On October 21, 2021 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, reported multiple clinical abstracts evaluating the potential use and utility of its novel technology were accepted for presentation during the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting, Oct. 24-27, in Chicago (Press release, RefleXion Medical, OCT 21, 2021, View Source [SID1234591717]). The company will showcase technology from the RefleXion X1 machine in its booth, #1309.

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"Particularly gratifying among our multiple abstracts are oral presentations demonstrating physical validation of biological guidance for delivering radiotherapy to an FDG-avid target and exploring whether novel prostate surface membrane antigen radiotracers hold promise for one day enabling BgRT in prostate cancer," said Shervin ‘Sean’ Shirvani, M.D., M.P.H., chief medical officer at RefleXion. "Also, our earliest clinical adopters are presenting work detailing commissioning of the very first commercial X1 machine, which has delivered hundreds of fractions of conventional radiotherapy, a critical step toward bringing BgRT to the clinic."

The following presentations taking place during ASTRO 2021 evaluate RefleXion’s X1 technology:

Sunday, Oct 24: Radiation and Cancer Physics

1:55 PM 1002 "Feasibility of using FDG in the Stereotactic Ablative Setting for Tracked Dose Delivery with BgRT: Results from a Prospective Study of Serial Inter-Fraction PET/CTs." (Oral Abstract, Room 178 a/b)
4:45 PM 2248 Poster Q&A 02 – Session 02 – "Dosimetric comparison of single-isocenter and multiple-isocenter techniques for two-lesion lung SBRT using the RefleXion high-speed ring-gantry system." (Room W375)
Monday, Oct 25, 11:20 AM: Radiation and Cancer Physics

40 "Physical validation of biology-guided radiotherapy for delivering a tracked dose distribution to a moving PET-avid target." (Oral Abstract, Room 184 a/b/c/d)
Tuesday, Oct 26:

1:30 PM 98 Radiation and Cancer Physics "Evaluation of PSMA-PET biology-guided radiotherapy sequential boost to the dominant intraprostatic lesion in low-volume advanced prostate cancer." (Oral Abstract, Room W185 a/b/c/d)
3:30 PM Poster Q&A 08 – Session 08 – Lung Cancer/Thoracic Malignancies and Palliative Care. (Outside Room 375)
2883 "Disease Burden on FDG-PET Predicts Outcomes for Advanced Non-Small Cell Cancer Patients Treated with First-Line Immunotherapy."
2884 "Characterization of the Entire Metastatic Spectrum for Non-Small Cell Lung Cancer in the Immunotherapy Era."
Wednesday, Oct. 27, 10:30 AM: Poster Q&A 09 – Session 09 – Physics Treatment Techniques and Patient Safety (Outside Room 375)

3067 "First Beam Commissioning Report of a Novel Medical Linear Accelerator Designed for Biologically Guided Radiotherapy."
3069 "Physical Confirmation of Biology-guided Radiotherapy Directed at Static Targets with Varying Shapes and Background Contrast Environments."
3074 "Comparison of a First-in-class LINAC-integrated PET System and a Diagnostic PET/CT Scanner."
3075 "Initial Evaluation of Biology-guided Radiotherapy (BgRT) Plans Generated Using PET Acquired on the First Installation of Reflexion X1 System."
3115 "The kVCT System Commissioning of a Novel Medical Linear Accelerator Designed for Biology-guided Radiotherapy."
3138 "Utilizing Biology-guided Radiotherapy for Coronary Artery Avoidance During Free-breathing External Beam Radiation Delivery."

On October 21, 2021 Biognosys, a leading inventor and developer of mass spectrometry-based proteomics solutions, reported they will be presenting major scientific and technological advances on their proprietary proteomics research services, software, and kits at the American Society for Mass Spectrometry (ASMS) Annual Conference from October 31st to November 4th in Philadelphia (USA) (Press release, Biognosys, OCT 21, 2021, View Source [SID1234591715]).

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Biognosys will present a record number of 3 oral presentations, 10 scientific posters, 2 poster collaborations, 1 workshop panel, and 2 Spectronaut breakfast seminars. In addition, their team of scientific experts will be present at booth #224 to answer questions and demo software. Further demo sessions will be offered at the Bruker Daltonics booth #719.

Collectively, this presence demonstrates Biognosys’ significant contributions to transforming life science and clinical research with next-generation proteomics, particularly in the areas of plasma proteomics, immunopeptidomics, and proteomics data analysis.

Lukas Reiter, PhD, Chief Technology Officer of Biognosys:
"Our major contribution to the ASMS scientific program is a testimony of Biognosys’ relentless commitment to innovation in mass spectrometry-based proteomics and progress in life science and clinical research."

Discovering biomarkers in cancer with next-generation plasma proteomics

The plasma proteome is an underexplored source of insights on the health state of an individual. Biognosys will present results from a deep human plasma profiling study on a cohort of 180 lung, breast, colorectal, pancreatic, and prostate cancer patients, using an early version of their next-generation Plasma Biomarker Discovery workflow, launching in November. The workflow is optimized for use on Thermo Fisher Scientific Exploris 480 and FAIMS Pro instruments. Out of the entire plasma proteome, they quantified over 2,700 proteins and identified a protein panel with a significant positive predictive value for individual cancer stages.

Andreas Huhmer, Senior Director Life Sciences Research OMICS Marketing at Thermo Fisher Scientific:
"Biognosys has a proven track record for maximizing all innovative features of the Thermo Scientific Orbitrap mass spectrometers in state-of-the-art proteome analysis. Their new Plasma Biomarker Discovery workflow is a good example of this. The unprecedented depth and quantitative precision they can achieve, coupled with the inherently unbiased nature of mass spectrometry-based analysis, has the potential to take plasma biomarker discovery to the next level."

Gaining insights on the immune system to support personalized drug development

Immunopeptides play an essential role in the immune system and can be analyzed to support the development of personalized treatments. Mass spectrometry is currently the only technology that can reliably measure and identify immunopeptide profiles of biological samples on a large scale. Biognosys will present their immunopeptidomics workflow, optimized to provide deep and comprehensive biological insights on the immune system in large-scale clinical studies.

Turning data to insights with Spectronaut, SpectroMine, and SpectroDive

Biognosys provides leading software products for proteomics data analysis. In a series of talks, their team will detail how they leverage the latest developments in Machine Learning and Deep Learning to allow deeper insights into the proteome. Biognosys is also excited to host two breakfast seminars with three guest speakers sharing their latest results from using Spectronaut in their research projects. In addition, a sneak-peak into the next planned release will be disclosed.

Gary Kruppa, Vice President, Proteomics at Bruker Daltonics:
"Biognosys’ software tools are among the top solutions for the analysis of proteomics data generated with Bruker instruments. Particularly the latest Spectronaut version yields spectacular performance improvements for dia-PASEF data. We invite all Bruker users to experience Spectronaut’s capabilities and enjoy the exceptional support Biognosys provides."

Visit biognosys.com/asms2021 for a complete overview of Biognosys’ presence at ASMS.

On October 21, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its third quarter 2021 financial results before the market opens on Thursday, November 4, 2021 (Press release, Personalis, OCT 21, 2021, View Source [SID1234591713]). In conjunction with the release, the company will host a conference call and webcast that day at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 7896264. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On October 21, 2021 Agilent Technologies Inc. (NYSE: A) reported it has received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers (Press release, Agilent, OCT 21, 2021, View Source [SID1234591711]).

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"The added indication of PD-L1 IHC 28-8 pharmDx will give physicians in Europe important information to inform first-line treatment decisions for patients with these common and potentially deadly cancers"

Gastric (stomach) cancer is the fifth most common cancer and the fourth leading cause of cancer death worldwide, with over 1,000,000 new cases and approximately 770,000 deaths in 2020.1 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. 1 Together with cancers of the gastroesophageal junction, they constitute an important – and growing – global health concern.

PD-L1 is a critical biomarker for response to anti-PD-1 therapies, including the immunotherapeutic agent OPDIVO (nivolumab). When used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, treatment with Opdivo in combination with chemotherapy provides the first and only PD-1-directed treatment to demonstrate superior overall survival (OS) and progression-free survival (PFS) when compared to chemotherapy alone in patients with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

"The added indication of PD-L1 IHC 28-8 pharmDx will give physicians in Europe important information to inform first-line treatment decisions for patients with these common and potentially deadly cancers," said Sam Raha, president of the Agilent’s Diagnostics and Genomics Group. "Agilent values opportunities such as this to partner with pharmaceutical companies in the development of clinically relevant IHC-based or NGS-based diagnostics that enhance confidence in targeted cancer therapy."

This approval builds on Agilent’s previous successes in expanding the applicability of PD-L1 IHC tests and marks the latest milestone in their ongoing commitment to drug/diagnostic co-development.

On October 21, 2021 PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported plans to present new updates on its pipeline during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 11-14, 2021 (Press release, PharmaEssentia, OCT 21, 2021, View Source [SID1234591710]).

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"Since we initiated the study in the U.S. earlier this year, we have heard from clinicians outside the U.S. who are eager to consider a new investigational option to support their ET patients. We are pleased to partner with these renowned MPN specialists to participate in this important study."

During the meeting, the company will provide an update on SURPASS ET, a Phase 3 pivotal clinical trial of its investigational ropeginterferon alfa-2b (P1101), a novel mono-pegylated proline interferon under evaluation for the treatment of essential thrombocythemia (ET). PharmaEssentia continues to enroll participants in the trial at sites throughout the United States and Asia, and has now expanded with new sites in Canada.

"People diagnosed with a myeloproliferative neoplasm (MPN), and particularly those with ET, have limited therapeutic options that can help them manage the progressive effects of the disease, so through this study, we will evaluate whether our mono-pegylated interferon could represent a useful alternative to currently available options," said Raymond Urbanski, M.D., Ph.D., U.S. Head of Clinical Development and Medical Affairs. "Since we initiated the study in the U.S. earlier this year, we have heard from clinicians outside the U.S. who are eager to consider a new investigational option to support their ET patients. We are pleased to partner with these renowned MPN specialists to participate in this important study."

The SURPASS ET open-label, randomized, active-controlled study is comparing the efficacy, safety, and tolerability and pharmacokinetics of P1101 as second line therapy for ET as compared with anagrelide, a commonly used oral platelet-reduction therapy. The study aims to enroll approximately 160 patients, who will be randomized to receive either P1101 subcutaneously every two weeks or anagrelide at a standard dose. Eligible patients include high-risk ET patients, those who are resistant to or intolerant of hydroxyurea and who have not received prior therapy with interferon.

The primary efficacy endpoint for the study employs the modified European Leukemia Net (ELN) criteria. Secondary efficacy endpoints include time to and durability of response, response rates based on hematologic parameters and symptomatic improvements. Changes in CALR, MPL, and JAK2 allelic burden over time is also being investigated. Topline data are expected by late 2022. More details on the study design and sites are available at www.clinicaltrials.gov (NCT04285086) or at www.SURPASSET.com.

PharmaEssentia continues to build momentum with its pipeline to deliver new solutions in MPNs. The company is seeking approval for its first indication in polycythemia vera (PV) in the U.S. and expects a decision by the U.S. Food and Drug Administration (FDA) in November 2021.

About Ropeginterferon alfa-2b

Ropeginterferon alfa-2b is a long-acting, mono-pegylated proline interferon aimed to be administered once every two weeks or longer. Ropeginterferon alfa-2b has Orphan Drug designation for treatment of polycythemia vera (PV) in the United States. Marketed as Besremi in Europe, the product was approved by the European Medicines Agency (EMA) in 2019. Ropeginterferon alfa-2b was discovered and is manufactured by PharmaEssentia in its Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018.

About Essential Thrombocythemia

Essential thrombocythemia (ET) is a myeloproliferative neoplasm (MPN) characterized by an overproduction of platelets in the blood that results from a genetic mutation; data indicates a JAK2 gene mutation is present in approximately half of diagnosed patients. ET is estimated to affect up to 57 per 100,000 people in the U.S. The disease is most commonly diagnosed through routine blood work, and is most common in people over the age of 50, with women 1.5 more times more likely to be diagnosed than men. As a chronic, progressive disease, ET requires regular monitoring and appropriate treatment. Over time, the disease may progress into more deadly conditions such as myelofibrosis or acute leukemia.1,2