NCCN’s Top Cancer Treatment Recommendations Available

On September 2, 2020 The National Comprehensive Cancer Network ( NCCN ) reported the availability of multiple non-English language versions of the NCCN Guidelines for various high-incidence cancers (Press release, NCCN, SEP 2, 2020, View Source [SID1234564351]). The specialized recommendations in French, German, Italian, Portuguese, Russian and Spanish can be consulted free of charge at NCCN.org/global or through the free Virtual Library of the NCCN Guidelines App .

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NCCN Guidelines Translations available for free at NCCN.org/global or via the Virtual Library of NCCN Guidelines App.
NCCN is dedicated to defining and advancing high-quality, high-value, patient-centered cancer care globally. The NCCN guidelines are the recognized standard for clinical and policy direction in cancer management and the most in-depth and frequently updated clinical practice guidelines available in any field of medicine. They are written by multidisciplinary, subject-specific expert panels from 30 leading cancer centers in the United States.

"NCCN is committed to maintaining and cultivating a growing library of global resources to ensure that providers and patients have access to the most up-to-date standards in cancer treatment around the world," said Robert W. Carlson , MD, CEO of NCCN. . " Nearly half of our registered users live outside of the United States and many may feel more comfortable in languages ​​other than English; NCCN guidelines have been downloaded in more than 180 countries. Expanding the number of non-English translations increases accessibility of this crucial information in Europe and other parts of the world. "

The recently translated NCCN guidelines cover the following types of cancer:

Acute Myeloid Leukemia (AML) – Portuguese and Spanish
B cell lymphomas – French, German, Italian and Spanish
Breast Cancer – Spanish
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL / SLL) – Portuguese and Spanish
Colon Cancer – Spanish
Gastric Cancer – Spanish
Hairy Cell Leukemia – Italian and Spanish
Head and Neck Cancers – Spanish
Hodgkin Lymphoma – Italian and Spanish
Melanoma (cutaneous) – Spanish
Multiple myeloma – Portuguese and Spanish
Non-Small Cell Lung Cancer – Italian and Spanish
Primary Cutaneous Lymphomas – Italian and Spanish
T Cell Lymphomas – Italian and Spanish
NCCN also offers palliative care guidelines, including the Russian version of the NCCN Guidelines for Management of Immunotherapy-Related Toxicities, covering immunotherapy-related side effects (irAEs) of immune checkpoint inhibitors and receptor T-cell therapy. chemical antigen (CAR). The NCCN Distress Thermometer – a tool to measure and address psychosocial well-being in people with cancer, has also been translated into 46 languages, including French, German, Italian, Portuguese, Russian, and Spanish.

In addition to all of these recommendations for adults with cancer, the NCCN also recently announced the translation of the NCCN Guidelines for Pediatric Acute Lymphoblastic Leukemia into Portuguese and Spanish.

Visit NCCN.org/global/international_adaptations.aspx to view and download 24 global adaptations and 230 translations of NCCN resources in 47 different languages. The NCCN global team also offers patient versions in multiple languages, including Czech, French, German, Italian, Russian, and Spanish. The NCCN provides the NCCN Framework for Resource Stratification of the NCCN Guidelines ( NCCN Framework ) and NCCN Harmonized Guidelines that combine optimal recommendations and pragmatic considerations for treatment in resource-limited settings, such as income countries low and medium.

Castle Biosciences Announces Commercial Launch of DecisionDx-SCC

On September 2, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that DecisionDx-SCC, its prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), is now commercially available (Press release, Castle Biosciences, SEP 2, 2020, View Source [SID1234564349]).

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"We are pleased to offer DecisionDx-SCC, intended for use in adding actionable, patient-specific information to risk assessment and to help guide management decisions in SCC," said Derek Maetzold, president and chief executive officer of Castle. "Using current SCC staging methods, about 200,000 patients annually are classified as high risk based on various clinical and pathological factors. But this relatively broad high-risk category leaves room for over- and undertreatment—a degree of uncertainty that patients and clinicians cannot afford, as death rates from SCC continue to rise. Now with the ability to add DecisionDx-SCC to commonly used clinical and pathological factors, we believe that this important innovation will improve prognostic accuracy and risk-appropriate management planning. We expect to see strong demand for DecisionDx-SCC, as we build upon our success with DecisionDx-UM and DecisionDx-Melanoma and follow our established model for commercialization."

Ashley Wysong, M.D., University of Nebraska Medical Center, Omaha NE stated, "As SCC cancer treatment plans and their outcomes are guided by risk of metastasis, improved prognostic accuracy has direct implications on patient management. By classifying SCC patients with existing risk factors into low, moderate and high biological risk categories, we believe DecisionDx-SCC can contribute positive predictive value to follow-up and management recommendations, potentially changing or narrowing recommendations in line with individual risk. I look forward to integrating tumor biology through DecisionDx-SCC into the clinical care of my patients."

The DecisionDx-SCC test is a qRT-PCR assay of 40 genes that uses a neural network algorithm to classify patients into risk categories. Independent validation was performed in a prospectively designed, multi-center (33 sites) study using archival tissue from 420 patients with known 3-year outcomes. The test’s validity and impact are supported by four peer-reviewed articles publications.

Conference Call and Webcast Details

As previously announced, Castle Biosciences, with guest speaker, Wysong, will hold a conference call on Wednesday, September 2, 2020, at 4:30 p.m. Eastern time to discuss the launch of DecisionDx-SCC.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (www.castlebiosciences.com). Slides to be presented during the webcast will be also be available on the Investor Relations page of the Company’s website. Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until September 23, 2020.

To access the live conference call via phone, please dial (877) 282-2581 from the United States and Canada, or +1 (470) 495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 4576527.

There will be a brief Question & Answer session following prepared remarks.

About Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (SCC) is one of the most common cancers. Approximately 1 million patients are diagnosed with SCC each year in the U.S. While the majority of these patients have a favorable prognosis, approximately 200,000 of these patients are identified as high risk. National guidelines for high-risk patients provide for broad, aggressive treatment plan recommendations relative to low-risk patients. Traditional clinicopathologic based risk-factor staging systems suffer from low positive predictive value, meaning many more patients are classified as high risk than actually develop metastatic disease. This may lead to over- and under-treatment of a substantial number of cutaneous SCC patients.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.mySCCskincancer.com.

SHINE Closes $80-million Series C Financing Supported by Fidelity Management and Research Company LLC

On September 2, 2020 SHINE Medical Technologies LLC, a nuclear technology company focused on becoming the world’s leading producer of medical isotopes, reported that it has closed an $80-million Series C financing (Press release, Shine Medical Technologies, SEP 2, 2020, View Source [SID1234564346]). Fidelity Management and Research Company LLC was the largest investor in the round, which also included participation from other new investors and the company’s current investors.

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"SHINE is grateful to Fidelity and all of our investors for providing us the capital to move our product commercialization efforts forward," said Todd Asmuth, president and chief financial officer of SHINE. "SHINE continues to make strong progress in our work to commercialize molybdenum-99, an essential diagnostic isotope, and lutetium-177, a therapeutic isotope that is showing great promise for the treatment of cancer."

SHINE is building a first-of-a-kind medical isotope production facility in Janesville, Wis. The facility will initially produce molybdenum-99, or Mo-99, which is used in more than 40 million patient procedures annually. There has been little or no domestic production of the isotope for decades, causing chronic shortages of Mo-99. These shortages routinely and significantly affect the diagnosis and treatment of patients around the world.

SHINE has off-take agreements with three of the world’s largest Mo-99 distributors for the future supply of Mo-99. The company’s production facility will be capable of supplying more than one-third of the global demand for Mo-99.

Last October, the company created SHINE Therapeutics to focus on critical customer needs in the rapidly growing therapeutic isotope market. The division is working to commercialize lutetium-177, or Lu-177, a therapeutic isotope used to treat prostate, neuroendocrine and other cancers. SHINE’s unique technology enables it to produce non-carrier-added, high specific-activity Lu-177, the form of the isotope most in demand by today’s clinical trial sponsors.

"This funding round will help SHINE’s continuing efforts to commercialize vital diagnostic and therapeutic isotopes that will be created by our revolutionary, responsible production technologies," said Greg Piefer, founder and CEO of SHINE. "The opportunity for SHINE to fill an urgent market need by creating a more robust supply of these isotopes was evident once again as patient supplies were being disrupted by the COVID-19 pandemic. This equity round is an affirmation by high-quality investors of our long-term business strategy and the ongoing success of our efforts to build a U.S. production platform that will produce a reliable isotope supply, fill an urgent market need and meet the needs of tens of millions of patients each year."

ImmunoGen Announces Webcast of Presentation at Upcoming H.C. Wainwright Virtual Global Investment Conference

On September 2, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, and Anna Berkenblit, Chief Medical Officer, will present at the upcoming H.C. Wainwright Virtual Global Investment Conference (Press release, ImmunoGen, SEP 2, 2020, View Source [SID1234564345]). The presentation is scheduled for September 14, 2020 at 11am ET.

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A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website on www.immunogen.com. Following the live webcast, a replay will be available at the same location.

Scholar Rock to Present at Upcoming Healthcare Conferences

On September 2, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will participate in the following upcoming virtual investor conferences (Press release, Scholar Rock, SEP 2, 2020, View Source [SID1234564343]):

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Baird’s 2020 Global Healthcare Conference on Wednesday, September 9, 2020 at 3:10 pm ET.
Citi’s 15th Annual BioPharma Virtual Conference on Thursday, September 10, 2020.
Morgan Stanley 18th Annual Healthcare Conference on Wednesday, September 16, 2020 at 2:00 p.m. ET.
A live webcast of this presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.
Cantor Virtual Global Healthcare Conference on Thursday, September 17, 2020.