On May 3, 2022 Agendia, Inc. , a commercial-stage company focused on facilitating optimized decision-making by providing clinicians with next-generation information and diagnostic solutions that can be used to help improve outcomes of breast cancer patients worldwide, reported that it will present new data at the European Society for Medical Oncology Breast Cancer Conference 2022 (ESMO Breast 2022) in Berlin, Germany, from 3 to May 5, 2022 (Press release, Agendia, MAY 3, 2022, View Source [SID1234613434]).

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The first of two poster presentations, titled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the sequencing version MammaPrint and BluePrint [1] Next-Generation Microarray Testing (NGS) is equivalent to centralized microarray testing, as evidenced by results from several laboratories worldwide. This enables a more accurate decentralized solution for breast cancer care, promoting global accessibility to more reliable genomic tests.

"Accessibility to breast cancer care is crucial and by validating the interchangeability of the NGS version of MammaPrint and BluePrint compared to standardized microarray tests, it opens new doors for clinicians around the world who may need to rely on platforms in the country to secure the MammaPrint and BluePrint results that their patients may need," says Annuska Glas, Senior Vice President of Research and Development and Innovation at Agendia. "MammaPrint is a valuable tool to aid treatment planning for breast cancer patients and with the decentralized NGS platform, it can be offered in even more countries. These results confirm that MammaPrint and BluePrint can provide the same accurate results through of NGS," he adds.

Agendia is creating new ways to ensure accessibility of care around the world, advancing solutions with a decentralized option for test kits to run on an NGS platform, and innovative modalities such as AI digital pathology. This data presented at the ESMO (Free ESMO Whitepaper) Breast 2022 conference follows Agendia’s announcement earlier this year that it was advancing its Digital MammaPrint artificial intelligence (AI) platform in Brazil to potentially radically change the way breast cancer is treated, providing essential information faster and elevating the capabilities of global clinicians treating women with breast cancer in their local communities.

A second poster presentation, entitled Budget impact analysis for the Health Care Package by using MammaPrint in Belgium [238P],builds on earlier research from the landmark MINDACT trial and combines it with interim analysis results from the pilot study conducted in Belgium (unpublished data). The budget impact model shows that the use of MammaPrint results in savings in breast cancer care in Belgium for the Belgian health package compared to no gene expression profiling testing. According to the budget impact model, the use of MammaPrint in patients selected according to the criteria of the pilot study represents a great saving. If gene expression profiling were performed on all clinically high-risk patients, the savings would be even greater.

Combining the cost of genomic testing with the savings from the net reduction in chemotherapy use, the annual savings amount to more than €5.8 million, which is an average saving of €3,900 per patient, compared to standard clinical care of a patient with breast cancer in Belgium. MINDACT has carried out previous analyzes of health savings in several countries, published in the European Journal of Cancer ,showing that genomic testing is beneficial as it provides valuable information that potentially allows patients to avoid the complexity of chemotherapy, resulting in significant financial savings for them, while generating significant cost savings for large healthcare systems around the world.

"A partir de los datos de impacto utilizados en el estudio piloto realizado en Bélgica, podemos determinar nuevas ideas de que el uso de MammaPrint podría conceder un ahorro sustancial de costes a las mujeres que no requieran quimioterapia y, en última instancia, podría aliviar parte de la carga del sistema sanitario belga en su conjunto", señala Pino Cusumano, MD, cirujano de mama del Centre Hospitalier Chrétien de Lieja en Bélgica. "Los datos han demostrado previamente que al desescalar a las mujeres con casos de bajo riesgo del tratamiento de quimioterapia, los resultados siguen siendo igual de buenos y las mujeres pueden seguir un plan de tratamiento más personalizado. Creemos que estos datos demuestran que el análisis anterior es válido para el estado de la atención del cáncer de mama en Bélgica en 2022,and that the overall benefit to the patient extends beyond physical care, to financial well-being as well," he continues.

Taken together, the two posters presented at ESMO (Free ESMO Whitepaper) Breast 2022 suggest that no matter where a patient is located, she can receive the same high-quality results with the added benefit of cost-effective treatment planning.

"The studies presented at EMSO 2022 support Agendia’s key initiatives to ensure that our genomic tests are widely accessible and affordable, without compromising scientific integrity or decision-making, to provide the clarity that women with breast cancer seek to guide treatment planning," says Bastiaan van der Baan, Director of Clinical and Commercial Development at Agendia. "With our strong commitment to facilitating the global adoption of MammaPrint and BluePrint, we look forward to continuing studies like these to increase the evidence supporting our goal of caring for women with breast cancer throughout their treatment," he concludes.

1 The MammaPrint and BluePrint next-generation sequencing kits have not yet been cleared by the Food and Drug Administration for sale in the United States; BluePrint has received CE marking for use in Europe. BluePrint is also marketed as a Laboratory Developed Test (LDT) and is CAP/CLIA audited in the United States.

On May 3, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported it will host a conference call to discuss its financial results for the year ended December 31, 2021 today at 5 pm ET (Press release, Perimeter Medical Imaging AI, MAY 3, 2022, View Source [SID1234613433]).

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Details on company presentations and webcasts can be found on the "Investors" section of Perimeter’s website at View Source When available, webcasts will be posted for replay following the event. The above listed dates and times are subject to change.

On May 3, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that the company will host a conference call and live audio webcast on Tuesday, May 10, 2022, at 8:00 a.m. ET to review its first quarter 2022 financial results and provide an update on the company (Press release, Gamida Cell, MAY 3, 2022, View Source [SID1234613432]).

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The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 3344029. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

On May 3, 2022 Bayer reported the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, Bayer, MAY 3, 2022, View Source [SID1234613431]).

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The sNDA is based on positive results from the investigational Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival (OS) for NUBEQA plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC compared to ADT plus docetaxel, which were published in The New England Journal of Medicine.1 NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

"Bayer remains dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease," said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of the Oncology SBU at Bayer. "Today’s sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for NUBEQA in combination with docetaxel to benefit men with mHSPC."

The application is being conducted under the FDA Oncology Center of Excellence’s (OCE) Project Orbis initiative, which provides a framework for concurrent submission and review of cancer treatments among participating international health authorities.

Bayer recently submitted applications to the European Medicine Agency (EMA), the Ministry of Health, Labor and Welfare (MHLW) in Japan, and China’s Center of Drug Evaluation (CDE). Additional submissions in mHSPC are planned globally.

About the ARASENS Trial2

The ARASENS trial (NCT02799602) is the only randomized, Phase III, multi-center, double-blind, placebo-controlled trial prospectively designed to compare the use of a second-generation androgen receptor inhibitor (ARi) (NUBEQA) plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of NUBEQA twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12-week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

About NUBEQA (darolutamide)3

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.3

On July 30, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily in combination with androgen deprivation therapy (ADT) or ADT alone. The primary efficacy endpoint was metastasis-free survival (MFS). NUBEQA is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating NUBEQA plus ADT versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov.

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of men with nmCRPC.3 The approvals of NUBEQA for nmCRPC in the U.S., European Union (EU), and other global markets have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus ADT compared to ADT alone.3 Filings in other regions are underway or planned.

INDICATION FOR NUBEQA (darolutamide)

NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

IMPORTANT SAFETY INFORMATION FOR NUBEQA (darolutamide)

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the prescribing information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.4

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy.5,6 Upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of docetaxel chemotherapy and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually experience progression to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.7,8

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On May 3, 2022 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported that data from its KRAS program will be presented in an oral presentation at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Affini-T Therapeutics, MAY 3, 2022, View Source [SID1234613430]). The data from Affini-T Therapeutics will be delivered by Tijana Martinov, Ph.D. from the Greenberg Lab at Fred Hutchinson Cancer Center .

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"KRAS mutations are the most prevalent oncogenic drivers in solid tumor cancers with G12V and G12D variants representing the most common substitutions within this oncogene," said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. "We are excited that our TCR-engineered T cell therapies, designed to orchestrate a coordinated CD4 and CD8 T cell response while targeting these common mutant variants of KRAS, show promising preclinical safety and efficacy profiles that support clinical development for solid tumor patients with KRAS mutations who have high unmet medical needs."

Presentation details are as follows:

Title: Preclinical Development of Safe and Effective T Cell Receptors Specific for Mutant KRAS G12V and G12D Peptides
Presenting Author: Tijana Martinov, Ph.D.
Abstract Number: 103
Session Title: Cell-Based Cancer Immunotherapies I
Date & Time: Monday, May 16, 2022 at 4:45pm – 5:00pm ET