Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Esophageal Squamous Cell Carcinoma

On April 5, 2022 Agilent Technologies Inc. (NYSE: A) reported it has expanded CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx as an aid in identifying esophageal squamous cell carcinoma patients for treatment with Bristol Myers Squibb’s PD-1-targeted immunotherapeutic OPDIVO (nivolumab), in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO in combination with YERVOY (ipilimumab) (Press release, Agilent, APR 5, 2022, View Source [SID1234611473]). These combined treatments provide new hope for patients diagnosed with these cancers.

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Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region and country.

PD-L1 is a critical biomarker for response to anti-PD-1 therapies, including the immunotherapeutic agent OPDIVO based on the Phase 3 CheckMate-648 trial results. When used in conjunction with PD-L1 IHC 28-8 pharmDx as a companion test, first-line treatment with OPDIVO in combination with chemotherapy or in combination with YERVOY provides PD-1-directed treatment to demonstrate superior overall survival when compared to chemotherapy alone in patients with unresectable advanced, recurrent, or metastatic previously untreated esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥ 1%.

"With the CE marking of expanded use in Europe of our PD-L1 IHC 28-8 pharmDx assay, Agilent enables pathologists the increased capability to identify patients with ESCC for first-line treatment with OPDIVO in combination with chemotherapy or YERVOY (ipilimumab)," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "We greatly value our relationship with Bristol Myers Squibb, and are committed to continuing developing and commercializing market-leading companion diagnostic products."

Agilent is the worldwide leader in partnering with pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy. With the expansion of PD-L1 IHC 28-8 pharmDx, Agilent continues to set the standard and lead with innovation, quality, and ease of implementation—furthering their ongoing commitment to fight cancer and enable new discoveries.

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.