On September 9, 2019 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), reported that Dan Spiegelman, Executive Vice President and Chief Financial Officer and Henry Fuchs, M.D., President, Worldwide Research & Development, will present at the Morgan Stanley 17th Annual Global Healthcare Conference on September 10, 2019 at 8:35am ET in New York (Press release, BioMarin, SEP 9, 2019, View Source [SID1234539386]). To access the live webcast, please visit the investor section of the BioMarin website, www.biomarin.com. A replay will also be archived on the site for at least one week following each event.

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On September 9, 2019 Novocure (NASDAQ: NVCR) reported 27 presentations on Tumor Treating Fields, including four oral presentations, will be featured at the American Society for Radiation Oncology (ASTRO) 2019 Annual Meeting, Sept. 15 through Sept. 18 in Chicago (Press release, NovoCure, SEP 9, 2019, View Source [SID1234539381]). The volume of Tumor Treating Fields presentations marks a record number of abstracts for Novocure at this conference. External authors prepared 16 of the presentations, pointing to a growing interest in Novocure’s proprietary Tumor Treating Fields platform within the radiation oncology community.

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Presentation highlights include a subgroup analysis of the STELLAR trial by radiological response patterns in malignant pleural mesothelioma and the first presentation of in vitro data combining treatment with Tumor Treating Fields and chemotherapy in gastric cancer.

"The presence of Tumor Treating Fields at the ASTRO Annual Meeting has grown substantially over the last three years," said Novocure’s Chief Medical Officer Ely Benaim. "We are excited to continue our partnership with the radiation oncology community to help establish Tumor Treating Fields as an important treatment for solid tumors. We look forward to participating in the exchange of scientific information at one of the premier meetings for radiation oncologists."

Oral Presentations

(Presentation 1070) Radiological Response Patterns in Malignant Pleural Mesothelioma (MPM): Subgroup Analyses of the Phase 2 STELLAR Trial of TTFields plus Chemotherapy for First-Line Treatment. F. Grosso. 8:40 to 8:45 a.m. CDT Monday, Sept.16.

(Presentation 1102) Blood Brain Barrier (BBB) Integrity is Affected By Tumor Treating Fields (TTFields) in Vitro and In Vivo. C. Hagemann. 4:25 to 4:30 p.m. CDT Monday, Sept.16.

(Presentation 212) Creating Conductivity Maps at 200 Khz of Brain and Tumor Tissue of Glioblastoma Patients with Water-Content Based Electric Properties Tomography. N. Gentilal. 1:55 to 2:05 p.m. CDT Wednesday, Sept. 18.

(Presentation 1277) Tumor Treating Fields Delivery to the Abdomen Is Unlikely to Cause Thermal Tissue Damage: Results of an Extensive Computational Analysis. N. Gentilal. 2:25 to 2:30 p.m. CDT Wednesday, Sept. 18.

Joint Interactive Session

Novel targeted therapies/Immuno-oncology and Clinical Trials/TTF. M. Ahluwalia. 4:32 to 4:44 p.m. CDT Monday, Sept. 16.

Poster Presentations

(3109) Efficacy and Thermal Safety of Tumor Treating Fields Delivered to the Thorax: A Simulation-Based Study. Z. Bomzon. 1:15 to 2:30 p.m. CDT Sunday, Sept. 15.

(3116) Malignant Pleural Mesothelioma: Survival Meta-Analysis from 15 Years of a Standard Systemic Therapy. J. Friedberg. 1:15 to 2:30 p.m. CDT Sunday, Sept. 15.

(3254) Clinical Value of TTFields Treatment in Mesothelioma Using ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) Frameworks. J. Kelly. 1:15 to 2:30 p.m. CDT Sunday, Sept. 15.

(3611) Animal Studies Evaluating the Safety of Tumor Treating Fields (TTFields) Alone and in Combination with Chemotherapy Agents Demonstrate No Additional Toxicities. M. Giladi. 1:15 to 2:30 p.m. CDT Sunday, Sept. 15.

(2159) Delivering Uniform TTFields Distribution to the Brain. Z. Bomzon. 10:45 to 12 p.m. CDT Monday, Sept. 16.

(2214) Prostaglandin E Receptor 3 Mediates Resistance to Tumor Treating Fields in Glioblastoma Cells. D. Chen. 10:45 to 12 p.m. CDT Monday, Sept. 16.

(2222) Tumor Treating Fields Combined with Radiotherapy and Temzolomide for the Treatment of Newly Diagnosed Glioblastoma: Final Results from a Pilot Study. R. Grossman. 10:45 to 12 p.m. CDT Monday, Sept. 16.

(2226) Analysis of the EF-14 Phase 3 Trial Reveals That Tumor Treating Fields Alter Progression Patterns in Glioblastoma. S. Jeyapalan. 10:45 to 12 p.m. CDT Monday, Sept. 16.

(2287) A Proof of Concept Study for Simulating Heat Transfer in Patients Treated with Tumor Treating Fields. Z. Bomzon. 10:45 to 12 p.m. CDT Monday, Sept. 16.

(2240) Single Institutional Experience with Tumor Treating Field Compliance and Overall Survival in Patients with Primary Glioblastoma. K. Qualls. 10:45 a.m. to 12 p.m. CDT Monday, Sept. 16

(3003) Treating Elderly Glioblastoma Patients > 65 Years with TTFields: A Cost-Effectiveness Perspective. F. Leonard. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3362) Updated Meta-Analysis of Toxicity Data in Thoracic and Abdominal Malignancies from Clinical Trials in Tumor Treating Fields. I. Vergote. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3486) Exploiting Conditional Vulnerabilities Caused By the Systems Level Effects of Tumor Treating Fields. M. Story. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3498) TTFields Induces Immunogenic Cell Death and Sting Pathway Activation through Cytoplasmic Double-Stranded DNA in Glioblastoma Cells. D. Chen. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3541) Tumor Treating Fields (TTFields) Suppress Tunneling Nanotube Formation in Malignant Mesothelioma. A. Sarkari. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3581) Patient-Derived Metastatic Non-Small Cell Lung Cancer (NSCLC) Cell Lines from Untreated and Treated Patients Are Sensitive to Tumor Treating Fields (TTFields) in Vitro. S. Michelhaugh. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3573) Tumor Treating Fields (TTFields) Plus Sorafenib Is Safe and Effective in Hepatocellular Carcinoma Tested in Vitro and in an Animal Model. S. Davidi. 1 to 2:15 p.m. CDT Tuesday, Sept.17.

(3514) Immunogenic Cell Death Induced by Tumor Treating Fields (TTFields) Enhances Efficacy When Combined with Anti-PD-1 Therapy in Lung and Colon Cancer Animal Models. T. Voloshin. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3582) Efficacy of Tumor Treating Fields (TTFields) in Combination with Cisplatin or Pemetrexed for the Treatment of Mesothelioma in Vitro and in Vivo. M. Munster. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3587) The Combined Treatment of 150 kHz Tumor Treating Fields (TTFields) and FOLFOX Inhibit Gastric Cancer in Vitro. E. Zeevi. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3845) Tumor Treating Fields Therapy Influences Patterns of Failure in Glioblastoma Patients in a Dose-Dependent Manner: A Multidisciplinary Analysis of the Randomized Phase III EF-14 Clinical Trial. M. Ballo. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

(3857) Optimizing Transducer Array Layout for the Treatment of Pancreatic Cancer Using Tumor Treating Fields (TTFields) in the Phase 3 PANOVA-3 Trial. Z. Bomzon. 1 to 2:15 p.m. CDT Tuesday, Sept. 17.

On September 9, 2019 Biodesix, Inc. reported positive clinical data from Oncimmune’s EarlyCDT Lung blood test, which harnesses the power of the immune system to detect evidence of the body’s natural response to cancer (Press release, Biodesix, SEP 9, 2019, View Source [SID1234539380]). The technology can detect cancer on average four years or more before standard clinical diagnosis . Results from the randomized controlled study of 12,209 people at high risk of developing cancer, Early detection of Cancer of the Lung Scotland (ECLS), were presented today at the International Association for the Study of Lung Cancer’s (IASLC) 2019 World Conference on Lung Cancer in Barcelona. In June, Biodesix announced acquisition of Oncimmune and the EarlyCDT Lung test in the United States.

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Prof. Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews and Chief Investigator for the ECLS trial, noted the global significance of a blood test, followed by CT scans, to increase the number of patients diagnosed at an earlier stage of disease, when surgery is still possible and prospects for survival are higher. This early diagnosis is especially important in the case of lung cancer because approximately 85 percent of patients are diagnosed with the disease at a late stage, when the cancer has spread to other parts of the body and the chances of survival are low.

Biodesix CEO David Brunel

"This represents a significant opportunity to improve the standard of care in screening for lung cancer. Current screening programs in the United States have seen very slow adoption rates, with only two percent of the eligible eight million U.S. high risk individuals undergoing screening in 2016. The EarlyCDT Lung test is a blood test that can be administered in primary care and used to direct at-risk patients into further investigation with imaging, thereby increasing the proportion of lung cancers diagnosed in early stages. We look forward to continuing our work with Oncimmune to extend the utility of the EarlyCDT Lung test in the U.S. to include lung cancer screening."

In addition to its potential in lung cancer screening, the EarlyCDT Lung test also helps physicians to determine if a pulmonary nodule is potentially cancerous, helping physicians manage nodule patients. The Biodesix Nodify XL2 test, is used to help physicians rule-out malignancy in low-to-moderate risk incidental lung nodules. Biodesix will offer complementary tests that help empower physicians to stratify patients into distinct nodule management pathways.

On September 9, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that it has entered into a research agreement with Invectys, a biopharmaceutical company focused on the development of innovative immunotherapy approaches to treat cancers (Press release, Personalis, SEP 9, 2019, View Source [SID1234539379]). Under the terms of the agreement, Personalis will provide comprehensive tumor immunogenomics capabilities to facilitate biomarker discovery in chronic lymphocytic leukemia (CLL) patients enrolled in a Phase II clinical trial assessing the efficacy of INVAC-1, a DNA plasmid encoding a modified human telomerase reverse transcriptase (hTERT) protein, as monotherapy or in combination with ibrutinib.

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"Personalis is known for their innovative and expansive cancer immunogenomics expertise, and we’re delighted to partner with them on this project to evaluate biomarker signatures in responders and non-responders to our leading cancer vaccine candidate, INVAC-1," said Pierre Langlade Demoyen, CEO of Invectys. "INVAC-1 has the potential to become a key component of combination therapy approaches for the treatment of various solid and hematologic cancer types. Our work with Personalis will help us to determine which patients are most likely to respond favorably to these novel treatment regimens."

Invectys is now enrolling CLL patients in this Phase II, open-label, single-arm trial consisting of two patient groups: 45 patients receiving INVAC-1 as monotherapy and an additional 45 patients receiving INVAC-1 in combination with ibrutinib, a Bruton’s Tyrosine Kinase inhibitor. The primary goal of the study is to achieve minimal residual disease negativity in both groups. The trial is being conducted at the MD Anderson Cancer Center in Houston, Texas. For more information, please visit clinicaltrials.gov identifier NCT03265717.

"Invectys has built an exciting pipeline of novel, next-generation immunotherapies, and we’re thrilled to help drive their lead program forward," said John West, CEO of Personalis. "Having already established ourselves as a leader in comprehensive tumor immunogenomic profiling and biomarker discovery for solid tumor indications, we’ve seen increasing use of our capabilities for biomarker evaluation in hematologic cancer types. This bodes well as we continue to rollout and onboard customers for our newly-launched, universal cancer immunogenomics platform, ImmunoID NeXT."

On September 9, 2019 Aptorum Group Limited (Nasdaq: APM) ("Aptorum Group"), a biopharmaceutical company focused on the development of novel therapeutics to address global unmet medical needs, reported the development of two preclinical drug candidates which target obesity and neuroblastoma, respectively (Press release, Aptorum, SEP 9, 2019, View Source [SID1234539378]).

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About CLS-1: Treatment of obesity via modulation of chemical signaling relating to gut microbiota

Under the recently-announced microbiota modulation platform operated by Aptorum Group’s wholly-owned subsidiary Claves Life Sciences Limited, we have commenced the preclinical development of macromolecule candidate CLS-1 targeting the treatment of obesity. CLS-1 is undergoing lead optimization and is expected to progress into the IND enabling stage in 2020.

The prevalence of obesity continues to escalate globally; however, there is no current optimal therapy for this condition1. For the majority of obese patients, conventional medical therapies (i.e., diet, exercise, behavioral counseling) often have a high failure rate for the long term2. We believe current pharmacotherapy has limited efficacy and is associated with substantial safety issues, and this will provide immeasurable market opportunity for CLS-1.

Chemical signaling of gut microbiota is known to be one of the major causes of obesity1. CLS-1 is an orally administered non-absorbable macromolecule that modulates the metabolite excreted by gut microbiota with high affinity and specificity. In this way, we believe the absorption of this particular metabolite, which is linked to obesity, can be inhibited.

Aptorum Group is also pursuing two further indications based on the modulation of microbiota based chemical signaling involving the above large molecule technology, which we believe to be highly scalable and we hope to be making further announcements regarding our efforts in due course.

About SACT-1: Repurposed Drug Candidates for the Treatment of Neuroblastoma

Under the recently announced Smart-ACTTM computational drug discovery platform operated by our wholly-owned subsidiary Smart Pharma Group, Aptorum Group has completed computational screening of approximately 1,615 marketed drugs against 3 therapeutic target proteins to potentially tackle poor prognosis of neuroblastoma, i.e., a rare type of children’s cancer that forms in certain types of nerve tissue and most frequently in the adrenal glands as well as spine, chest, abdomen or neck, especially in children3. For the high-risk group, the 5-year survival rate of this condition is around 40-50% as observed by the American Cancer Society.4 Aptorum Group has identified an array of repurposed candidates and has proceeded to evaluate them in cell-based and animal models in order to validate the candidates’ usage for such new indication and potential efficacies.

Aptorum Group is also pursuing two further indications under the Smart-ACTTM drug discovery platform and hopes to be making further announcements regarding our research in due course.