient-centric culture, and opening of new markets to advance ground-breaking medicines. With several candidates now in ongoing Phase I and Phase II studies, Frank has a tremendous opportunity to accelerate FORMA’s R&D activities to provide sustained impact."

"FORMA’s ten-year foundation of excellence in discovery research and development, the depth of scientific talent and mission driven culture, as well as the multiple potentially transformative medicines now in the clinic, provide a unique opportunity to dramatically improve the lives of patients with serious diseases," said Frank D. Lee, incoming CEO, FORMA Therapeutics. "I’m excited to lead such a remarkable organization through the next growth phase including product approval and launch, while continuing to sustain an innovative pipeline for the long-term. It’s an honor to continue the legacy of building an innovative research company committed to patients, transformative science and company culture."

Peter Wirth added, "The FORMA Board of Directors extends deep gratitude to Steve for his contributions as founder and years of service as CEO and we wish him the best for his next endeavor. Steve’s entrepreneurial talent and interests reside in reinventing the way potential new drugs are identified, explored and developed, and he grew FORMA with disruptive innovation as part of its core DNA. During Steve’s time at FORMA, he championed the company’s evolution from a chemistry platform focused organization, toward a premiere research partner delivering high quality drug candidates, and recently to a fully integrated R&D company with a robust proprietary pipeline of clinical and preclinical assets in oncology, hematology and inflammatory diseases."

"After leading the company for over 10 years, I believe now is the ideal time for a transition," said Steve Tregay, Ph.D. "With an incoming CEO who has the ideal background to propel the pipeline towards commercialization and realize the company’s vision to change lives for patients, I am truly excited about FORMA’s future. I plan to work with the Board, Frank and FORMA’s leadership team to ensure a smooth transition and equally look forward to my next journey in continuing to transform the paradigm of drug discovery." Steve is founder and Chairman of the Board of Compass Therapeutics and a founding Board member of LabCentral.

Frank’s thirteen-year career at Genentech included leadership positions of increasing scope and responsibility for delivering transformative medicines to patients. Most recently, as Senior Vice President, Global Product Strategy, he was responsible for driving development and commercial strategy for a broad portfolio of molecules in development and for global in-line product sales of more than $11 Billion. Previously, as Vice President of the HER2/Breast Cancer Franchise, Frank was responsible for the US P&L for Herceptin, Perjeta and Kadcyla, driving revenues over $4 Billion and launching the first HER2 neoadjuvant indication shaping a new market and treatment paradigm for early HER2 breast cancer patients. As Vice President of Oral Oncolytics, Frank held P&L responsibility for Tarceva, Zelboraf, Erivedge and Xeloda, advancing personalized medicine for cancer patients with EGFR+ NSCLC and BRAF+ melanoma, and establishing a new treatment option for patients with advanced basal cell carcinoma. Other roles at Genentech included Franchise Head, Transplant and Tamiflu as well as Director of Marketing for Ophthalmology and Respiratory. Prior to joining Genentech, Frank spent approximately 13 years across Novartis, Janssen and Eli Lilly in engineering, manufacturing, sales/marketing and business development.

Frank received a bachelor’s degree in chemical engineering from Vanderbilt University, Nashville, TN., and an M.B.A. in Marketing and Finance from the Wharton Graduate School of Business, Philadelphia, PA. He previously served on the Board of the Genentech Foundation.

Aura Biosciences to Present Interim Phase 1b/2 Clinical Data for AU-011 at the International Society of Ocular Oncology 2019 Annual Meeting

On March 21, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that interim clinical data from its Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the International Society of Ocular Oncology (ISOO) 2019 Annual Meeting being held March 22-26, 2019, in Los Angeles (Press release, Aura Biosciences, MAR 21, 2019, View Source [SID1234534532]).

"These 18-month safety and efficacy data demonstrate that light-activated AU-011 is well-tolerated, including with multiple administrations, and has shown initial evidence of tumor control and preservation of visual acuity even in high risk patients whose tumors are close to the fovea and optic disk," said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School, and lead author of the presentation.

"Light-activated AU-011 continues to show a compelling degree of tumor control, tolerability and vision preservation as a potential first line treatment option for patients with small choroidal melanoma and indeterminate lesions, especially given the lack of targeted treatment options for these patients," commented Cadmus Rich, M.D., Chief Medical Officer of Aura. "It is also remarkable that no drug-related severe adverse events, serious adverse events or dose limiting toxicities have been observed in the study to date. We are excited to share these data with the medical community at ISOO this year."

This open-label, multicenter trial is designed to investigate single and multiple ascending doses of light-activated AU-011 in approximately 52 adult subjects with clinically diagnosed primary choroidal melanoma. The details for the ISOO 2019 presentation are as follows:

Title: Eighteen Month Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Date and time: Sunday, March 24, 2019; 11:10-11:15am PT
Location: The Ritz-Carlton Marina del Rey

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 primary treatment of 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.