On May 31, 2022 Pillar Biosciences, the leader in Decision Medicine, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and overall testing costs, reported that its abstract, "Reducing Pre-analytical Sample QC Failure Rates for Cancer Molecular Genetic Assays with SLIMamp Technology", has been published online in the Journal of Clinical Oncology, in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Pillar Biosciences, MAY 31, 2022, View Source [SID1234615283]). The company will also be showcasing its highly accurate and sensitive NGS genetic testing technology at booth #17157 June 4 through June 6, 2022.

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"There is a critical need for NGS tests that can accurately and rapidly identify somatic variants in cancer patients. Current NGS tests can have high failure rates which delay the return of actionable results to physicians, significantly impacting time to diagnosis and critical treatment decisions," said Randy Pritchard, CEO of Pillar Biosciences. "The findings from our study underscore the accuracy and reliability of our SLIMamp technology and demonstrate its ability to generate highly accurate results from lower quality samples that have failed other NGS tests. We are pleased that this study has been published online and look forward to demonstrating the capabilities of our NGS genetic testing solutions at ASCO (Free ASCO Whitepaper)."

In the study, 48 tumor samples failing one or more pre-analytical quality control (QC) sample parameters for whole exome sequencing (WES) from an accredited diagnostic genomics laboratory were sequenced using Pillar Bioscience’s oncoReveal Solid Tumor Panel. Results demonstrated that the panel achieved high sequencing coverage (>3,000X) for all 48 samples and was able to generate clinical reports for 45 samples (94%). 38 of these reports (79%) contained clinically actionable or significant variants that would not have otherwise been identified with currently available panels. The study showed that oncoReveal Solid Tumor Panel with Pillar Biosciences’ proprietary SLIMamp technology, was able to generate reliable, interpretable results for almost all of the samples that had failed pre-analytical QC for WES.

At booth #17157, Pillar Biosciences will also be featuring the company’s extensive portfolio of NGS genetic testing solutions, including the oncoReveal Dx Lung and Colon Cancer Assay, PillarHS Multi-Cancer Panel, Essential MPN Panel, Multi-Cancer with CNV and RNA Fusion Panel, and Myeloid Panel.

On May 31, 2022 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it will present data at two upcoming scientific congresses this spring: the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 3-7 in Chicago, Ill. and the 30th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), June 9-12 in Vienna, Austria (Press release, Takeda, MAY 31, 2022, View Source [SID1234615282]). Takeda’s latest research in oncology focuses on enhancing and improving patient care while exploring novel approaches for patients with limited treatment options.

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Data presentations span a range of cancers, including lymphoma, leukemia, multiple myeloma and non-small cell lung cancer, including early insights into investigational therapies that leverage the innate immune system.

"Our data at this spring’s medical congresses are indicative of our quest to outsmart cancer and our ability to work collaboratively with partners to further our research capabilities," said Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. "In addition to sharing data on currently approved therapies, we look forward to presenting early findings from our innate immunity clinical programs – many of which are exploring novel mechanisms of action – that we believe have the power to advance the field of oncology and recast current standards of care."

A full list of company-sponsored abstracts are available for ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

On May 31, 2022 Eureka Therapeutics Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat solid tumors, and City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that City of Hope treated the first patient with GPC3-positive advanced hepatocellular carcinoma (HCC), the predominant type of liver cancer, with ECT204, an experimental T cell therapy (Press release, Eureka Therapeutics, MAY 31, 2022, View Source [SID1234615281]). This marks the first-in-human use of GPC3 targeting ARTEMIS T cells for the treatment of HCC.

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Glypican 3 (GPC3) is a promising target for HCC therapies and is found in more than 70% of HCC cells. The GPC3 protein is also expressed in other solid tumors, including ovarian and lung cancer. During the ARYA-3 investigational study evaluating ECT204, a patient’s T cells are collected, engineered to express Eureka’s proprietary ARTEMIS cell receptors targeting GPC3, and infused back into the patient’s body to target and kill GPC3-expressing cancer cells. In January of this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to ECT204 for the treatment of HCC. Additional information about this Phase I/II study may be found at ClinicalTrials.gov using Identifier NCT: NCT04864054.

"First patient dosing of ECT204 is a significant step forward in our commitment to expand the use of T cell therapy into solid tumors," said Dr. Cheng Liu, founder and CEO, Eureka Therapeutics. "ARTEMIS T cells have demonstrated superior tumor infiltration and excellent safety profile in preclinical studies. We look forward to further developing it in the clinical setting to fully unlock the potential of T-cell therapy in solid tumors."

"City of Hope is committed to finding innovative treatments for challenging solid tumors that currently do not have effective medical treatments," said Daneng Li, M.D., co-director of the Neuroendocrine Tumor Program and principal investigator of the ARYA3 trial at City of Hope. "Targeting GPC3 with T cell immunotherapy would be a promising approach to treating advanced liver cancer."

Liver cancer is the fourth leading cause of cancer deaths worldwide, accounting for an estimated 830,000 deaths in 2020. About 41,000 new cases and nearly 31,000 deaths from liver cancer are expected to occur in the U.S. in 2022. According to the American Cancer Society, liver cancer diagnosis has more than tripled since 1980. Patients with advanced HCC have a poor prognosis and limited treatment options.

"Liver cancer patients have very limited treatment options, and more innovative therapies with novel mechanisms of action are desperately needed to bring hope to patients with this challenging diagnosis," Li said. "I look forward to treating more patients with this experimental therapy and seeing data from the study to understand the potential of ECT204."

Patients, caregivers and health care professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com.

On May 31, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application for its lead product candidate, JANX007, a PSMA-TRACTr in development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Janux Therapeutics, MAY 31, 2022, View Source [SID1234615280]). JANX007 is the Company’s lead novel T cell engager (TCE) therapeutic from its TRACTr platform. Janux plans to initiate a Phase 1 clinical trial for JANX007 in the second half of 2022.

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"We are proud to announce today the clearance of Janux’s first IND – a critical milestone for our TRACTr platform and for the Company as we advance a broad pipeline of next generation immunotherapies to address unmet needs and improve the treatment of cancer," said David Campbell, Ph.D., President and CEO of Janux. "JANX007 is uniquely designed to overcome the clinical limitations of existing TCE approaches, potentially providing mCRPC patients a safer therapeutic option, while also generating potent anti-tumor activity by enabling the delivery of a higher concentration of active drug. With this IND acceptance, we are on track to advance JANX007 into the clinic in the second half of this year."

Unlike existing TCE approaches to prostate cancer that have been limited to-date by dose-limiting toxicities, poor pharmacokinetic (PK) profiles and attenuated efficacy, JANX007 is designed as a safer, highly potent anti-tumor approach to mCRPC. In preclinical studies, JANX007 was well tolerated in non-human primates with limited healthy tissue toxicities and cytokine release syndrome and exhibited enhanced safety and PK properties relative to unmasked TCEs. These data along with the superior manufacturability properties of JANX007 support its further development as an attractive mCRPC therapeutic.

On May 31, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the launch of the Twist Human Methylome Panel, a product now available to customers that can advance applications in cancer metastasis, human development and functional genetics (Press release, Twist Bioscience, MAY 31, 2022, View Source [SID1234615279]). The panel can be used to identify a robust, collated set of CpG sites, methylated cytosine and guanine nucleic bases, across the human genome to identify biologically relevant methylation markers. Compared to traditional array based or whole genome bisulfite sequencing approaches, this panel provides overall cost savings while also covering previously unknown methylation markers. The Twist Human Methylome Panel can also be used as a first pass discovery tool to identify methylation biomarkers that can then be used in a variety of applications, such as more targeted liquid biopsy panels.

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The DNA methylome is the comprehensive set of nucleotides within the genome that have a methyl group attached. DNA methylation plays a key role in many biological processes, including cancer. When present on a single nucleotide, a methyl group can alter genetic behavior without changing the DNA sequence. Analyzing the pattern in which methylation occurs within a specific genetic sequence as well as the fraction of the genome that has a methyl group attached (methylated) provides a unique understanding of disease pathology. CpG sites, which often repeat to create CpG islands, turn a gene "on" or "off" and are associated with neurodegeneration, cancer and multiple rare diseases. Detection of CpG islands therefore can inform diagnoses or development stage of multiple diseases.

The Twist Human Methylome Panel is highly targeted to capture and detect the most recently identified and relevant CpG methylation regions in the genome. Twist uses hybrid capture panels to explore the methylome and the content that can be investigated to include 84.2% of CpG islands as well as other CpG sites.

"With the customizable Twist Human Methylome Panel, we are able to cover four times the amount of CpG sites compared to average microarrays. Using our NGS-based panel provides a higher dynamic range, allowing more accurate identification of differentially methylated regions, which we believe will enhance research-based assays and diagnostic tests that incorporate this dynamic tool," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Previously, when identifying methylation markers, researchers had to choose between a low-cost, static option or a very expensive panel that covers a significant portion of the methylome, but often more than needed. As technology progresses, the compromise that researchers need to make between cost and coverage becomes less and less."

"We look forward to expanding our work with Twist as well as extending our epigenomics expertise and offerings to customers by incorporating the Twist Human Methylome Panel into our Epigenomics Profiling Services. This aligns with our efforts to continue offering new solutions to link methylation research with a wide range of disease indications and progression," said Didier Allaer, CEO of Diagenode, a leading epigenomics company and early access customer for the Twist Human Methylome Panel. "The new panel will enable us to offer a solution with broad coverage of the human methylome and to bring epigenetics research to new frontiers of biomarker discovery on clinical samples."

About Twist Human Methylome Panel

The Twist Human Methylome Panel enables the identification and study of methylation biomarkers spanning a wide range of targets and applications. The 123 megabase panel covers 84.2% of CpG island sites contained within the human genome and is optimized with the Twist Methylation workflow for robust end-to-end performance. The high capture efficiency increases the sensitivity of detection and internal data show that the Twist Human Methylome Panel achieves a depth of coverage of 90% of bases at 30x coverage with high probe specificities of 95% on-target rates, as well as high uniformity across the target region.