On August 27, 2020 CURE Media Group, the industry-leading multimedia platform devoted to cancer updates and research that reaches more than 1 million patients, reported the three finalists for the 2020 Extraordinary Healer Award for Oncology Nursing and the winner of the 2020 The Finest Hour award (Press release, CURE Media Group, AUG 27, 2020, View Source [SID1234564112]).

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This year’s celebration, which will be held in a virtual format, recognizes exceptional nurses for their efforts in the oncology community. The Finest Hour, an award to honor the selfless achievements of an extraordinary nurse working to provide care during the COVID-19 pandemic, also will be presented.

This year’s finalists for the Extraordinary Healer award are:

Vicki Dodson, B.S.N., RN, OCN, has 36 years of nursing experience. She works as an oncology nurse navigator at Providence Sacred Heart Medical Center in Spokane, Washington. Dodson takes time to listen to patients expressing their fears and frustrations and helps them figure out the confusing health care system, educating them on the treatments and therapies they will be receiving. She recently volunteered to run a cancer support group that had lost its facilitator, in addition to the many other organizations she supports. Dodson credits her career in nursing to her love of people and the ever-everchanging research and treatment.
Maria Rodriguez, B.S.N., RN, is a nurse navigator at the cancer center at Temple University Hospital in Philadelphia, Pennsylvania. Rodriguez looks beyond patients’ diagnoses and tries to soothe the spirit in addition to treating the illness. She is bilingual and became a dual-role medical interpreter for Spanish-speaking patients. Rodriguez made the cancer center’s holiday food drive more inclusive for Hispanic families and spearheaded the center’s Feliz Navidad celebration. Her inspiration for becoming a nurse was her grandmother, who always told her that she had healing hands and to share them with others who were suffering because of an illness.
Christie Santure, B.S.N., RN, OCN, is an infusion nurse at UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania. Santure launched a Caring for the Caregiver program at UPMC, a support group for those who are caring for someone undergoing cancer treatment. She offers sessions twice a month at Hillman Cancer Center and is working with leadership to start the program at other UPMC locations. Santure started as a candy-striper and has been a nurse for 40 years. She aspires to walk in the shoes of the nurses before her who inspired her journey.
The winner of the Finest Hour award is Elizabeth Farrat, B.S.N., RN, CCRN-K. Farrat works as a perioperative nurse liaison in the operating room at Memorial Sloan Kettering (MSK) Cancer Center in New York City. Prior to her current role, Farrat worked in the intensive care unit (ICU) at MSK for 10 years, where she helped design and facilitate the ICU orientation trajectory, ICU preceptor expectations and workflow. In addition, she helped create an ICU Teaching the Teacher Continuing Education Program for ICU preceptors. Farrat also was a palliative care unit champion and is an end-of-life nursing education consortium critical care trainer. During the COVID-19 surge in New York, Farrat was redeployed to the ICU to care for patients who were critically ill with the virus. She helped implement the real-time, critical-care training of step-down registered nurses so that they were able to provide ICU care.

"Each of these nurses has demonstrated incredible compassion, expertise and helpfulness in caring for their patients," said Mike Hennessy Jr., president, and CEO of MJH Life Sciences, parent company of CURE Media Group. "They have gone above and beyond their call of duty during this difficult time, and we look forward to shining a light on them for their tremendous efforts."

The 2020 Extraordinary Healer Award for Oncology Nursing virtual celebration will take place Thursday, Sept. 17.

For more information on the winners and to register to attend, click here.

This event is supported by Bristol Myers Squibb and Janssen.

On August 27, 2020 Carl Zeiss Meditec reported that The use of targeted intraoperative radiotherapy (TARGIT), as a single dose – with ZEISS INTRABEAM – directly after removal of a tumor, has been confirmed as non-inferior, when compared with external beam radiotherapy (EBRT) (Press release, Carl Zeiss, AUG 27, 2020, View Source [SID1234564111]). Within the accuracy of the study, the risk of a local tumor recurrence in the breast is similar and non-breast cancer death is reduced. The TARGIT-A randomized, multi-center phase 3 study involving 2,298 patients with a median patient follow-up time of 8.6 years meets the highest scientific standards.

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Globally, more than 40,000 patients have already been treated, in over 350 breast cancer centers, with the TARGIT method.

"Single dose intraoperative radiotherapy for early stage breast cancer can be a better alternative to conventional whole breast radiotherapy for most patients during primary tumor management," stated the principal investigator Professor Jayant Vaidya, Professor of Surgery and Oncology and Scientific Director at University College London, when presenting the results of the study.

"These excellent results provide real clinical justification for single intraoperative radiation in suitable patients with early breast cancer. It is now essential to develop the corresponding treatment guidelines as soon as possible," added Professor Jeffrey Tobias, Professor of Oncology at University College London and joint initiator of the TARGIT-A study.

Positive clinical study results validate TARGIT as an option in breast cancer treatment

The local, recurrence-free survival rate of women treated with single dose TARGIT is non-inferior when compared with EBRT. The mortality in the TARGIT arm was even lower because of fewer cardiovascular deaths.

"We are delighted with the positive results, as the ZEISS INTRABEAM 600 now represents an outstanding treatment alternative for many patients. We are confident that the procedure can now find its way into everyday clinical practice," said Ludwin Monz, CEO of Carl Zeiss Meditec AG.

TARGIT method underscored as an efficiency-oriented treatment

"This study reflects two decades of interdisciplinary clinical research by leading radiation oncologists, surgeons, physicists and health economists. The TARGIT-A trial has offered many breast cancer patients a treatment that is well-tolerated, effective, convenient and highly cost-efficient," summarized Professor William Small, Professor of Radiation Oncology at Loyola University, Chicago and one of the world’s leading radiation oncologists.

On August 27, 2020 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported that it will meet with the FDA to finalize the protocol for its clinical study in support of its Premarketing Application for the LuViva Advanced Cervical Scan (Press release, Guided Therapeutics, AUG 27, 2020, View Source [SID1234564110]). The meeting has been set for October 14, 2020. The FDA already has provided the Company with guidance for drafting the study protocol through useful feedback on the Company’s Pre-submission documents and its previous meeting with the FDA.

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To gear up for the clinical study, the Company is interviewing potential clinical sites. The study plans to enroll patients at four clinical sites that represent a cross section of the U.S. population of women who are screened for cervical cancer. Because of limitations inherent in current imaging technology, as much as 40% to 50% of disease is missed, even with invasive and expensive biopsy. Under the draft protocol submitted to FDA for review, LuViva will be studied to document its ability to detect a significant number of these missed diagnoses. New national guidelines for cervical cancer management published in April of 2020 stress a preferred risk-based approach, a primary feature of LuViva’s AI-based risk profile algorithms.

"Once FDA has completed the review of the study protocol, we intend to begin enrolling patients as soon as practicable," said Gene Cartwright, CEO. "Starting our study will be major milestone for the Company’s plans to commercialize LuViva in the U.S."

On August 27, 2020 Sarah Cannon, the Cancer Institute of HCA Healthcare, and Lyell Immunopharma reported a strategic collaboration for the advancement of oncology-focused immune-effector, or T-Cell, therapies (Press release, Sarah Cannon Research Institute, AUG 27, 2020, View Source [SID1234564108]). This partnership brings together Lyell’s research and development of cell-based immunotherapies and Sarah Cannon’s expertise in designing and optimizing clinical trials to expand treatment options and access for patients.

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"We look forward to partnering with Lyell Immunopharma to accelerate development and access to innovative T-Cell therapies for patients who could potentially benefit from these treatment options," said Howard A. "Skip" Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. "By bringing together Lyell Immunopharma’s scientific expertise with Sarah Cannon’s experience and expansive network, we can pursue an innovative approach to bring these cutting-edge treatment options into the community more rapidly and affordably for patients."

Sarah Cannon is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Additionally, Sarah Cannon’s Blood Cancer Network is one of the largest providers of hematopoietic cell transplants, offering patients access to complex blood cancer care, including clinical trials and innovative therapies such as CAR T-Cell therapy.

Since 2015, Sarah Cannon has activated T-Cell therapy studies, which are overseen by immune cell therapy committees that advise on the coordination and standardization of research processes across centers for both blood cancer and solid tumor indications.

"Lyell is very excited to be partnered with Sarah Cannon," said Tina Albertson, MD, PhD, Chief Medical Officer of Lyell. "This collaboration should result in the ability to more rapidly and efficiently initiate clinical trials and thus bring Lyell’s innovative cell therapy treatments to patients more quickly once trials are authorized to commence."

Lyell Immunopharma, Inc. is a cellular therapy company dedicated to mastering immune cell functionality by focusing on advancing the science of T-Cell differentiation, functionality, and specificity to develop curative treatments.

T-Cell therapies have become an effective approach for treating many forms of blood cancers, with CAR T-Cell therapies currently approved in acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL), as well as hundreds of additional trials for both blood cancer and solid tumors.

"There are challenges in developing and providing access to the latest T-Cell therapies due to care fragmentation and related barriers for integrating these novel therapies into clinical settings," said Fred LeMaistre, MD, Senior Vice President, Market Operations and Physician-in-Chief, Blood Cancers for Sarah Cannon. "By collaborating, Sarah Cannon and Lyell Immunopharma will work to create a more cohesive approach to introducing new T-Cell therapy standards of care into clinical practice, and developing strategies for these innovative therapies."

Through Sarah Cannon Development Innovations, its full-service, oncology-focused contract research organization (CRO), Sarah Cannon will provide comprehensive clinical development services and operational delivery for the collaboration.

On August 27, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported the commencement of an investigator-initiated Phase 2 study led by Senior Member and Professor Ahmad A. Tarhini, M.D., Ph.D. of the H. Lee Moffitt Cancer Center and Research Institute and the University of South Florida Morsani College of Medicine to evaluate its lead product candidate, TAVO (interleukin-12 or IL-12 plasmid) immunotherapy as neoadjuvant treatment (administered before surgery) in combination with intravenous OPDIVO (nivolumab) in up to 33 patients with operable locally/regionally advanced melanoma (Press release, OncoSec Medical, AUG 27, 2020, View Source [SID1234564107]).

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Anti-PD-1 immune checkpoint therapies, such as OPDIVO, are an established first-line treatment for advanced melanoma, and encouraging clinical data suggest that they have clinically meaningful activity in the neoadjuvant setting as well. This investigator-initiated Phase 2 study has been designed to evaluate whether the addition of TAVO can increase the published anti-tumor response observed with monotherapy OPDIVO, an anti-PD-1 checkpoint inhibitor, in patients with locally/regionally advanced melanoma prior to surgical resection of tumors.

Recent trials with anti-PD-1 and anti-PD-1 combinations have shown significant advantages in both relapse free survival (RFS) and overall survival (OS) when administered as neoadjuvant therapy as compared to adjuvant therapy (administered after surgery) alone for metastatic melanoma. The TAVO-specific immunological signatures associated with coordinated innate and adaptive cellular responses were identified in earlier TAVO monotherapy trials and continue to be essential in driving the clinical efficacy in late-stage, anti-PD-1-refractory metastatic melanoma patients. These immunological pathways that sensitize lesions to checkpoint therapy in a late-stage setting are likely to be highly active in an earlier disease setting, which along with TAVO’s excellent safety record, provides a strong rationale to leverage this therapeutic combination within the neoadjuvant setting.

"Patients with locally/regionally advanced melanoma present a major challenge for surgical and medical management," said Dr. Tarhini, who is Director, Cutaneous Clinical & Translational Research and Senior Member in the Departments of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center & Research Institute. "Following surgical treatment, these patients continue to have a high risk of relapse and death despite the use of standard adjuvant therapy. Neoadjuvant therapy with an effective immunotherapeutic agent, such as TAVO, combined with the anti-PD-1checkpoint inhibitor nivolumab, has the potential to improve overall outcomes such as operability, pathologic tumor response and long-term disease control. This, combined with the excellent safety and tolerability profile TAVO has demonstrated with hundreds of patients to-date, leaves me very encouraged and eager to evaluate TAVO-nivolumab combination treatment in the neoadjuvant setting."

"This Phase 2 study will highlight the advantages of bringing TAVO into an earlier disease setting. It will be an important validation of the broad utility of TAVO, and is anticipated to build on its excellent safety and efficacy profile to date," commented Kellie Malloy Foerter, OncoSec’s Chief Operating Officer. "We look forward to collaborating with Dr. Tarhini’s team and to supporting other potential investigator-initiated studies that can further the understanding of TAVO’s capabilities in treating cancer. We also want to express our appreciation of the patients and their families who participate in clinical trials."