On April 5, 2022 Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported the company will participate in a company presentation at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13th, 2022, at 1:30 p.m. ET/10:30 a.m. PT (Press release, Alpine Immune Sciences, APR 5, 2022, View Source [SID1234611474]).

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Alpine will host a virtual investor event on April 12th, 2022, at 6:30 p.m. ET, to coincide with the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The meeting will commence 30 minutes later than previously announced and will begin at 6:30 p.m. ET.

A live webcast of both events will be available online in the investor relations section of the company’s website at View Source A replay of each presentation will be available on the company website for 90 days following the webcast.

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.

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

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."

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."