US Oncology Research Announces Schedule of Presentations at the Virtual 2020 American Society of Hematology Annual Meeting and Exposition

On December 2, 2020 During the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, principal investigators from The US Oncology Network (The Network) and US Oncology Research reported that it will share detailed results from 30 studies covering topics that include Hodgkin lymphoma, multiple myeloma and the effects of cancers on older patient populations (Press release, US Oncology, DEC 2, 2020, View Source [SID1234572098]). The ASH (Free ASH Whitepaper) Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will be taking place virtually from Dec. 5-8, 2020.

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"In this landscape impacted by COVID-19, real-world evidence shows that our collective fight against cancer must include advancing clinical research and empowering patients through timely health screenings," said Robert L. Coleman, MD, chief scientific officer, US Oncology Research. "At this year’s ASH (Free ASH Whitepaper) virtual meeting, we are looking forward to sharing the latest advances from investigators in The Network and to exploring ways we can continue working together to navigate the unprecedented challenges and risks that patients with cancer are facing today."

Christopher A. Yasenchak, MD, associate chair of hematology research for US Oncology Research and a hematologist with Willamette Valley Cancer Institute and Research Center, will present an oral abstract titled, "Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients," on Sunday, Dec. 6, at 2:15 p.m. ET.

"Older patients with Hodgkin lymphoma often have poorer outcomes than younger patients due to comorbidities and the toxicity of conventional first-line chemotherapy," said Dr. Yasenchak. "Brentuximab vedotin, as monotherapy and in combination with other agents, shows high response rates and clinically meaningful improvements in progression-free survival and tolerability compared to conventional combination chemotherapy. The study, SGN35-015, presents compelling evidence underscoring the growing interest and urgency in research to advance cancer treatment and care for older populations."

In addition, Robert Rifkin, MD, FACP, medical director of biosimilars for McKesson, associate chair of hematology research and myeloma disease lead for US Oncology Research and a hematologist with Rocky Mountain Cancer Centers, a practice in The Network, co-authored "The Phase 3 TOURMALINE-MM2 Trial: Oral Ixazomib, Lenalidomide, and Dexamethasone (IRd) Vs Placebo-Rd for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (NDMM)." The oral presentation will take place on Monday, Dec. 7, at 7:45 a.m. ET.

"Patients who are newly diagnosed with multiple myeloma and not eligible for autologous stem cell transplants need additional treatment options," said Dr. Rifkin. "We believe the findings from TOURMALINE-MM2 emphasize the need for all-oral, proteasome inhibitor-based treatment options and will help pave the way for future innovation on behalf of the multiple myeloma community."

Dr. Rifkin will also present a trial-in-progress poster, "DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) With Bortezomib, and Dexamethasone (B-Vd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)," on Monday, Dec. 7, from 7:00 a.m.–3:30 p.m. ET.

Another oral abstract, "Subgroup Analyses of Elderly Patients Aged ≥ 70 Years in MAGNIFY: A Phase IIIb Interim Analysis of Induction R2 Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma," was co-authored by David Andorsky, MD, a hematologist with Rocky Mountain Cancer Centers. The presentation will take place on Sunday, Dec. 6, at 10:30 a.m. ET.

"Results from MAGNIFY indicate an important option for older, high-risk patients with non-Hodgkin lymphoma who have relapsed or did not respond to previous treatment with chemotherapy," said Dr. Andorsky. "In this patient population, lenalidomide combined with rituximab—with close attention to dose reduction—demonstrated encouraging efficacy and a tolerable safety profile."

Mitul Gandhi, MD, a medical oncologist with Virginia Cancer Specialists, a practice in The Network, co-authored the poster, "Safety and Antitumor Activity Study Evaluating Loncastuximab Tesirine and Rituximab Versus Immunochemotherapy in Diffuse Large B-Cell Lymphoma." The presentation will take place on Sunday, Dec. 6, from 7:00 a.m.–3:30 p.m. ET.

"Options are critically needed to improve outcomes for patients with diffuse large B-cell lymphoma who did not respond to previous therapy, are unsuitable for autologous stem cell transplantation or relapsed shortly after a transplantation," said Dr. Gandhi. "I am looking forward to presenting findings that indicate the potential to meet the needs of more patients with this aggressive form of lymphoma."

Furthermore, Houston Holmes, MD, a medical oncologist and hematologist at Texas Oncology, a practice in The Network, co-authored the oral abstract "Single-Agent Mosunetuzumab Is a Promising Safe and Efficacious Chemotherapy-Free Regimen for Elderly/Unfit Patients With Previously Untreated Diffuse Large B‑Cell Lymphoma." The presentation will take place on Sunday, Dec. 6, at 12:15 p.m. ET.

"Among patients with diffuse large B-cell lymphoma, approximately 30% over age 75 do not receive standard chemotherapy as a first-line treatment due to concerns about frailty and comorbidities," said Dr. Holmes. "Based on early clinical data, single-agent mosunetuzumab could offer a promising chemotherapy-free regimen for these patients who otherwise have limited options."

Researchers with McKesson Data, Evidence and Insights also worked with US Oncology Research and The US Oncology Network physicians on studies advancing the applications of real-world evidence, which will be presented this year.

Dr. Yasenchak will present a real-world evidence study titled, "Real-World Adherence to National Comprehensive Cancer Network (NCCN) Guidelines Regarding the Usage of PET/CT and Reported Deauville Scores in Advanced Stage Classical Hodgkin Lymphoma: A Community Oncology Practice Perspective." The poster presentation will take place on Sunday, Dec. 6, from 7:00 a.m.–3:30 p.m. ET.

"Providers may not always have the comprehensive information needed to optimize treatment modifications for patients with Hodgkin lymphoma," added Dr. Yasenchak. "Based on our findings, there is an opportunity to educate oncologists and radiologists about the importance of consistently reporting PET/CT Deauville scores in the initial staging and assessment of treatment response for these patients."

An additional real-world evidence poster, "NHL Patients and Nurses in the US Prefer Subcutaneous Rituximab Injection Versus Intravenous Rituximab Infusion: A Real-World Study," will be presented by Dr. Gandhi on Saturday, Dec. 5 from 7:00 a.m.–3:30 p.m. ET.

"As the COVID-19 pandemic adds new barriers to our health systems and the completion of clinical trials, real-world evidence is pivotal in providing insights into how we can improve outcomes," said Nicholas J. Robert, MD, medical director, McKesson Data, Evidence and Insights. "By leveraging data from our electronic medical records, healthcare providers and researchers are making an impact and optimizing care for patients managing cancer."

The full schedule of affiliated data presentations, including timing and author information, can be found here. For more information or to interview a trial investigator, contact Claire Crye at 281.825.9927 or [email protected] or Edie DeVine at 209.814.9564 or [email protected].

Puma Biotechnology, Inc. Prevails Before European Patent Office Board of Appeals in Decision Upholding European Patent (EP 1848414) as Granted

On December 2, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has prevailed in final appeal proceedings brought against its licensed European patent EP Patent 1848414, which covers the use of irreversible EGFR inhibitors in treating gefitinib and/or erlotinib resistant cancer and cancer with a T790M EGFR mutation (Press release, Puma Biotechnology, DEC 2, 2020, View Source [SID1234572097]). The European Board of Appeals announced its decision at a hearing on December 1st, rejecting the opposition of EP Patent 1848414 initiated by a Boehringer Ingelheim entity.

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The EP Patent 1848414 originally granted in April 2011 covers the use of irreversible EGFR inhibitors in treating gefitinib and/or erlotinib resistant cancer and cancer with a T790M EGFR mutation. On November 28, 2011, an opposition was filed seeking invalidation of the patent. The Opposition Division of the European Patent Office issued a decision on February 4, 2014 revoking some claims but upheld a subset of the granted claims relating to a pharmaceutical composition for use in treating cancer in a subject having a T790M EGFR mutation without any modification. Both parties appealed that decision in 2017. At a final hearing, the Board of Appeals announced its decision, concluding that the opposition was inadmissible and reversing the European Opposition Division decision issued in 2014, thereby upholding the EP Patent 1848414 as originally granted.

Gamida Cell to Host Virtual Pipeline Deep Dive

On December 2, 2020 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that it will host a virtual event discussing the company’s pipeline, including omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of a bone marrow transplant, and GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy, on Wednesday, December 9, 2020 at 8:00 a.m. ET (Press release, Gamida Cell, DEC 2, 2020, View Source [SID1234572096]).

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The live event will be available at the following link. A replay of the webcast will be available in the "Investors & Media" section of the Gamida Cell website, www.gamida-cell.com, and will be available for at least 14 days following the event.

Bluestar Genomics and University of Chicago Publish First-Ever Complete Whole Genome Map of Key Biomarker for Detection of Cancer and Other Diseases

On December 2, 2020 Bluestar Genomics, an innovative company leading the development of next-generation epigenomic approaches to cancer detection, and University of Chicago reported the publication of a genome-wide 5-hydroxymethylcytosine (5hmC) map across multiple human tissue types (Press release, Bluestar Genomics, DEC 2, 2020, View Source [SID1234572095]). The study, published in the peer-reviewed journal Nature Communications, demonstrated the robust performance of 5hmC as a global biomarker for the detection of multiple serious illnesses, such as cancer and various chronic diseases. Unlike 5mC which is a gene repression mark, 5hmC is a gene activation mark representing one of the most prevalent pathways involved in the regulation of embryogenesis, neurological processes, and carcinogenesis. The new map advances the understanding of diverse biological drivers in various diseases, which is necessary for the development of next-generation diagnostic tests.

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"While previous studies have shown that 5hmC can serve as an excellent biomarker for the diagnosis and prognosis of human diseases including cancer, the lack of a whole-body tissue map limits our global understanding of this mark and its potential tissue specificity," says Dr. Chuan He, Professor of Chemistry at the University of Chicago and the senior author of the study. "Through this collaboration with Bluestar Genomics, the new publication significantly expands our understanding of this global biomarker, delivering what we believe is the broadest reported human tissue map that catalogs 5hmC modifications. The new map confirms 5hmC as a prevalent gene activation mark for both gene bodies and enhancers with superb tissue and cell type specificity, which is key to future early diagnosis of human cancer and monitoring of human chronic diseases."

In this study, the University of Chicago scientists collaborated with Bluestar Genomics to evaluate the performance and reproducibility of 5hmC as a biomarker across 19 tissue types from multiple male and female organs. The published results demonstrate that the 5hmC profiles identified in the new map provide an unprecedented database of potential diagnostic development, specifically in cancer.

Based on a study of 96 samples representing ten major organ systems: nervous, cardiovascular, digestive, reproductive, endocrine, respiratory, urinary, integumentary, skeletal, and lymphatic, the map represents the most comprehensive examination of 5hmC as a biomarker for cancer detection. The data confirms the profiling accuracy (Spearman r = 0.82 compared with gold standard TAB-seq profiles) and reproducibility (Spearman r = 0.974) of the genome-wide 5hmC profiles obtained in various tissues, which underscores its clinical relevance and provides a unique resource to study distributions of 5hmC in the human genome.

Building on Bluestar Genomics’ previously published work, the new publication highlights that 5hmC reveals known biology in human tissues by enabling the measurement of gene transcriptional and gene regulation activity with the same assay. The published map, which characterizes the genomic distributions of 5hmC in 19 human tissues derived from ten organ systems lays the foundation for the future development of diagnostic tests.

"With the ultimate goal of developing a robust cancer screening test, this map brings us a step closer to enhancing our ability to accurately read and interpret cancer signals coming from tumor tissues in cell-free DNA," says Samuel Levy, Ph.D., Chief Executive and Chief Scientific Officer at Bluestar Genomics, co-senior author of the study. "I’m proud that our work will also contribute to the broader scientific community by deepening scientists’ precise understanding of the breadth of biology through the utilization of 5hmC."

Greenwich LifeSciences to Present at the Annual LD Micro Main Event

On December 2, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that it will be presenting at the Annual LD Micro Main Event to be held virtually from December 14-15, 2020 (Press release, Greenwich LifeSciences, DEC 2, 2020, View Source [SID1234572094]).

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Snehal Patel, CEO of Greenwich LifeSciences, will present and then participate in a live Q&A session by a panel of investors. The presentation will be held at 1:20 pm EST on December 15, 2020, and will highlight the Company’s recently published GP2 data and its plans to commence a Phase III clinical trial. The corporate presentation is currently available on the investor section of the Company’s website at: View Source

About LD Micro

LD Micro is the host of the most influential conferences in the small-cap world. LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into several influential events annually (Invitational, Summit, and Main Event). With the recent SRAX acquisition, LD has access to the largest active base of micro-cap investors in the world at over 2 million and counting. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.