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

On October 21, 2021 Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, reported its two lead conditional inhibitor programs: an inhibitor of TEAD for the treatment of solid tumors, such as mesothelioma and certain squamous cell carcinomas; and a highly selective inhibitor of CDK2 for the treatment of multiple tumor types, including CDK4/6-resistant breast cancer, ovarian, uterine, stomach, and esophageal cancers (Press release, Cedilla Therapeutics, OCT 21, 2021, View Source [SID1234591709]). Both programs are wholly owned by Cedilla. In addition, Cedilla is pursuing discovery research efforts against a portfolio of high value cancer targets.

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"Over the past three years, we have built an integrated suite of capabilities that enable us to understand the relevant functional states of important yet elusive cancer targets, and identify previously unrecognized small molecule binding sites," said Alexandra Glucksmann, Ph.D., President and Chief Executive Officer of Cedilla Therapeutics. "Today, we are excited to announce our two lead programs from our internal efforts to discover conditional inhibitors: an inhibitor of TEAD and a highly selective inhibitor of CDK2. We look forward to advancing these programs closer to the clinic and creating novel medicines with the potential to deliver profound benefit to patients."

The discovery of both programs was enabled by Cedilla’s novel approach to developing small molecule conditional inhibitors. Cedilla recognizes proteins as dynamic entities, whose function is orchestrated by inter-molecular associations and post-translational tailoring. By accounting for the native full-length protein with relevant post-translational modifications, protein-protein interactions and sub-cellular localization, Cedilla is able to understand proteins in their functional state to discover new ways to access key cancer drivers that have been considered undruggable.

"Since our founding, we have worked to develop a deep understanding of high-value, historically inaccessible targets, and to identify new vulnerabilities that may enable us to drug them more effectively, delivering superior clinical benefit," said Brian Jones, Ph.D., Chief Scientific Officer. "Based on preclinical data, I believe our TEAD and CDK2 programs have clear advantages relative to historical approaches, offering the opportunity for preferential clinical utility, in terms of targeted efficacy or combinability with other therapeutic mechanisms. We look forward to advancing both programs into IND-enabling studies next year."

About Cedilla’s TEAD Program
TEAD (transcriptional enhanced associate domain) is a key component of the Hippo signaling pathway that is aberrantly regulated in solid tumors such as mesothelioma and certain squamous cell carcinomas. TEAD is also increasingly implicated in resistance to targeted therapies, including those for the treatment of EGFR-mutated and KRAS-mutated lung cancer.

Cedilla’s program is designed to inhibit the function of TEAD by preventing a post-translational modification required for full function. The company’s portfolio of TEAD inhibitors encompasses multiple chemotypes with different effects on TEAD isoforms and cofactors, providing Cedilla a range of starting points for selecting a candidate with an optimal profile for effective and combinable TEAD inhibition. Cedilla plans to be conducting investigational new drug (IND) application-enabling studies in the first half of 2022.

About Cedilla’s CDK2 Program
CDK2 (cyclin dependent kinase 2) has been a major target of interest for cancer indications driven by amplification or high levels of Cyclin E, including in roughly half of patients with CDK4/6-resistant breast cancer. In addition, Cyclin E amplification drives genetically defined subsets of ovarian, uterine, stomach and esophageal cancers. The CDK2-Cyclin E cancer node has remained inaccessible due to challenges achieving selectivity over other CDKs (cyclin dependent kinases), particularly CDK1, and Cyclin E isoforms.

Cedilla has developed a unique series of inhibitors that bind to a previously unreported site on the CDK2-Cyclin E complex with unprecedented selectivity, potentially offering a substantial advance over two decades of industry efforts. Preclinical characterization suggests that the exquisite selectivity of Cedilla’s inhibitor could result in a better safety profile compared to traditional kinase inhibitors, particularly with respect to dose-limiting hematological toxicities. Cedilla plans to be conducting IND application-enabling studies in the second half of 2022. In addition, based on its unique insights into Cyclin biology, Cedilla has the potential to pursue additional drug discovery programs against related targets.