On May 26, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an electronic-poster (ePoster) with clinical data from the Company’s AWARE-1 window-of-opportunity breast cancer study (Press release, Oncolytics Biotech, MAY 26, 2020, View Source [SID1234558466]). The data demonstrates a pelareorep-induced adaptive immune response in the tumor microenvironment (TME) and the potential of a predictive biomarker (T cell clonality) to identify patients with breast cancer most likely to respond to pelareorep. The ePoster was published on May 23, 2020, and presented over the weekend, as part of the European Society for Medical Oncology Breast Cancer Virtual Meeting.

"The preliminary AWARE-1 data showing a pelareorep-induced adaptive immune response in the tumor microenvironment are highly encouraging and strongly support the trial design and rationale," said Dr. Aleix Prat, co-author and lead translational investigator for the AWARE-1 study. "Observed increases in CelTIL, which are associated with a favorable response to treatment, are particularly noteworthy. Additionally, I am especially excited by data supporting the use of T cell clonality as a predictive and prognostic biomarker of pelareorep response, as the ability to accurately identify patients most likely to respond favorably to treatment will facilitate the success of future trials."

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The AWARE-1 study combines the appropriate intervention for each patient’s breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq), followed by surgery in early-stage breast cancer patients. To date, 13 patients have been treated in the AWARE-1 study, including the completion of cohort 1, patients with HR+/HER2- disease receiving pelareorep with letrozole.

"The AWARE-1 study provides a window for us to view changes in the tumor immune environment following intravenous administration of pelareorep to treatment-naïve, early-stage breast cancer patients," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "The study design, using paired biopsies, allows us to assess the correlation between T cell clonality and CelTIL, a measurement of tumor inflammation in these patients. The results tell us we can enrich the immune environment of these tumors and increase the expression of PD-L1, which may have a significant impact on future treatment directives, including the use of checkpoint inhibitors. This initial data demonstrates that pelareorep treatment primes an adaptive immune response, supporting the observed survival benefit in the previous randomized phase two study in metastatic breast cancer patients. We expect final data from AWARE-1 to provide mechanistic proof of concept for pelareorep and support our registration pathway."

Key data and conclusions from the ePoster include:
•Intravenous systemic administration resulted in tumor cell-specific pelareorep replication
•All patients treated with pelareorep demonstrated an increase in CD8+ T cells as confirmed in tumor biopsies (range of 1.6-fold to 11.2-fold increase)

•All patients treated with pelareorep experienced an increase in the number of PD-L1 positive cells in their tumors in as early as three weeks after beginning treatment (range of 1.3-fold to 11.0-fold increase)
•Four out of six evaluated patients exhibited an increase in CelTIL, which is associated with favorable clinical response, the study’s primary endpoint
•Peripheral T cell clonality correlated with changes in the TME and CelTIL, highlighting its potential as a compelling biomarker of pelareorep response in breast cancer

The results show intravenous delivery of pelareorep reaches the primary breast cancer tumor target. Importantly, the large increase in CD8+ T cells is prognostic of positive treatment outcomes, and the increased expression of PD-L1 suggests a treatment synergy when combining pelareorep and anti-PD-L1 checkpoint inhibitors, such as Tecentriq. The correlation between T cell clonality and tumor inflammation continues to show promise across multiple indications and increases our ability to identify patients likely to respond to treatment.

The ePoster, "A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer," was co-authored by Dr. Prat Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) along with several other colleagues from the academic cancer research group SOLTI, and institutions across North America and Europe. It can be found on the Posters & Publications page of the company’s website: View Source

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early stage breast cancer enrolling 38 patients into five cohorts:
•Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
•Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
•Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
•Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
•Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On May 26, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.61 per share of the company’s common stock for the second quarter of 2020 (Press release, Merck & Co, MAY 26, 2020, View Source [SID1234558464]). Payment will be made on July 7, 2020 to shareholders of record at the close of business on June 15, 2020.

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On May 26, 2020 Nurse-scientists from the Phyllis F. Cantor Center for Research in Nursing and Patient Care Services at Dana-Farber Cancer Institute reported that received more than $1.3 million dollars in funding for two separate research projects (Press release, Dana-Farber Cancer Institute, MAY 26, 2020, View Source;cantor-center-for-research-in-nursing-and-patient-care-services-awarded-two-major-research-grants/ [SID1234558463]).

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The American Association for Cancer Research (AACR) (Free AACR Whitepaper) announced that in partnership with the Lung Cancer Initiative at Johnson & Johnson (LCI) it will award $1 million dollars to a multi-institutional team focused on developing digital tools to engage high-risk smokers in an innovative smoking cessation program designed to encourage behaviors that promote lung health.

This team project is co-led by Dana-Farber nurse-scientist Mary E. Cooley, PhD, RN, FAAN, whose research arose out of her experience as an advanced practice nurse working as part of a multidisciplinary team focused on treating and supporting lung cancer patients and their families. "Smoking cessation, even after the diagnosis of lung cancer, is essential to improving clinical outcomes," said Cooley. "Our hope is this program encourages behaviors that promote lung health and early lung cancer detection." The other co-leaders are Peter Castaldi, MD, MSC, assistant professor of medicine at Harvard Medical School and Sun S. Kim, PhD, associate professor of nursing at the University of Massachusetts.

A separate research project recently received funding from the National Institutes of Health (NIH) to study chemotherapy-induced peripheral neuropathy. The study, led by Dana-Farber nurse-scientist Robert Knoerl, PhD, RN, looks at metabolomic and genetic markers of neuropathy in adolescents and young adults with cancer.

"Essentially there’s only one first-line treatment for neuropathy," said Knoerl. "One reason for the lack of effective treatments is that we don’t understand the underlying causes of neuropathy. We hope with this study to identify potential biomarkers that can be targeted in the future."

The mission of the Cantor Center is to reduce the burden of cancer through scholarly inquiry and rigorous research. The focus of the Center’s research is the patient/family experience of living with cancer, as well as survivorship issues post-treatment.

On May 26, 2020 Stand Up To Cancer research reported A recent FDA approval provides a new treatment option for patients with an aggressive form of prostate cancer (Press release, SU2C, MAY 26, 2020, View Source [SID1234558462]). The drug, called olaparib, is a precision therapy that targets certain molecular qualities of advanced prostate cancer in patients with genetic mutations that often lead to aggressive cancers, including BRCA1 and BRCA2.

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A collaborative ‘Dream Team’ of scientists funded by Stand Up To Cancer and the Prostate Cancer Foundation contributed to the research that led to the approval of olaparib for advanced prostate cancer.

"I’m delighted that the Dream Team’s work has led to a therapy that will impact patients with aggressive forms of prostate cancer," said Arul Chinnaiyan, MD, PhD Dream Team leader and professor of Pathology and Urology at the University of Michigan. "Our research was the first to demonstrate that over 20% of patients with metastatic prostate cancer have mutations in genes such as BRCA1 or BRCA2 and that over 10% of these mutations are inherited, which led to the clinical trials that tested olaparib as a potential treatment for these patients."

Prostate cancer is the second most common cancer in American men, following skin cancer. Furthermore, black men are at increased risk of a prostate cancer diagnosis, and significantly greater risk of dying from prostate cancer compared to whites. In 2020, close to 200,000 men will be diagnosed with new cases of prostate cancer, and about 33,000 men will die from the disease. A common therapy for prostate cancer lowers the levels of male hormones in the body with drugs or by removal of the testes. However, some men develop castration-resistant disease, meaning that the cancer is able to grow and continue to spread despite hormone therapy. As the cancer grows, it may also metastasize to parts of the body outside the prostate.

"New treatments are urgently needed for metastatic castration-resistant prostate cancer, which is particularly aggressive and difficult to treat," said SU2C Scientific Advisory Committee Vice-Chair William Nelson, MD, PhD, director of the Sidney Kimmel Comprehensive Cancer Research, Johns Hopkins University and a recognized expert in prostate cancer. "Stand Up To Cancer is proud to have contributed to the development of this targeted treatment option for people whose prostate cancer has progressed to this stage."

Uncovering the genetic and molecular characteristics of metastatic castration-resistant prostate cancer is key to finding novel treatments. The Dream Team analyzed DNA from metastatic castration-resistant prostate cancer samples gathered from eight clinical trials. In a study published in the journal Cell, the team showed that several genetic mutations, including BRCA1 and BRCA2, are prevalent in 23% of patients with metastatic castration-resistant prostate cancer.

"Prior to our research, certain genetic mutations such as BRCA1 were connected mainly to breast and ovarian cancer," said Chinnaiyan. "Our findings led us to question if drugs utilized for BRCA-positive breast and ovarian cancers – such as olaparib – could also be utilized for prostate cancer patients with the same genetic mutations, which launched an effort to test olaparib in clinical trials for men with prostate cancer."

Chinnaiyan and the Dream Team presented their initial findings at the annual SU2C Scientific Summit in 2015. Another Dream Team of SU2C scientists focused on women’s cancers immediately offered data from prior testing of drugs, including olaparib, that have been used successfully for women’s cancers with the same BRCA1 and BRCA2 mutations. "This type of collaboration is characteristic of SU2C," said Sung Poblete, PhD, RN, SU2C CEO. "Sharing this data saved the Prostate Cancer Dream Team nearly $500,000 and six months of work, allowing this compelling research to be accelerated to benefit patients faster."

Collaborating with colleagues testing olaparib in a clinical trial, the Dream Team analyzed each patient’s DNA for the genetic mutations they had identified in their previous studies. The trial results, published in the New England Journal of Medicine, revealed that metastatic castration-resistant prostate cancer patients with genetic mutations such as BRCA1 and BRCA2 often responded preferentially to olaparib. These results led to olaparib receiving a ‘Breakthrough Therapy Designation’ from the FDA, which laid the groundwork for the recent FDA approval of olaparib in metastatic prostate cancer.

Olaparib is a type of drug called a PARP inhibitor. PARP is a group of enzymes used by cells to repair damaged DNA. Olaparib suppresses PARP’s function, which inhibits DNA repair in cells with genetic DNA repair mutations such as BRCA1 or BRCA2. In many cases, this causes the cells with DNA repair mutations to die while sparing healthy cells.

The FDA approved olaparib for homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer on May 19, 2020.

The research that supported this FDA approval was funded in part by the SU2C−Prostate Cancer Foundation Prostate Dream Team: Precision Therapy of Advanced Prostate Cancer.

The Dream Team focused on women’s cancers that contributed drug testing data was the SU2C PI3K Dream Team: Targeting the PI3K Pathway in Women’s Cancers.

On May 26, 2020 Boston Scientific Corporation (NYSE: BSX) reported to participate in the Jefferies 2020 Virtual Healthcare Conference on June 2 (Press release, Boston Scientific, MAY 26, 2020, View Source [SID1234558461]).

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Joe Fitzgerald, executive vice president and president, Rhythm Management; Kenneth Stein, M.D., senior vice president and chief medical officer, Global Health Policy and Rhythm Management; Mark Bickel, vice president, controller, Rhythm Management; and Susie Lisa, vice president, Investor Relations will participate in a 25-minute question-and-answer session with the host analyst beginning at approximately 8 a.m. EDT.

A live webcast and replay of the webcast will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of the event.