Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Muscle-Invasive Urothelial Carcinoma (MIUC)

On April 5, 2022 Agilent Technologies Inc. (NYSE: A) reported CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx immunohistochemical assay to extend the use of the test to patients diagnosed with muscle-invasive urothelial carcinoma (MIUC) who have tumor cell PD-L1 expression ≥ 1% for adjuvant treatment with OPDIVO (nivolumab), a PD-1-targeted immunotherapeutic from Bristol Myers Squibb (Press release, Agilent, APR 5, 2022, View Source [SID1234611472]).

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Urothelial carcinoma is the 10th most common cancer worldwide, with over 500,000 new cases and approximately 212,000 deaths in 2020.1 The rate of relapse with distant occurrence is approximately 50% in patients with MIUC.2

PD-L1 is a biomarker for response to anti-PD-1 therapies, including OPDIVO. The expanded use of PD-L1 IHC 28-8 pharmDx helps physicians in the EU identify MIUC patients for adjuvant treatment with OPDIVO.

When used in conjunction with PD-L1 IHC 28-8 pharmDx as a companion test, OPDIVO provides the first and only PD-1-directed treatment approach that can help reduce the risk of disease recurrence and offers new hope for patients diagnosed with MIUC.

"Agilent supports pathologists with products that provide accuracy and reliability in PD-L1 testing," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "We are pleased that this now includes the treatment of MIUC for adjuvant treatment with OPDIVO."

This new indication CE-marking for PD-L1 IHC 28-8 pharmDx in the EU expands the current treatment options for urothelial cancer patients to include MIUC patients whose tumor cells express PD-L1 ≥ 1% and are high-risk of recurrence after undergoing radical resection, for the adjuvant treatment with OPDIVO. The new labeling builds on Agilent’s previous successes in growing the clinical applicability of therapeutic biomarker analysis, further cementing the company’s position as a provider of diagnostic assays that deliver high quality and ease of implementation.

References

1. View Source
2. John Michael DiBianco, Arvin K George, Daniel Su, Piyush K Agarwal. Managing noninvasive recurrences after definitive treatment for muscle-invasive bladder cancer or high-grade upper tract urothelial carcinoma. Curr Opin Urol. 2015 Sep;25(5):468-75

PathAI and GlaxoSmithKline Sign Multi-Year Agreement to Accelerate Research and Drug Development

On April 5, 2022 PathAI, a global leader in AI-powered pathology, and GlaxoSmithKline (GSK), reported a strategic multi-year partnership to accelerate scientific research and drug development programs in oncology and non-alcoholic steatohepatitis (NASH) by leveraging PathAI’s technologies in digital pathology including the use of PathAI’s AIM-NASH tool (Press release, GlaxoSmithKline, APR 5, 2022, View Source [SID1234611471]).

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"GSK’s world-leading AI/ML capability, including our dedicated in-house hub in London, is applying a predictive and data-driven approach to drug discovery and clinical trials with the aim of improving the success rates of new medicines. We look forward to leveraging both PathAI’s expertise and models to advance GSK’s proprietary AI models and focus on designing better models to deliver improved treatment options for patients with cancer and NASH," said Kim Branson, SVP Global Head of Artificial Intelligence and Machine Learning at GSK.

"Our partnership will combine GSK and PathAI’s AI and platform engineering teams to scale algorithm development and enable the discovery of new insights that can be rapidly integrated into clinical trials," said Andrew Beck, CEO and Co-founder of PathAI. "With our combined efforts, we aim to harness the power of machine learning to predict which patients will benefit from therapies in key high need areas."

Oxford Finance Announces the Closing of a $75 Million Credit Facility With Fusion Pharmaceuticals

On April 5, 2022 Oxford Finance LLC ("Oxford"), a leading specialty finance firm that provides senior debt to life sciences and healthcare services companies worldwide, reported the closing of a $75 million senior secured term loan with Fusion Pharmaceuticals Inc. (NASDAQ: FUSN) ("Fusion" or "the Company"), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers (Press release, Fusion Pharmaceuticals, APR 5, 2022, View Source [SID1234611470]).

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Proceeds from the transaction will be used for general working capital and to fund the advancement of the Company’s pipeline.

Fusion Pharmaceuticals is leveraging its targeted alpha therapy ("TAT") expertise and platform to advance a pipeline of alpha-emitting radiopharmaceuticals using various classes of targeting molecules to pursue cancer targets in areas of high unmet medical need.

"The Company’s TAT platform has the potential to enhance the tumor-killing power of radiation and is designed for broader applicability across multiple tumor types," said Christopher A. Herr, senior managing director at Oxford. "We are happy to partner with Fusion, and support its diversified pipeline focused on addressing the unmet needs in cancer treatment."

Takeda and the New York Academy of Sciences Announce 2022 Innovators in Science Award Winners

On April 5, 2022 Takeda (TSE:4502/NYSE:TAK) and the New York Academy of Sciences reported the winners of the fourth Innovators in Science Award for their excellence in, and commitment to, innovative science that has significantly advanced the field of research in gastroenterology (Press release, Takeda, APR 5, 2022, View Source [SID1234611469]). Each winner receives an unrestricted prize of $200,000 USD.

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The 2022 Senior Scientist Award winner is Jeffrey Gordon, M.D., Director of the Edison Family Center for Genome Sciences and Systems Biology and Dr. Robert J. Glaser Distinguished University Professor at Washington University School of Medicine in St. Louis. Dr. Gordon is widely recognized as the "Father of Microbiome Science" and has served as the research mentor for more than 140 doctoral students and post-doctoral fellows who have become the next generation of leaders in the field. His pioneering interdisciplinary research has revealed the profound effects of the human gut microbial community on physiology and metabolism. Dr. Gordon’s preclinical studies have yielded fundamental insights about the mechanisms that underlie the formation and functioning of the human gut microbiome, as well as its causal links to disease states, including malnutrition. Dr. Gordon’s group has developed microbiome-targeted therapeutic foods for the precision repair of the gut microbiomes of malnourished children and restoration of their growth.

"This award is a wonderful recognition of the excitement and promise that the field of microbiome research offers, and of the collective efforts of the inspiring group of talented students, staff, and collaborators who I’ve been privileged to work with as we strive to better understand how the gut impacts our health," said Dr. Gordon.

The 2022 Early-Career Scientist Award winner is Elaine Y. Hsiao, Ph.D., De Logi Associate Professor of Biological Sciences at UCLA. Dr. Hsiao has made groundbreaking discoveries into how the gut microbiome influences the brain and behavior. Her research has upended conventional thinking about the cause and treatment of neurological diseases such as autism and epilepsy. Some of Dr. Hsiao’s most impactful work investigating the influence of the maternal microbiome on fetal brain development has laid the foundation for hypotheses of microbial contributions to risk for neurodevelopmental disease. Dr. Hsiao has also advanced the understanding of how microbiota influence serotonin-producing endocrine cells in the gut — research that has the potential to affect the understanding of intestinal and neurological diseases.

"Winning the Innovators in Science Award is a great privilege for me as an early-career scientist," said Dr. Hsiao. "Not only does it signal a welcome to new researchers to help advance the field, it also recognizes the discoveries made possible by my talented and inspiring colleagues in the lab who share my dedication to uncovering interactions between the gut, its native microbes, and the brain. This award will continue to motivate me to go where science leads, and toward better understanding how life works in ways that I hope will one day benefit people."

"The work of Dr. Gordon and Dr. Hsiao to uncover more about the role of our gut microbiome in disease pathology and apply that understanding to create meaningful interventions for patients suffering from gastrointestinal, neurological diseases, and beyond is truly inspiring," said Andrew Plump, M.D., Ph.D., president, Research & Development at Takeda. "We proudly support the Innovators in Science Award because at Takeda we deeply value the pursuit of science and those who push the boundaries of what is possible to dramatically improve people’s lives."

"We are pleased to join Takeda in championing the tireless work of researchers around the world," said Nicholas Dirks, Ph.D., president and CEO of the New York Academy of Sciences. "The 2022 Innovators in Science Award winners are pursuing groundbreaking medical research that reveals the workings of the gut microbiome to potentially bring innovations to patients everywhere who are affected by gastrointestinal disease and more."

The 2022 winners will be honored at the Innovators in Science Award ceremony and symposium October 13-14, 2022, in Boston. For more information and to register for the 2022 Innovators in Science Award virtual symposium, please visit: View Source

About the Innovators in Science Award

The Innovators in Science Award grants two unrestricted prizes of US $200,000 each year: one to an early-career scientist and the other to a well-established senior scientist who have distinguished themselves for the creative thinking and impact of their research. The Innovators in Science Award is a limited submission competition in which research universities, academic institutions, government, or non-profit institutions, or equivalent from around the globe with a well-established record of scientific excellence are invited to nominate their most promising early-career scientists and their most outstanding senior scientists. The therapeutic focus rotates each year through one of five fields — neuroscience, gastroenterology, rare diseases, oncology, and regenerative medicine. The 2022 focus was gastroenterology, next year the focus will be on oncology. Prize winners are determined by a panel of judges, independently selected by the New York Academy of Sciences, with expertise in these disciplines. The New York Academy of Sciences administers the Award in partnership with Takeda.

Foundation Medicine and Collaborators to Share Scientific Advances at AACR22 Reinforcing the Power of Genomic Testing in Precision Cancer Care

On April 5, 2022 Foundation Medicine, Inc. reported that the company and its collaborators will present a total of nine studies, including two clinical science symposia presentations and seven poster discussions, at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 8-13 (Press release, Foundation Medicine, APR 5, 2022, View Source [SID1234611468]).

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Highlights of these presentations include:

Two studies spotlighting the concordance between Foundation Medicine’s tissue and blood-based comprehensive genomic profiling (CGP) tests and their complementary value as tools to provide genomic insights to researchers and clinicians.
Data on Foundation Medicine’s new algorithm to predict homologous recombination deficiency (HRD) status and identify patients who may be candidates for PARP inhibitors across multiple disease types. Patient identification for PARP inhibitors remains a challenge, but these findings suggest that HRD status, including indel and copy number features, is associated with instability beyond ovarian cancer.
A new study leveraging existing data to identify 165 ancestry-associated features across multiple common cancer types. These findings help address the lack of knowledge about ancestry-specific alterations in an effort to overcome barriers to implementing precision medicine, including inequities in genetic testing, targeted treatment and clinical trial design for cancer patients from underserved populations.
"Data being presented at this year’s AACR (Free AACR Whitepaper) meeting emphasize our role as an essential partner for our collaborators who are working to identify patients most likely to benefit from new precision therapies," said Priti Hegde, PhD, chief scientific officer at Foundation Medicine. "Our research also highlights how the data derived from our portfolio of tests can shape the future of cancer care and research, including through our novel HRD algorithm."

The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at AACR (Free AACR Whitepaper), please visit AACR (Free AACR Whitepaper).org.

Follow Foundation Medicine on Twitter and LinkedIn for more updates from #AACR22 and visit us in person at booth #2301.

Abstract #

Title

Collaborator

Product

Clinical Science Symposia

2139

Monday, April 11

2:35 PM – 2:50 PM

Evaluation of tissue- and plasma-derived tumor mutational burden and genomic alterations of interest from the CheckMate 848 clinical trial

Bristol Myers Squibb

Clinical trial assay based on FoundationOne CDx & Foundation Medicine bTMB Clinical Trial Assay

CT031

Monday, April 11

3:20 PM – 3:30 PM

TALAPRO-1: Talazoparib monotherapy in metastatic castration-resistant prostate cancer (mCRPC) with tumor DNA damage response alterations (DDRm)—Exploration of genomic loss of heterozygosity (gLOH) and potential associations with antitumor activity

Pfizer

Clinical trial assay based on FoundationOne CDx

Posters

57/18

Sunday, April 10

1:30 PM – 5:00 PM

Patients with germline ATM mutations develop clonal hematopoiesis characterized by co-occurrence of multiple somatic ATM alterations

FoundationCore

753/9

Monday, April 11

9:00 AM – 12:30 PM

Comprehensive genomic profiling (CGP) reveals site-specific enrichment of immunotherapy biomarkers and targetable alterations in non-small cell lung cancer (NSCLC) metastasis

FoundationCore

798/7

Monday, April 11

9:00 AM – 12:30 PM

Comprehensive genomic profiling of tissue and liquid biopsies reveals the landscape of reversion mutations

FoundationCore

1166/13

Monday, April 11

9:00 AM – 12:30 PM

Leveraging existing data to identify ancestry-associated features across multiple cancer types

Dana Farber Cancer Institute

FoundationCore

1243/15

Monday, April 11

9:00 AM – 12:30 PM

Identification of aneuploidy biomarkers associated with response to first-line treatment of metastatic pancreatic cancer

Foundation Medicine and Flatiron Health’s Clinicogenomic Database

1249/21

Monday, April 11

9:00 AM – 12:30 PM

Development of a pan-cancer algorithm to predict homologous recombination deficiency and sensitivity to PARPi therapy

University of Minnesota

Foundation Medicine and Flatiron Health’s Clinicogenomic Database & FoundationCore

3413/19

Tuesday, April 12

1:30 PM – 5:00 PM

Clinical utility of circulating tumor DNA sequencing with a large panel: The experience of Gustave Roussy/ National Center for Precision Medicine (PRISM)

Gustave Roussy Cancer Center

FoundationOne Liquid CDx