On August 3, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a publication in Blood Cancer Journal, a peer-reviewed journal that focuses on hematologic malignancies and related disorders (Press release, BostonGene, AUG 3, 2021, View Source [SID1234585644]). The manuscript "Lack of intrafollicular memory CD4+ T cells is predictive of early clinical failure in newly diagnosed follicular lymphoma" underscores the role of intrafollicular CD4 expression to independently predict treatment outcomes of high-risk follicular lymphoma (FL) patients.

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"We’re proud to support Mayo Clinic in its mission to predict treatment outcomes for patients with newly diagnosed follicular lymphoma"

Early event-free status (EFS) at 12 and 24 months are good indicators of subsequent prolonged survival and lengthy life expectancy in FL. However, an unmet need remains to predict early EFS at diagnosis to better treat patients with optimal therapeutics. This discovery and validation study evaluated the tumor microenvironment (TME) determinants of early failure in patients with newly diagnosed FL and integrated the results into the Follicular Lymphoma International Prognostic Index (FLIPI), the clinically-driven scoring system of survival in FL. This research study analyzed the prevalence of T-cell subsets and macrophages in the pretreatment biopsy specimens of newly diagnosed patients with FL who were prospectively enrolled in the Molecular Epidemiology Resource (MER) cohort at Mayo Clinic and the University of Iowa. To support this work, BostonGene conducted comprehensive analysis of Co-Detection by Indexing (CODEX) multiplex immunofluorescence data generated by the Villasboas Lab at Mayo Clinic to characterize intratumoral immunophenotypes. The study revealed that insufficient intrafollicular CD4 expression was the main predictor of early failure, leading to the development of a novel bio-clinical risk model (called BioFLIPI), where lack of CD4 intrafollicular expression moved patients up one FLIPI risk group, ultimately improving the identification of patients at risk for early failure at diagnosis.

"Leveraging BostonGene’s analytical capacity to explore the ultrahigh plex CODEX imaging datasets generated in our laboratory furthered our understanding of the composition and spatial distribution of immune cells within the TME," said J. C. Villasboas, MD at Mayo Clinic. "These key insights are critical to improving clinical outcomes for FL patients."

This work is the result of the research collaboration between Mayo Clinic and BostonGene to uncover key tumor characteristics that can be exploited to develop personalized therapies for lymphoma patients.

"We’re proud to support Mayo Clinic in its mission to predict treatment outcomes for patients with newly diagnosed follicular lymphoma," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "With our combined transformational technologies, we have a significant opportunity to identify patients with the highest risk of early failure and personalize treatment."

On August 3, 2021 NantHealth, Inc. (NASDAQ: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported the appointment of Tiffany Avery, MD, MPH, as Chief Medical Officer (Press release, NantHealth, AUG 3, 2021, View Source [SID1234585643]). In her new position, Dr. Avery will be responsible for providing clinical strategic direction and guiding the development and deployment of NantHealth’s Eviti decision support platform and other innovative products and services.

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"Appointing Dr. Avery to our leadership team is an incredibly valuable addition to the organization, particularly as we expand into areas like population health and additional disease states for Eviti," said Ron Louks, Chief Operating Officer, NantHealth. "With her background in medical oncology, epidemiology, and cancer and health disparities, Dr. Avery will play a key role in helping NantHealth to deliver valuable, equitable care and improved outcomes to the patients and populations we serve."

Dr. Avery joined NantHealth in January of 2019 as Medical Director of Oncology. Prior to her role at NantHealth, she served as an Assistant Professor of Oncology at Thomas Jefferson University and Wake Forest Baptist Health. After completing fellowship training at The University of Texas MD Anderson Cancer Center in Houston, Texas, Dr. Avery focused and lectured on clinical research and the care of breast cancer patients. In the community, Dr. Avery is a recognized expert and invited speaker on topics including cancer prevention, treatments, clinical trials, and survival disparities. Over the course of her career, Dr. Avery has produced peer-reviewed publications, conference abstracts, editorials, and served as an investigator on numerous breast cancer clinical trials.

"I’m excited to be a part of NantHealth to reach our collective goal of improving health outcomes and providing value-based, quality healthcare," said Dr. Avery. "As an advocate for equitable care, in cancer but certainly in all of healthcare, not only does it make financial sense to all stakeholders, but it’s absolutely the right thing to do. Our technology helps deliver on that mission, and I’m honored to help guide us on this journey."

Dr. Avery earned her BS and MPH in Epidemiology from Tulane University, and MD from LSU Health Sciences Center New Orleans. She completed fellowship training in Hematology and Medical Oncology at MD Anderson Cancer Center. Dr. Avery recently earned certification in Lifestyle Medicine and is a co-host of 3 Black Docs, a podcast aimed at addressing health and cancer disparities.

On August 3, 2021 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its second quarter financial results for the period ended June 30, 2021, on Monday, August 9, 2021, after the market closes (Press release, Omeros, AUG 3, 2021, View Source [SID1234585642]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 4195376. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 4195376.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at View Source

On August 3 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, and GE Healthcare reported the signing of an exclusive agreement for the manufacturing and distribution of iodine-123 (I-123) capsules in the United States (Press release, NorthStar Medical Radiostopes, AUG 3, 2021, View Source [SID1234585641]). Under the contract terms, GE Healthcare’s Pharmaceutical Diagnostics unit will manufacture and supply NorthStar with I-123 capsules under the NorthStar label using a new, state-of-the-art production system at its facility in Arlington Heights, Ill. Upon receipt of the required regulatory approvals, NorthStar will retain exclusive U.S. marketing and distribution rights for these I-123 capsules, which will be available in 100µCi and 200µCi formulations.

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Iodide I-123 (as sodium iodide I-123) is a radioisotope of iodine, a staple product in radiopharmacies that is used routinely in nuclear medicine as the proven standard for the diagnosis of physiological abnormalities in the thyroid, including thyroid cancer. The American Cancer Society estimates that approximately 44,280 Americans will be diagnosed with thyroid cancer in 2021.

"This exclusive sales and manufacturing agreement marks NorthStar’s strong and growing relationship with GE Healthcare, and we look forward to working with the company in meeting the needs of radiopharmacy customers and the patients we all serve," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "NorthStar is strongly committed to the future of nuclear medicine. The ability to provide I-123 further expands our diagnostic imaging portfolio, which includes domestically produced, non-uranium Mo-99/technetium-99m and FibroScint, a novel fibrin-specific diagnostic imaging agent with potential clinical utility in cardiovascular care."

"We are pleased to sign this agreement and look forward to working with NorthStar in providing patients across the United States with I-123 capsules," said Chris Vessell, U.S. Nuclear Medicine Supply Chain Leader, GE Healthcare Pharmaceutical Diagnostics. "NorthStar has proven itself a leader in successfully driving technology development to produce innovative, real-world solutions for radioisotope production to meet healthcare needs, and we anticipate a productive relationship with the company."

GE Healthcare Pharmaceutical Diagnostics imaging agents support three patient procedures every second worldwide across MRI, X-ray/CT, ultrasound and nuclear medicine imaging.

On August 3, 2021 Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported the first patient has been dosed in a Phase 1, multicenter, open-label, dose-escalation, and dose expansion study to evaluate the safety, pharmacokinetics (PK), and anti-tumor activity of ARX517 in subjects with prostate specific membrane antigen (PSMA) expressing tumors found in prostate, pancreatic, lung and ovarian cancers (Press release, Ambrx, AUG 3, 2021, View Source [SID1234585640]).

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ARX517 is an anti-PSMA antibody drug conjugate (ADC) that demonstrated activity in both enzalutamide sensitive and resistant preclinical models for prostate cancer while demonstrating favorable PK and toxicity profiles in IND-enabling GLP toxicity studies.

"I am excited to announce that we dosed our first patient in our Phase 1 trial, and thus have taken the first steps in evaluating the potential clinical benefit of ARX517 in cancer patients with tumors overexpressing PSMA," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "ARX517 is the second ADC in our internal pipeline to enter the clinic, which I believe speaks to the broad applicability and productivity of our technology platform. I look forward to updating you on the progression of this trial."

The Phase 1 trial will be a multi-center, open-label, dose escalation and dose expansion study. This trial, referred to as APEX-01, is designed to assess the safety, tolerability and PK profile, as well as the anti-tumor activity, of ARX517 as a monotherapy. The trial will enroll up to 76 patients with advanced solid tumors whose diseases have failed prior standard therapies.

About PSMA, prostate cancer and other solid tumors

PSMA has been found highly expressed in prostate cancer, particularly in metastatic castration-resistant prostate cancer (mCRPC). Additionally, PSMA has been found in a variety of other solid tumors. Prostate cancer represents a significant unmet need and sizable market opportunity. There were 1.3 million new cases of prostate cancer with five-year survival rates of approximately 27% and 359,000 associated deaths worldwide in 2018. For men, prostate cancer is the second most frequent cancer and the fifth leading cause of cancer death. The global market for prostate cancer therapies was estimated to be $9.3 billion in 2018 and is forecast to grow to $12.8 billion by 2028. While non-ADC therapies are available to treat mCRPC, there is no approved therapy specifically targeting PSMA to treat prostate cancer.