Herantis Pharma will attend Bio-Europe 2022 and Redeye Neurology Day

On October 5, 2022 Herantis Pharma Plc ("Herantis"), developing disease modifying therapies for Parkinson’s disease, reported that CEO Antti Vuolanto and CSO Henri Huttunen will be attending and holding 1×1 meetings at Bio-Europe 2022 between October 24th–26th, 2022 (Press release, Herantis Pharma, OCT 5, 2022, View Source,c3643277 [SID1234621715]). Additionally, CEO Antti Vuolanto will be attending, presenting, and participating in a CNS panel discussion at Redeyes’ Theme: Neurology Day on October 12th, 2022.

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Conference Details:

Redeye Theme: Neurology

Bio-Europe 2022

If you are interested in scheduling a 1×1 meeting with Herantis management you can contact the conference organizers, connect with us via the Bio-Europe 1×1 platform, and/or send an email to [email protected].

Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for Enhertu

On October 5, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment (Press release, Hoffmann-La Roche, OCT 5, 2022, https://diagnostics.roche.com/global/en/news-listing/2022/roche-receives-fda-approval-for-first-companion-diagnostic-to-id.html [SID1234621714]). Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

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HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient’s HER2 status, pathologists evaluate, or score, the level of HER2 receptor protein expressed in breast cancer tissue samples. If a patient’s tumour expresses high levels of HER2, the patient is identified as HER2-positive and may be considered for HER2-targeted treatment. However, half of all patients with metastatic breast cancer express low levels of HER2 which historically classified them as HER2-negative.

The PATHWAY anti-HER2 (4B5) test now includes a scoring algorithm that helps pathologists to identify "low expressors" of HER2, assigning a HER2 low status to this group of patients. With this lower cutoff, the test is able to identify patients who may benefit from Enhertu as a treatment option.

"Roche is proud to lead the way in HER2 diagnostics through critical innovations that support the identification of patients who may benefit from novel HER2-targeted therapies," said Thomas Schinecker, CEO of Roche Diagnostics. "Previously, metastatic breast cancer patients with a lower level of HER2 expression were considered to be part of the HER2-negative population and had no HER2-targeted treatment options. Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes."

The PATHWAY anti-HER2 (4B5) test was used as part of the DESTINY-Breast04 trial sponsored by AstraZeneca and Daiichi Sankyo to identify patients whose tumours expressed low levels of HER2 protein. The trial reported a 50% reduction in the risk of disease recurrence or death and an overall gain of six months over standard of care in patients treated with Enhertu whose tumours had low levels of HER2 expression.

Breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases diagnosed worldwide each year. More than 620,000 people die from breast cancer every year.4,5

The FDA approval of the new HER2 low indication expands on the intended use for Roche’s proven, on-market PATHWAY anti-HER2 (4B5) test, delivering timely, clear and confident results. The launch exemplifies Roche’s commitment to continuing to innovate integrated, high medical value solutions that help to advance personalised healthcare.

About PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Antibody

Roche’s pre-diluted PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, used in combination with the fully automated BenchMark IHC/ISH slide staining instrument, standardises all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error.5 It also minimises inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones6 and demonstrates high concordance with HER2 FISH7,8, empowering laboratories to employ the most widely adopted and reliable HER2-IHC primary antibody.

CRISPR Therapeutics to Present at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On October 5, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported an oral presentation and a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, taking place in Boston, MA or virtually from November 8 to 12, 2022 (Press release, CRISPR Therapeutics, OCT 5, 2022, View Source [SID1234621713]).

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Title: CTX130 allogeneic CRISPR-Cas9–engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: Results from the Phase 1 COBALT-RCC study
Abstract Number and Type: 558, oral
Session Number: 113, Cellular Therapies + Bispecifics
Date and Time: Thursday, November 10, 2022, 5:37 PM ET

Title: CRISPR/Cas9 gene-edited, allogeneic anti-CD83 CAR-T cells demonstrate potent activity in GvHD and AML tumor models
Abstract Number and Type: 367, poster
Date and Time: Thursday November 10, 2022, 9:00 am – 9:00 pm

Merck Foundation awards Case Comprehensive Cancer Center 5-year, $2M grant to advance equitable cancer care in Northeast Ohio?

On October 5, 2022 The Case Comprehensive Cancer Center (Case CCC) reported that it received a $2 million grant through the Alliance for Equity in Cancer Care (the Alliance), an initiative funded by the Merck Foundation (the Foundation) and designed to make cancer care more equitable in the United States by helping patients living in underserved communities receive timely access to high-quality, culturally responsive care (Press release, Case Western Reserve University, OCT 5, 2022, View Source [SID1234621712]).

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"This is a very transformative initiative," said Stan Gerson, dean of the Case Western Reserve University School of Medicine and acting director of the Case CCC. "The funding provided by this award will help Case Comprehensive Cancer Center and our partnering organizations address the needs of our region’s most medically vulnerable by creating a multi-level intervention model that promotes delivery of cancer-care services to ensure earlier detection, earlier-stage diagnoses, informed cancer treatment decision-making and patient tailored treatment."

Nearly 40% of Americans will be diagnosed with cancer in their lifetime, according to the National Cancer Institute. Members of racial and ethnic minority groups, those living in rural areas, low-income individuals and the uninsured are disproportionately affected by cancer, yet often have limited access to cancer screenings, care and treatment.

In 2019, Cleveland proper was ranked in U.S. Census data as the poorest "big city" in the country and, based on the Ohio Cancer Incidence Surveillance System, is observed to have among the sharpest racial/ethnic disparities in lung, prostate, breast and colorectal cancer mortality in Northeast Ohio.

Data from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System study reveals far lower-than-recommended mammogram and colorectal cancer screening rates throughout the Case CCC’s 15-county service area.

Through the Alliance, a new collaborative effort has been forged by Case CCC, Care Alliance Health Center, El Centro, University Hospitals Accountable Care Organization, University Hospitals Seidman Cancer Center and The Gathering Place, titled PARTNERS: Promoting Access, Resources and Treatment through Novel and Equitable Solutions for Cancer Care.

Erika Trapl (left) and Jennifer Cullen
PARTNERS, led by Erika Trapl, associate director of community outreach and engagement, and Jennifer Cullen, associate director of cancer population sciences—both members of Case CCC and faculty at the Case Western Reserve School of Medicine—will address cancer disparities in access to screening and fragmentation of care for cancer patients. The project will implement patient navigation to improve access to cancer screening, timely follow-up care for suspicious findings and, ultimately, timely cancer treatments and psychosocial cancer support.

PARTNERS aims to serve those experiencing the greatest cancer burden in the Case CCC and those who are in greatest need for intervention to improve equity in cancer care: men and women 45 years and older who are African American or Latino/Latina and /or individuals with incomes near or at the poverty level.

"The severity of the need to take action on advancing equity in cancer care cannot be overstated and will not be overlooked," said Carmen Villar, CEO of the Merck Foundation. "We must move with urgency and work together to provide all people living with cancer access to high-quality care and treatment. The creation of the Alliance is an important step toward ensuring social determinants of health no longer factor into an individual’s ability to receive vital healthcare."

In addition to Case CCC, the Alliance program grantees include: Boston Medical Center; Conquer Cancer, the ASCO (Free ASCO Whitepaper) Foundation; Mary Bird Perkins Cancer Center; Memorial Sloan Kettering Cancer Center; RWJ Barnabas Health; and University of Kentucky Markey Cancer Center. The Foundation is also supporting a National Program Office at Virginia Commonwealth University (VCU) Massey Cancer Center, in partnership with the VCU Center on Health Disparities, which will assist Alliance program grantees in building partnerships with community-based organizations and provide technical assistance to support their programs.

The Alliance program grantees will meet regularly with the National Program Office to discuss lessons learned, share insights, , and explore tangible actions to support the delivery of equitable cancer care within their local communities and beyond. The National Program Office will evaluate the effectiveness of Alliance programs and identify and promote best practices that can enhance the delivery of cancer care in the United States.

Artiva Announces AB-101 Abstract Accepted for Presentation at Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting

On October 5, 2022 Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies that are safe and accessible to cancer patients, reported that an abstract highlighting further in vivo and in vitro preclinical data for AB-101, the Company’s clinical-stage ADCC-enhancer product candidate, was accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, to be held virtually and at the Boston Convention & Exhibition Center from November 8 to 12, 2022 (Press release, Artiva Biotherapeutics, OCT 5, 2022, View Source [SID1234621710]).

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Details of the presentation are as follows:

The abstract will be available for viewing on November 7 at 8:00 am EST at the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC) website (JITC link to be provided on the SITC (Free SITC Whitepaper) Annual Meeting website at View Source). The poster will also be available for viewing on November 10 at 9:00 am EST at View Source.

The poster will present data on the universal use of an ADCC-enhancer NK cell, AB-101, in combination with ADCC-mechanistic therapeutic antibodies and will describe a broader set of antibody combinations beyond rituximab. Artiva is conducting a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.